Pharmig Ireland (video highlights)

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Pharmig Ireland Microbiology Conference Highlights

Highlights from the Pharmig Ireland Microbiology Conference - enjoy!

 

 

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Pharmig virtual events

Pharmig want to leave this year on a virtual high note and have restructured the traditional face-to-face Annual Adriatic Conference (21st & 22nd Oct) and 28th Annual Conference (2nd & 3rd Dec) to now become ‘new normal’ virtual meetings.

Although the Adriatic event was researched with local contacts – you might well find the sessions are of interest to you too. Presentations include:

- Draft Annex 1 changes and its impact on cleaning & disinfection
- Impact of SARS-CoV-2 in cleanroom operations
- Biofilms in water
- Microbiological culture media

For the 28th Annual Conference sessions include:

- Megalab experience – testing for SARS-CoV-2 RNA from 0 to 3 million tests in 5 months
- Hand sanitizers: what to look for and how to test
- Conducting an effective remote audit
- Why wont my bugs grow?
 

And lots more...!

Do go to the website to view the agendas www.pharmig.org.uk

Take care and stay safe
#pharmig #microbiology #covid #audit #cleaninganddisinfection #culturemedia #mythsofpharmamicro #staysafe

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Pharmig News #74

A new edition of Pharmig News has been published. In the latest issue:

• The hidden problems with relaundering microfibre mops by Karen Rossington
• Endotoxin hot topics and issues by Ruth Noé and Julie Roberts
• Validation of contact plates for environmental monitoring by Merck KGaA, Darmstadt, Germany
• Pharmig Membership Survey by Tim Sandle
• Latest regulatory news
• And more!

Copies have been sent out. If you would like to see a copy, please email: info@pharmig.org.uk

Key reference:

Sandle, T. (2019) Pharmig membership survey, Pharmig News, Issue 74, pp9-12



Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Pharmig Guide to Bacterial Identification

Pharmig’s latest publication is a guide to bacterial identification. The guide discusses why identification is important and what needs to be identified, answering the often-challenging questions of ‘what’, ‘when’ and ‘how often’?

There are several text books on identification. These, however, err towards the clinical. Texts on identification approaches for pharmaceutical microbiology are not common and guidance on understanding the appropriate level of identification is difficult to obtain.

Microbial identification represents an important part of the microbiology function. This includes screening products for objectionable organisms, profiling the environmental microbiota, and investigating out-of-limits events with a view to assigning a probable point of origin. In deciding what and when (and subsequently to what level) to identify, and by the way of which methods, requires an identification strategy. This is a document each microbiology laboratory should develop.

Many parts of pharmaceutical microbiology are outlined in compendia or in guidance documents issued by regulators; included within these are the importance of bioburden assessments of intermediate and finished products, and the need to monitor the environment using standard environmental monitoring methods. What is less clear is expectation with regards to microbial identification. For identification, there are established and emerging methods, based around the microbial phenotype or genotype, yet the choice between systems is not straightforward and the selection depends, in part, on what needs to be identified. Deciding which types of samples to identify; what level of identification is appropriate (morphology, genus, or species); and what can be done with the collected information needs careful thought.

Written by Dr. Anna Lovatt (GSK) and Dr. Tim Sandle (BPL), the guide discusses different methods for phenotypic and genotypic identification, and the latest rapid methods. Troubleshooting sections and case notes are included with each section. The guide comes with a foreword from Andrew Hopkins of the MHRA.

The reference is:

Lovatt, A. and Sandle, T. (2018) Guide to Bacterial Identification, Pharmig, Stanstead Abbotts, UK

For details contact Pharmig

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Pharmig Annual Conference 2018

Pharmigs 26th Annual Conference Programme Interactive 2018 Final (1) by Tim Sandle on Scribd

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Pharmig News #72

A new edition of Pharmig News has been issued. In this edition:

• Pharmig events update
• Review of Pharmig Irish conference and risk management by Tim Sandle
• Brexit uncertainty by Tim Sandle
• Latest regulatory news
• And more!

Copies will have been sent to member organisations. To see a copy, please email Pharmig at: info@pharmig.org.uk

Tim Sandle's articles in this edition are:

Sandle, T. (2018) Microbiology Risk Management (QRM): a practical approach meeting, Pharmig News, Issue 72, pp2-4

Sandle, T. (2018) Brexit uncertainty for pharmaceutical companies, Pharmig News, Issue 72, pp5-6

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology

Pharmig publications

Factsheets cleanroom isolates

Standard microbiology text books are biased to medical bacteria. These factsheets provide pharmaceutical microbiologists with details on the most common isolates from pharmaceutical cleanrooms.

