Pharmaceutical Cleanroom Technology Europe 2019
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SMi Group's Pharmaceutical Cleanroom Technology Europe 2019 conference takes place in London this October
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Pharmaceutical Cleanroom Technology Europe 2019
- 1. A: Environmental Classifi cation, Qualifi cation and Monitoring of GMP Controlled areas referencing ISO 14644-1 and risk based GMP: Workshop Leader: James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society 08.30 - 12.30 B: Gowning Theory and Best Practice Implementation Workshop Leaders: Conor Murray, Chairman, Irish Cleanroom Society, Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB 13.30 - 17.30 www.cleanroomtechnology.co.uk Register online or fax your registration to +44 (0) 870 9090 712 or call +44 (0) 870 9090 711 PLUS TWO INTERACTIVE HALF DAY PRE CONFERENCE WORKSHOPS | TUESDAY 8TH OCTOBER 2019, COPTHORNE TARA HOTEL, LONDON, UK SMi Pharma @SMiPharm #SMiCleanroom BOOK BY 31ST MAY AND SAVE £400 BOOK BY 28TH JUNE AND SAVE £300 BOOK BY 30TH AUGUST AND SAVE £200 SMi Group Proudly Presents… WORKSHOPS: 8TH CONFERENCE: 9TH - 10TH OCT 2019 Pharmaceutical Cleanroom Technology Europe Addressing the Microbiological Aspects in Cleanroom Design and Engineering COPTHORNE TARA HOTEL, LONDON, UK HIGHLIGHTS FOR 2019: • EXPLORE the characteristics and relevance of air fl ow to better advise cleanroom design, engineering and manage contamination • DISCUSS the most current approaches to minimised cost and improved energy effi ciency without compromising product quality • EXAMINE the latest contamination control strategies from leaders in the pharmaceutical industry • GAIN insight into cleaning and disinfection protocols from a risk-management approach CHAIR FOR 2019: James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society FEATURED 2019 SPEAKERS INCLUDE: • Christine Arbesser-Rastburg, Director, Global Microbiology, Takeda • Alexander Stoll, Vice President, Head of Competence Centre of Microbiology and Aseptic Technique, Fresenius Kabi • Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB • Conor Murray, Chairman, Irish Cleanroom Society • Joseph McCall, Technical Services Specialist, STERIS Corporation • Koos Agricola, Contamination Control Expert, VCCN Sponsored by:
- 2. 08.30 Registration and Coffee 09.00 Chairman’s Opening Remarks James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society CLEANROOM DESIGN AND ENGINEERING VCCN SPOTLIGHT SESSION 09.10 Effective cleanroom HVAC systems • Evaluating the contamination removal efficiency by mechanical ventilation • Improving energy efficiency of HVAC systems • Developing technologies in HVAC control Koos Agricola, Contamination Control Expert, VCCN 09.50 Towards future proof high-tech facilities • What keeps pushing contamination control? • Distinctive trends in science, technologies and markets • New challenges and solutions (case studies) for cleanroom facility design • How contamination control could look like in 2050 Eric Stuiver, Chairman, VCCN 10.30 Morning Coffee 11.00 CFD as a Tool for Implementing Quality by Design in Pharmaceutical Cleanroom Projects • Introduction to CFD • CFD in the life-cycle of a pharmaceutical cleanroom project • CFD applied to the design of new cleanroom systems • CFD as a tool for trouble-shooting and design for remediation in existing systems • How CFD can help in the Commissioning and Qualification phases Pier Angelo Galligani, Past-President, Board Member, ASCCA ENVIRONMENTAL MONITORING AND CONTAMINATION CONTROL 11.40 Addressing new GMP Annex 1 requirements - selection of adequate cleanroom clothing that is part of efficient QRM system for aseptic manufacturing process • The different types of risks for quality linked with cleanroom garments • Elements to be considered in the risk assessment of cleanroom clothing • Mitigating the risks coming from cleanroom garments Steve Marnach, EMEA Training Manager Critical Environments Sales and Marketing Specialist, DuPont 12.20 Aligning Standards and Best Practice in integrating Non-Viable and Viable Environmental Monitoring (EM) in GMP Cleanrooms (as part of a contamination control plan) • Applying ISO 14644-2:2015 for Non-Viable EM • Applying QRM and new concepts in the revision of ISO 14698 (prEN17141) for Viable EM • Challenges of integrating Non-Viable and Viable EM and real time vs indirect measurement • Applying 21CR 11 and Annex 11 to qualified EM systems for continuous and periodic EM Conor Murray, Chairman, Irish Cleanroom Society 13.00 Networking Lunch 14.00 Personnel, Premises and Cleanliness Requirements from a Quality Risk Management Approach – Annex 1 (2008) versus Draft Annex 1 (2017) • Cleanliness requirements today and in the future • Are operators needed in the future and to what extent? • Open systems, RABS, isolators or closed process system? • Operators in cleanrooms – Future problems or…? Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB 14.40 Impact of the EU Biocidal Products Regulation 528/2012 on cleanroom disinfection • Background to EU Biocidal Products Regulation 528/2012 • Understand the regulation in more detail with regards to life science disinfectants • Explanation of the current situation with regards to common active ingredients • Impact of the BPR on cleanroom disinfectant users and how to prepare for it Siobhan Murphy, European Regulatory Specialist, Contec, Inc. 15.20 Afternoon Tea FRESENIUS KABI SPOTLIGHT SESSION 15.50 Contamination Control Elements for Manufacturing Units and Compounding Centers • Importance of design elements (e.g. design of cleanroom equipment) for contamination control • Importance of procedural elements (e.g. cleaning disinfection) for contamination control • Tools to verify implemented contamination control elements are effective • Challenges, case examples and areas to especially look for Alexander Stoll, Vice President, Head of Competence Centre of Microbiology and Aseptic Technique, Fresenius Kabi 16.30 Implementation of an aseptic mentoring program (AMP) in manufacturing sites • How it works, what are the targets and how to be successful • How to set it up, points to consider, aseptic mentors, how to perform audits for aseptic technique • Experiences lessons learned Alana Poloni, Manager Microbiology Aseptic Technique, Fresenius Kabi 17.10 Chairman’s Closing Remarks and Close of Day One Pharmaceutical Cleanroom Technology Europe Day One | Wednesday 9th October 2019 www.cleanroomtechnology.co.uk Register online at www.cleanroomtechnology.co.uk SPONSORSHIP AND EXHIBITION OPPORTUNITIES SMi offer sponsorship, exhibition, advertising and branding packages, uniquely tailored to complement your company’s marketing strategy. Prime networking opportunities exist to entertain, enhance and expand your client base within the context of an independent discussion specific to your industry. Should you wish to join the increasing number of companies benefiting from sponsoring our conferences please call: Alia Malick on +44 (0) 20 7827 6168 or email: amalick@smi-online.co.uk Sponsored by: Contec is a leading manufacturer of contamination control products for critical cleaning in pharmaceutical manufacturing environments worldwide. Contec’s cleanroom wipes, mops and disinfectants are used across the globe in biotechnology, pharmaceutical, medical device and other critical life science institutions. Contec’s extensive product line for cleanrooms and critical environments includes: • Sterile and Filtered 70% Alcohols • Sterile and Filtered Disinfectants • Mopping Systems and Cleaning Tools • Pre-saturated Wipes • Knitted and Non-woven Dry Wipes • Spill Control Products, Sponges and Swabs www.contecinc.com DuPont Personal Protection (www.ipp.dupont.com) uses the experience of DuPont as one of the safest companies in the world, its recognised scientific and technological expertise and its knowledge of key markets to source solutions to protect people, products, businesses and the environment. About DowDuPont Specialty Products Division DowDuPont Specialty Products, a division of DowDuPont (NYSE: DWDP), is a global innovation leader with technology-based materials, ingredients and solutions that help transform industries and everyday life. Our employees apply diverse science and expertise to help customers advance their best ideas and deliver essential innovations in key markets including electronics, transportation, building and construction, health and wellness, food and worker safety. DowDuPont intends to separate the Specialty Products Division, which will be called DuPont, into an independent, publicly traded company. More information can be found at www.dow-dupont.com
- 3. 08.30 Registration and Coffee 09.00 Chairman’s Opening Remarks James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society CLEANROOM DESIGN AND ENGINEERING OPENING ADDRESS 09.10 Development of Aseptic-Containment strategies (ACS) for processing of new toxic, potent or bio-hazard sterile medicinal products and therapies • Rationale for development of an Aseptic Containment strategy (ACS) to sit alongside the Annex 1 Contamination control strategy CCS required for sterile medicinal product manufacture • Aseptic-Containment risk characterisation and risk control containment levels at Health based exposure levels • Research into Aerosol distribution and containment in fi lling sterile Toxic and Biohazard medicinal and therapy products in barrier and combined cleanroom technology James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society 