An Introduction to Sterile Manufacturing

THE VOICE OF MICROBIOLOGY FOR 30 YEARS: 1991 - 2021

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If yes, please click here An Introduction to to send your details. Sterile Manufacturing WEDNESDAY 21ST & THURSDAY 22ND OF APRIL 2021 A VIRTUAL ZOOM EVENT SPLIT OVER TWO DATES

Topics covered include:

• Introduction to sterile manufacturing • Process manufacturing • Introduction to microbiology • Sterility assurance • Introduction to cleanrooms • Sterile manufacturing and the regulations and • Methods of sterilisation compliance to GMP

Do also take a look at Pharmig current publications outlined on pages 6 - 8 AND our interactive on-line training module on Cleaning & Disinfection of Cleanrooms On page 9 you can view additional upcoming meetings & webinars

Pharmig ‘Virtual’ Testimonials:

“Thank you for all the work in preparing the “Excellent presentations & organisation – really presentations and presenting over the last two enjoyed it” - MML days. It has been valuable learning and the feedback is very positive” - HPRA “This was one of the most engaging virtual events I have attended so far. Loved the variety of topics” “Keep up the good work” - Sartorius - AstraZeneca

For more information please contact Pharmig: T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk An Introduction to About Pharmig www.pharmig.org.uk Pharmig is a non-profit making professional organisation, Sterile Manufacturing established in 1991, that represents the interests of individuals who work in, have responsibility for, or work Description alongside microbiology within pharmaceutical, healthcare, cosmetics & NHS Industries. It provides a focus for Designed for those people who are new to industry this continuing professional development and serves as a virtual training course will help you understand what sterile manufacturing is and will cover topics which unique network for the exchange of microbiological include: microbiology, clean room design, sterilisation information through training courses, conferences, processes, sterility assurance, manufacturing methods and publications and its website forum. The Group has grown regulatory oversight. significantly since 1991 expanding the portfolio of products it now offers to the Membership whilst remaining true to Target audience (those new to industry): Microbiologists, the initial needs of microbiologists which include: cleanroom operators, production, quality, engineers, and • Organising meetings, training courses, conferences and sales & marketing producing publications that provide topical information and views on microbiologically related topics It is designed to: • Advancing the science of microbiology and its practical • Get you to think about the risks associated with sterile application manufacturing • Understand the basic elements of sterility assurance • Influencing the development of regulations and guidelines surrounding microbiology The course will support: • Acting as a confidential forum for the dissemination of • Building greater people capability and consistency in your information concerning all aspects of microbiology sterile operations • Reducing quality issues, waste, defects and accidents At the end of this virtual training programme you will: • Being better able to meet your regulators expectations • Have an underpinning awareness of sterile manufacturing • Releasing batches more consistently v get products to the and associated risks. patient more reliably • Attain an introductory understanding and knowledge of • Better management of individual performance key sterile processes and controls Your Presenter: David Keen, Director Pharmaceutical Microbiology & Consulting - Ecolab & Pharmig Chair David is a microbiologist working for investigating significant microbial contamination events Ecolab as Director, Pharmaceutical with suppliers and products. He was lucky enough to be Microbiology in their Lifesciences sent across the world investigating microbiological issues on division. With reference to Pharmig – behalf of the company. If you get caught by him at the bar, David became a Committee member he can bore you to death on the wonders of seaweed. in 2007 and in November 2013 he had the honor of being elected as In 2012 David moved back to GSK at the Ulverston site in the Pharmig Chair. Lake District. This is a large-scale primary API manufacturing site makes bulk sterile antibiotics. It uses isolator technology in a David started life at GSK Barnard Castle. Here he performed primary environment, which was a bit of a steep learning curve. environmental monitoring and clean room qualification David started a new role as a microbiological consultant before moving on to sterile finished product testing. He for Ecolab in March 2018. In this role David utilizes his then moved to a small startup company called SCM Pharma. experience to help Ecolab’s clients with microbiological and Here he set up a new microbiology lab and developed a new manufacturing issues, across the globe. microbiology team. He helped design and qualify the new clean rooms. He then moved from microbiology to project He is experienced in most drug dose forms from sterile management and became the technical manager. needless injection systems, explosive aseptic ampoules to inhalation devices, oral doses of microbial sensitive David then moved to Reckitt Benckiser at their Hull site products and sticky capsules. Plus, a great deal of primary where he discovered the magic and pain of working in an manufacturing to boot. He is now dipping his toe into FMCG environment. His role was to improve microbiological the world of disinfectants and contamination control – a awareness on the site and a large amount of time was spent microbiologist’s best friend.