The factsheets provide descriptive information and characteristics of the main organisms, to help microbiologists tasked with investigations, together with full colour colony and growth characteristics, and typical Gram-stain profiles, to assist those who carry out identifications.

These laminated sheets are ideal for use on the laboratory bench, to assist microbiologists as they carry out their work, and as handy training aids.

See: https://www.pharmig.org.uk/en/product/a-series-of-8-fact-sheets-on-cleanroom-environmental-isolates-november-2016/

Factsheets on fungi

Regulators have stated that knowledge of fungal identification is weak in microbiology laboratories, and many inspectors expect fungi to be identified as part of microbial contamination tracking. The problem is, few text books focus on the most common cleanroom isolates.

Pharmig has addressed a gap by profiling the most common fungi found in cleanrooms (based on FDA recalls) and presenting full colour guides to the cultivation and identification of these fungi.  Included with the macroscopic and microscopic images is detailed advice on where these fungi are found and what the implications for their recovery means.

These laminated sheets are ideal for use on the laboratory bench, to assist microbiologists as they carry out their work, and as handy training aids.

See: https://www.pharmig.org.uk/en/product/a-series-of-8-fact-sheets-on-pharmaceutically-important-fungi-2/

Rapid and alternative methods

Most microbiologists are seeking to invest in and develop rapid or alternative microbiological methods, in order to produce more accurate and faster results. There are also advantages in terms of automation and data integrity.

Finding out about the different technologies and then selecting between methods can be challenging. This publication provides an overview of different types of technologies and profiles many of the current methods available.

The guide also provides microbiologists (and their management chain) with guidance on selecting and qualifying methods (running the IQ, OQ and PQ spectrum). Also included is detail on how to build a case for justifying a method, considering factors like return on investment.

See: https://www.pharmig.org.uk/en/product/pdf-publication-on-rapid-alternative-microbiological-methods-joint-publication-between-pharmig-ctpa/

Factsheets on objectionable organisms

Objectionable organisms is a buzz phrase in the pharmaceutical sector, prompted by a push from regulators to consider those microorganisms beyond those described in the pharmacopeia as specified organisms that might pose a risk to products.

This series of factsheets describes the criteria for determining whether an organism is objectional or not (looking at things like product risk profiles and the patient population), and presents profiles of many common objectionales. These organisms have been selected based on their commonality to the environment and appearance in recall observations from inspectors.

The fact sheets use colour photographs illustrating growth on agar and by Gram-stain. These are supported by facts relating to the organism’s profile and methods for identification.

The sheets are presented in a pack and together provide a unique, informative and colourful guide to an important area of quality control microbiology.

See: https://www.pharmig.org.uk/en/product/a-series-of-8-fact-sheets-on-major-objectionable-organisms/

Factsheets on Microbial Limits Test organisms

The Microbial Limits Test is the mainstay of many pharmaceutical microbiology laboratories. While the test is common there are challenges, such as identifying and characterising the specific microorganisms described in the pharmacopeia.

These factsheets are designed to act as a training aid for new staff, and an aide memoire for more experienced staff. The sheets use colour photographs to illustrate growth on agar and by Gram-stain. Each organism is additionally profiled, with information relating to the organism’s profile and risks to the patient.

The sheets are laminated and presented in a pack and together provide a unique, informative and colourful guide to an important area of quality control microbiology.

See: https://www.pharmig.org.uk/en/product/a-series-of-8-microorganisms-fact-sheets/

Best Practices in Microbiological Documentation – Electronic Pack One

Microbiology laboratories contain many computerised systems, SOPs, protocols and forms. When setting up a microbiology laboratory, generating the required documentation is a huge task. This Pharmig pack provides all of the necessary templates you’ll need in a downloadable and editable format.

The pack includes:

·         Training in setting up electronic systems.

·         Advice on electronic systems.

·         Templates for laboratory SOPs and protocols.

·         Examples of test forms for a range of common QC microbiology tests.

·         The full range of validation documentation for laboratory equipment, from URS to IQ, OQ, and PQ files.

The various files will also be of interest to the established laboratory manager, serving as a useful best practice benchmark.

