PDA EU00184 Understanding Sterilization

Darren Beckett is the Technical Director for SteriTech Ltd. SteriTech are the partner company for Fedegari and Masco Groups in the UK and Ireland. Darren heads the technical team responsible for support, training and consultancy focused on washing, sterilisation and associated aseptic processes including cycle development and validation activities. Darren has over 20 years’ hands-on industrial experience in the Biotech and Pharmaceutical industry focusing on commissioning and validation of moist and dry heat sterilisers and critical utility systems. Since 2013, he has managed the technical centre which includes client product R&D and process development/validation projects and acts as the principle technical and process trainer both at our technical centre and at customer’s sites across Europe and the US.

Graduated in Medical and Pharmaceutical Biotechnology (Master degree – 110/110 cum laude) at University of Pavia in September 2019, with a degree thesis entitled: ‘Autoclave sterilisation of polymers for biomedical applications: Hyaluronic acid case study’ held in collaboration with R&D department of Fedegari Autoclavi Spa. Alessia started to work in Fedegari in October 2019. She is involved in the improvement and development of moist heat sterilization, hydrogen peroxide decontamination, and especially cleaning processes in order help customer’s to perform the best sterilization/decontamination/washing cycle for their products.

Annick accumulated up to 15 years of experience in ethylene oxide sterilization field, quality management and pharma manufacturing. In her role as Technical Director, EO Pharma, Annick leads the Ethylene Oxide (EO) sterilization projects at numerous Sterigenics facilities and supports the facilities as the technical expert with pharmaceutical project responsibility. She’s now also supporting the development and validation of NO2 projects in Sterigenics European facilities. A seasoned speaker, Annick presents at industry conferences—such as CPhI and the A3P Congress—and hosts webinars. Annick has also been published in Medical Design & Outsourcing. Annick often presents on innovative and customized solutions for terminal sterilization of pharmaceuticals.

Andrew leads the technical team responsible for all technical support external and internal. Andrew has over 9 years’ hands-on experience in the Biotech and Pharmaceutical industry. Andrew started as a trainee engineer at SteriTech and has now established himself as an SME on Fedegari equipment. Andrew has had lots of exposure on site with challenging technical projects over the years which he now uses to support the wider team. Andrew has a passion for helping others which suits the role and the his unique skillset proves invaluable in providing an exceptional high level of support.

Lucia Maita is Technical Customer support at Fedegari group.

After a Master Degree in Molecular Biology and experience as a research fellow in the National Council of Research, she has specialized with a second-level master in current Good Manufactory Practice and Validation in the Pharmaceutical Industry.

She is currently working on cycle design, development and validation of moist heat sterilization, decontamination with hydrogen peroxide and washing.

Born 1946 in Milan (Italy), Vittorio Mascherpa he graduated 1970 with full marks and honours as 'Dottore in Ingegneria Chimica' (Chemical Engineering) at the 'Politecnico di Milano' and is a registered professional 'Ingegnere' since 1971.

1971-72 he served in the Italian National Service as an Officer of the S.Te.A. (Technical Department of Artillery).

Between 1972 and 1980 he worked for chemical industry (process engineering and project management), then he was engaged by pharmaceutical companies (Glaxo S.p.A. and Istituto Biochimico Italiano S.p.A.) for engineering and maintenance. He has been intensively involved in successful validation projects.

1988 he joined Fedegari Autoclavi S.p.A. (R&D Laboratory) and was initially in charge of the functional tests of the new electronic controllers. Later he became responsible for the process specification of the controller software and progressively imported into the Company the development activities of application process software.

He has been R&D Manager since April 1992 until his retirement in 2003. Since then, he co-operates with Fedegari Autoclavi S.p.A. as registered Engineering Consultant.

1992-94 he participated from the very beginning in the developing of the First and Second Draft of the GAMP Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture; in the following years his care was to ensure the training of Fedegari R&D Department Personnel in the application of the subsequent versions of GAMP Guide.

Since 1999 he has been an active member of the PDA's Task Force Europe for the revision of TM no. 1, 'Validation of Moist Heat sterilization in Autoclaves'.

He is also member of Sub-Committee 12 ('Sterilizers') of UNI (Italian Standars Body) and of CEN TC102/WG2/3 ('Testing/Requirements for Sterilizers'), engaged at present in the revision and “maintenance” of EN 285 Standard.

On behalf of Fedegari Autoclavi S p A., since 1988 he has lectured more times per years on all topics of industrial sterilization, both for fidelized or new Customers and for national or foreign Inspection Bodies.