Publications
by Tim Sandle
Publications
by Tim Sandle
This
page lists all of my major publications.
Note:
some of the listed publications are available as reprints free of charge, for
others a nominal reprint charge is required ($25). Please email me if you would
like a copy of any of the papers or chapters listed (timsandle@btinternet.com or tim.sandle@bpl.co.uk)
Books
Saghee, M.R., Sandle, T. and Tidswell,
E.C. (Eds.) (2011): Microbiology and
Sterility Assurance in Pharmaceuticals and Medical Devices, New Delhi :
Business Horizons
Sandle, T. (2011): Two extremes? Flexible working in Europe: A study of differences in
Flexible Working Time between two European Plasma Fractionators in Britain and
the Netherlands, Saarbrucken: VDM Publishing, IBSN 978-3-639-34965-8
Sandle,
T. (2012). The CDC Handbook: A Guide to
Cleaning and Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey,
UK (2nd edition published in 2016)
Sandle,
T. (2012). Pharmaceutical Microbiology
Glossary, Microbiology Solutions: UK (Kindle only eBook ASIN: B0092G1246)
Sandle,
T. (2012). E-Guide to Cleanrooms,
Microbiology Solutions: UK (Kindle only eBook ASIN: B009IXFJ92)
Sandle,
T. and Saghee, M.R. (2013). Cleanroom Management in Pharmaceuticals and Healthcare, Euromed
Communications: Passfield, UK
Second
edition:
Sandle,
T. and Saghee, M. R. (Eds) Cleanroom
Management in Pharmaceuticals and Healthcare, 2nd Edition, Euromed
Communications, Passfield, U.K. (2017)
Sandle,
T. (2013) Sterility Testing of
Pharmaceutical Products, PDA / DHI, River Grove, IL, USA
Sandle,
T. (2013). Sterility, Sterilisation and
Sterility Assurance for Pharmaceuticals: Technology, Validation and Current
Regulations, Woodhead Publishing Ltd.: Cambridge, UK (ISBN 1 907568 38 7)
Sandle,
T. (2014) Data Review and Analysis for
Pharmaceutical Microbiology, Microbiology Solutions, UK. ISBN 9781492235217
Sandle, T. and Vijayakumar, R. (2014) Cleanroom Microbiology,
DHI/PDA: Bethesda, MD, USA, ISBN:
1933722843
Hanlon. G. and Sandle, T. (Eds.) (2015) Industrial Pharmaceutical Microbiology: Standards and Controls, Euromed
Communications: Passfield, UK
Sandle, T. (2016) Pharmaceutical Microbiology: Essentials for
Quality Assurance and Quality Control, Woodhead Publishing, Cambridge, UK
Sandle,
T. (2016). The CDC Handbook: A Guide to
Cleaning and Disinfecting Cleanrooms, 2nd Edition, Grosvenor House
Publishing: Surrey, UK
Sandle,
T. (2016) Introducing Cleanrooms,
Microbiology Solutions: USA, ISBN: 978-1533-16078
Sandle, T. (2016) Risk Assessment and Management for
Healthcare Manufacturing: Practical Tips and Case Studies, PDA / DHI,
Bethesda, MD, USA.
Sandle,
T. (2017) Sterilization: Establishing the
Process, PDA/DHI, River Grove, Il, USA.
Sandle,
T. (2017) Sterilization: Practical
Approaches, PDA/DHI, River Grove, Il, USA
Chesca, A., Cengiz, M. and Sandle, T. (Eds.) Theory and Practice of Disease Diagnosis,
LAP LAMBERT Academic Publishing, Germany, ISBN-13: 978-3330084384
Sandle,
T. and Tidswell, E. C. (Eds.) (2017) Aseptic
and Sterile Processing: Control, Compliance and Future Trends, DHI/PDA, Bethesda, MD, USA, ISBN:
9781942911128
Booklets
and monographs
Sandle, T. and Boschi, F. (2006): ‘Environmental Monitoring Handbook’,
Advanstar, Duluth, USA (HBEM06). Published in July 2006 (http://www.industrymatter.com/environmentalmonitoringhandbook.aspx)
Sandle, T. (editor) (2010): ‘Current Perspectives on Environmental
Monitoring: Pharmig Review Number 1’, Published by Pharmaceutical
Microbiology Interest Group, UK. ISBN 978-0-9560804-1-7
Sandle, T., Saghee, M.R. and Ramstrop,
M. (2010): Environmental Monitoring and Cleanrooms, IDMA-APA Guideline, Technical Monograph No.5, Indian Drug
Manufacturers Association, Mumbai
Sandle,
T. (2011). Polls Apart? Flexible working
in the European Pharmaceutical Sector, Microbiology Solutions: UK (Kindle only
eBook ASIN: B0090RIK6K)
Roberts, J. and Sandle, T. (2011). A Guide to Microbiology Laboratories in the
Pharmaceutical Industry. Pharmaceutical Microbiology Interest Group,
Pharmig: Stanstead Abbotts, UK
Upton,
A. and Sandle, T. (2012). Best Practices
for the Bacterial Endotoxin Test: A Guide to the LAL Assay, Pharmaceutical
Microbiology Interest Group: Stanstead Abbotts, UK
Sandle,
T. (2016) Guide to cleanroom operation and contamination control,
Pharmaceutical Microbiology Interest Group: Stanstead Abbotts, UK (ISBN: 978-0-9560804-6-2)
Blount,
R., Gaurdi, L., Morwood, K. and Sandle, T. (2017) Pharmig Guide to Disifectants and their us in the pharmaceutical
industry, Pharmig, Stanstead Abbotts, UK
Sandle,
T. (2017) Pharmig Guide to Cleanroom Operation
and Contamination Control, Pharmig, Stanstead Abbotts, UK
Contributor to:
IVT
(2017) Utility Qualification Vol. II, Institute of Validation Technology, USA:
- Biodecontamination
of Cleanrooms and Laboratories Using Gassing Systems - Tim Sandle
- Validation
and Assessment of Computerized System Software in a Pharmaceutical
Facility - Tim Sandle
- Risk
Consideration for Aging Pharmaceutical Facilities - Tim Sandle
- Microbiological
Assessment of Compressed Gases in Pharmaceutical Facilities - Tim Sandle
- Sanitization
of Pharmaceutical Facilities - Tim Sandle
- The Rouging
Effect in Pharmaceutical Water Systems: Causes and Strategies for
Prevention - Tim Sandle
- Control of
WFI and Clean Steam Systems for Bacterial Endotoxins - Tim Sandle
- Ensuring
Sterility: Autoclaves, Wet Loads, and Sterility Failures - Tim Sandle
Book
chapters
Sandle,
T. ‘Selection and use of cleaning and disinfection agents in pharmaceutical
manufacturing’ in Hodges, N and Hanlon, G. (2003): Industrial Pharmaceutical Microbiology Standards and Controls,
Euromed Communications, England (chapter revised on several occasions)
Sandle,
T. ‘Best practices for microbiological documentation’ in Hodges, N and Hanlon,
G. (2009): Industrial Pharmaceutical
Microbiology Standards and Controls, Euromed Communications, England,
Supplement 9, S9.1 – S9.24
Sandle, T. (2010): Best practices in
microbiology laboratory training in Hodges, N. and Hanlon, G. Industrial
Pharmaceutical Microbiology: Standards and Controls, Supplement 11, ppS11.1 to S11.16
Sandle, T. (2010): 'The Media Kitchen: Preparation and Testing of
Microbiological Culture Media' in
Sutton, S. (ed.): Laboratory Design: Establishing the Facility and
Management Structure, Parenteral Drug Association, Bethesda, MD, United States, ISBN
1-933722-46-0, pp269-293
Sandle,
T. and Saghee, M. R. (2011): ‘The Essentials of Pharmaceutical Microbiology’,
in Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in
Pharmaceuticals and Medical Devices, New Delhi: Business Horizons, pp1-30
Sandle,
T. (2011): ‘Selection of Microbiological Culture Media and Testing Regimes’ in
Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and Medical
Devices, New Delhi: Business Horizons, pp101-120
Sandle,
T. (2011): ‘Practical Approaches to Sterility Testing’ in Saghee, M.R., Sandle,
T. and Tidswell, E.C. (Eds.) (2011): Microbiology
and Sterility Assurance in Pharmaceuticals and Medical Devices, New Delhi:
Business Horizons, pp173-192
Vina,
P., Rubio, S. and Sandle, T. (2011): ‘Selection and Validation of
Disinfectants’, in Saghee, M.R., Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in
Pharmaceuticals and Medical Devices, New Delhi: Business Horizons, pp219-236
Sandle,
T. (2011): ‘Environmental Monitoring’ in Saghee, M.R., Sandle, T. and Tidswell,
E.C. (Eds.) (2011): Microbiology and
Sterility Assurance in Pharmaceuticals and Medical Devices, New Delhi:
Business Horizons, pp293-326
Ashtekar,
D. and Sandle, T. (2011): ‘Microbial Content Testing of Pharmaceutical and
Biotechnologically Derived Products’ in Saghee, M.R., Sandle, T. and Tidswell,
E.C. (Eds.) (2011): Microbiology and
Sterility Assurance in Pharmaceuticals and Medical Devices, New Delhi:
Business Horizons, pp327-362
Sandle,
T. (2011): ‘Risk Management in Pharmaceutical Microbiology’ in Saghee, M.R.,
Sandle, T. and Tidswell, E.C. (Eds.) (2011): Microbiology and Sterility Assurance in Pharmaceuticals and Medical
Devices, New Delhi: Business Horizons, pp553-588
Sandle,
T. (2011). ‘Assessment of Culture Media in Pharmaceutical Microbiology' in
Hodges, N and Hanlon, G. (2011 rev.): Industrial
Pharmaceutical Microbiology Standards and Controls, Euromed
Communications, England, Supplement 10
Sandle,
T. and Lamba, S. S. "Effectively Incorporating Quality Risk Management
into Quality Systems". In Saghee, M.R. (2012) Achieving Quality and Compliance Excellence in Pharmaceuticals: A Master Class GMP Guide, New Delhi:
Business Horizons, pp89-128
Sandle,
T. (2012). "Qualification and Validation". In Saghee, M.R. (2012) Achieving Quality and Compliance Excellence
in Pharmaceuticals: A Master Class GMP
Guide, New Delhi: Business Horizons, pp169-206
Sandle,
T. and Saghee, M.R. (2012). "Compliance Aspects of Sterile Manufacturing".
In Saghee, M.R. (2012) Achieving Quality and Compliance Excellence in
Pharmaceuticals: A Master Class GMP
Guide, New Delhi: Business Horizons, pp517-560
Sandle,
T. (2012). ‘Environmental Monitoring: a practical approach’ In Moldenhauer, J. Environmental Monitoring: a comprehensive
handbook, Volume 6, PDA/DHI: River Grove, USA, pp29-54
Sandle,
T. (2012). ‘Introduction’. In Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and Disinfecting Cleanrooms,
Grosvenor House Publishing: Surrey, UK, ppxv-xxi
Sandle,
T. (2012). ‘Cleaning and Disinfection’. In Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and
Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, pp1-31
Sandle,
T. (2012). ‘Application of Disinfectants and Detergents in the Pharmaceutical
Sector’. In Sandle, T. (2012). The CDC
Handbook: A Guide to Cleaning and Disinfecting Cleanrooms, Grosvenor House
Publishing: Surrey, UK, pp168-197
Sandle,
T. (2012). ‘Validation of Disinfectants’. In Sandle, T. (2012). The CDC Handbook: A Guide to Cleaning and
Disinfecting Cleanrooms, Grosvenor House Publishing: Surrey, UK, pp241-261
Sandle,
T. (2013) Risk Management in Sterile Environments. In Thomas, P. (Ed.) Aseptic Manufacturing - a road map to
excellence, Pharmaceutical Manufacturing, USA, pp3-9 (http://www.pharmamanufacturing.com/assets/wp_downloads/pdf/dpt.pdf)
Sandle,
T. and Saghee, M.R. (2013). ‘Introduction’. In: Sandle, T. and Saghee, M.R. Cleanroom Management in Pharmaceuticals and
Healthcare, Euromed Communications: Passfield, UK
(revised
for second edition: pp1-6)
Sandle,
T. (2013). ‘History and development of cleanrooms’. In: Sandle, T. and Saghee,
M.R. Cleanroom Management in
Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK
(revised
for second edition: pp7-24)
Sandle,
T. and Saghee, M.R. (2013). ‘Cleanroom certification and ongoing compliance’.
In: Sandle, T. and Saghee, M.R. Cleanroom
Management in Pharmaceuticals and Healthcare, Euromed Communications:
Passfield, UK
(revised
for second edition: pp155-170)
Midcalf,
B, Neiger, J. and Sandle, T. (2013). ‘Fundamentals of pharmaceutical isolators’.
In: Sandle, T. and Saghee, M.R. Cleanroom
Management in Pharmaceuticals and Healthcare, Euromed Communications:
Passfield, UK
(revised
for second edition: pp171-212)
Sandle,
T., Budini, M. and Rajesh, T. (2013). ‘Airflow studies and airflow mapping’.