09.50 Cleanroom Cost, Quality, Environmental Sustainability – can I afford to compromise? The presentation will discuss the many options open to cleanroom users to minimise the energy consumption and operational costs of these highly energy intensive spaces. There are many effi ciency improvements available that have proven to have no detrimental impact on the critical product quality needs. Topics discussed will include: • Practical proven top tips you can apply today to make a real signifi cant improvement • Heads up on ISO 14644 part 16 • The business case to support action – illustrated with case studies • Future game changing innovation in cleanroom controls Keith Beattie, Life Sciences Lead, Energy Effi ciency Ltd 10.30 Morning Coffee 11.00 HVAC on a green fi eld fi lling plant project from CD to Validation • Is the organisational structure important? • How can we use interface agreements for HVAC? • Ensuring fl exible and simple validation Birger Lerche-Jorgensen, HVAC Responsible, SME, ALK-Abelló Nordic A/S ENVIRONMENTAL MONITORING AND CONTAMINATION CONTROL 11.40 Case study: What happened in China with the contaminated WFI system? • Preventive maintenance of water systems • Corrective versus preventive actions • Phenotypic versus genotypic identifi cations • Risk of false negative test with endotoxin Olivier Chancel, Sterility and Aseptic Process Assurance Expert, Boehringer Ingelheim 12.20 Networking Lunch TAKEDA SPOTLIGHT SESSION 13.20 Implementation of a global contamination control program – A fi eld report • Overview: From the idea to the roll out of a global contamination control program (CCP) • Contamination control program key elements and documents • Current status / sustain phase of the contamination control program Christoph Hansy, SR QC Scientist, Takeda 14.00 Microbial contamination investigation tool • Background and advantages • Overview and key elements • Case study Christine Arbesser-Rastburg, Director, Global Microbiology, Takeda 14.40 Afternoon Tea 15.10 A risk-based approach to cleaning and disinfection • Will cover current industry regulations in the US, Europe and Globally related to cleaning and disinfection • Regulatory expectations including the latest revision of Annex I and recent FDA Warning Letters and 483’s related to cleaning and disinfection • Cleaning frequency, disinfectant rotation, rinsing and residue removal, disinfectant coverage calculations and the most current equipment and methodologies for cleaning and disinfection will be covered in detail • The topic of sterility relating to cleanroom disinfectants and sporicides will be explained • This session will provide the ability to design an effective risk- based approach to cleaning and disinfection Joseph McCall, Technical Services Specialist, STERIS Corporation 15.50 Particle contamination monitoring in high-tech cleanrooms • Particle contamination risk assessment • Classifi cation versus monitoring in particle contamination control • Example of particle deposition monitoring • Example of surface particle contamination control • Link with airborne biocontamination Isabelle Tovena-Pecault, Head of International and European Projects, ALPHA-RLH 16.30 Chairman’s Closing Remarks and Close of Day Two Pharmaceutical Cleanroom Technology Europe www.cleanroomtechnology.co.uk Day Two | Thursday 10th October 2019 Supporters:Official Media Partners: Alternatively fax your registration to +44 (0)870 9090 712 or call +44 (0)870 9090 711 MARKETING PARTNERSHIP OPPORTUNITIES SMi Group is offering companies the opportunity to partner on our dedicated events in order to help raise your company profi le, add value, create awareness of your products/services to our key audience within the pharmaceutical industry. Interested in partnering? Contact Simi Sapal, Marketing Manager on +44 (0) 20 7827 6162 or email: ssapal@smi-online.co.uk
- 4. Environmental Classification, Qualification and Monitoring of GMP Controlled areas referencing ISO 14644-1 and risk based GMP Workshop Leader: James Drinkwater, Chairman, Pharmaceutical and Healthcare Science Society Overview of the workshop: EU GMP Annex 1 differentiates Environmental classification, Qualification and risk based (holistic) monitoring of GMP controlled areas that are used in the manufacture of sterile medicines. ISO 14644-1 is generic for Cleanroom classifications and it is not always clear how to apply considering a risk based GMP approach. Qualification extends through establishing environmental control through process simulations and media fills with strategies required or how to qualify Cleanrooms and Barrier technology (Isolators RABS). EM programs require a holistic approach considering risk based/ risk assessed sampling locations that are connected through all stages of