Tim Sandle
Pharmaceutical Microbiologist
Dr. Sandle has over twenty-five years experience of microbiological research and biopharmaceutical processing. He is Head of Microbiology at Bio Products Laboratory (U.K.) and a visiting tutor with The University of Manchester School of Pharmacy. Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control. He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); and is a member of several editorials boards for scientific journals.

Dr. Sandle has written over three hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle's current research interests are cleanroom fungi; microbiology of water; disinfectants; and rapid microbiological methods.

In addition, Dr. Sandle serves on several national and international committees relating to pharmaceutical microbiology and cleanroom contamination control (including the ISO cleanroom standards). He is a committee member of the Pharmaceutical Microbiology Interest Group (Pharmig); serves on the National Blood Service advisory cleaning and disinfection committee; and is a member of eleven editorials boards for scientific journals.

Dr. Sandle has acted as a consultant, expert witness and technical advisor to sterile and non-sterile manufacturing facilities, microbiology laboratories, the medical device industry and hospitals. Dr. Sandle has also undertaken several technical writing and review projects.
Upcoming Webinar
Fungal Contamination and Pharmaceutical Products Recall
In this webinar speaker will examine the risks posed by fungi to pharmaceutical products and has emphasized how this is an issue of growing importance (as seen by the extent of product recalls relating to fungal contamination).
Live Session Thursday, 19 September 2019, 10:00 AM PDT | 01:00 PM EDT, Duration: 60 Minutes