In: Sandle, T. and Saghee, M.R. Cleanroom
Management in Pharmaceuticals and Healthcare, Euromed Communications:
Passfield, UK
(revised for second edition: pp361-376)
Sandle,
T. and Saghee, M.R. (2013). ‘Environmental monitoring in cleanrooms’. In:
Sandle, T. and Saghee, M.R. Cleanroom
Management in Pharmaceuticals and Healthcare, Euromed Communications:
Passfield, UK
(revised for second edition: pp401-432)
Sandle,
T. and Saghee, M.R. (2013). ‘Cleaning and disinfection practices’. In: Sandle,
T. and Saghee, M.R. Cleanroom Management in
Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK
(revised for second edition: pp433-464)
Sandle,
T. and Saghee, M.R. (2013). ‘Auditing cleanroom operations’. In: Sandle, T. and
Saghee, M.R. Cleanroom Management in
Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK
(revised for second edition: pp553-568)
Sandle,
T. and Saghee, M.R. (2013). ‘Developments in cleanroom technology’. In: Sandle,
T. and Saghee, M.R. Cleanroom Management
in Pharmaceuticals and Healthcare, Euromed Communications: Passfield, UK
(revised for second edition: pp569-581)
Sandle,
T. (2013). 'Dimorph and Filamentous Fungi'. In Mascellino, M. T. (Ed.) Bacterial and Mycotic Infections in
Immunocompromised Hosts: Clinical and Microbiological Aspects, OMICS Group
Inc.: Henderson, NV, USA. In print: http://esciencecentral.org/ebooks/bacterial-mycotic-infections/pdf/dimorph-filamentous-fungi.pdf
Sandle,
T. (2013). Contamination Control Risk Assessment in Masden, R.E. and
Moldenhauer, J. (Eds.) Contamination
Control in Healthcare Product Manufacturing, Volume 1, DHI Publishing,
River Grove: USA, pp423-474
Sandle,
T. (2013). Contamination Control: Cleanrooms and Clean Air
Devices,
Encyclopedia of Pharmaceutical Science
and Technology, Fourth Edition, Taylor and Francis: London, pp634 - 643
(http://dx.doi.org/10.1081/E-EPT4-120050223)
Sandle,
T. (2013). Microbial Control of Pharmaceuticals, Encyclopedia of Pharmaceutical Science and Technology, Fourth
Edition, Taylor and Francis: London, pp2122-2132 (http://dx.doi.org/10.1081/E-EPT4-120050301)
Sandle,
T. and Saghee, M.R. (2013). Basic Concepts of GMP Requirements. In Saghee, M.R.
(Ed.) Pharmaceutical Regulatory
Inspections, Euromed Communications: Passfield, UK, pp1-76
Barr,
D. and Sandle, T. (2013). System Based Approach to Inspections. In Saghee, M.R.
(Ed.) Pharmaceutical Regulatory
Inspections, Euromed Communications: Passfield, UK, pp119-182
Brutsche,
A. and Sandle, T. (2013). Preparing and Management of International
Inspections. In Saghee, M.R. (Ed.) Pharmaceutical
Regulatory Inspections, Euromed Communications: Passfield, UK, pp285-328
Sandle,
T., Saghee, M.R. and Barr, D. (2013). Handling and Responding to Post
Inspection Observations. In Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Communications:
Passfield, UK, pp329-360
Sandle,
T. (2013). Preparing for Regulatory Inspections of Sterile Facilities: the
Focal Points. In Saghee, M.R. (Ed.) Pharmaceutical
Regulatory Inspections, Euromed Communications: Passfield, UK, pp361-462
Sandle,
T. (2014). ‘Microbial Identification: Laboratory Techniques and Methods. In
Chesca, A. (Ed.) Methods for Diseases:
Diagnostic with Applicability in Practice, Lambert Academic Publishing,
Germany, pp15-26
Sandle,
T. and Saghee, M.R. (2014) Basic concepts of global GMP requirements. In
Saghee, M.R. (Ed.) Pharmaceutical
Regulatory Inspections, Euromed Publications, Passfield, UK, pp1-76
Barr,
D. and Sandle, T. (2014) System based approach to GMP inspections. In Saghee,
M.R. (Ed.) Pharmaceutical Regulatory
Inspections, Euromed Publications, Passfield, UK, pp119-182
Brutsche,
A. and Sandle, T. (2014) Handling and responding to post inspectional
observations. In Saghee, M.R. (Ed.) Pharmaceutical
Regulatory Inspections, Euromed Publications, Passfield, UK, pp285-328
Sandle,
T., Saghee, M.R. and Barr, D. (2014) Handling and responding to post
inspectional observations. In Saghee, M.R. (Ed.) Pharmaceutical Regulatory Inspections, Euromed Publications,
Passfield, UK, pp329-360
Sandle,
T. (2014) Preparing for regulatory inspections of sterile facilities: the focal
points. In Saghee, M.R. (Ed.) Pharmaceutical
Regulatory Inspections, Euromed Publications, Passfield, UK, pp361-462
Sandle,
T., 2014. Biochemical and Modern Identification Techniques: Enterobacteriaceae,
Coliforms, and Escherichia Coli. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, 2nd
edition, vol 1. Elsevier Ltd, Academic Press, pp. 232–237
Sandle,
T., 2014. Biochemical and Modern Identification Techniques: Food-Poisoning
Microorganisms. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, 2nd edition, vol 1.
Elsevier Ltd, Academic Press, pp. 238–243
Sandle,
T., 2014. Laboratory Design. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, vol
2. Elsevier Ltd, Academic Press, pp. 393–401
Sandle,
T., 2014. Fungi: Classification of the Peronosporomycetes. In: Batt, C.A.,
Tortorello, M.L. (Eds.), Encyclopedia of
Food Microbiology, vol 2. Elsevier Ltd, Academic Press, pp. 44–53
Sandle,
T., 2014. Trichoderma. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food Microbiology, vol
3. Elsevier Ltd, Academic Press, pp. 644–646
Sandle,
T. (2014) Bacterial Diseases and their Diagnosis. In Chesca, A. (Ed.) Techniques and Procedures for Disease
Diagnostic, Lambert Academic Publishing, Saarbruken, Germany, pp31-60
Sandle,
T. (2014) Best Practices in Microbiology Laboratory Training. In Handlon, G.
and Sandle, T. (Eds.) Industrial
Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 2.1-2.24
Sandle,
T. (2014) The Use of Culture Media in Pharmaceutical Microbiology. In Handlon,
G. and Sandle, T. (Eds.) Industrial
Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 3.1–3.26
Sandle,
T. (2014) Selection and use of Cleaning and Disinfection Agents in
Pharmaceutical Manufacturing. In Handlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology:
Standards & Controls, Euromed Communications, Passfield, UK, 9.1–9.32
Sandle,
T. (2014) Microbiology of Pharmaceutical Grade Water. In Handlon, G. and
Sandle, T. (Eds.) Industrial
Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 10.1–10.19
Sandle,
T. (2014) Biological Indicators, In Handlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology:
Standards & Controls, Euromed Communications, Passfield, UK, 16.1–16.26
Sandle,
T. (2014) Containment System Integrity: Microbial Challenges for Sterile
Products. In Handlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 18.1–18.13
Sandle,
T. (2014) The Regulatory Control and Quality Assurance of Immunological
Products. In Handlon, G. and Sandle, T. (Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 22.1–22.14
Sandle, T. (2015) Cleanroom Design. In Moldenhauer, J. (Ed.) Environmental Monitoring: a Comprehensive
Handbook, Volume 7, pp3-28
Sandle,
T. (2015) Bacterial Endotoxin Testing using the Limulus Amebocyte Lysate Assay.
In KÅszegi, T. and Chesca, A. (Eds.) Laboratory
Techniques with Applicability in Medical Practice, Lambert Academic
Publishing, pp19-32
Sandle,
T. (2015) Investigating Sterility Test Failures. In McCullough, K.Z. and
Moldenhauer, J. (Eds.) Microbial Risks
and Investigations, DHI/PDA, River Grove, USA, pp261-290
Sandle,
T. (2015) Contamination Control Risk Assessment. In McCullough, K.Z. and
Moldenhauer, J. (Eds.) Microbial Risks
and Investigations, DHI/PDA, River Grove, USA, pp783-836
Contributor
to Masden, R. E. and Jornitz, M. W. (2015) Lessons of Failure: When things go
wrong in pharmaceutical manufacturing, PDA/ DHI Books, Bethesda, MD, USA
Sandle, T. (2016) Antibiotic / Antimicrobial
Resistance. In Boslaugh, S. (Ed.) The
Sage Encyclopedia of Pharmacology and Society, Volume 1, Sage Publications:
Los Angeles, pp136-139
Sandle, T. (2016) Antimalarials. In Boslaugh, S. (Ed.)
The Sage Encyclopedia of Pharmacology and
Society, Volume 1, Sage Publications: Los Angeles, pp190-192
Sandle, T. (2016) Drug-Resistant Diseases. In
Boslaugh, S. (Ed.) The Sage Encyclopedia
of Pharmacology and Society, Volume 2, Sage Publications: Los Angeles,
pp546-550
Sandle, T. (2016) European Medicines Agency. In
Boslaugh, S. (Ed.) The Sage Encyclopedia
of Pharmacology and Society, Volume 2, Sage Publications: Los Angeles,
pp593-596
Sandle, T. (2016) Lyme Disease. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and
Society, Volume 2, Sage Publications: Los Angeles, pp842-844
Sandle, T. (2016) Medicines and Healthcare Products
Regulatory Agency (UK). In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 2, Sage
Publications: Los Angeles, pp899-902
Sandle, T. (2016) National Institute For Biological
Standards and Control. In Boslaugh, S. (Ed.) The Sage Encyclopedia of Pharmacology and Society, Volume 3, Sage
Publications: Los Angeles, pp948-950
Sandle, T. (2016) Smallpox Eradication. In Boslaugh,
S. (Ed.) The Sage Encyclopedia of
Pharmacology and Society, Volume 3, Sage Publications: Los Angeles,
pp1298-1301
Sandle, T. (2016) U.S. Pharmacopeial Convention. In
Boslaugh, S. (Ed.) The Sage Encyclopedia
of Pharmacology and Society, Volume 4, Sage Publications: Los Angeles,
pp1503-1505
Sandle,
T, (2016) Tests for Antimicrobial Effectiveness, Chesca, A. and Cengiz, M.
(Eds.) Theory and Practice for Medical
Diagnosis, Lambert Academic Publishing, Germany, pp7-19
Sandle,
T. (2016) ISO 14644 Parts 1 and 2 - The revised cleanroom standard and
contamination control. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare Product
Manufacturing, Volume 4, DHI, River Grove, USA, pp3-32
Sandle,
T. (2016) Risk of microbial spores, prevention measures and disinfection
strategies. In Madsen, R. E. and Moldenhaurer, J. (Eds.) Contamination Control in Healthcare Product Manufacturing, Volume
4, DHI, River Grove, USA, pp59-95
Sandle,
T. (2016) Disinfectants in the Pharmaceutical Industry. In Cardoso, A. S.,
Almeida, C. M. M., Cordeiro, T. C. and
Gaffney, V.J. (Eds.) Disinfectants: Properties, Applications and
Effectiveness, Nova Science Publishers, New York, pp109-142
Sandle,
T. (2017) Clean room design principles: Focus on particulates and microbials.
In Esteves, S. C., Varghese, A. C., and Worrilow, K. C. (Eds.) Clean Room Technology in ART Clinics: A
Practical Guide, CRC Press, Boca Raton, U.S., pp75-91
Hallworth,
M., Sahee, M.R. and Sandle, T. (2017) Cleanroom standards and GMP requirements.
In Sandle, T. and Saghee, M. R. (Eds.) Cleanroom
management in pharmaceuticals and healthcare, 2nd edition, Euromed
Communications, Passfield, UK, Cleanroom standards and GMP requirements, pp25-44
Sandle,
T. (2017) Bow Street Runners. In Robertiello, G. (Ed.) In The Use and Abuse of Police Power in America: Historical Milestones
and Current Controversies, ABC-CLIO Books, U.S., pp13-15
Sandle,
T. (2017) Southern Slave Patrols. In Robertiello, G. (Ed.) In The Use and Abuse of Police Power in
America: Historical Milestones and Current Controversies, ABC-CLIO Books,
U.S., pp15-17
Sandle, T. (2017) Environmental Control and Environmental Monitoring in
Support of Aseptic Processing. In Sandle, T. and Tidswell, E. C. (Eds.) Aseptic and Sterile Processing: Control,
Compliance and Future Trends, DHI/PDA, Bethesda,
MD, USA, ISBN: 9781942911128, pp447-540
Sandle, T. (2017) The Sterility Test: Current Practice and Future
Applications. In Sandle,
T. and Tidswell, E. C. (Eds.) Aseptic and
Sterile Processing: Control, Compliance and Future Trends, DHI/PDA, Bethesda, MD, USA, ISBN:
9781942911128, 645-702
Papers
in peer reviewed journals
Sandle,
T. The use of a risk assessment in the pharmaceutical industry – the application of FMEA to a sterility
testing isolator: a case study, European Journal of Parenteral and
Pharmaceutical Sciences, 2003; 8(2): 43-49
Sandle,
T. Practical Approaches to Sterility Testing, Journal of Validation
Technology, Vol. 10, No.2, 2004, pp131 – 141
Sandle,
T. ‘Gram’s Stain: History and Explanation of the Fundamental Technique of Determinative
Bacteriology’, IST Science and Technology Journal, April 2004 (No.
