Cleanroom Technology Conference 2019: Speakers
Maximising sterility assurance – protecting equipment pre and post sterilisation
Aaron Mertens is a Technical Service Manager at STERIS Life Sciences Contamination Control Solutions responsible for providing global technical support primarily for critical environments, sterility assurance products, application and validation.
Mertens holds a bachelor’s degree in Genetics from the University of Wisconsin – Madison. He specialises in cleaning, disinfection, sterilization and contamination control in parenteral drug manufacturing. He has also contributed to the industry by presenting posters and talks at meetings, as well as participating in local chapter functions.
HVAC – It’s Only an Air Filter!
Alan has worked in air-filtration for over 20 years. During this time, he has helped many Pharma clients from across the globe reduce their overall energy, maintenance and disposal costs, whilst increasing safety and filtration efficiencies on site through offering the optimum choices in filtration terms. In 2002 Alan assumed control of the heavy dust collection division of Camfil in Ireland, he drove many product advances and changes to help clients and the industry. In this position, he advances the process of efficient and contained filtration, dust collection, safety in dust handling and clean process applications. This role brings him into contact with a wide range of Pharma issues every day, which leads to a great industry cross over of information and solutions.
Comparison of ISO 14644-3 Filter Testing Techniques – Photometers and Particle Counters
Andy Worsick has recently been appointed to the role of Regional Sales Manager at Gateshead based WHP Engineering – a multi-disciplinary, engineering company dedicated to providing both standalone and turnkey solutions for manufacturing processes across Europe.
Prior to this, Andy worked as the Applications Manager at Air Techniques International (ATI – UK), responsible for supporting customers and distributors in the UK and in the EMEA region. Andy has expertise is a wide range of cleanroom testing equipment. His particular specialities include HEPA filter leak testing equipment, filter test rigs and particle counters – both portable units and ones integrated into continuous environmental monitoring systems. Worsick is a science graduate and has a history in application engineering, product management, and technical sales. He is a regular speaker at industry events, and also delivers ATI training courses at their UK head office in Letchworth as well as dedicated on-site courses for customers across a range of industries.
Aseptic manufacturing: The open flaw in using humans in your critical operations
David is a microbiologist working for Ecolab Lifesciences. David started working in at GSK Barnard Castle. Where he performed environmental monitoring and clean room qualification before moving on to sterile finished product testing.
He then moved on to Reckitt Benckiser where he discovered the magic and pain of working in an FMCG environment. His role was to improve microbiological awareness on the site and a large amount of time was spent investigating significant microbial contamination event with suppliers and products.
In 2012 David moved back to GSK at the Ulverston site in the Lake District. This was a large scale primary API manufacturing site makes bulk sterile antibiotics. He then joined Ecolab in 2018!
Materials selection: reducing cleanroom energy and facility operating costs with modern insulation technology
Eleanor Howland is a Technical Support Engineer at Zotefoams plc where she currently works with the T-FIT business unit of specialist insulation products. A first-class Materials Science postgraduate, with an MEng from the University of Oxford, Eleanor joined
Zotefoams due to her interest in Zotefoams’ unique manufacturing process and materials. In her role, she generates, analyses and interprets data to produce technical information about these unique products. This year, Howland received the James S Walker Award for a student project on the subject of polymers from the Institute of Materials, Minerals and Mining.
GMP and contamination control for the food industry
Geerd Jansen is an active board member within the international strategic alliance between Brecon Group and PP4CE formed with the aim to offer ISO 14644 and GMP classified cleanrooms for the various market segments like the food sector.
A systems approach to hygiene in food processing environments
Glenner Richards is a microbiologist with experience that spans government agencies, regulatory entities, academia, and private research organisations. She joined Microban International in 2014 and is currently the Director in Microbiology & Analytical Chemistry Labs. Richards is responsible for providing technical support for research and development of surface technologies that enhance hygiene systems in various industries.
Richards earned BSc. and M. Phil (Biology) degrees from the University of the West Indies (Mona) and Ph.D. in Food Science & Technology with emphasis in Food Safety/Microbiology from University of Georgia, Athens GA. She is a certified Lean Six Sigma Green Belt.
Chairman and Opening Day One
Gordon Farquharson, B.Sc.(Hons), C.Eng. is a Chartered Consulting Engineer with more than 30 years of experience of quality & safety critical processes and facilities. In recent years, he has been active in the development of regulatory guidance and standards. In particular, he is working on CEN/ISO Cleanroom & Contamination Control Standards, WHO GMP guidance and ISPE Baseline Guides.
Chairman of BSI’s LBI 30 Committee and of CEN Technical Committee 243, Gordon is also Convenor of WG1 and a UK expert working on the ISO TC209 and CEN TC243 family of contamination control standards that provide the platform for contamination control standardisation.
He also worked with the EMA in London to help update and improve the cleanroom classification and monitoring requirements in the 2008 version of Annex 1 of the EU and PIC/S GMPs and has contributed to WHO’s Pharmaceutical water GMP Guidance. He was a member of the WHO expert panel that revised the WHO GMP guidance on sterile products in alignment with the PIC/S GMP and is active in WHO regulatory work. He has recently been advising the joint EMA/PIC/S Annex 1 revision rapporteur on the application of EN ISO 14644-1&2:2015.