An Introduction to Sterile Manufacturing 21ST AND 22ND APRIL 2021 An Introduction to Sterile Manufacturing (via Zoom) Programme outline running as 2 half-day virtual meetings

WEDNESDAY 21st April THURSDAY 22nd April

13.00 – 13.10 13.00 – 13.10 08.00 – 08.10 Welcome: David Keen, Director 08.00 – 08.10 Welcome back Pharmaceutical Microbiology & Consulting - Ecolab & Pharmig Chair 13.10 – 13.55 08.10 – 08.55 Methods of sterilisation 13.10 – 13.55 • Moist and dry heat 08.10 – 08.55 Introduction to sterile manufacturing • Filtration • What does sterile mean? • Irradiation and e-beam • Why do we need sterile products? • Chemical • Sterile vs aseptic – are they the same? 13.55 – 14.00 13.55 – 14.00 08.55 – 09.00 Q&A session 08.55 – 09.00 Q&A session 14.00 – 14.45 14.00 – 14.45 09.00 – 09.45 Process manufacturing 09.00 – 09.45 Introduction to microbiology • Common product dose forms • What is microbiology? • How to manufacture these dose forms • The bacteria, moulds and yeasts, virology, • Isolators RABS and open filling parasites and TSEs • Blow fill seal, freeze drying • Controlling and understanding microbial • Process simulations, media fills and broth growth trials

14.45 – 15.00 14.45 – 15.00 09.45 – 10.00 Q&A session and virtual break 09.45 – 10.00 Q&A session and virtual break

15.00 – 15.45 15.00 – 15.45 10.00 – 10.45 Introduction to cleanrooms 10.00 – 10.45 Sterility assurance • What is a cleanroom • What is sterility assurance? • Cleanroom grades and controls • Risk based manufacturing • Design and equipment • Determination of sterility • Cleanrooms as a contamination control system 15.45 – 15.50 • Cleanroom behaviours 10.45 – 10.50 Q&A session

15.45 – 16.00 15.50 – 16.30 10.45 – 11.00 Q&A session and close of virtual 10.50 – 11.30 Sterile manufacturing and the day one regulations and compliance to GMP • Why is there a need for regulations? • Who regulates the pharmaceutical industry? • Are you inspection ready? KEY RE: TIMES BLUE – BST (British Summer Time) 16.30 – 16.45 GREEN – EST (Eastern Standard Time) 11.30 – 11.45 Q&A session and closing remarks of virtual day two

Please note: all information addressed by the speakers are of their own/ their company opinions and viewpoints. Pharmig is not responsible for any content presented at the meeting. Pharmig also has the right to change the programme at any time due to unforeseen circumstances.

An Introduction to Sterile Manufacturing 21ST AND 22ND APRIL 2021 BOOKING FORM: AN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES: 21ST & 22ND APRIL 2021

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INFORMATION ON FEES & PAYMENTS

• The fees advertised cover 2 half-days on the 21st & 22nd April 2021.

• Pharmig cannot reduce this fee if you can only attend one of the morning sessions.