classification, qualification and monitoring. This workshop explains the relationship and methodology for Classification, Qualification and Environmental monitoring. Why you should attend? • Classification of GMP controlled areas with a focus on 0.5micron particle sizes is a GMP requirement and referenced in Annex 1 but it is not always clear on how ISO14644-1 is applied. • Qualification combines particle sizes of 0.5 and 5.0 micron plus not to exceed microbiological levels (surface and airborne) and requires rationale. Consideration provided to the PHSS rationale (reviewed by the MHRA). • Environmental monitoring data is critical to sterile product release as evidence sterile products have not been contaminated from the processing environment. Current best practice is explained including rationales for monitoring environments that may contain toxic or biologically active sterile products or therapies. Agenda: 08.30 Registration Coffee 09.00 Workshop leader introduction 09.10 Session 1- Environmental Classification of GMP controlled areas • ISO14644-1 application in GMP cleanroom classification • Classification sampling positions – risk based • Classification of Cleanrooms and Barrier GMP Zones – why different approaches are required 09.50 Session 2 - Environmental Qualification • GMP Compliance environmental qualification considering 1m3 sample volumes • Environmental qualification start-up to state of control including microflora characterisation, operational monitoring • Environmental qualification through process simulations and Media Fills 10.30 Coffee Break 11.00 Session 3 - Risk based environmental monitoring methods, program and data trending • EM risk assessments for sample locations and sample type • EM programs: management, structure and data processing • Perspective on use of Rapid Micro Methods: RMM 11.40 Session 4 - Case study: Environmental Classification, Qualification and Risk based monitoring of a vial/ syringe Filling line and relationship with Contamination Control Strategy: CCS for EU GMP Annex 1 compliance • Overview of Case study: Biological product Vial/ Syringe Filling Line in Isolator Barrier technology with use of pre-sterilised containers transferred to Grade A aseptic processing zone via NTT: No-touch-transfer technology • Overview of Rationale for Environmental Classification, Qualification and Monitoring for the Aseptic processing filling zones and surrounding Cleanroom • Application of QRM: Quality Risk Management applied where application varies from conventional/ generic GMP 12.20 Closing remarks 12.30 End of workshop About the workshop leader James Drinkwater is a pharmaceutical process engineer with additional education in pharmaceutical microbiology. Having spent 10 years in the pharma industry (Amersham-GE Healthcare) James had director roles at barrier technology and hydrogen peroxide vapor generator companies achieving subject matter expert status. Current roles include Head of GMP compliance and Aseptic process support for F Ziel GmbH, the largest Isolator and RABS manufacturer in Germany working on major filling line projects and independently an elected role as Chairman of the PHSS: Pharmaceutical Healthcare Sciences Society and leader of the PHSS Aseptic processing, Aseptic- Containment and Annex 1 focus groups. About the company: At F Ziel the role includes process integration of environmental control barrier systems with sterile product aseptic processing and support for GMP compliance including environmental control and monitoring risk assessments. The PHSS is a Not for Profit educational platform for GMP providing supportive guidance in the form of technical monographs, impact statements and Clarity on GMP guidance notes. PHSS provide workshop and training courses in the UK having a strong connection with the UK MHRA. HALF-DAY PRE-CONFERENCE WORKSHOP A Tuesday 8th October 2019 Copthorne Tara Hotel, Central London, UK 08.30 – 12.30
- 5. HALF-DAY PRE-CONFERENCE WORKSHOP B Tuesday 8th October 2019 Copthorne Tara Hotel, Central London, UK 13.30 – 17.30 Gowning Theory and Best Practice Implementation Workshop Leaders: Conor Murray, Chairman, Irish Cleanroom Society Matts Ramstorp, Professor in Cleanroom Technology, BioTekPro AB Workshop Overview: This will be interactive workshop combining theory and practice, where best practice PAL design and configuration will be outlined along with presenting the theory of gowning and selection criteria, coupled with participation by attendees in getting real world experience of different gowning techniques for aseptic processing and terminal sterilisation GMP applications. Why should you attend: • How to set user requirements • Understand PAL/Gowning space planning and configuration for different GMP classifications • Get an insight