Recorded Webinar
Developing a contamination control strategy to meet EU GMP Annex 1 requirements
Contamination control is an important part of both sterile and non-sterile pharmaceutical manufacturing, regulators, as signaled by the revised EU GMP Annex 1 and from FDA inspections are increasingly expected the contamination control to be devised and presented as a formal program. This means a detailed, facility-specific contamination control strategy. This webinar sets out the key elements of the strategy. To be effective, this needs to be an approach that can assess seemingly isolated contamination events holistically and which is capable of putting appropriate corrective and preventive actions (CAPAs) in place. This approach signals a new paradigm in terms of contamination control, shifting the risk review process to one that assesses the impact of a contamination event in a far wider context.
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Best practices for designing and implementing an environmental monitoring programme
The purpose of microbiological environmental monitoring is to assess the cleanliness of pharmaceutical (sterile and non-sterile) and medical device manufacturing environments. Environmental monitoring involves the collection of data relating to the numbers or incidents of microorganisms present on surfaces, in the air and from people. In addition, non-viable particle counting, is undertaken in conjunction with viable monitoring because of the relationship between high numbers of airborne particles and microorganisms. Monitoring is not the same as control, although the two are connected. This webinar looks at the key factors required for building and developing a successful environmental monitoring control program.
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Handling data integrity in the microbiology laboratory
Despite the current high profile, the subject of data integrity in the pharmaceutical microbiology laboratory has not been afforded very much attention in terms of regulatory guidance or in terms of active discussion through articles penned by those working in the pharmaceuticals or healthcare sectors. To bridge this gap, this webinar outlines some of the data integrity concerns within the microbiology laboratory and considers some of the steps that can be taken to address identified weaknesses.
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Practical Approaches to Sterility Test Validation: Overcoming difficult products
This webinar examines some practical approaches to sterility test method validation, in relation to the pharmacopeia described culture based method. Method validation is important because products must be shown to be non-inhibitory to the recovery of any microorganisms that may be present in the sample. The main concerns here are with products not being validated due to problems with the method or, more seriously, the risk of a false-negative where a product is released when it appears to pass the sterility test whereas it actually contains microorganisms. The webinar also addresses the significance and risks in relation to sterility test failures.
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How to justify doing less microbiological sampling and testing, and still pass a regulatory inspection
This presentation is about environmental monitoring, considering why we perform environmental monitoring and how a value added program can be constructed. This is a program that delivers appropriate information at the right frequency which can be reviewed by microbiologist, quality assurance and production personnel. The focus is developing risk based thinking and evaluating what actually takes place within different types of cleanrooms. This approach involves assessing a range of different factors relating to cleanroom design, use, control parameters, product exposure, operators and so on.
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Applying FMEA risk assessment to a sterility testing isolator
Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high-quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label. To achieve this, manufactures have always needed to be mindful of risk and to undertake proactive risk assessments. This webinar discusses how the risk analysis tool of Failure Modes and Effects Analysis (FMEA) can be applied. This is based on a case study of a sterility testing isolator.
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Out of Specification Investigations: A New Look at the Topic
Despite the guidance that is in place, many regulatory cite poor out-of-specification (OOS) investigations and these features high up on lists of inspectorate findings. Notably these are renewed calls by agencies for the OOS investigation to be thorough, timely, unbiased, well documented and scientifically sound. Hence key challenges for many companies are with having a clear understanding of regulatory expectations on how to handle OOS investigations. To help, this presentation takes a look at how OOS are conducted and presents different ways through which OOS investigations can be improved.
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The Problem of Bacterial Spores and Sporicidal Disinfection
There have been a number of pharmaceutical and healthcare product recalls associated with bacterial contamination, and a number of these are associated with spore forming organisms. In addition, there have been some reported cases of patient illness, especially in relation to aseptically produced medicines. Investigations have shown that poor contamination control has led to spores being prevalent in the production environment. Improved contamination control strategies are required to prevent such incidents from occurring.
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What to identify? Why Screening Cleanroom Microbes Matters
This webinar will look at microbial identification for pharmaceutical and healthcare facilities, examining the common types of organisms isolated from pharmaceutical cleanrooms; the methods of identification; and the inferences that can be drawn from identification patterns; how often to identify and when to identify; ways to trend cleanroom microorganisms; the level of detail that can be assessed from genotypic and phenotypic identification; and the uses of isolates in terms of the testing of culture media, use in microbial validation; and for disinfectant efficacy testing.
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Control of Cleanroom Garments and Supplies: Contamination Control
This webinar considers the important considerations for the control of operators in cleanrooms so that microbial and particulate contamination can be reduced. The focus is with people being the main contamination source within cleanrooms. Considered in the webinar are: Selection of gowns, gowning requirements, gowning tests, environmental monitoring associated with people, selection of gloves and facemasks. Other topics considered include the differences between disposable gown and re-laundered gowns, gown repair policy, and sterilization of gowns.
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Global Best Practices for Cleaning and Disinfection of Cleanrooms and Disinfection Validation
Cleaning and disinfection of cleanrooms is of great importance as part of a contamination control strategy. For this to be effective, correct disinfectants need to be selected, rotation between biocides must in place, a sporicidal agent needs to be selected, disinfectants need to be qualified cleaning frequencies need to be established, and appropriate training given. This is hampered by the lack of a global approach to satisfy regulatory agencies. This webinar provides an overview of the focal points required to achieve a global approach for cleanroom disinfection.
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Burkholderia cepacia - Risks in Context for Non-Sterile Pharmaceutical Products
Burkholderia cepacia complex (BCC) organisms can survive or multiply in a variety of non-sterile and water-based products because it is resistant to certain preservatives and antimicrobial agents. This makes the organism a risk in terms of non-sterile aqueous products. Detecting BCC bacteria is also a challenge and requires validated testing methods that take into consideration the unique characteristics of different BCC strains. This webinar discusses where the organism may be found, how to detect it and what to do if it is present in the manufacturing environment.
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ISO 14644 - The Revised Standard and Implications for Cleanrooms
The international standard for cleanrooms has undergone a major revision. This webinar discusses the revisions in the context of global GMPs and the overall contamination control strategy. The webinar discusses testing approaches and the assessment of test data. The learning point is with keeping cleanrooms compliant.
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Human Microbiome and Implications for Contamination Control
People are the biggest source of contamination in cleanrooms. The findings from the human microbiome project suggest an overview of controls is required. This presentation reviews the latest research into the human microbiome, especially in relation to the skin, and looks at the levels of controls and risks required, such as behaviors and gowning practices. The presentation also considers the impact of the knowledge on the use of environmental isolates for culture media testing and applied areas like disinfectant efficacy testing.
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Good Design Practices For Pharmaceutical Water Systems
Water-borne microorganisms are ubiquitous and varied in their ability to survive and grow under different conditions. Therefore, an out-of-control water system can cause harm to the patient or adulterate pharmaceutical products. Purification of water is required to prevent interaction with drug substances or other ingredients in the product formulation. Water must also be microbiologically controlled and monitored. This webinar will assesses some of the requirements for good design, together with the control measures necessary to maintain effective microbiological control in pharmaceutical facility water systems.
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The Problem of Bacterial Spores and Sporicidal Disinfection
There have been a number of pharmaceutical and healthcare product recalls associated with bacterial contamination, and a number of these are associated with spore forming organisms. In addition, there have been some reported cases of patient illness, especially in relation to aseptically produced medicines. Investigations have shown that poor contamination control has led to spores being prevalent in the production environment. Improved contamination control strategies are required to prevent such incidents from occurring.
Recorded Session Get life time access for one participant with download option!

Fungal Contamination and Pharmaceutical Products Recall
Over the past decade, the number of pharmaceutical product recalls due to fungi has increased significantly, with many different product groups affected. Data suggests a link between product contamination and the process environment. A key concern is a lack of knowledge, even among microbiologists, about identifying fungi and understanding their origins. This webinar will explain different types of fungi, risks to products, guidance on identification, and a focus on remediation measures to remove, eliminate and to prevent fungi.
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EU GMP Annex 1 - What's New for Sterile Product Manufacturing?
A major revision is taking place with the European regulations covering the manufacture and distribution of sterile products. This is the first major update in 20 years, with the new draft text bringing in many changes, several of which will be far reaching.
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Investigating Sterility Test Failures
Sterility testing is widely used in both the medical device and pharmaceutical industries. The pharmacopeia test is the official procedure for testing the sterility of pharmaceutical products. Despite its importance and its widespread use, many people are not aware of the limitations of the sterility test and are unsure how to proceed when a failure investigation occurs.
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Risk Based Approach to Environmental Monitoring
Regulators frequently cite concerns with environmental monitoring and the lack of a well-thought out rationale. This shortfall can be overcome through the application of risk assessment and scientific approaches. The application of risk assessment applies to selecting location for monitoring and frequencies of monitoring; and for data assessment. This presentation outlines the primary tools that can be used to achieve this.
Recorded Session Get life time access for one participant with download option!

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