54), pp3-4
Sandle,
T. An Approach for the Reporting of Microbiological Results from Water Systems, PDA
Journal of Pharmaceutical Science and Technology, Vol. 58, No.4,
July-August 2004, pp231 – 237 (Pub Med http://www.ncbi.nlm.nih.gov/pubmed/22293526)
Sandle,
T. and Skinner, K. Examination of
the optimal cultural conditions for the microbiological analysis of a cold
demineralised water system in a pharmaceutical manufacturing facility, European
Journal of Parenteral and Pharmaceutical Sciences, Vol. 10, No.1, 2005,
pp9-14
Sandle,
T. Understanding Clean Air Devices, Science Technology Journal,
April 2005, pp3 – 5
Sandle,
T. Environmental Monitoring Risk Assessment, Journal of GXP Compliance, Volume
10, Number 2, 2006, pp54-73 (Link: http://www.gxpandjvt.com/ivtnews/templates/templateblank.aspx?articleid=1444&zoneid=18)
Sandle,
T. The use of polymeric flooring to reduce contamination in a cleanroom
changing area, European Journal of Parenteral and Pharmaceutical
Sciences, Vol. 11, No.3, 2006, pp75-80 [1]
Sandle,
T. Selection of Laboratory Disinfectants: Part One’, Science Technology
Journal, Institute of Science Technology, Summer 2006, pp16-18
Sandle,
T. Selection of Laboratory Disinfectants: Part Two, Science Technology
Journal, Institute of Science Technology, Spring 2007, pp5-7
Tours,
N. and Sandle, T. Comparison of dry-heat depyrogenation using three different
types of Gram-negative bacterial endotoxin, European Journal of
Parenteral and Pharmaceutical Sciences, Volume 13, No.1, 2008, pp17-20
Sandle,
T. A method to determine the effect of dehydration on agar plates and microbial
recovery, The Institute of Science and Technology Journal, Spring
2008, pp24-27
Sandle,
T. The assessment of air -cleanliness in cleanrooms and cleanzones using
optical particle counters, The Journal, Institute of Science and
Technology, Winter 2009, pp4-7
Sandle,
T. ‘Selection of Active Air-Samplers’, The
Journal, Institute of Science and Technology, Summer 2010, pp25-31
Note: A version of the paper was included
on the BioSciences Quality Testing Forum (BioQT) website: http://www.bioqtforum.com/Selection-of-active-air-samplers
(accessed 15th September 2010)
Sandle, T. 'Selection of active air
samplers', European Journal of Parenteral and
Pharmaceutical Sciences,
Vol. 15, No.4, 2010, pp119-124
Note: The EJPPS paper is different to
the paper on air-samplers published in The Journal (both 2010).
Sandle, T. (2011): 'Selection of active
air samplers', Clean Air and Containment
Review, Issue 5, pp8-10
[Note: The paper is an alternate version of
the one published in the EJPPS, 2010]
Sandle, T. (2011): 'History and development of
microbiological culture media', The Journal (Institute of
Science and Technology), Winter 2010-2011, pp10-14
Sandle, T. (2011): 'Microbial recovery on settle
plates in unidirectional airflow cabinets', Clean
Air and Containment Review, Issue 6, pp8-10
Sandle, T. (2011). A
study of a new type of swab for the environmental monitoring of isolators and
cleanrooms (the Heipha ICR-Swab), European Journal of Pharenteral
and Pharmaceutical Sciences, Vol. 16, No.2, pp42-48
Sandle, T.
(2011): ‘A Review of Cleanroom Microflora: Types, Trends, and Patterns’, PDA Journal of Pharmaceutical Science and
Technology, Vol. 65, No. 4, July–August 2011, pp392-403 (Pub Med: http://www.ncbi.nlm.nih.gov/pubmed/22293526)Sandle, T. and Saghee, M. R. (2011): Some considerations for the implementation of disposable technology and single-use systems in biopharmaceuticals, Journal of Commercial Biotechnology, Vol. 17, No. 4: 319–329 doi: 10.1057/jcb.2011.21 (view here: http://www.palgrave-journals.com/jcb/journal/vaop/ncurrent/abs/jcb201121a.html)
Sandle, T. (2011): "A Practical
Approach to Depyrogenation Studies using Bacterial Endotoxin", Journal
of GXP Compliance,
Autumn 2011, electronic
version: http://www.ivtnetwork.com/gxp-journal/journal-of-gxp-compliance-2687
Sandle,
T. (2011): ‘Evaluation of two different types of contact plates for
microbiological environmental monitoring’, European
Journal of Parenteral and Pharmaceutical Sciences, Vol. 16, No.4, pp116-120
Sandle,
T. (2012). "Real-time counting of airborne particles and microorganisms: a
new technological wave?", Clean Air
and Containment Review, Issue 9, pp4-6
Sandle, T. (2012): Sterility Test Failure Investigations, Journal
of GxP Compliance, Vol. 16, No.1, electronic version: http://www.ivtnetwork.com/gxp-journal/journal-of-gxp-compliance-2011
Sandle,
T. (2012). Microbiological control and monitoring of cleanrooms: Revised USP
<1116> chapter, Clean Air and
Containment Review, Issue 11, pp22-23
Vijayakumar, R.,
Sandle, T. and Manoharan, C. (2012). “A review of fungal contamination in
pharmaceutical products and phenotypic identification of contaminants by
conventional methods”, European Journal of Parenteral and Pharmaceutical
Sciences, Vol. 17, No.1: 4-19
Sandle, T. and Saghee, M.R. (2012). Application of Sterilization
by Gamma Radiation for Single-Use Disposable Technologies in the
Biopharmaceutical Sector, Journal
of GXP Compliance, Spring 2012, Vol. 16, Issue 2, electronic journal: http://www.ivtnetwork.com/gxp-journal/journal-of-gxp-compliance-2010
Sandle,
T. (2012). “A new wave of sporicidal disinfectants”, Clean Air and Containment Review, Issue 10, pp10-13
Sandle,
T. (2012). “Isolators in international GMP guidelines”, Clean Air and Containment Review, Issue 10, pp21-23
Vijayakumar, R., Kannan, V.V., Sandle, T., and Manoharan,
C. (2012). In vitro Antifungal Efficacy of Biguanides and Quaternary Ammonium
Compounds against Cleanroom Fungal Isolates, PDA Journal of Pharmaceutical Science and Technology, May/June 2012,
Vol. 66, No. 3: 236-242
Sandle,
T. (2012). Examination of air and surface particulate levels from cleanroom
mats and polymeric flooring, European
Journal of Parenteral and Pharmaceutical Sciences 2012; 17(3): 110-11
Sandle,
T. (2012). Speedier automated microbial methods for environmental monitoring of
cleanrooms, Clean Air and Containment
Review, Issue 12.
Sandle,
T. (2012). Application of Quality Risk Management To Set Viable Environmental
Monitoring Frequencies in Biotechnology Processing and Support Areas, PDA Journal of Pharmaceutical Science and
Technology, Vol. 66, No. 6, November–December 2012: 560 - 579
Sandle,
T. (2012). Container Closures for Pharmaceutical Preparations: A review of
Design and Test Considerations, BioPharm
International, Vol. 25, No. 12, pp32-36
Sandle,
T., Leavy, C. and Needham, G. (2012). A Risk Matrix Approach for Media
Simulation Trials, Journal of Validation
Technology, Vol. 18, No.4, pp70-78
Sandle,
T. and Tours, N. (2013). Validation and
Operation of a Sterility Testing Isolator: a Study Proposal, Journal of validation Technology, Vol.
19, No.1, on-line edition available at: http://www.ivtnetwork.com/article/peer-reviewed-validation-and-operation-sterility-testing-isolator-study-proposal
Sandle,
T. and Skinner, K. (2013). Study of psychrophilic and psychrotolerant
microorganisms isolated in cold rooms used for pharmaceutical processing, Journal of Applied Microbiology, 114 (4),
1166—1174
Sandle,
T. (2013). In situ study of particles generated from the use of pharmaceutical
grade cleanroom wipes, European Journal
of Parenteral and Pharmaceutical Sciences, Vol. 18, No.1, pp5-11
Sandle,
T. (2013). Revision of ISO 14698 - Biocontamination control: Personal
reflections on what might be desirable, Clean
Air and Containment Review, Issue 14, pp20-21
Republished in Pharmig News: Sandle, T. (2013). ISO
14968 – biocontamination control standard revision, Pharmig News Number 51, pp6-8
Sandle,
T. (2013). Bacterial Adhesion: an Introduction, Journal of Validation
Technology, Volume 19, Issue 2, June 2013, on-line: http://www.ivtnetwork.com/article/bacterial-adhesion-introduction
Tim
Sandle, Kerry Skinner, Jennifer Sandle, Barbara Gebala, Pavitra Kothandaraman
(2013): Evaluation of the GEN III OmniLog® ID System microbial identification
system for the profiling of cleanroom bacteria, European Journal of Parenteral & Pharmaceutical Sciences 18(2):
44-50
Sandle,
T., Skinner, K. and Yeandle, E. (2013). Optimal conditions for the recovery of
bioburden from pharmaceutical processes: a case study, European Journal of Parenteral and Pharmaceutical Sciences, 18 (3):
84-91
Gebala,
B. and Sandle, T. (2013). Comparison of different fungal agar for the
environmental monitoring of pharmaceutical-grade cleanrooms, PDA J Pharm Sci Technol.;67(6):621-33
Sandle,
T. (2013). Pharaohs and Mummies: Diseases of Ancient Egypt and Modern Approaches,
Journal of Ancient Diseases &
Preventive Remedies, 1 (4): e110. doi: 10.4172/2329-8731.1000e110
Sandle,
T. (2013). Global Strategies for Elimination of Leprosy: A Review of Current
Progress, Journal of Ancient Diseases
& Preventive Remedies, 1 (4): e112. doi: 10.4172/2329-8731.1000e112
Sandle T (2014) Novel Methods to Address Antimicrobial
Resistance. SOJ Microbiol Infect Dis
2(1): 2-3 (see here: http://symbiosisonlinepublishing.com/microbiology-infectiousdiseases/microbiology-infectiousdiseases11.pdf)
Sandle,
T. (2014) Variations in the Resistance of Biological Indicators Used to Assess
Sterilization, Journal of Validation Compliance, Vol. 20, Issue 1, Mar 2014
(at: http://www.ivtnetwork.com/printpdf/article/variations-resistance-biological-indicators-used-assess-sterilization)
Sandle,
T. (2014) Examination of the Order of Incubation for the Recovery of Bacteria
and Fungi from Pharmaceutical Cleanrooms, International
Journal of Pharmaceutical Compounding, 18 (3): 242 – 247
Sandle,
T., Banenko, D., Lavrinenko, A., Azizov, I. and Chesca, A. (2014) The current
state of PCR approach in detection and identification of carbapanem hydrolysis
Ī²-lactamases genes, European Journal of
Parenteral and Pharmaceutical Sciences, 19 (1): 153-164
Sandle, T., Leavy, C., Jindal, H. and Rhodes, R.
(2014) Application of rapid microbiological methods for the risk assessment of
controlled biopharmaceutical environments, Journal of Applied Microbiology,
116 (6): 1495-1505
Chesca, A., Sandle, T. and Gyurka, G.A.
(2014) Study on the incidence of certain neoplastic diseases, Acta Medica Transilvanica, 2 (2): 168 –
172Sandle, T. (2014) Approaching the Selection of Rapid Microbiological Methods, Journal of Validation Technology, Vol. 20, Issue 2, Jun 2014. Published on-line: http://www.ivtnetwork.com/article/approaching-selection-rapid-microbiological-methods
Sandle,
T. (2014) The Lean Laboratory and Its Application for the Review of
Environmental Monitoring Samples, Journal
of Validation Technology, Vol. 20, Issue 2, Jun 2014. Published on-line
http://www.ivtnetwork.com/article/lean-laboratory-and-its-application-review-environmental-monitoring-samples
Sandle,
T. (2014) The Test for Sterility of Medicinal Products, International Journal
of Microbiology and Allied Sciences, 1 (1): 1-9 (at:
http://www.ijomas.com/wp-content/uploads/2014/08/Editorial1-Issue1.pdf)
Sandle, T. (2014) Sterile Ophthalmic Preparations
and Contamination Control, Journal
of GXP Compliance, 18 (3):
1-5
Sandle, T. (2014) Sanitation of Pharmaceutical
Facilities, Journal of GXP
Compliance, 18 (3): 6-10
Chesca, A. and Sandle, T. (2014) Functional Lung Disease, Acta Medica Transilvanica, 2 (3): 42-44
Sandle, T. (2014) The Possible Origins of Tuberculosis in
South America, Journal of
Ancient Diseases & Preventive Remedies, 2 (2): 1-2
Sandle, T. (2014) Santitization of Pharmaceutical Facilities, Journal of GXP Compliance, 18 (3): pp1-5
Chesca,
A. and Sandle, T. (2014) Data on the examination of functions in pulmonary
disease, Acta Medica Transilvanica, 2
(3): 208 – 210
Sandle, T. (2014) Good Documentation Practice, Journal of Validation Technology, Vol.