into the science, experimental data and issues around laundered vs reusable vs limited use gowns • Understand how Gowning materials are assessed and monitored during use (EM) • Gain practical experience in gowning and degowning, Aseptic vs Non Aseptic techniques Agenda: 13.30 Registration Coffee 14.00 Opening remarks and introductions 14.10 Session 1 - THEORY Setting Requirements Gowning/PAL Planning • Setting user requirements • Space planning design configurations to meet different classifications - establishing control • EM considerations - demonstrating control 14.50 Session 2 - THEORY Gowning Selection Characteristics of different types Gown materials • Testing methods • Experimental test data • Selection criteria and considerations • Gowning vs Degowning differences 15.30 Tea Break 16.00 Session 3 - THEORY PRACTICAL Gowning • Importance of Hygiene • Preparation for Gowning • Hand Washing technique and demonstration 16.30 Session 4 - PRACTICAL Gowning Applications • Aseptic processing vs terminal sterilisation applications • Gowning exercises • Degowning exercises 17.20 Closing remarks 17.30 End of workshop About the Workshop Leaders: Conor Murray has over 30 years’ experience in design and construction of cleanrooms and biosafety labs, and since 2007 independently in an oversight and auditing role. Conor represents the National Standards Authority of Ireland (NSAI), as Head of Delegation and SME at ISO TC 209 on cleanroom standardisation. Conor is Convenor of WG-05 in CEN TC243 and advises the Irish Health Service. Conor is Chairman of the Irish Cleanrooms Society (ICS) and a past Chairman of the International Confederation of Contamination Control Societies, (ICCCS). Conor lectures internationally and gives cleanroom training and education courses on behalf of the ICS. Matts Ramstorp has been working for more than 30 years with cleanliness and hygiene as a researcher, consultant, and educator. Matts is a Master of Science in Chemical Engineering, Technology Doctor of Applied Biochemistry (Biotechnology) and Professor of Renewable Engineering and Production Hygiene at LTH, Lund University of Technology. Matts has also published a number of books in the field of cleanroom technology.
- 6. PHARMACEUTICAL CLEANROOM TECHNOLOGY EUROPE 2019 Conference: Wednesday 9th Thursday 10th October 2019, Copthorne Tara Hotel, London, UK Workshops: Tuesday 8th October 2019, Copthorne Tara Hotel, London, UK 4 WAYS TO REGISTER ONLINE at www.cleanroomtechnology.co.uk FAX your booking form to +44 (0) 870 9090 712 PHONE on +44 (0) 870 9090 711 POST your booking form to: Events Team, SMi Group Ltd, India House, 45 Curlew Street, London, SE1 2ND, UK If you have any further queries please call the Events Team on tel +44 (0) 870 9090 711 or you can email events@smi-online.co.uk EARLY BIRD DISCOUNT □ Book by 31st May to receive £400 off the conference price □ Book by 28th June to receive £300 off the conference price □ Book by 30th August to receive £200 off the conference price Payment must be made to SMi Group Ltd, and received before the event, by one of the following methods quoting reference P-299 and the delegate’s name. 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Cancellation: If you wish to cancel your attendance at an event and you are unable to send a substitute, then we will refund/credit 50% of the due fee less a £50 administration charge, providing that cancellation is made in writing and received at least 28 days prior to the start of the event. Regretfully cancellation after this time cannot be accepted. We will however provide the conferences documentation via the Document Portal to any delegate who has paid but is unable to attend for any reason. Due to the interactive nature of the Briefi ngs we are not normally able to provide documentation in these circumstances. We cannot accept cancellations of orders placed for Documentation or the Document Portal as these are reproduced specifi cally to order. If we have to cancel the event for any reason, then we will make a full refund immediately, but disclaim any further liability. Alterations: It may become necessary for us to make alterations to the content, speakers, timing, venue or date of the event compared to the advertised programme. Privacy policy / Opt Out: For full details on our privacy policy please go to http://smi-online.co.uk/privacy-legals/privacy-policy. If you no longer wish to receive email updates you can opt out by going to the following webpage http://www.smi-online.co.uk/opt-out Terms and Conditions of Booking DELEGATE DETAILS VENUE Copthorne Tara Hotel, Scarsdale Place, Kensington, London W8 5SY □ Please contact me to book my hotel Alternatively call us on +44 (0) 870 9090 711, email: events@smi-online.co.uk or fax +44 (0) 870 9090 712