See: https://www.pharmig.org.uk/en/product/best-practices-in-microbiological-documentation-electronic-pack-one/

Setting up and Managing an Effective Training Programme in the Micro Laboratory – Electronic Pack Two

In every regulatory inspection training features and the training folder of the microbiologist is certain to be inspected. Are you using the most appropriate format for your training? This pack provides an array of templates for the full range of QC microbiology tests.

Just as important as training is assessment. But how to assess? What should be practically demonstrated? Which questions to ask of the trainee? This pack provides a range of downloadable and fully editable assessments for everything from microbial identifications to environmental monitoring.

Also included are templates to allow laboratory managers to track, trace and trend training. By purchasing this pack, the managers and the microbiology team will be audit ready.

See: https://www.pharmig.org.uk/en/product/setting-up-and-managing-an-effective-training-programme-in-the-micro-laboratory-electronic-pack-two/

LAL factsheets

Endotoxin testing is an important area for many microbiology laboratories. Training in the LAL test is often best broken down into bite-sized chunks, and these factsheets provide single-point lessons on the key aspects of the test.

Areas covered include:

·         What is LAL/BET?

·         Calculation of endotoxin limits

·         Medical devices

·         Gel clot methods

·         Photometric methods

·         Product validation quantitative methods

These areas are explained in clear and concise language, together with practical examples and with illustration.

The sheets are presented in a pack and they are laminated, making them an ideal bench-side training aid.

See: https://www.pharmig.org.uk/en/product/lal-fact-sheets/

Best practices for the Bacterial Endotoxin Test: A Guide to the LAL Assay

The core parts of the LAL test for endotoxin is described in the main pharmacopeia, but there are many things left out and others that are less clear, especially when training new staff.

This comprehensive guide describes how to:

·         How to undertake method development.

·         How to validate new samples.

·         Explains concepts like maximum Valid Dilution and Endotoxin Limits.

·         Outlines how to run a depyrogenation study.

·         Looks at medical device testing.

·         Contains a detailed trouble shooting guide.

This book provides a useful reference document for LAL users.

See: https://www.pharmig.org.uk/en/product/best-practices-for-the-bacterial-endotoxin-test-a-guide-to-the-lal-assay/

Current perspectives on Environmental Monitoring

All microbiologists need to carry out environmental monitoring, whether this is of a major plant or within the laboratory safety cabinet. Many aspects of monitoring are not well described and this Pharmig book addresses this.

The book contains chapters written by industry experts, covering:

·         How to set up an environmental monitoring programme.

·         Cleanroom microbiology.

·         How to evaluate environmental monitoring methods.

·         How to clean and disinfect effectively.

·         Tips for achieving particulate control.

·         How to run a risk assessment following an adverse trend.

Whether a beginner or an advanced practitioner, this guide has something for pharmaceutical microbiologists and their management teams.

See: https://www.pharmig.org.uk/en/product/current-perspectives-on-environmental-monitoring-review-1/

Microbiological Control for Non-Sterile Pharmaceuticals

There is far more guidance for sterile manufacturers than those involved with non-steriles in relation to microbial contamination risks and control measures. To address this gap, Pharmig has produced this guide for microbiologists working in this field.

The guide covers:

·         Best facility design requirements.

·         Microbial risks in non-sterile manufacturing.

·         Best practice tips for achieving microbial control.

·         How to clean and disinfect effectively.

·         Advice on undertaking risk assessments.

·         Microbiological testing.

·         Environmental monitoring.

The guide helps steer the microbiologists through the regulatory expectations, offering many practical examples.

See: https://www.pharmig.org.uk/en/product/microbiological-control-for-non-sterile-pharmaceuticals/

Guide to Cleanroom Operation and Contamination Control

Cleanrooms are the fabric within which most pharmaceutical processing takes place, yet not all pharmaceutical microbiologist are familiar with how they work and the contribution they make to minimising contamination.

In addition there are several different cleanroom standards and making sense of these and drawing comparisons can be changing. 

This Pharmig guide:

·         Describes the contamination control features of cleanrooms.

·         Explain the different cleanroom standards and how they compare.

·         Provides detail of the recently updated ISO 14644 standard (Parts 1 and 2).

·         Descries the different test methods for cleanrooms, like particle classification; pressure monitoring; air change rates and so on.