20, Issue 3, pp1-11
Sandle,
T., Vijayakumar, R., Saleh Al Aboody, M. and Saravanakumar, S. (2014) In vitro fungicidal activity of biocides
against pharmaceutical environmental fungal isolates, Journal of Applied Microbiology, 117 (5): 1267 – 1273
Sandle,
T. (2014) Assessment of the suitability of R3A agar for the subculture of
microorganisms isolated from pharmaceutical water systems, European Journal of Parenteral and Pharmaceutical Sciences, 19 (3):
85-94
Sandle, T. (2014)
Emergence of New Antibiotics, J J
Microbiol Pathol., 1(1): 001
Sandle, T. (2014) Applying spectrophotometric
monitoring to risk assessments in biopharmaceutical cleanrooms, Clean Air and Containment Review,
Issue 20, pp22-25
Sandle, T. (2014) The Antibiotic Crisis and the Need for
New Forms of Antibiotics, EC Microbiology,
1 (1): 1-3
Sandle,
T., Azizov, I., Babenko, D., Lavrinenko, A., Chesca, A. (2014) Comparative
Evaluation of Traditional Susceptibility Testing for MRSA with the PCR Approach,
Advances in Microbiology, 4,
1204-1211 http://dx.doi.org/10.4236/aim.2014.416130
Sandle,
T. (2014) People in Cleanrooms: Understanding and Monitoring the Personnel
Factor, Journal of GXP Compliance, 18
(4): 1-5
Sandle,
T. (2015) Dracunculiasis and the Long Decline of an Ancient Disease, Journal of Ancient Diseases & Preventive
Remedies, 2 (3): 1-2
Sandle,
T., Vijayakumar, R. , Saleh A Aboody, M. and Saravanakumar, S. (2015) In vitro
fungicidal activity of biocides against pharmaceutical environmental fungal
isolates: a response to the Letter of Rout and Humphreys (2015), Journal of Applied Microbiology, 118,
779-780
Sandle,
T., Leavy, C. and Rhodes, R. (2015) Assessing airborne contamination using a
novel rapid microbiological method, European
Journal of Parenteral & Pharmaceutical Sciences, 19(4): 131-142
Sandle,
T. (2015) Teixobactin: A New Class of Antibiotic, SOJ Microbiology & Infectious Diseases, 3 (1): 1-2 (http://symbiosisonlinepublishing.com/microbiology-infectiousdiseases/microbiology-infectiousdiseases28.pdf)
Sandle,
T., Gyurka, G.A. and Chesca, A. (2015) Medical conditions regarding heart
failure, ACTA Medica Transilvanica, 20(1):39-41
Sandle,
T. (2015) Exhuming Skeletal Remains: How Cholera Deaths of the Past Could Shine
a Blue Light of Hope, Journal of Ancient
Diseases & Preventive Remedies, 3 (1):
http://dx.doi.org/10.4172/2329-8731.1000e121
Sandle,
T. (2015) The Rouging Effect in Pharmaceutical Water Systems: Causes and
Strategies for Prevention, Journal of GXP Compliance, Vol. 19, Issue 1, Mar
2015: http://www.ivtnetwork.com/article/rouging-effect-pharmaceutical-water-systems-causes-and-strategies-prevention
Sandle,
T. (2015) Assessing Non-endotoxin Microbial Pyrogens in Relation in
Pharmaceutical Processing, Journal of GXP Compliance, Vol. 19, Issue 1, Mar
2015: http://www.ivtnetwork.com/article/assessing-non-endotoxin-microbial-pyrogens-relation-pharmaceutical-processing
Sandle,
T. (2015): Aseptic Transfer Risk Assessment: A Case Study, Journal of Validation Technology, 21(1): 1-10 Online: http://www.ivtnetwork.com/article/aseptic-transfer-risk-assessment-case-study
Sandle,
T. (2015): Risk Considerations for
Installation of a New Autoclave in a Pharmaceutical Manufacturing Facility, Journal of Validation Technology, 21(1):
1-10 Online: http://www.ivtnetwork.com/article/risk-considerations-installation-new-autoclave-pharmaceutical-manufacturing-facility
Sandle,
T. “Human Microbiome of the Skin: Advances in Metagenomics”. EC Microbiology 1.3 (2015): 162-165.
Sandle,
T. “From Head to Toe: Mapping Fungi across Human Skin”. EC Microbiology 2.1 (2015): 211-213
Sandle,
T. (2015) Towards a Rapid Sterility Test?, Microbial
& Biochemical Technology, 7 (4): 216-217 doi:10.4172/1948-5948.1000209
Sandle,
T. (2015) Ensuring Sterility: Autoclaves, Wet Loads, and Sterility Failures, Journal of GXP Compliance, 19 (2):
1-10 http://www.ivtnetwork.com/article/ensuring-sterility-autoclaves-wet-loads-and-sterility-failures
Chesca,
A., Gyurka, A., and Sandle, T. (2015) Data concerning the incidence of
respiratory pathology in different seasonal periods, Archives of the Balkan Medical Union, 50 (2): 208-212
Sandle,
T. (2015) Settle plate exposure under unidirectional airflow and the effect of
weight loss upon microbial growth, European
Journal of Parenteral & Pharmaceutical Sciences 2015; 20(2): XX
Sandle,
T. (2015) Incidences and Treatments for Buruli Ulcer, Journal of Ancient Diseases &
Sandle, T. (2015) Characterizing the Microbiota of a
Pharmaceutical Water System-A Metadata Study, SOJ
Microbiology & Infectious Diseases, 3 (2): 1-8
Chesca,
A., Sandle, T., Babenko, D. and Azzov, I. (2015) Structural aspects regarding
surgical pathology of children, Annals of
the Romanian Society for Cell Biology, 14 (9): 65-69 doi:
10.ANN/RSCB-2015-0024:RSCB
CheÅcÄ,
A., Luculescu, M.C., Sandle, T. (2015) Considerations of melanocytic nevi in
children, Annals of the Romanian Society
for Cell Biology, 19 (2): 19 - 22 doi: 10.ANN/RSCB-2015-0001:RSCB
Antonella
CheÅcÄ, Tim Sandle, Dmitriy Babenko (2015) Ethical and Legal Aspects of
Mediation and the Involvement of Mediators in Conflicts Solution, Journal Plus Education, 12 (A): 14-19
Sandle,
T. (2015) Settle plate exposure under unidirectional airflow and the effect of
weight loss upon microbial growth, European
Journal of Parenteral & Pharmaceutical Sciences, 2015; 20 (2): 45-50
Sandle,
T. (2015) FDA Signals a New Approach for Analytical Method Validation, Journal of Validation Technology, 21
(2): 1-5
Also published in IVT
Network Analytical Method Validation Vol.
IV, 2017
Sandle,
T. (2015) Assessing Process Hold Times for Microbial Risks: Bioburden and
Endotoxin, Journal of GXP Compliance,
Vol. 19, Issue 3, Oct 2015, pp1-9
Sandle,
T. (2015) Microbiological Assessment of Compressed Gases in Pharmaceutical
Facilities, Journal of Validation
Technology, Vol. 21, Issue 2, August 2015, pp1-8
Vijayakumar,
R., Saleh Al-Aboody, M. and Sandle, T. (2015) A review of melanized (black)
fungal contamination in pharmaceutical products—incidence, drug recall and control
measures, Journal of Applied Microbiology,
120(4): 831-841
Accepted
Article: doi:10.1111/jam.12888
Sandle,
T. (2015) Advances in Rapid Pathogen Detection, Journal of Microbiology & Experimentation, 2 (5): 00063. DOI:
10.15406/jmen.2015.02.00063
Sandle,
T. (2015) Microbiological Identification with MALDI-TOF MS, Journal of Validation Technology, 21
(3): 1-10 at: http://www.ivtnetwork.com/article/microbiological-identification-maldi-tof-ms
Sandle,
T. and Satyada, R. (2015) Assessment of the disinfection of impaction air sampler
heads using 70% IPA, as part of cleanroom environmental monitoring, European Journal of Parenteral and
Pharmaceutical Science, 20 (3): 94-99
Sandle,
T. (2015) Approaching Microbiological Method Validation, Journal of GXP Compliance, 19 (4): 1-15
Also published in IVT
Network Analytical Method Validation Vol.
IV, 2017
Sandle,
T. (2015) Searching for Antimicrobials in the Unlikeliest of Places, J Pharm Microbiol, 1 (1): 1-3
Chesca,
A., Sandle, T., Babenko, D. and Azizov, A. (2015) Structural issues of the tegument regions adjacent to the melanocytic nevi, Annals of the Romanian Society for Cell Biology, 20 (1): 7-10
Sandle,
T. (2016) Risk-Based Approach to Internal Quality Auditing, Journal of Validation Technology, 22
(1): 1-10
Sandle,
T. (2016) Bacteriophages offer an Antimicrobial Solution, Journal of Microbiology & Experimentation, 3 (1): 1-2 (DOI:
10.15406/jmen.2016.03.00077)
Sandle,
T. and Satyada, R. (2016) Determination of the cleaning efficiency for glassware
in the pharmaceutical microbiology laboratory, European Journal of Parenteral and Pharmaceutical Sciences, 21 (1):
20- 28
Chesca,
A., Chesca, S.A., Sandle, T., Babenko, D., and Azizov, I. (2016) Alzheimer's
Medical Considerations, Archives of the
Balkan Medical Union, 51 (1): 90-93
CheÅcÄ
A., CheÅcÄ S. A., Sandle T. (2016) Medical data regarding functional
exploration in lung pathology, Clinical
Medicine, 78 (1): 67-71
Sandle,
T. and Satyada, R. (2016) Determination of the cleaning efficiency for glassware
in the pharmaceutical microbiology laboratory, European Journal of Parenteral & Pharmaceutical Sciences;
21(1): 16-22
Vijayakumar,
R., Al-Aboody, M. S., AlFonaisan, M. K., Sandle, T. (2016) In vitro
susceptibility of multidrug resistant Pseudomonas
aeruginosa clinical isolates to common biocides, International Journal of Research in Pharmaceutical Sciences, 7
(1): 110-116
Babenko,
D., Amirbekova, Z., Turmuhambetova, A., Sandle, T. and Chesca, A. (2016) In
silico comparison serotyping and genotyping methods for Chlamydia trachomatis, Annals of Romanian Society for Cell Biology,
Vol. XX, Issue 2, 2016, pp. 1 – 4
Akhmaltdinova, L.L., Azizov, I., Sandle, T., Gyurka, A.G. and
Chessca, A. (2016) Use of flow cytometry for the evaluation of disinfectant
effectiveness, Archives of the
Balkan Medical Union, 51 (2): 213-215
Sandle, T. (2016) Risk Assessment for
Intervention Scoring in Relation to Aseptic Processing, Journal of Validation Technology, 22 (2): 1-10
Sandle, T. (2016) Risk Consideration for Aging
Pharmaceutical Facilities, Journal of
Validation Technology, 22 (2): 11-20
Sandle
T. The Importance of Water Activity for Risk Assessing Pharmaceutical Products,
J Pharm Microbiol. 2016, 2 (1): 1-2
CheÅcÄ
A., Sandle T., Gyurka G. (2016) A. Medical considerations regarding chronic
obstructive pulmonary disease, Medicine
and Ecology, 79 (2): 91-94
Gyurka
A. G., CheÅcÄ S. A., Sandle T. (2016) Statistical study on cardiopulmonary
diseases, Medicine and Ecology, 79
(2): 95-98
Sandle,
T. (2016) Designing Aseptic Process Simulations: The Time and Container Number
Conundrum, Journal of GxP Compliance, 20 (3): 1-12
Lavrinenko,
A., Tishkambayevi, Y., Serbo, Y., Shambilova, N., Azizov, I., Sandle, T.,
Gyurka, A. and Chesca, A. (2016) Prevalence of urinary Tract Infections in
Pregnant Women, Archives of the Balkan
Medical Union, 15 (3): 307-310
Sandle,
T. (2016) Control of WFI and Clean Steam Systems for Bacterial Endotoxins, Journal of GxP Compliance, 20 (4): 1-15
Babenko,
A., Turmuhambetova, A., Sandle, T. and Chesca, A. (2016) In silico comparison
of molecular typing methods for characterization of Staphylococcus aureus, Acta Medica Mediterranea, 32: 1021-1027
Vijayakumar,
R., Al- Aboody, M. S., AlFonaisan, M. K., Alturaiki, W., Mickymaray, S.,
Premanathan, M., Alsagaby, S. A. and Sandle, T. (2016) Determination of minimum
inhibitory concentrations of common biocides to multidrug-resistant
gram-negative bacteria, Applied Medical
Research, 2 (3): 56-62 (DOI: 10.5455/amr.20161012082036)
Babenko, D., Omarkulov, B., Azizov, I., Sandle, T., Moraru, D. and
Chesca, A. (2016) Evaluation of sequence based typing methods (SPA and MSLT)
for clonal characterization of Staphylococcus
aureus, Acta Medica Mediterranea, 32: 1851-1856
Sandle,
T. (2016) Data Integrity Considerations for the Pharmaceutical Microbiology
Laboratory, Journal of GXP Compliance, 20 (6): 1-12
Chescha, A., Sandle, T. and Gyurka, G. A. (2016) Considerations on
the structures involved in the control of transmission mechanism mediated of
calcium pulses, Annals of The
Romanian Society for Cell Biology, 21 (1): 1-6
CheÅcÄ A., CheÅcÄ S. A., Sandle T. (2016) An approach on chronic
obstructive pulmonary disease, Medicine
and Ecology, 80 (3): 116-119
CheÅcÄ A., Ciomeica A., Sandle T. Structural aspects on pathologic
appendix versus normal appendix, Medicine
and Ecology, 80 (3): 120-123
Sandle, T. (2017) Biodecontamination of
Cleanrooms and Laboratories Using Gassing Systems, Journal of GxP Compliance, 21 (1): 1-12 - http://www.ivtnetwork.com/article/biodecontamination-cleanrooms-and-laboratories-using-gassing-systems
Vijayakumar, R., Al- Aboody, M.S., Alturaiki, W.
and Sandle, T. (2017) Review on endotoxin mediated toxic anterior segment
syndrome (TASS) in ophthalmic products- Outbreaks, product recall and testing
limits, European Journal of Parenteral
and Pharmaceutical Science, 22 (1): 20-25
Chesca, A. and Sandle, T. (2017) Structural aspects of tonsillitis, Medicine and Ecology, 82 (1): 112-114
Chesca, A. and Sandle, T. (2017) A new approach related to
structural aspects of pathological appendix versus normal appendix, Medicine and Ecology, 82 (1): 115-118
Sandle, T. (2017) Santitization of Pharmaceutical Facilities, IVT Special Edition Utility Qualification
Volume II, pp56-62
Sandle, T. (2017) Validation and Assessment of Computerized System
Software in a Pharmaceutical Facility, IVT
Special Edition Utility Qualification Volume II, pp13-20
Babenko,
D., Turmuhambetova, A., Sandle, T., Pestrea, A.A., Moraru, D. and Chesca, A.
