Some of the cleanroom sector's most knowledgeable experts in regulations and standards gathered to discuss the latest regulatory changes and best practice at the Cleanroom Technology Conference 2017 in Birmingham this week
Some 250 people are attending the Cleanroom Technology conference set over two days to hear the expert views on changes to regulation, standards, best practice and cleanroom operation.
Speaking to a sell out audience, Gordon Farquharson tackled the implications of the latest changes to the EU GMP Annex 1 – currently going through a major revision process. Other major ISO Standards were also considered.
Chair BSI LBI/030; CEN TC243; UK and ISO TC209, Farquharson commented that the current Annex 1 prevented good risk-based classification practices but that delegates could expect many changes in the revised version due out this Autumn, including “some ISO 14644-1: 2015 alignment, increased requirement for environmental monitoring, the updating of many aspects of aseptic processing and new GMP guidance on non-distillation WFI.
Dick Gibbons (Chartered Engineer and convenor of ISO cleanroom committees for chemical contamination and energy management, spoke about ISO/AWI 14644-16 - Part 16: code of practice for improving energy efficiency.
Other topics included: a look at classification and monitoring in aseptic processing (James Drinkwater, PHSS chairman); a review of the impact of the BPR on biocide use in the cleanroom sector (Alison Livsey, Contec); changes for cleanroom PPE due to the PPE Regulation being replaced by (EU) 2016/425 (Joe Neilson, PPE certification expert, BSI); and Cleanroom Validation and ISO 14664 standards and requirements (Joe Hughes, founder member of the I-CTB and an active member of the Scottish Cleanroom Society S2C2).
The second day covers many of the latest trends and best practice in cleanroom monitoring, cleaning and disinfection, garment choice and validation, air filtration practices, environmental monitoring, and cleanroom design and construction.
Co-joined to the conference is an exhibition of 40 plus cleanroom sector companies offering the opportunity for delegates to discuss the latest, monitoring and cleaning equipment, consumables and garments.
Based on the success of this, its first multi-sector conference, Cleanroom Technology plans to hold another event next year.