• Fees must be paid in advance in order to attend the virtual conference. This can be done via credit card payment OR by an approved company purchase order number

FEES - VIRTUAL INTRODUCTION TO STERILE MANUFACTURING (which covers 2 half-day events on the 21st & 22nd April)

PHARMIG MEMBER FEES Euro / Dollar NON MEMBER FEES Euro / Dollar Delegate £200 / *€245/ *$284 Delegate £400 / *€470/ *$560 *Fee is higher to cover conversion rates *Fee is higher to cover conversion rates

NHS PHARMIG MEMBER FEES NHS NON MEMBER FEES Delegate £100 Delegate £200

For more information contact T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk PAYMENT: AN INTRODUCTION TO STERILE MANUFACTURING (VIA ZOOM) SPLIT OVER 2 DATES: 21ST & 22ND APRIL 2021

Please note: Due to these unusual times, and the need for Pharmig to ensure fees are received in a timely manner before the event, it will have the right to cancel a delegate’s attendance unless alternative arrangements have been agreed in advance of the event(s) by both parties.

Please raise an invoice to cover the delegate fee(s) £/€/$

UK BACS Sort code: 60 19 28 Account: 80843867 £/€/$

Wire Transfer: £/€/$ Natwest Bank, 118 High Street, Slough, Berkshire SL1 1JH SWIFT (BIC) NWB KGB2L Account: 80843867

IBAN GB64 NWBK 6019 2880 843 867 For £/€/$

Please quote company approved purchase order no.

We wish to pay by credit card (Pharmig will contact you for details)

EMAIL OR FAX YOUR COMPLETED BOOKING FORM FOR A PROVISIONAL/CONFIRMED PLACE

Email: [email protected] Fax: to +44 (0) 1920 871 156

INFORMATION ON ZOOM SET UP

Once you have sent back your registration form and payment (please see info of fees and payments above), Pharmig will add you to the Zoom list and will send out an email which will include TWO SEPARATE ZOOM LINKS (one for each day) for you to click onto for the 21st & 22nd April.

For those not familiar with Zoom – we will do a quick tour around the screen (it’s all very straightforward) before starting the session on the afternoon of the 21st April.

PRIVACY POLICY: By registering for these events, I accept the processing of my Personal Data. Pharmig will use my data for the processing of this order for which I hereby declare to agree that my personal data is stored and processed. Pharmig will only send information in relation to this order or similar events/publications/training courses etc. Pharmig may send your name and company only to other companies attending the same event in the form of an attendee list. Your full personal data will not be disclosed to third parties (see also privacy policy at https://www.pharmig.org.uk/en/privacy-policy/). You can ask for the modification, correction or deletion of my data at any time via an email to [email protected]

CANCELLATION POLICY: Written cancellation will be accepted up to 5 working days prior to the event, and all cancellations will incur a fee. No refunds are available 2 working days before the start date and full fees will be due for delegates who fail to attend. Substitutions may be made at any time, preferably in writing to Maxine Moorey. Please email: [email protected]

For more information contact T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk PHARMIG’S INTERACTIVE ON-LINE TRAINING MODULE ON: CLEANING AND DISINFECTION OF CLEANROOMS

DON’T LET COVID STOP YOUR VITAL STAFF TRAINING.

• Ensure your teams stay up-to-date on the crucial aspects of • The Pharmig Training Portal features full administrator control Cleaning and Disinfection of Cleanrooms by using our dynamic, enabling you to: interactive online training portal which will make: • Set the required pass mark • Personnel training easy • Monitor and manage user activity • Convenient • All of which results in better trained operatives working to best • Quantifiable practice • The Pharmig Training Portal (TP) features high quality demonstration footage for the training of cleanroom operatives in Interested? the Pharmaceutical, Healthcare, Cosmetics and Medical Device Then please do visit the Pharmig website for more information and a Industries. video of the on-line Training Portal capabilities www.pharmig.org.uk.

Each training video is followed by detailed multiple choice • If you would like a more detailed ‘virtual’ demonstration led by a questions about the subjects covered in the video modules. Pharmig Committee Member, please do email Pharmig at info@ • Each user is issued with a personalised certificate upon pharmig.org.uk and we will schedule in a time that suits you. successful completion of the module.

