Professional Documents
Culture Documents
Publications by Tim Sandle
Publications by Tim Sandle
Publications by Tim Sandle
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. 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
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
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/bacterialmycotic-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, pp176
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. 232237
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. 238243
Sandle, T., 2014. Laboratory Design. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of
Food Microbiology, vol 2. Elsevier Ltd, Academic Press, pp. 393401
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. 4453
Sandle, T., 2014. Trichoderma. In: Batt, C.A., Tortorello, M.L. (Eds.), Encyclopedia of Food
Microbiology, vol 3. Elsevier Ltd, Academic Press, pp. 644646
Sandle, T. (2014) Bacterial Diseases and their Diagnosis. In Chesca, A. (Ed.) Techniques and
Procedures for Disease Diagnostic, Lambert Academic Publishing, Saarbruken, Germany, pp3160
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, 3.13.26
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, 9.19.32
Sandle, T. (2014) Microbiology of Pharmaceutical Grade Water. In Handlon, G. and Sandle, T.
(Eds.) Industrial Pharmaceutical Microbiology: Standards & Controls, Euromed
Communications, Passfield, UK, 10.110.19
Sandle, T. (2014) Biological Indicators, In Handlon, G. and Sandle, T. (Eds.) Industrial
Pharmaceutical Microbiology: Standards & Controls, Euromed Communications, Passfield, UK,
16.116.26
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, 18.118.13
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, 22.122.14
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
Kszegi, 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
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. '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, JulyAugust 2011, pp392403 (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: 319329 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/gxpjournal/journal-of-gxp-compliance-2687
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: 10.4172/23298731.1000e110
Sandle, T. (2013). Global Strategies for Elimination of Leprosy: A Review of Current Progress,
Journal of Ancient Diseases & Preventive Remedies, 1 (4): e112. doi: 10.4172/23298731.1000e112
Sandle T (2014) Novel Methods to Address Antimicrobial Resistance. SOJ Microbiol Infect Dis
2(1):
2-3
(see
here:
http://symbiosisonlinepublishing.com/microbiologyinfectiousdiseases/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-biologicalindicators-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 -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): 168 172
Sandle, 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 online
http://www.ivtnetwork.com/article/lean-laboratory-and-its-application-reviewenvironmental-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/wpcontent/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
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-transferrisk-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-newautoclave-pharmaceutical-manufacturing-facility
Sandle, T. Human Microbiome of the Skin: Advances in Metagenomics. EC Microbiology 1.3
(2015): 162-165.
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. Microbiology and the World Wide Web - Revisited, PharMIG News, Issue 28, pp1011
Sandle, T. Some Considerations on the Use of Endotoxin Indicators in Depyrogenation
Studies, Pharmaceutical Microbiology Forum Newsletter, Vol. 13, No. 10, November 2007, pp211
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 microbiologists 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/28/128disinfectants_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.cleanroomtechnology.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. (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 fr den Einsatz in der Pharmaindustrie, IAB
Cleanroom
GmbH
website:
http://www.iab-reinraumprodukte.de/infoportal/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
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.medicaldevicedevelopments.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.cleanroomtechnology.co.uk/technical/article_page/Biocontamination_control__moves_toward_a_better_sta
ndard/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/1504White-Papers-Application-Notes/140112-Implications-of-the-Human-Microbiome-onPharmaceutical-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/FeaturedArticles/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-andthe-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/FeaturedArticles/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. (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.ipv6exp.l.google.com%2Fgen_204%3Fip%3D81.156.212.12%26ts%3D1309692715373476%26auth
%3Dpds7hrga6grshaf6rlfeatpwd464noyf%26rndm
%3D0.00039878398549886285&v6s=2&v6t=8449&usg=AFQjCNHAVVyROwwVYokmKQI3TKg5TiLIQ&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-forpharmaceutical.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-laune/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 Einfhrung", IAB website, published 27th July
2012 (see IAB) (http://www.iab-reinraumprodukte.de/info-portal/fachartikel/desinfektionsmitteleine-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)
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