The guide is useful for microbiologists and cleanroom managers – helping to link engineering principles for microbiologists.

See: https://www.pharmig.org.uk/en/product/guide-to-cleanroom-operation-and-contamination-control/



Posted by Dr. Tim Sandle

Pharmig News #71

The latest edition of Pharmig News has been issued (edition #71). In this issue:

• Update on Pharmig events
• Report from PHSS conference on Annex 1
• Pharmig’s response to the draft Annex 1
• Review of new electronic training module
• Regulatory update
• And more..

Copies have been sent to Pharmig members. If you are interested in reading a copy, contact: info@pharmig.org.uk

There are two pieces by Tim Sandle in the newsletter:

The EU GMP Annex 1 draft was subject to a consultation period during which interested partiels submitted responses. Pharmig was one of the member organisations that submitted a response. Pharmig welcomed the draft and see it as a long overdue reclarification of the requirements of sterile products manufacturing. The stronger link to Quality Risk Management and references to new technologies were particularly welcomed.

Sandle, T. (2018) Pharmig’s response to EU GMP Annex 1 draft concept paper, Pharmig News, 71, pp4-7

Pharmig has established an interactive on-line training platform. The first module covers cleaning and disinfection, aimed at GMP cleanrooms. To understand how e-learning can be delivered effectively, Tim Sandle interviewed one of the co-developers, Laura Guardi.

Sandle, T. (2018) Insight into Pharmig’s new e-learning module, Pharmig News, 71, pp7-9



Posted by Dr. Tim Sandle

Pharmig News #70

The 70^th edition of Pharmig News has been published.

In the new issue:

• Report from the Royal Society of Microbiology, by Julie Roberts.
• Report of the Pharmig 25^th Anniversary Conference, including reviews of the different presentations.
• Hot topics in pharmaceutical microbiology.
• Review of Pharmig’s Adriatic Region conference.
• Pharmig’s round-up of regulatory news.
• And more….

Copies have been sent to Pharmig member companies. If you are interested in reading a copy or finding out more about Pharmig, please contact Pharmig at: info@pharmig.org.uk

Posted by Dr. Tim Sandle

Pharmig conference report

The new to invest in new technologies and a call for a new paradigm for approaching risk assessment were the keynote messages from the 2017 Pharmig conference, which focused on making medicines safe for patients.

Despite innovations in rapid microbiological methods the pharmaceutical sector has been slow to adopt the latest technologies; moreover, the approach to assessing the risks to products is too often rooted in poor science and an over-reliance upon scoring every tiny detail with an arbitrary number. These were the messages delivered by a pharmaceutical regulator and one of the world’s foremost pharmaceutical microbiologists.

The Pharmaceutical Microbiology Interest Group (Pharmig) hosts an annual conference each year in the U.K. This year’s event took place at Heythrop Park, part Grade II listed Baroque building designed for the Duke of Shrewsbury, and part modern conference center.

The conference opened with addresses from two former chairs of Pharmig: Sharon Johnson and David Begg. Begg called on the industry not to forget what really matters - protecting patients; and Johnson queried why progress with the adoption of rapid methods was so slow.

David Begg, a former medicines inspector, addresses the 2017 Pharmig conference.

Tim Sandle

Need for a less conservative pharmaceutical industry

The call for the pharmaceutical industry to be less conservative with the adoption of rapid microbiological methods came from healthcare regulator Andrew Hopkins (the pertinent points from his presentation are discussed in the article “Rapid methods needed to help safety of medicines”). Hopkins stressed that better dialogue was required between regulators and pharmaceutical manufacturers, and he outlined a forum that can be used for this purpose.

One of the exhibition stands at the Pharmig conference, with a display of the special clothing required to access production areas.

Tim Sandle

The need for a renewed focus on risk assessment came from Dr. Edward Tidswell (Merck-U.S.), who is also an expert in how microorganisms adhere to surfaces and co-editor of the book “Aseptic and Sterile Processing: Control, Compliance and Future Trends”. Dr. Tidswell, in conjunction with Kevin O’Donnell, who represents the Irish regulator agency the HPRA, said that too many risk assessments are based on a lack of data and use a poorly conceived scoring system. Called out for greatest criticism was ‘Failure Modes and Effects Analysis’ (FMEA), a risk tool commonly used in the engineering sector.

Dr. Edward Tidswell address the 2017 Pharmig conference.