New selection criteria of protective garments for cleanrooms and controlled environments
Helen Tebay is the Business Development Team Manager for Connect 2 Cleanrooms Ltd. Helen and her team are responsible for delivering consumables and equipment along with Aftersales, validation and testing services throughout to support our customer’s critical environments to ensure they remain fully replenished with quality supplies of products and services.
With previous management positions within Connect2Cleanrooms Ltd, Helen brings a wealth of knowledge of cleanroom products and applications such as full furniture fit outs and bespoke requirements. Through these roles Helen has gained vast experience of working with customers and suppliers in the advanced engineering, aerospace, medical device manufacturing, and pharmaceutical industries. She has been instrumental in the growth of Aftersales revenue generation year on year within the consumables and equipment area.
A practical approach to measuring cleanroom residues from manual disinfectants
James’ background is in microbiology and molecular biology. He holds an MSc in bioinformatics and first degree in applied biology; he also holds a LSS greenbelt as well as a post graduate diploma in marketing. James moved from the laboratory into a product manager role for a European based diagnostics company, gaining experience of contract manufacturing and project management.
He has more than 10 years’ experience in the cleanroom industry in different roles including technical roles, offering advice on cleaning and disinfection, director of marketing for Ecolab’s contamination control business and commercial operations. He currently sits on the CEN TC216 (the European group for forming and maintaining norms including efficacy for chemical disinfection and antiseptics) as a work group convener.
Dr. Jochen Wirsching brings more than 20 years of experience with Vileda Professional, currently working as a Manager in their Science and Training Centre. Previously, he has held various positions in their R&D and technical marketing functions.
Dr Wirsching holds a degree in chemistry from Aachen University and a PhD in macromolecular chemistry. He has written extensively on nonwoven technology and has provided lectures covering various topics including cleaning, hygiene, nonwovens and cleanroom technology.
Microbial aspects of water quality in Cleanroom Environments
John McKenzie PhD, FRSC has an extensive background in the life sciences industry with over 20 years of management experience across the European and Asian continents. Over the course of his career he has been involved in various roles including pharmaceutical business development, drug registration services, analytical services support and quality
In 2015, Dr McKenzie joined Wickham Laboratories Ltd, a contract research organisation providing testing services to the pharmaceutical and medical device industries, as Chief Executive Officer and has since been instrumental in the growth and development of the company’s service portfolio.
Cleanroom energy reduction – possibilities for now and in the near future
Keith is a chartered engineer and chartered energy manager with over 18 years’ experience in the pharmaceutical industry in roles including laboratory facilities management, engineering maintenance and manufacturing. For 6 years, Keith led energy, waste and water sustainability improvements for Eli Lilly & Company Limited in the UK, consulting on and facilitating improvement projects globally as a key member of the Lilly global energy reduction team.
In 2013, Keith joined EECO2, a global energy efficiency consultancy with a specialism in laboratory and pharmaceutical cleanroom HVAC energy reduction. As a leading practitioner in his field, Keith is also a member of ISPE’s global HVAC Sustainability Steering Group and ISO TC209 committee responsible for ISO14644 (Cleanrooms and associated controlled environments) contributing to the development of standards, training and code of practice guidelines in the discipline. Keith is also now the Co-Chair of ISPE HVAC/Sustainability CoP.
A New Rapid Microbiology Method based on Measuring Oxygen
A graduate in Applied Microbiology with PhD in skin cancers, Dodd has had an interesting career in research, development and methods in traditional, rapid and real-time microbiological, particulate and facility environmental monitoring. His previous experience includes similar roles within SHS, Biomerieux, Merck and BD. Having joined EMS in 2012, he is responsible for business development of PMS technologies into the UK life science and microelectronics sectors.
A look at the potential impact on regulations and the supply chain! Are you BREXIT ready?
Lynne Byers has gained more than 35 years’ of extensive pharmaceutical manufacturing management and QA experience working for three major international pharmaceutical manufacturers, culminating in the role of Global Head (VP) of External Supply Operations QA for Novartis in Switzerland. In addition, she worked as Head of Inspectorate and Licensing for the MHRA from 2004-2006. She joined NSF in 2017.
Byers has broad experience in manufacturing management and QA of a wide range of sterile and non-sterile dosage forms, and is fully conversant with current EU and FDA GMP regulations and requirements. She has extensive experience in international QA auditing of a wide range of pharmaceutical manufacturers who are suppliers to the pharmaceutical industry worldwide. She also has extensive experience in managing QA teams in country affiliates. Byers is eligible to act as a Qualified Person and was a QP assessor on behalf of the Royal Society of Chemistry from 1999 to 2004.