Publication orders can be placed Pharmig Publications via the website - www.pharmig.org.uk

A series of 8 Major Objectionable A series of 8 Pharmaceutically Important Microorganisms Fact Sheets Fungi Fact Sheets

One of the expectations of GMP regulators is that microbiology laboratories are This set of fact sheets features seven fungi which feature high in causes of knowledgeable about the main objectionable microorganisms that could be fungal contamination of pharmaceutical products and which have led to several found in pharmaceutical products or in the manufacturing environment. major pharmaceutical product recalls. Each fact sheet presents information The identification, characterisation and interpretation of these microorganisms about the fungus, including growth conditions and product / patient risks. Each can be challenging. To act as a training aid and information resource, Pharmig sheet details a striking photograph of the fungus macroscopically, growing on has produced eight new fact suitable agar, and microscopically sheets (Fact Sheet Pack 2). (as a methylene blue stain.) The Seven of the fact sheets profile eighth fact sheet is a guide on some of the most important the staining and microscopic objectionable microorganisms examination of fungi, including (together with Geobacillus key features to note to help stearothermophilus, used you with identification. The fact for biological indicators). An sheets are laminated, making eighth fact sheet provides useful them suitable for the laboratory information about risk assessing bench, and come enclosed within objectionable microbes. a presentation folder.

Member £30 Member £30 Non Member £50 Non Member £50

For more information contact T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk Publication orders can be placed Pharmig Publications via the website - www.pharmig.org.uk

Water Microbiota – Pharmig’s latest series of 8 fact sheets

This series of 8 fact sheets will cover:

• Ralstonia pickettii • Sphingomonas paucimobilis • Stenotrophomonas maltophilia • Pseudomonas aeruginosa • Burkholderia cepacia complex • General overview of water • Acinetobacter baumannii microorganisms • Brevundimonas diminuta

Member £30 Non Member £50

LAL Fact Sheets A series of 8 Microorganisms Fact Sheets

A series of Limulus Amoebocyte Lysate (LAL) laminated Fact Sheets on pyrogen/ The microbial enumeration test and test for specified microorganisms can represent a endotoxin testing have been produced by the LAL Action Group. challenging area for pharmaceutical microbiology. To act as a training aid for new staff, The series of 6 LAL fact sheets (as a package) and an aide memoire for more experienced staff - Pharmig has produced eight fact currently available are: sheets. Seven of the fact sheets profile each one of the key microorganisms (or microbial • What is LAL/BET? groups), using colour photographs • Calculation of illustrating growth on agar and Endotoxon Limits by Gram-stain. These are • Medical Devices supported by facts relating • Gel Clot Methods to the organism’s profile and • Photometric Methods Purchase methods for identification. The • Product Validations in conjunction eighth sheet offers some useful Quantitative Methods with Best practices for guidance about the interpretation the Bacterial Endotoxin of the test. Test: A Guide to the LAL Member £20 Assay and receive the Member £30 Non Member £35 LAL Fact sheets Non Member £50 free of charge

Guide to Disinfectants & their use in the Current perspectives on Environmental Pharmaceutical Industry Monitoring - Review # 1

The objective of this Guide is to review This review surveys some of the current current standards to aid in the selection practices, trends and approaches to A GUIDE TO and validation of disinfectants. DISINFECTANTS & THEIR environmental monitoring. Key topics include: USE IN THE PHARMACEUTICAL Technical articles include: INDUSTRY • Types & selection of disinfectants • Constructing an environmental • Validation of disinfectants detailing monitoring programme the BSEN current test methods • Particle monitoring & control • Practical use of disinfectants • Environmental monitoring & Member £60 Non Member £85 risk assessment • Microbiological risk assessment case study Member £60 Non Member £85

8791 Pharmig A Guide to Disinfectants and their Use in the Pharmaceutical Industry.indd 1 24/05/2017 14:55

Best practices for the Bacterial Endotoxin Test: Guide to Microbiology Laboratories in the A Guide to the LAL Assay Pharmaceutical Industry