(2017) In silica comparison of
different types of MLVA with PFGE based on Pseudomonas
aeruginosa genomes, Acta Medica
Mediterranea, 33: 607-612
Vijayakumar,
R., Al-Aboody, M.S., Alturaiki, W., Suliman A. Alsagaby, S.A., Sandle, T.
(2017) A study of airborne fungal allergens in sandstorm dust in Al-Zulfi,
central region of Saudi Arabia, Journal of Environmental and Occupational
Science, 6 (1): 27-33 (DOI: 10.5455/jeos.20170120094512)
Sandle,
T. (2017) Design and control of pharmaceutical water systems to minimize
microbial contamination, Pharmaceutical
Engineering, 37 (4): 44-48
Akhayeva,
A., Azizov, I., Kenzhetayeva, T., Zhupenova, D., Sandle, T., Gyurka, A. G.,
Pestrea, S.A. and Chesca, A. (2017) Diagnostic value of IL-6 for community
acquired pneumonia in children, Archives of the Balkan Medical Union, 52 (2):
11-14
Sandle,
T. (2017) Design and Control of Pharmaceutical Water Systems to Minimize
Microbiological Contamination, Pharmaceutical
Engineering, 37 (4): 44-48
Sandle,
T. (2017) Pharmaceutical Microbiology: Current and Future Challenges, Journal of GxP Compliance, 21 (4): 1- 5:
http://www.ivtnetwork.com/article/pharmaceutical-microbiology-current-and-future-challenges
Sandle,
T. (2017) Matrix Approach for the Qualification of a Pharmaceutical Facility
Autoclave, Journal of GxP Compliance,
21 (4): 1- 10: http://www.ivtnetwork.com/article/matrix-approach-qualification-pharmaceutical-facility-autoclave
Sandle,
T. (2017) Microbial Identification strategy for pharmaceutical microbiology, Journal of GxP Compliance, 21 (4):
11-20: http://www.ivtnetwork.com/article/microbial-identification-strategy-pharmaceutical-microbiology
University
courses
Sandle,
T. Environmental Monitoring Module for University of Manchester School of
Pharmacy PMAT MSc course (100,000 word module divided into nine units). First
edition: 2007; revised 2011 and in 2013
Sandle,
T. Sterility and Sterility Assurance Module for University of Manchester School
of Pharmacy PMAT MSc course. Written in 2013.
Sandle,
T. Introduction to Pharmaceutical Microbiology for University of Manchester
School of Pharmacy PMAT MSc course. Written in 2013.
Tim
Sandle is the tutor for each of the above courses.
Training materials
Training
CDs produced for Pharmig (Pharmaceutical Microbiology Interest Group):
Sandle,
T. and Alexander, B. (2011). Electronic Pack 1: Best Practices in
Microbiological Documentation, Pharmaceutical
Microbiology Interest Group, Pharmig: Stanstead Abbotts, UK
Sandle,
T. and Alexander, B. Electronic Pack 2: Setting up and managing an effective
training programme in the microbiology laboratory, Pharmaceutical Microbiology Interest Group, Pharmig: Stanstead
Abbotts, UK
Technical
articles
Sandle, T. Environmental Monitoring in a Sterility
Testing Isolator, PharMIG Newsletter No.1, March 2000
Sandle,
T. Microbiology Web-sites - A Survey, Institute of Science Technology
Journal, July 2000
Sandle,
T. Microbiological Culture Media: Designing a Testing Scheme, PharMIG News No.2,
August 2000
Sandle,
T. Performance characteristics of Automated LAL Tests, PharMIG News No.
4, April 2001
Sandle,
T. Repeatability and Precision - Necessary Factors in Standard Testing?, PharMIG
News, No.5, August 2001
Sandle,
T. Conference Report: 2001, PharMIG News No. 7, December 2001
Sandle,
T. LAL Test Method - Which Technique?, PharMIG News No.10,
October 2002
Sandle,
T. Particle Monitoring and Control, Pharmaceutical Manufacturing and
Packaging Sourcer, Spring 2003, pp8-11(extract http://www.samedanltd.com/magazine/15/issue/82/article/1854)
Sandle,
T. The Changing Role of the Pharmaceutical Microbiologist, PharMIG News,
Issue 12, June 2003
Sandle,
T. Cleanroom Monitoring – What, Where and How Often?, PharMIG News,
Issue 13, September 2003, pp9 – 12
Sandle,
T. General Considerations for the Risk Assessment of Isolators used for Aseptic
Processes, Pharmaceutical Manufacturing and Packaging Sourcer,
Samedan Ltd, Winter 2004, pp43-47 (extract http://www.samedanltd.com/magazine/15/issue/60/article/1367)
Sandle,
T. 50 Years of Providing the Lifeblood of the Nation, Around Radlett:
The Newsletter of Aldenham Parish Council, No. 63, Spring 2004, p5
Sandle,
T. ‘Review of Current Approaches for the Validation of Disinfectants’, PharMIG
News, No. 15, March / April 2004, pp10-15
Sandle,
T. Fifty Years of Continuous Achievement: The History of the Bio Products
Laboratory (BPL), Internal BPL Publication, April 2004 (limited
print run: 1, 500 copies)
Sandle,
T. Three Aspects of LAL Testing: Glucans, Depyropgenation and Water System
Qualification. PharMIG News No. 16. June / July 2004, pp3-12
Sandle,
T. A Golden Jubilee: BPL at 50, Circulation, August 2004, NationalBlood Service Magazine, p8
Sandle,
T. Training within the Microbiology Laboratory, PharMIG News,
Issue 17, October 2004, pp3-6
Sandle,
T. Notable Scientists Who Worked Locally, Around Radlett: The
Newsletter of Aldenham Parish Council, No. 66, Christmas 2004, p6
Sandle,
T. Microbiological Environmental Monitoring in Clean Areas: Using Risk
Assessment, Pharmaceutical Manufacturing and Packaging Sourcer,
Winter 2004, pp105-107
Sandle,
T. Gram’s Stain: History and Explanation of the Fundament Technique of
Determinative Bacteriology, PharMIG News, Issue 18, January 2005,
pp5-6
Sandle,
T. Book ending surface sampling –
In Defence of Swabs, PharMIG News, Issue 19, April 2005, pp8-9
Sandle, T. ‘Keeping It
Clean’, Circulation, National Blood Service, August 2005, p10
Sandle, T. A
Microbiological Risk Assessment Case Study, PharMIG News, Issue 20,
July 2005, pp6-9
Sandle, T. Some
Reflections on Trend Analysis, PharMIG News, Issue 21, October
2005, pp12-15
Sandle, T. Active
Air Sampling – The Selection Process Made Easy, Pharmaceutical
Manufacturing and Packaging Sourcer, Winter 2005, pp30-33
Sandle,
T. Constructing an Environmental Monitoring Programme: Part 1,PharMIG News,
Issue 22, February 2006, pp2-6
Sandle,
T. A final floor show for bugs’, Cleanroom Technology, April 2006, 12 (4):
19-21
Sandle,
T. Constructing an Environmental Monitoring Programme: Part 2,PharMIG News,
Issue 23, May 2006, pp2-7
Sandle,
T. Evaluation of two different types of contact plate, PharMIG News,
Issue 24, pp4-7
Sandle,
T. Micro Management: Monitoring the Cleanroom Environment,Pharmaceutical
Manufacturing and Packaging Sourcer, Autumn 2006, pp64-66
Sandle,
T. Use of Risk Assessment to Assess Environmental Monitoring Data: Part
One, PharMIG News, Issue 25, pp8-11
Skinner,
K. and Sandle, T. (2006): How Effective are Swabs? An Examination of Swab
Recovery, PharMIG News, Issue 25, pp4-5
Ross,
S. and Sandle, T. (2007): Air Pattern Analysis of a Filtration Transfer,PharMIG
News, Issue 26, pp3-4
Sandle,
T. Use of Risk Assessment to Assess Environmental Monitoring Data: Part
Two, PharMIG News, Issue 26, 2007, pp9-15
Sandle,
T. Use of Risk Assessment to Assess Environmental Monitoring Data: Part
Three, PharMIG News, Issue 27, pp7-13
Sandle,
T. A Breath of Fresh Air: the validation of active air sampling, Pharmaceutical
Manufacturing and Packaging Sourcer, Summer 2007, pp8-12 (extract: http://www.samedanltd.com/magazine/15/issue/82/article/1854)
Sandle, T. Microbiology and the World Wide Web - Revisited, PharMIG News, Issue 28, pp10-11
Sandle,
T. Some Considerations on the Use of Endotoxin Indicators in Depyrogenation
Studies, Pharmaceutical Microbiology Forum Newsletter, Vol. 13, No.
10, November 2007, pp2-11
Sandle,
T. Calling Time on the Pyrogen Test, PharMIG News, Issue 29, 2007,
pp03-04
Tours,
N. and Sandle, T. A Comparative Study of Different Methods of
Endotoxin Destruction, Pharmig News, Issue 30, March 2008, pp4-8.
Sandle,
T. and Skinner, K. ‘A Practical Example Arising from the Harmonization of the
Microbial Enumeration Method for Water’, Pharmaceutical Microbiology Forum
Newsletter, Vol. 14, No.4, pp2-5
Roberts,
J. and Sandle, T. ‘Assessment of the Potassium Hydroxide Test as a
Complimentary Test for the Gram-stain’, Pharmig News, No. 31, June
2008, pp1-4
Sandle,
T. The Sterility Test and other changes to the European Pharmacopeia, 6th edition, Pharmig
News, No. 32, September 2008, pp1-3
Sandle,
T. Biological Safety: The despatch of microbial cultures, Pharmig News,
No. 32, September 2008, pp5-7
Sandle,
T. Calculation of warning (alert) and action levels for a water system, Pharmig
News, No.33, December 2008, pp1-4
Sandle,
T. Book Review: Guide to Microbiological Control in Pharmaceuticals and Medical
Devices, 2nd edition edited by Stephen Denyer and Rosamund
Baird, Pharmig News, No.33, December 2008, pp9
Sandle,
T., Roberts, J. and Skinner, K. (2009): 'An examination of the sample hold
times in the Microbiological Examination of Water Samples', Pharmaceutical
Microbiology Forum Newsletter, Vol. 15, No.2, pp2-7
Sandle,
T. (2009): 'Biological Indicators for Steam Sterilisation', Pharmig
News, No.34, pp10-14 (updated
and reproduced on-line at: http://microbiologystudents.com/article.php?article_id=198, 6th December 2010 for ‘Microbiology Students’)
Sandle,
T. and Roberts, J. The microbiologist’s dilemma: optimising time, temperature
and culture media, Pharmig News, Issue 35, 2010, pp1-5
Sandle,
T. Cleanroom Operator Training: An Approach for Basic Hygiene, Pharmig News, Issue
37,2010, pp1-9
Sandle,
T. Microbiology and the World Wide Web, Pharmaceutical Microbiology
Forum Newsletter, Vol. 15, Number 11, 2010, pp2-5
Sandle,
T. ‘Introduction to Antimicrobials’, Pharmig
News, Issue 39, 2010, pp5-7
Sandle,
T. (2010): 'Choosing Disinfectants', Cleanroom Technology, August 2010, 18 98):
11-13
Also
published at: http://www.schulke.co.uk/media/28/128-disinfectants_in_pharmaceutical_industry_tim_sandle.pdf
Sandle, T. (2010): PIC/S Guide on Aseptic
Processing, Pharmaceutical Microbiology Forum Newsletter, Vol.16, No.2, pp10-11
Sandle,
T. (2010): ‘Effective and Efficient Hand Sanitisation’, Inside Hospitals, December 2010
(reproduced
on-line at: http://www.inside-hospitals.co.uk/
under features, infection prevention, schulke)
Sandle, T. (2010): 'Cleaning Cleanrooms', Cleanroom Technology, December 2010,
pp22-24 (reproduced on-line at: http://www.cleanroom-technology.co.uk/technical/article_page/Cleaning_cleanrooms/57871)
[26th November 2010]
Sandle, T. (2010): ‘Changes to the European
Pharmacopoeia: 2008 - 2010’, Pharmaceutical
Microbiology Forum newsletter, Vol. 16, No.12, December 2010, pp10-14
Sandle, T. (2010):
"Medical and social development of the English and Welsh Blood Service:
the evolving status of venepuncture", Wellcome History, Issue 45,
pp17-18
Sandle, T. (2010):
"Training within the Microbiology Laboratory", Global BioPharmaceutical
Resources Inc. Newsletter, December 2010, pp1-11 (available
to view at: http://www.gbprinc.com/pdf/TrainingWithinTheMicrobiologyLaboratory.pdf)
Sandle, J. and Sandle, T. (2011): ‘Infection Control in Healthcare’,
Pharmig News, Number 42, pp3-6
Sandle, T. (2011): ‘A review of current developments in cleanroom
standards’, Pharmig News, Number 42,
pp12-14
Sandle, T. (2011):
'Investigating Sterility Test Failures', Global
BioPharmaceutical Resources Inc. Newsletter, February 2011, pp1-16 (http://www.gbprinc.com/pdf/InvestigatingSterilityTestFailures.pdf)
Sandle, T. (2011)
"Glucans and the Bacterial Endotoxin Test", Global Pharmaceutical Resources Inc Newsletter, April 2011, pp1-12
(available at: http://www.gbprinc.com/pdf/Whitepaper041411-4.pdf)
Sandle, T. (2011): 'The Consequence of Failure to Monitor Air
Quality in Cleanrooms: A Case Study', Pharmig News No. 43, pp3-7
Sandle, T. (2011): ‘Biological Indicators for Steam Sterilization:
Failure Investigations’, Pharmaceutical
Microbiology Forum Newsletter, Vol. 17, No.5, pp2-8
Sandle, T. (2011): 'Advances in Cleanroom Technology', Process India, Vol. 1, No.3, pp42-44
Sandle, T. (2011):
‘Container-Closures for Pharmaceutical Preparations’, GBPR, Inc. Newsletter, August 2011, pp1-6 (available at: http://www.gbprinc.com/pdf/GBPRContainerClosures.pdf)
Sandle, T. (2011):
“Maintaining hygiene: keeping surfaces clean”, Inside Hospitals, August 2011, p40
Sandle, T. (2011).