A scientific approach to Pharma cleanroom design
Nigel is a recognised SME (subject matter expert) in pharmaceutical HVAC & CQV and is part of a global ISPE network of peers involved in critical HVAC and energy reduction within the Pharmaceutical sector.Lenegan also co-founded the ISPE Global Sustainable Facilities CoP. He has been involved in “client side” technical leadership on many high-value cleanroom and laboratory facility designs with decades of experience and provides Expert Witness services for litigation.
Use of DPTE Rapid Transfer Technology to ensure sterlity and precent contamination within barrier systemsg
Paolo is currently Getinge Product Line Manager – Sterile Transfer Solutions. His fields of expertise include DPTE® Transfer Applications
to Isolator Technology and Electron Beam sterilization. Prior to this, he has worked in the Bio-Pharma Industry as Sales Support Manager in Isolator Technology for several applications (aseptic, containment and customiSed turn-key solutions). Paolo graduated from Bologna University (Italy).
BRC HVAC Document / Risk Assessment – Is it working?
Ross Dumigan began his career with Camfil 13 years ago. Today, he is the Food & Beverage Segment Manager for Continental Europe & the British Isles.
Dumigan works with the biggest food manufacturers in the world improving indoor air quality (IAQ) standards and reducing energy consumption without compromising processes. His customer base exclusively uses Camfil products, which are specifically designed for the food & beverage market to offer maximum protection for the customers’ product, people and process. Dumigan has a degree in Mechanical Engineering, Accounting and Business.
The importance of considering process flow for your cleanroom at the design stage
Rowin Vos is the General Manager for Connect 2 Cleanrooms BV. Rowin oversees Connect 2 Cleanrooms activities in Benelux and is responsible for business development within the Benelux region, using his strong commercial and strategic leadership experience. With previous senior management positions at Basan, VWR International and ThermoFisher Scientific, Rowin brings a wealth of knowledge of cleanroom products and applications. In these roles he gained a vast experience of working with customers and suppliers in the semiconductor, microelectronics and pharmaceutical industries.
Having helped grow Basan from a local to pan-European distributor, Rowin’s appointment reinforces Connect 2 Cleanrooms’ vision to be internationally recognised as the industry innovator for critical environments.
Impact of the EU Biocidal Products Regulation 528/2012 on cleanroom disinfection.
Siobhan Murphy is the European Regulatory Specialist for Contec Inc, responsible for providing regulatory and technical support for Contec’s contamination control products, throughout Europe and Asia. Based in the UK, Siobhan has over 10 years of experience working in the area of biocides regulatory compliance. Before joining Contec as a Regulatory Specialist she worked for 8 years as a Senior Regulatory Scientist at a UK-based consultancy. Siobhan’s projects have included preparation and submission of a number of biocidal active substance dossiers, biocidal product authorisation dossiers, as well as REACH lead registration work. Siobhan is an expert in the IT tools required for biocides submissions in the EU, including IUCLID and R4BP.
New selection criteria of protective garments for cleanrooms and controlled environments
Steve has a Masters’ degree in Business Administration and has joined DuPont in 1995. After having held various positions within the company, he is currently the EMEA Training Manager and critical environments marketing and specialist for DuPont Personal Protection, the chemical protective garments business that Steve has been working for since 2003. In his current role, Steve is providing training sessions on the selection and safe handling of chemical protective garments used in, amongst others, pharmaceutical production and GMP grade B, C and D cleanroom operations as well as giving technical support to health and safety specialists.
Chairman and opening Day 2
Tim’s current role is General Manager of ATI UK (Air Techniques International), EMEA Director and member of the ATI Leadership Team. He is a Director of DOP Solutions and the Academy for Cleanroom Testing which are now ATI companies in the UK. He is also a Director of Cleanroom Equipment Suppliers (Pty) Ltd in South Africa. Tim Triggs leads a team focused on manufacture, supply, service and calibration of cleanroom and containment testing solutions, with international presence. He also trains and lectures on clean air and containment system testing, in conferences and for company training programmes. He holds qualifications in Engineering and Pharmaceutical Sciences and is a member of the BSI Cleanrooms committee, Pharmaceutical Healthcare and Sciences Society and Institute of Healthcare Engineering and Estates Management.
Recurring Microbial Contamination in grade A (ISO 5) filling the Restricted Access Barrier System (RABS).
Walid El Azab is an Industrial Pharmacist and a former Qualified Person (QP). Walid works as a Technical Services Manager at STERIS Life Science. He currently provides technical support related to cleaning, disinfectants, sterility assurance and process validation, and also leads audits at manufacturer sites. In addition, he leads workshops to improve inspection readiness to regulatory audits, to improve the process and release time and to review GMP documents (e.g. Annex 15, Annex 1, ATMP GMP). His areas of expertise include both upstream and downstream pharmaceutical operation and validation in non-sterile and sterile processes. Walid has held various positions including Project Manager, Inspection Readiness Manager, Quality and Regulatory Manager, Lead Auditor and QP. Walid’s responsibilities and experience have also included project management, handling deviations and complaints, releasing raw materials, drug products and investigational medicinal product (IMP), conducting external supplier audits, customer and regulatory (FDA, EMA, SFDA, ANVISA…) audits. He is also a certified Lean Six Sigma green belt.