This guide to the Bacterial Endotoxin Test This Guide details what Pharmig considers to (BET) provides the reader with an overview be best practice for establishing and operating of the history, regulation and practical use microbiology laboratories in pharma and of the different BET assays. Information associated industries. on method development, validation and The Guide describes considerations to be routine testing are discussed as well as more applied to the design, set up and running of the advanced subjects such as depyrogenation, microbiology unit. Topics range from: medical devices, trouble shooting and problem samples. The guide should provide a • Test methods useful reference document for LAL users and • Environmental monitoring • Documentation laboratory management. • Method verification and validation Member £50 Non Member £75 Member £60 Non Member £85

Guide to Cleanroom Operation Rapid & Alternative Microbiological Methods and Contamination Control

This publication provides a short and informative introductory guide to cleanrooms. Rapid Microbiological Method technologies aim to provide more sensitive, Cleanrooms provide controlled, critical environments for both accurate, precise and reproducible test results when compared with conventional, sterile and non-sterile pharmaceutical manufacturing. growth-based methods. They normally involve some form of automation and they The guide examines: often capture data electronically.

• Cleanrooms GUIDE TO CLEANROOM OPERATION AND Microbiologists can be inundated with literature advertising equipment • Different grades of cleanrooms CONTAMINATION CONTROL and courses relating to ‘Rapid Microbiological Methods’ and ‘Alternative • The important aspects of physical control • Contamination control and environmental monitoring Microbiological Methods’. • Important cleanroom parameters required by the Often, however, the literature does not explain whether the method will work regulatory standards for the company’s product range, whether it is cost effective, how it should Member £60 be validated, how any changes to microbiological risk are managed and if the Non Member £85 purchase can be justified. Whilst costs cannot be discussed, this document has been prepared: • to describe the range of well developed, established, Microbiological Control for commercially available methods and their suitability Non-Sterile Pharmaceuticals for evaluating the microbiological quality of products or raw materials; • to provide some guidance for microbiologists who This publication is relevant to pharmaceuticals/cosmetics & are investigating the use of R/AMM in routine quality toiletry industries and aims to provide guidance around GMP. control of cosmetics personal care products Topics include: and pharmaceuticals. • Facility, design and requirements This publication is produced and sold as a PDF • Micro control document only and is for the sole use of the • Cleaning & disinfection individual purchasing it. • Risk assessment & management • Microbiological monitoring Member £20 Member £60 Non Member £35 Non Member £85

Guide to Bacterial Identification

Microbial identification represents an important part of the The foreword has kindly been written by Andrew Hopkins – MHRA microbiology function. This includes screening products for objectionable organisms, profiling the environmental microbiota, Chapters within the Guide include: and investigating out-of-limits events with a view to assigning • Cleanrooms a probable point of origin. In deciding what and when (and • Different grades of cleanrooms subsequently to what level) to identify, and by the way of which • The important aspects of physical control methods, requires an identification strategy. This is a document each microbiology laboratory should develop. • Contamination control and environmental monitoring • Important cleanroom parameters required by the During a Pharmig presentation on microbial identification strategy regulatory standards and a Q&A session that followed there was a variation in approach, and sometimes a lack of clarity, concerning good identification Member £60 practices and in outlining a strategy of what to identify and when. Non Member £85 To provide guidance for members and other microbiologists, in the way of a training aid, and to provide the basis for microbiology laboratories to benchmark against, this guide was put together.