'Validating surface cleaning agents', Cleanroom Technology, September 2011, 19
(9): 15-18
Sandle, T. (2011): "Characterization of
Microbial Contamination in Pharmaceutical Facilities", Global
BioPharmaceutical Resources Inc. Newsletter, September 2011, pp1-15
(available at: http://www.gbprinc.com/pdf/GBPRCharacterization092311.pdf)
Sandle, T. (2011).
"Risk Management in Pharmaceutical Microbiology", Pharmaceutical Manufacturing, September
2011, Vol 10, Issue 8: 30-36 (http://www.scribd.com/doc/95778970/PM-Sept2011)
Sandle, T. (2011): "Sterility Test
Requirements for Biological Products", Pharmaceutical
Microbiology Forum Newsletter, Vol. 17, No.8, pp5-14 (available at: http://www.microbiologyforum.org/PMFNews/PMFNews.17.08.1108.pdf)
Sandle, T. (2011): "Environmental
Monitoring: Corrective and Preventative Actions", Global
BioPharmaceutical Resources Inc. Newsletter, October 2011, pp1-18
(available at: http://www.gbprinc.com/pdf/GBPROctober2011NewsletterFeaturedArticleIssue2.pdf)
Sandle,
T. (2011): Keeping Hands and Surfaces Clean, Arab Medical Hygiene, Issue 3, pp11-17
Sandle, T. (2011):
"Cleanrooms and Air Quality – A Risk-Based Approach", Global Biopharmaceutical Resources Inc. Newsletter, December
2011, pp1-13
(available at: http://click.icptrack.com/icp/relay.php?r=37671113&msgid=1460557&act=RAB6&c=623139&destination=http%3A%2F%2Fwww.gbprinc.com%2Fpdf%2FGBPRDecember2011FeaturedArticle.pdf)
Sandle, T. (2012) "Recent Developments in European
Regulatory Requirements: Issues Affecting the Microbiologist", Pharmaceutical Microbiology Forum
Newsletter, Vol. 18, No.1,
pp5-15 (available at: http://www.microbiologyforum.org/PMFNews/PMFNews.18.01.1201.pdf)
Sandle, T. and Sandle, J. (2012). “Data Analysis
– Shewhart Chart”, Pharmig News, Number
46, pp2-5
Sandle, T. (2012). “Cleanrooms and Clean Air”, Arab Medical Hygiene, Issue 4, pp19-25
Sandle, T. (2012). "Approaching Risk
Assessment: Tools and Methods", Global Biopharmaceutical Resources Inc.
Newsletter, February 2012, pp1-23 (available at: http://www.gbprinc.com/pdf/GBPRFebruary2012FeaturedArticle.pdf)
Sandle, T. (2012). Cleanroom Cleaning
and Disinfection: Eight Steps for Success, Controlled
Environments Magazine, March 2012 (http://www.cemag.us/print/5636)
Sandle, T. (2012). “Introducing Antimicrobials”, Arab
Medical Hygiene, Issue 5: 37-41
Sandle, T. (2012). “Airflow visualisation in an aseptic facility”,
Cleanroom Technology, May 2012, 20 (5): 13-17
Sandle, T. and Saghee, M.R. (2012). “Application of
Sterilization by Gamma Radiation for Single-Use Disposable Technologies in the
Biopharmaceutical Sector”, Pharmaceutical
Technology, Supplement: Bioprocessing and Pharmaceutical Manufacturing, May
2012, S20-S27 (http://digital.findpharma.com/nxtbooks/advanstar/pt_201205_supp/index.php?startid=s30#/20)
Sandle, T. and Saghee, M. R. (2012). “Cleanroom Technology:
Setting the Scene”, Pharmaceutical
Manufacturing and Packaging Sourcer, May 2012, pp38-42
Sandle, T. (2012). The Characterization of Microbial
Contamination’, Pharmig News Number
47, pp2-4
Sandle, T. (2012). FDA: Sterility Test Requirements for Biological
Products, Pharmig News Number 47,
pp5-8
Sandle, T. (2012). Pyrogens, Endotoxin and the LAL Test: An
Introduction in Relation to Pharmaceutical Processing, Global BioPharmaceutical Resources Newsletter, May 2012, pp1-16 (http://www.gbprinc.com/pdf/GBPRMay2012FeaturedArticle.pdf)
Sandle,
T. (2012). Pharmaceutical Microbiology and Pharmig, Innovations For Success, Issue 29, summer 2012, p35 (http://viewer.zmags.com/publication/ec07d7ab#/ec07d7ab/34)
Sandle, T. and Saghee, M.R.
(2012). Application of Sterilization by Gamma Radiation for Single-Use
Disposable Technologies in the Biopharmaceutical Sector, Pharmaceutical Technology, Volume 36, Issue 5, pp. s20-s30
Sandle,
T. (2012). “A silver lining? The use of antimicrobial bandages”, Arab Medical Hygiene, Issue 6, July
2012, pp19-25
Sandle, T. (2012). "Sanitization of
Pharmaceutical Facilities", Global
BioPharmaceutical Resources Inc. Newsletter, July 2012, pp1-14
Sandle,
T. (2012) "Contamination Control Underfoot", Controlled Environments, Vol. 15, No.7, pp10-11 (http://www.cemag.us/print/6121)
Sandle,
T. (2012). "Practical Selection of Cleanroom Disinfectants", Hospital Pharmacy Europe, Issue 63,
pp39-41
Also
as:
Sandle,
T. (2012). “Desinfektionsmittel – Auswahl fĆ¼r den Einsatz in der
Pharmaindustrie”, IAB Cleanroom GmbH website: http://www.iab-reinraumprodukte.de/info-portal/fachartikel/desinfektionsmittel-pharmaindustrie.html
(published 301st July 2012)
Sandle,
T. (2012). Good practices for microbiology laboratories, GMP Review, Vol. 11, No.3, October 2012, pp6-8
Reprinted
in Logfile:
Sandle,
T. (2013) Good practices for microbiology laboratories, Logfile, 1, pp1-4
(https://www.gmp-publishing.com/media/files/leitartikel_2013/LOGFILE-1-2013-good-practices-for-microbiology-labs.pdf)
Sandle, T. and Saghee, M.R. (2012). “Cleanroom Technology: Inside the Box” Pharmaceutical Manufacturing
and Packaging Sourcer, Summer 2012, pp54-57
Sandle,
T. (2012). “Introduction to particle counting”, Pharmig News, Number
48, pp6-9
Sandle,
T. (2012). “Cleaning endoscopes: Considering the risks and benefits of
enzymatic and non-enzymatic detergents”, Inside
Hospitals, June 2012, pp14-15
Sandle,
T. (2012). ‘Introduction to Particle Monitoring’, Pharmig News, Issue 48, pp6-9
Sandle,
T. (2012). An Air of Safety: The application of cleanrooms and clean air
devices within the hospital setting, European
Medical Hygiene, Issue 1, pp11-17
Sandle,
T. (2012). Wipe study measures particle shedding, Cleanroom Technology,
September 2012, 20 (9): 26-29
Sandle,
T. (2012). ‘Detergent choices for endoscope reprocessing’, The Clinical Services Journal, Volume 11, Issue 8, pp71-75
Sandle,
T. (2012). European Pharmacopeia Proposes Revision to Biological Indicators
Chapter, Pharmaceutical Microbiology
Forum Newsletter, Vol. 18, No.5, pp4-7
Sandle,
T. (2012). Ensuring Contamination Control: The validation of disinfectants, European Medical Hygiene, November 2012,
pp33-39
Sandle,
T. (2012). Pharmig History: A Potted Guide (1992-2012), Conference Paper
provided to delegates at the 2012 Pharmig Conference (Chipping Norton, UK).
Sandle, T. (2012). Making the grade in filters, Cleanroom
Technology, December 2012, 20 (12): 19-20
Sandle,
T. (2012). Review of FDA warning letters for microbial bioburden issues
(2001-2011), Pharma Times, Vol. 44,
No.12, pp29-30
Sandle,
T. (2012). Making the grade in filters, Cleanroom Technology, December 2012,
pp19-20
Sandle,
T. (2012). Utilisation de la gamma, Salles
Propes, Issue 81, pp42-54
Sandle, T. and Saghee, M.R. (2012).
Gamma irradiation cleans up, Medical
Device Developments, October 2012, reproduced on-line at:
http://www.medicaldevice-developments.com/features/featuregamma-rays-irradiation/
Sandle,
T. (2013). Revised FDA Guidance on Pyrogens and Endotoxin, Pharmig News, Number
51, p10
Sandle,
T. (2013). Pharmig hosts successful twentieth anniversary conference, Pharmig
News, Number 51, p4-5
Sandle,
T. (2013). Electron beam processing: A rapidly developing sterilisation
technology, European Medical Hygiene,
February 2013, pp9-13
Sandle,
T. (2013). Variability and the LAL assay, Pharmaceutical
Microbiology Forum Newsletter, Vol. 19(1), pp4-12
Sandle,
T. (2013). New guidance for environmental monitoring in cleanrooms, GMP Review, Vol. 11, No.4, pp9-11
Sandle,
T. (2013). Sandle, T. (2013). Biocontamination control - Moves toward a better
standard, Cleanroom Technology, 21 (4): 14-15. Online: http://www.cleanroom-technology.co.uk/technical/article_page/Biocontamination_control__moves_toward_a_better_standard/87172
Sandle,
T. (2013). Avoiding Dilution Error With the LAL Assay, Pharmaceutical Microbiology Forum Newsletter, Vol. 19(2), pp2-13
Sandle,
T. (2013). 'A new ray of hope to address water pollutants', Industry 2.0, Vol. 12, Issue 8, pp33
Sandle,
T. (2013). 20 years of Microbiology, Cleanroom Technology, March 2013,
21 (3): 24-25
Sandle,
T. (2013). Bacteria and temperature of growth: a simple introduction, Pharmig News Number 51, pp2-3.
Siew,
A. (2013): Ensuring Sterility of Parenteral Products: an interview with James
Agalloco, Tim Sandle and Benoit Verjans, Pharmaceutical
Technology, Vol. 37, Number 4, pp62-67
Sandle, T. (2013).
Single-Use: Sterile Disposable Technology, Industry
2.0, Vol.12, Issue 9, pp45-47
Wilder, C., Sandle, T. and Sutton, S. (2013).