Tim Sandle

New paradigm for risk management

Instead, Dr. Tidswell said, quantitative risk management was needed - real-time data and lots of it. Only through big data analytics, the pharmaceutical microbiologist stated, can risks of microbial contamination transfer to a pharmaceutical product be truly understood and quantified. For this to work, and in a link back to the presentation made by Hopkins, a greater adoption of rapid methods is needed. Hence both new approaches to risk assessment and rapid methods are needed for the digital transformation of pharmaceutical microbiology.

Examples of rapid microbiological methods on show at the Pharmig conference, including real-time biologica air-samplers.

Tim Sandle

Another presentation of note was delivered by Professor Willy Verstraete of the University of
Ghent, Belgium. This presentation looked at ecological microbiology and how understanding microbial communities better is the basis for better environmental control, especially in relation to agriculture. Here biotechnology, such as the use of nitrogen-utilizing bacteria in bioreactors, can be used for such innovations as microbial protein to be used as a meat substitute. For more on Professor Verstraete’s treatise see the article “Will microbial protein replace meat on the table?"

New microbial contamination concerns

Contamination of pharmaceutical products with water-borne organisms was a theme addressed in two presentations. The first was a case study outlined by Geert Verdonk, from the German pharmaceutical giant Merck. The second was a regulatory perspective given by Dr. John Metcalfe, from the U.S. Food and Drug Administration (FDA).

David Keen, chair of Pharmig, addresses the 2017 conference.

Tim Sandle

In these presentations that growing regulatory focus on the organisms that form the Burkholderia Cepacia Complex was detailed, especially in relation to non-sterile pharmaceutical products. Burkholderia Cepacia Complex is a group of some twenty organisms; bacteria that are naturally resistant to many common antibiotics and thereby posing a public health hazard. If pharmaceutical products are contaminated with such organisms, then based on the patient population and the total bioburden, this would pose a risk of serious illness.

According to Dr. Metcalfe it is beholden upon pharmaceutical manufacturers to stablish procedures to prevent these objectionable microorganism contaminating of drug products. This includes having adequate procedures to assure adequate quality of incoming materials; ensuing processes are of sanitary design with appropriate maintenance and cleaning of equipment. In addition there should be production and storage time limitations, supported by the monitoring of environmental conditions.

Delegates meeting with exhibitors at the Pharmig 2017 conference.

Tim Sandle

Sanitary design was discussed by another presenter, Neil Lewis who is the Global Household Care Microbiologist at Proctor and Gamble. This looked at how alternative methodologies can be used to assess the cleanliness of equipment, arguing that legacy approaches to do not adequately address microbial risks.

New technologies on the horizon

The new technology theme was continued by Dr. Mark Sutton, who works for Public Health England. Dr. Dutton has developed an alternative means for assessing biodecontamination of clean areas. Instead of the sometimes imprecise method of adding bacterial spores onto strips of paper or stainless steel to assess microbial kill, Dr. Sutton is proposing an enzymatic test using thermostable Adenylate Kinase. This enzyme is found in all cells and it plays a role in cellular energy homeostasis.

Other presentations took different directions. Les Meader, who runs two companies - Omnia CS and Foresight Innovations Limited, discussed why human error occurs and how understanding this can be applied to pharmaceutical and healthcare manufacturing. Understanding human psychology, Meader argued, is necessary if processes are to be designed in an optimal way as so to reduce people related mistakes.

The theme of training was central to new a digital training module developed by Pharmig for those tasked with cleaning and disinfection. The online platform uses digital technology and e-learning to reinforce best practices. The module was previewed by Rachel Blount and Laura Guardi, both representing Pharmig.

Rachel Blount and Laura Guardi presenting a new interactive training video.

Tim Sandle

Brexit and regulations

Andrew Hopkins gave a second presentation addressing a concoction of topics, from ways to produce pharmaceutical grade water (reverse osmosis or distillation) to Brexit (the impact of regulations on making medicines in the U.K.) His central theme was, however, Good Manufacturing Practice (GMP) and the forthcoming changes to the guidance for sterile products (Annex 1 to European Union GMP). The new guidance foster the need for a formal microbial contamination risk assessment.

The take-home messages from the conference, chaired by GlaxoSmithKline expert microbiologist David Keen, were that more can be done to protect patients in the production of safe medicines. For this, quality risk management and new technologies are the tools required to achieve this.

Written by Dr. Tim Sandle