Best Practices in Microbiological Setting up & Managing an Effective Training Documentation - Electronic Pack One Programme in the Micro Laboratory – Electronic Pack Two This CD provides an overview of the most efficient practices in maintenance of the QC aspect of the microbiology laboratory and its This training pack aims to help you gain a clear associated documentation with reference to understanding of the structure of a regulatory current regulatory expectations. acceptable and compliant training programme and includes example documents to assist Topics range from: companies in improving / aiding their current • General documentation training programmes. • Equipment documentation Topics range from: • Laboratory test documentation • Electronic documentation • Employee development & appraisal management systems • GMP introduction • Non conformance documentation • Training in microbiological • Example documents are also included techniques & non conformances to assist companies in improving their • Train the trainer documentation practices. • Training matrix Member £75 Non Member £99 Member £75 Non Member £99

For more information contact T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk Pharmig: An additional meeting and a series of webinars currently available

VIRTUAL MEETING: ENGINEERING PRINCIPLES FOR MICROBIOLOGISTS & NON-ENGINEERS: A BRIEF ‘VIRTUAL’ SNAPSHOT Wednesday 31st March 2021 A cost and time-effective ½ day virtual meeting for non-engineers to Who should attend: gain a quick snapshot into understanding key engineering principles • Anyone who has responsibility for, or contributed to, production used in the life-sciences. It will help enable individuals to converse environment measures, modification and controls (eg QP’s, QA effectively with suppliers and engineers, and contribute to operational personnel, microbiologist, R & D specialist, production technician) teams during projects, deviation investigations, risk assessments, and • People working in operations, technical and quality functions as well operational improvements. as microbiologists

Please click here to view the full agenda

CURRENT WEBINARS

FEES FOR EACH WEBINAR: Pharmig Members £70 / $110 (per person attending) Non Members £100 / $150 (per person attending)

Handling data integrity Risks and control strategies Help! I have bacterial spore concerns in the microbiology for Burkholderia cepacian contamination & I don’t know laboratory complex what to do about it

Wednesday 24th March @2pm (BST) / 9am (EST) Wednesday 14th April @2pm (BST) / 9am (EST) Thursday 21st October @2pm (BST) / 9am (EST) Led by Dr Tim Sandle Led by Dr Tim Sandle Led by Dr Tim Sandle

Data integrity for microbiology includes different The major organism of concern for non-sterile Bacterial spores are difficult to eliminate from aspects, which need drawing out (such as specific microbiology is Burkholderia cepacian, presenting cleanrooms and present challenges for cleaning and equipment and culture media). This webinar considers: a risk to inhalers and water systems. This webinar disinfection regimes. This webinar considers: • What is data integrity? considers: • Overview of spores • Regulations • What is the Burkholderia cepacia complex? • Bacterial • Data and ALOCA+ • Why is BCC a concern? • Fungal • Variability of microbial data • Where is it found in pharmaceuticals and healthcare? • This is an important distinction • Examples of DI and microbiological data • Patient risk factors • Risks posed by spores • Rapid microbiology methods • Regulatory views • Issue of disinfectant / sporicide resistance • Test method • Best practice examples Click here for more information • Risk assessment • Identification Click here for more information Click here for more information

EN17141 - What to make of the new Biocontamination Control Standard?

Thursday July 8th @2pm (BST) / 9am (EST) Led by Dr Tim Sandle

In 2020 a new contamination control standard has been issued, specifically focusing • Considerations in developing a contamination control program on biocontamination control, titled EN 17141: 2020 “Cleanrooms and associated • Sample locations and sample frequencies controlled environments — Biocontamination control”. Does this standard address • Methods and their application the needs of the industry? This does not seem to be the case. While the standard • Limit setting, trending and data distribution covers a number of important areas, there are stand-out gaps and some inaccuracies • Microbiota to be addressed. Tim Sandle looks at these in the context of what is needed for a • Overall assessment of the standard and the gaps to be filled robust biocontamination control program. In this presentation, Tim Sandle will look at: Click here for more information • What is the EN 17141:2020 standard? Where did come from and what does it cover? • What is biocontamination and control? • The standard’s risk-based approach to contamination

For more information contact T: + 44 (0) 1920 871 999 F: +44 (0) 1920 871 156 E: [email protected] W: www.pharmig.org.uk Pharmig T5 The Maltings Roydon Road Stanstead Abbotts Hertfordshire SG12 8HG United Kingdom.

Tel: +44 (0) 1920 871 999 Fax: +44 (0) 1920 871 156 Email: [email protected] Web: www.pharmig.org.uk

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