Implications of the Human Microbiome on Pharmaceutical Microbiology, American Pharmaceutical Review, 16 (5):
pp17-21
Also:
June 2013, on-line publication: http://www.americanpharmaceuticalreview.com/1504-White-Papers-Application-Notes/140112-Implications-of-the-Human-Microbiome-on-Pharmaceutical-Microbiology/?catid=6262
Sandle
T (2013) Could the ‘Black Death’ Become a Re-Emerging
Infectious
Disease? J Anc Dis Prev Rem 1: e104. doi:10.4172/jadpr.1000e104
Sandle, T. (2013). Automated Microbial
Identifications: A comparison of USP and EP approaches, American
Pharmaceutical Review, 16 (4): 56-61
Sandle,
T. (2013): Risk assessment and monitoring of cleanrooms, Hospital Pharmacy Europe, May / June 2013, pp54-56
Sandle,
T. (2013). FDA Guidance on pyrogens and endotoxin, GMP Review, 12 (2): 7-9
Sandle,
T. (2013). Understanding cleanroom microflora, The Journal: the Official
Journal of the Institute of Science and Technology, Summer 2013, pp35-45
Sandle, T. (2013). Avoiding Contamination of Water Systems, The Clinical Services Journal, 12
(9): 33-36
Sandle, T. (2013) Risk Management in Sterile
Environments. In Thomas, P. (Ed.) Aseptic
Manufacturing - a road map to excellence, Pharmaceutical Manufacturing,
USA, pp3-9 (http://www.pharmamanufacturing.com/assets/wp_downloads/pdf/dpt.pdf)
Sandle, T. and Sandle, J. (2013). An Important Aspect of
Healthcare: Outlining the many considerations of infection control, Arab Medical Hygiene, October 2013,
pp34-39
Sandle, T. (2013): Pharmaceutical Product Impurities: Considering
Beta Glucans, American Pharmaceutical
Review, 16 (5) Special Edition Supplement 'Furthering Pharmaceutical
Microbiology': 16-19
Sandle,
T. (2013). Skin cleaning before cathererisation, Inside Hospitals, October 2013, pp40-41
Sandle,
T. (2013). Water Quality Concerns: Contamination control of hospital water
systems, European Medical Hygiene, November
2013, pp14-19
Sandle,
T. (2013). USP updates: cleanrooms and sterilization, Clean Air and Containment Review, Issue 16, pp24-25
Sandle,
T. (2013). Single-use technology for biopharma, Cleanroom Technology, 21 (12): 15-19
Sandle,
T. (2013). A comparative study of different methods of endotoxin destruction, American Pharmaceutical Review,
Supplement on Endotoxin Detection: techniques and developments, November 2013,
pp15-17
Sandle,
T. (2013). Using an antimicrobial skin cleanser before catheterisation, Journal of Community Nursing, Vol. 27,
No.5, pp30-34
Sandle,
T. (2013). Innovations in Cleanroom Technology, Pharma Times, 45 (12): 14-15
Sandle,
T. (2014) Recent changes to bacterial taxonomy, Micrographia Today, 1 (1): 31-36
Sandle,
T. (2014) Modern Approaches to Pharma Cleanroom Design, Controlled Environments, 17 (1): 8-10
Sandle, T. (2014). Biologics and biosimilars: the regulatory
environment, Clean Air and
Containment Review, Issue 17, pp20-21
Sandle,
T. (2014) Selection of Laboratory Disinfectants, Lab World Magazine, 3 (2): 17-22
Sandle,
T. (2014) Fungal contamination of pharmaceutical products: the growing menace, European Pharmaceutical Review, 19 (1):
68-71
Sandle,
T. (2014) The rise of antimicrobial resistant microorganisms, Microbiology World, Issue 2, pp10-16
Sandle, T. (2014) EU GMP Annex 15 Revisions: Improving
Qualification and Validation, Cleanroom
Technology, April 2014, pp14-16
Sandle,
T. (2014) Revision to EU GMP Annex 15: Qualification and Validation, Clean Air and Containment Review, Issue
18, pp22-23
Sandle, T. (2014) WHO updates endotoxin
guidance for parenteral products, GMP Review, 13 (1): 7-8
Sandle, T. (2014) Selecting cleanroom
disinfectants, La Vague, Issue 42,
pp28-31
Sandle,
T. (2014) Assessment of Culture Media in Pharmaceutical Microbiology, American
Pharmaceutical Review, June 2014:
http://www.americanpharmaceuticalreview.com/Specialty/Microbiology/Featured-Articles/163589-Assessment-of-Culture-Media-in-Pharmaceutical-Microbiology/?catid=6262
Sandle, T. (2014) Examination
of air and surface particulate levels from cleanroom mats and polymeric
flooring, Pharmig News 56, pp2-8
Sandle, T. (2014) Non-sterile
pharmaceutical manufacturing: USP chapter in development, Clean Air and Containment Review, Issue 19, pp19-20
Sandle, T. (2014) Quality control of hospital water systems, Microbiolz India, Issue 7,
pp20-25
Sandle, T. (2014) Medicines and the Microbiome, The Medicine Maker, Issue 1, p18-19: http://themedicinemaker.com/issues/2100-a-medicine-manufacturing-odyssey/medicines-and-the-microbiome/
Sandle,
T. (2014) Quality Control of Hospital Water, The Clinical Services Journal, 13 (8): 47-51
Sandle,
T. (2014) Variability and Test Error with the LAL Assay, American Pharmaceutical Review, October 2014, pp1-5: http://www.americanpharmaceuticalreview.com/Featured-Articles/167404-Variability-and-Test-Error-with-the-LAL-Assay/
Sandle, T. (2014) Are alcohol wipes effective in the presence
of protein?, The Dentist,
October 2014, pp92-94
Sandle, T. (2014) Pharmacopeial
changes in relation to pyrogens and endotoxin, GMP Review, 13 (3): 10- 12
Sandle, T. (2014) Review Of cGMPs For Sterile
Manufacturing, GMP Insight, Issue 1,
pp2-4
Sandle, T. (2014) A Practical Approach to the
Selection of Cleanroom Disinfectants, Pharma
Focus Asia, Issue 21, pp27-30 (http://www.pharmafocusasia.com/articles/practical-approach)
Sandle, T. (2014) The Risk
of Bacillus cereus to Pharmaceutical
Manufacturing, American Pharmaceutical
Review, 17 (6): pp-pp
Sandle, T. (2014)
Taking on the Resistance, Laboratory
News, March 2014, pp8-10: http://www.labnews.co.uk/features/taking-on-the-resistance/
Sandle,
T. (2015) Auditing Cleanrooms, Cleanroom
Technology, February 2015, pp66-68
Sandle,
T. (2015) Cleanroom wipes, European
Medical Hygiene, February 2015, pp24-29
Sandle,
T. (2015) Cleanroom Disinfectants, Cleanroom
Technology, January 2015, pp10-11 (interview: http://flickread.com/edition/html/index.php?pdf=54ba1a26714b8&dm_i=8EU,358EB,AW0FAO,B9QJX,1#62
Sandle, T. (2015) Cleanroom Wipes, European Medical Hygiene, Issue
9, pp24-29
Sandle,
T. (2015) Real-time biological particle counting in environmental monitoring,
European Pharmaceutical Review, Vol. 20, Issue 2, pp39-42
Sandle,
T. (2015) Sanitization of Pharmaceutical Facilities, Pharmig News, number 59, pp2-7
Sandle, T. (2015) FDA
opens up review into hand disinfectants, GMP
Review, 14 (2): 8-9
Sandle, T. (2015) Innovations in cleanrooms and environmental
monitoring, Cleanrooms:
Express Pharma Special Supplement, July 2015, pp12-14
Sandle,
T. (2015) Contamination control guidances under review, Clean Air and Containment Review, Issue 23, pp22-23
Sandle,
T. (2015) European Sterile Products Guidance Under Review, American Pharmaceutical Review, September / October 2015: 1-4
Sandle,
T. (2015) Current Methods and Approaches for Viral Clearance, American Pharmaceutical Review,
September / October 2015: 1-4
Sandle,
T. (2015) FDA issues revised guidance for analytical method validation, GMP Review, 14 (3): 8-10
Sandle, T. (2015) Importance of
Risk Assessment for a Aseptic Transfer in Pharmaceutical Compounding, Clean Air and Containment Review, Issue
24, pp18-23
Sandle,
T. (2015) Safe use of disinfectants and detergents in cleanrooms, Innovation
Into Success (quarterly journal of UKSPA), Issue 38, pp81-84
Sandle,
T. (2015) Embracing Rapid Microbiology, The
Medicine Maker, Issue 12, pp18-19
Sandle,
T. (2015) 10 Most influential microbiologists of the 21st Century, Microbioz India, Vol. 2, Issue 21,
pp8-14: http://www.microbiozindia.com/top-10-most-influential-microbiologist-of-21st-century.htm
Sandle,
T. 2015 Development of a biocontanination control strategy, Cleanroom Technology, 23 (11), 25 - 30
Sandle,
T. (2015) Current Developments with Disposable Technology and Single-Use
Systems for Aseptic Processing, BioPharma
Asia, 4 (6): 5-11
Sandle, T. (2016)
Calling time on the General Safety Test, GMP
Review, 14 (4): 11-13
Sandle,
T. (2016) Standards and controls for skin disinfection, The Clinical Services Journal, 15 (2): 25-28
Sandle, T. (2016) New estimates of microbial numbers in our
bodies, Microbioz India, Vol. 3, pp9-13
Sandle,
T. (2016) Pharmaceutical Facility Sanitization: Best Practices Considered, American Pharmaceutical Review, March
2016, pp1-5
Sandle,
T. (2016) Beneath the surface of new cleanliness standard ISO 14644-13, Cleanroom Technology, April 2016,
pp27-28
Sandle,
T. (2016) Pharmaceutical Facility Sanitization: Best Practices Considered, American Pharmaceutical Review, 19 (2):
32-29
Sandle,
T. (2016) ŠŠ·ŃŃŠµŠ½ŠøŠµ
Š¼ŠøŠŗŃŠ¾ŃŠ»Š¾ŃŃ Š²Š¾Š“Ń, ŠøŃŠæŠ¾Š»ŃŠ·ŃŠµŠ¼Š¾Š¹ Š“Š»Ń ŃŠ°ŃŠ¼Š°ŃŠµŠ²ŃŠøŃŠµŃŠŗŠøŃ
ŃŠµŠ»ŠµŠ¹, - Š°Š½Š°Š»ŠøŠ· Š¼ŠµŃŠ°Š“Š°Š½Š½ŃŃ
(Placing
sedimentation plates in a unidirectional air flow and the effect of the weight
loss (dry agar) on the growth of microbes), Š§ŠøŃŃŃŠµ
ŠæŠ¾Š¼ŠµŃŠµŠ½ŠøŃ Šø ŃŠµŃ
Š½Š¾Š»Š¾Š³ŠøŃŠµŃŠŗŠøŠµ ŃŃŠµŠ“Ń [Cleanrooms
and technological environments], 56 (4): 46-53
Sandle,
T. (2016) Š Š°Š·Š¼ŠµŃŠµŠ½ŠøŠµ
ŃŠµŠ“ŠøŠ¼ŠµŠ½ŃŠ°ŃŠøŠ¾Š½Š½Š¾Š¹ ŠæŠ»Š°ŃŃŠøŠ½Ń Š² Š¾Š“Š½Š¾Š½Š°ŠæŃŠ°Š²Š»ŠµŠ½Š½Š¾Š¼ Š²Š¾Š·Š“ŃŃŠ½Š¾Š¼ ŠæŠ¾ŃŠ¾ŠŗŠµ Šø Š²Š»ŠøŃŠ½ŠøŠµ ŠæŠ¾ŃŠµŃŠø
Š¼Š°ŃŃŃ (Š²ŃŃŃŃ
Š°Š½ŠøŃ Š°Š³Š°ŃŠ°) Š½Š° ŃŠ¾ŃŃ Š¼ŠøŠŗŃŠ¾Š±Š¾Š² (The study of the microflora of water
used for pharmaceutical purposes, - meta analysis), Š§ŠøŃŃŃŠµ ŠæŠ¾Š¼ŠµŃŠµŠ½ŠøŃ Šø ŃŠµŃ
Š½Š¾Š»Š¾Š³ŠøŃŠµŃŠŗŠøŠµ ŃŃŠµŠ“Ń [Cleanrooms and technological environments], 56 (4): 30-39
Sandle, T. (2016) Revision
to cleanroom standard: ISO 14644 Parts 1 and 2, GMP Review, 15 (1): 4-7
Sandle,
T. (2016) Key Criteria for the Selection of Rapid and Alternative Microbiological
Methods, American Pharmaceutical Review,
19 (3): 46-48
Sandle,
T. (2016) Improving microbiological assurance for bioburden tests, European Pharmaceutical Review, 21 (3):
41-44
Sandle,
T. (2016) New EMA draft guideline on sterilisation of the medicinal product, GMP Review, 15 (2): 6-8
Vijakumar,
R. and Sandle, T. (2016) Bacterial endotoxin contamination and testing limits
in ophthalmics, European Pharmaceutical
Review, 21 (4): 16-18
Sandle,
T. (2016) Top Cleanroom Advances, The
Medicine Maker, July / August 2016 (issue 7), pp403-404
Sandle,
T. (2016) The importance of detergent selection, The Clinical Services Journal, 15 (8): 72-74
Sandle,
T. (2016) Removal of Endotoxin from Protein in Pharmaceutical Processes, American Pharmaceutical Review, 19 (8):
1-5
(http://www.americanpharmaceuticalreview.com/Featured-Articles/190810-Removal-of-Endotoxin-from-Protein-in-Pharmaceutical-Processes/)
Sandle,
T. (2016) Evaluation of Quaternary Ammonium Compound Disinfectants against Mycobacteria in Dental Practices, Dental Update, 43, 723-726
Sandle,
T. (2016) Risk of Microbial Spores in Cleanrooms. Part 1: Introduction to
Microbial Spores and Survival Mechanisms, Clean
Air and Containment Review, 28, pp4-6
Sandle,
T. (2016) The development of cleanrooms: an historical review. Part 1: From
civil war to safe surgical practice, The
Journal – Institute of Science & Technology, Autumn 2016, pp41-47 (ISSN
2040-1868)
Sandle, T. (2017) The European approach to disinfectant
qualification, La Vague, No. 52,
pp45-48
Sandle,
T. (2017) Risk of microbial spores to cleanrooms: Part 2: Selection of sporicidal disinfectants, Clean Air and Containment Review, Issue
29, pp14-16
Sandle,
T. (2017) Establishing a Contamination Control Strategy for Aseptic Processing,
American Pharmaceutical Review, 20
(3): 22-28
Sandle,
T. (2017) Effective cleaning and disinfection of dental practices, Dental Practice Magazine, March 2017,
pp58-66
Sandle,
T. (2017) Cleaning and disinfection of dental practice surfaces, Dental Nursing, 13 (2): 86-87
Sandle,
T. (2017) Risk assessment and pharmaceutical processing hazards, Microbioz India 3 (3): 10-18
Sandle,
T. (2017) Microbiological monitoring of pharmaceutical water systems, European Pharmaceutical Review, 22 (2):
25-27
Sandle,
T. (2017) The development of cleanrooms: an historical review – Part 2– The
path towards international harmonisation, IST
The Journal, Summer 2017, pp1-5
Sandle,
T. (2017) European Pharmacopoeia revises Biological Indicator Chapter, GMP Review, 16 (1): 4-6
Sandle,
T. (2017) Designing cleanroom equipment for particulate control, Cleanroom News, Issue 2, pp22-23
(Turkish publication: "ParƧacık kontrolĆ¼ iƧin temiz oda tasarımı").
