Cleanroom Technology Conference 2019: Speakers

Alan Sweeney LinkedIn

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.

Aaron Mertens LinkedIn

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.

Andy Worsick LinkedIn

Comparison of ISO 14644-3 Filter Testing Techniques – Photometers and Particle Counters

Andy Worsick is the Applications Manager at Air Techniques International (ATI – UK), responsibility 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.

David Keen LinkedIn

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!

Gordon Farquharson LinkedIn

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.

Geerd Jansen LinkedIn

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.

Gilberto Dalmaso LinkedIn

Energy usage for Cleanrooms, designing in efficiency and sustainability

Gilberto Dalmaso collaborates and supports pharma companies with sterility assurance and pharmaceutical compliance, especially for aseptic productions, through training and consultancy. He specialises in pharmaceutical microbiology, microbiological contamination control, rapid microbiological methods, process understanding, Quality by Design, aseptic processes and PAT in microbiology. He is a member of the Parenteral Drug Association (PDA) Steering Committee and an auditor of the ISO 9001 quality system and HACCP. Companies that he has collaborated with in the past include: Fresenius-Kabi, NSA, Baxter, DSM, Pfizer, BSP Pharmaceutical and TEVA.

Glenner Richards LinkedIn

A systems approach to hygiene in food processing environments

James Tucker LinkedIn

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 LinkedIn

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.

John McKenzie LinkedIn

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.

Keith Beattie LinkedIn

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.

Lynne Byers

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.

Nigel Lenegan LinkedIn

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.

Tim Triggs LinkedIn

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.

Victor Chia LinkedIn

Contamination-free manufacturing – AMC and SMC in the cleanroom

Walid EL Azab LinkedIn

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.