at: http://www.cleanroomnews.org/sayi-2
Sandle,
T. (2017) Antimicrobial copper surfaces in hospitals, The Clinical Services Journal, 16 (6): 47-51
Sandle,
T. (2017) MHRA annual deficiency review highlights sterility assurance issues, GMP Review, 16 92): 4-7
Sandle,
T. (2017) Assessment of Bacterial Endotoxin by Fluorescent Labeling, American Pharmaceutical Review,
Endotoxin Supplement, October 2007, pp1-3
Sandle,
T. (2017) Applying design and construction standards to cleanroom builds, Cleanroom Technology, 25 (8): 16-18
Sandle, T. (2017) The people factor: investigating
the gown, European Pharmaceutical Review,
22 (4): 23-26
Technical
articles (internet and on-line published articles)
Sandle,
T. ‘Update on Bacterial Taxonomy’, internet only article, published in the
members’ section of PharMIG (www.pharmig.org.uk),
December 2005
Sandle,
T. Dycem Flooring. On-line at: http://www.cleanroom-technology.co.uk/story.asp?storyCode=39685 (first
accessed 29th July 2006);
Also
printed on-line at Lifesciences News:http://www.lifesciencesnews.com/articleView~idArticle~73104_937924181052006.html(10th
May 2006)
And
in Packaging Today at:
http://www.packagingtoday.co.uk/story.asp?storyCode=39685 (accessed
29th July 2006)
And
at the Dycem website:
http://www.dycem.com/latestnews.php (accessed
10th April 2007)
Sandle,
T. Selection of Active Air-Samplers, BioSciences Quality Testing Forum (BioQT) website:
http://www.bioqtforum.com/Selection-of-active-air-samplers (accessed 15th
September 2010)
Sandle,
T. (2010): The use of risk assessment tools for microbiological assessment of
cleanroom environments, Internet article, GMP
Guru, Insight Systems Inc., at: http://www.insightcgmp.com/gmp-guru/risk-assessment-tools.pdf (uploaded on 27th September 2010).
Saghee,
M.R. and Sandle, T. (2010): 'Embracing quality risk management: The new
paradigm', Express Pharma, Pharma
Technology Review, 16th - 30th September 2010, On-line paper at:
http://www.expresspharmaonline.com/20100930/pharmatechnologyreview02.shtml
(accessed 30th September 2010)
Sandle,
T. and Saghee, M.R. (2010): Advances in cleanroom technologies, Express Pharma, 16th-30th September,
On-line Paper: http://www.expresspharmaonline.com/20100930/expressbiotech13.shtml
(accessed 30th September 2010)
Sandle, T. (2010): The use of risk assessment tools for
microbiological assessment of cleanroom environments, Internet article, GMP Guru, Insight Systems Inc., at: http://www.insightcgmp.com/gmp-guru/risk-assessment-tools.pdf (uploaded on 27th September 2010).
Sandle, T. (2011):
Nontoxic And Nonfuming Sporicide: Science At Its Best, on-line article
published by Go1Bio (February 2011): http://www.google.co.uk/url?sa=t&source=web&cd=51&ved=0CC8QFjAAODI&url=http%3A%2F%2Fwww.go1bio.com%2Fclientuploads%2Fdirectory%2Fnewsdirectory%2FSTERIPLEX%2520HC_Nontoxic%2520Nonfuming%2520Sporicide.pdf&rct=j&q=tim%20sandle&ei=K1MQTpqpCoWY8QPCsb2eDg&v6u=http%3A%2F%2Fdualstack.ipv6-exp.l.google.com%2Fgen_204%3Fip%3D81.156.212.12%26ts%3D1309692715373476%26auth%3Dpds7hrga6grshaf6rlfeatpwd464noyf%26rndm%3D0.00039878398549886285&v6s=2&v6t=8449&usg=AFQjCNHAVVyROwwVYokmK-QI3TKg5TiLIQ&cad=rja
Sandle T. (2011):
“Advances in Cleanroom Technology: Manufacturing Perspective”, Process Worldwide at: http://www.process-worldwide.com/index.cfm?pid=9963&pk=17888
(28th June 2011)
Sandle, T. (2011): 'Selection of
Disinfectants for Use in the Pharmaceutical Industry', Online article published
by PharmaHireWire on 28th June 2011
at: http://www.mypharmacareers.com/pharmajournal/archives/jun11.html
Sandle, T. (2011). “Good Practices for Pharmaceutical Microbiology
Laboratories: A review of the 2011 WHO Guidance”, Cryologics, Inc. Newsletter,
August 2011 (re-printed at: www.pharmig.blogspot.com) at:
http://pharmig.blogspot.com/2011/08/good-practices-for-pharmaceutical.html
Sandle,
T. (2012). “Quality Management System”, A3P website, published 1st
May 2012 (http://www.a3p.org/index.php/fr/base-documentaire/articles/203-a-la-une/3990-quality-management-system)
Sandle, T. (2012). “Cleaning endoscopes:
Considering the risks and benefits of enzymatic and non-enzymatic
detergents”, Hospital Bulletin website, published 1st July 2012 (see Hospital
Bulletin) http://www.hospital-bulletin.co.uk/features/Infection%20Prevention/shulke.htm
Sandle, T. (2012). "Desinfektionsmittel –
Eine EinfĆ¼hrung", IAB website, published 27th July 2012 (see IAB)
(http://www.iab-reinraumprodukte.de/info-portal/fachartikel/desinfektionsmittel-eine-einfuehrung.html)
Sandle,
T. (2012). “Toward a Revised International Cleanroom Standard”, Controlled Environments, on-line article
August 2012, pp1-3. Available at: http://www.cemag.us/print/6201
(accessed 3rd August 2012)
Sandle,
T. (2012). "Risk Management in Pharmaceutical Microbiology: at look at how
HACCP and FMEA can make a difference in the pharma micro lab.", Pharmaceutical Manufacturing Magazine
on-line: http://www.pharmamanufacturing.com/articles/2011/126.html?page=full
(accessed 9th October 2012).
Rapid
Microbial Methods: A Q&A with Dr. Tim Sandle, Rapid Micro Biosystems:
http://www.rapidmicrobio.com/blog/rapid-microbial-methods-a-qa-with-dr.-tim-sandle
(July 2014)
Microbiological
Monitoring Roundtable - conversation with Tim Sandle and other microbiologists,
with American Pharmaceutical Review
http://www.americanpharmaceuticalreview.com/Featured-Articles/167343-Microbiological-Monitoring-Roundtable/
Sandle,
T. (2010) Cleanroom Particle Counting: The 5 Micron Issue, Pharmaceutical
Online (online publication): http://www.pharmaceuticalonline.com/doc/cleanroom-particle-counting-the-5-micron-iss-0001
Tim
Sandle - participant (2016) LAL Roundtable, American
Pharmaceutical Review, 19(6): 47-51 http://www.americanpharmaceuticalreview.com/Featured-Articles/239887-LAL-Roundtable/
Tim
Sandle Q&A - in conversation with Institute of Validation Technology, April
2017 at: http://www.ivtnetwork.com/article/meet-ivt-board-tim-sandle
Sandle,
T. (2017) Risk and Microbiological Contamination, PDA Letter, Volume LIII
(7), (July 2017, pp8 at: https://www.pda.org/pda-letter-portal/archives/full-article/pda-summer-reading-for-2017
Technical
guides
Author
of Pharmig LAL Fact Sheet Series (series editor). 2005 -2007 (sheets 1 to 6)
[re-designed and re-printed 2010]
Technical
adviser to publication: Microbiological
Control for Non-Sterile Pharmaceuticals, published by Pharmig and PQG, 2008
Author of Pharmig Microorganism Fact Sheets. 8
full colour sheets relating to the Microbial Examination of Non-Sterile
Products, written by Tim Sandle and issued in November 2013.
Author of Pharmig Microorganism Fact Sheets. 8
full colour sheets relating to the Objectionable Microorganisms, written by Tim
Sandle and issued in November 2014.
Contributing author / editor to PHSS (2014)
Bio-contamination, Technical Monograph No. 20, Pharmaceutical and Healthcare
Sciences Society, Wiltshire, U.K. https://phss.site-ym.com/store/ViewProduct.aspx?id=3427062
PDA Technical Report #69: Bioburden and Biofilm
Management in Pharmaceutical Manufacturing Operations, 2015
PDA Technical Report #70: Fundamentals of
Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities, 2015
Contributing author to The Cosmetic, Toiletry and Perfumery Association
& Pharmig (2015) Rapid and
Alternative Microbiological Methods, published by the CPTA, London
Author of Pharmig Microorganism Fact Sheets. 8
full colour sheets relating to pharmaceutical important fungi, written by Tim
Sandle and issued in November 2015.
Author of Pharmig Microorganism Fact Sheets. 8
full colour sheets relating to important environmental isolates, written by Tim
Sandle and issued in November 2016
Written
conference papers
Sandle,
T. Cleanroom Monitoring – What, When and How Often, included in Pharmaceutical
Cleanrooms conference pack for the ‘Cleanrooms 2003 Conference’ 16 – 19th March
2003, Cambridge
Sandle,
T. Sterility Testing – A Practical Approach. Written paper presented to PharMIG
Microbiological Methods Validation Conference, St. Albans, 4th June
2003
Sandle,
T. Points to Consider In Performing Risk Assessments Of Isolators Used For
Aseptic Processes. Written paper presented to the AUDITS 13 conference,
organised by La Calhene, Brussels, 16th September 2003
Sandle,
T. Current Practices in Sterility Testing. Written paper presented to Institute
of Validation Technology Microbiology Event of the Year, December 2003,
Dublin
Sandle,
T. Sterility Testing – A Practical Approach (Revised). Written paper presented
to PharMIG Microbiological Methods Validation Conference,Dublin, 25th March
2004
Sandle, T. Three Aspects of LAL Testing: Glucans, Depyropgenation and Water System Qualification. Written paper presented to PharMIG Endotoxin Course, Waltham Abbey, 3rd June 2004.
Sandle,
T. Microbiological Environmental Monitoring in an Isolator Used for Aseptic
Filling or Sterility Testing, written paper presented to the La Calhene
Audits 15 Conference, Brussels, 21st September 2004
Sandle,
T. Environmental Monitoring Risk Assessment. Written paper presented
to Institute of Validation Technology Microbiology Event of
the Year’, Amsterdam, November 2004
Sandle,
T. The Use of Risk Assessment in Developing a Viable Environmental Monitoring
Programme. Written paper presented toPharmaceutical Cleanrooms 2005, Cambridge,
September 2005
Sandle,
T. A guide to the Pharmaceutical Microbiology Interest Group Web Forum, paper
presented to the PharMIG Conference, 23rd November
2005
Sandle,
T. The Distribution of Microbiological Data, Written Paper for the PharMIG
Irish Conference, Cork, 7th June, 2006
Alexander,
B. and Sandle, T. Managing a Microbiology Laboratory Training Programme, a
PharMIG training package (issued to delegates with the one-day workshop papers
on 29th March 2007)
Sandle,
T. Applying Failure Mode and Effects Analysis (FMEA) to a Sterility Testing
Isolator: A Case Study, written paper included with the PharMIG Risk Based
Management in Pharmaceutical Microbiology, 27th June 2007
Reports
Sandle, T. (2011): ‘Pharmig Conference Summary:
November 2010’, Pharmig News, Number
42, pp10-11
Contributing
interview to ‘Ensuring Sterility of Parenteral Products’, along with James
Agalloco and BenoƮt Verjans. Published in Pharmaceutical
Technology, April 2013, pp2-6
Cox, B. (2013). Are Cleanrooms Clean? Human Microbiome Project
Raises Some Questions, The Gold
Sheet, 47 (11): 16-18 - a review of Tim Sandle's 2013 PDA Microbiology
presentation.
Interviews
An interview with Tim Sandle, conducted by Pharmaceutical
Bioprocessing (http://www.future-science.com/doi/pdf/10.4155/pbp.13.64):
Sandle,
T. (2014). Pharmaceutical Microbiology, Pharmecutical
Bioprocessing; 2(1): 17–21
Interview with Tim Sandle for Microbiology Today by Saumyadip
Sarkar.
Sakar, S. (2014) Portrait - an interview with Dr. Tim Sandle, Micrographia Today, 1 (2): 16-20
http://www.wethemicrobiologist.in/uploads/9/4/5/2/9452624/06._magazine_feb_-_mar_1.pdf
Regulatory updates
Tim
Sandle writes a quarterly column on regulatory updates for Pharmig News. The
series began in 2008 and continues to date.
Poster abstract
Poster
abstract ‘Assessing airborne contamination using a novel rapid microbiological
method’ by Tim Sandle, Clare Leavy and Rachel Rhodes. Published in Helapet
Newsletter, Issue 4, 2015, p2.
Notes
[1] This paper was featured in a book about
marketing:
Title
|
Principles of
direct and database marketing
|
Author
|
|
Edition
|
4, illustrated
|
Publisher
|
Pearson
Education, 2008
|
ISBN
|
0273713027,
9780273713029
|
Length
|
517 pages
|
Comments