A new standard for cleanrooms has arrived; BS EN 17141:2020 replaces both ISO 14698-1:2003 and 14698-2:2003, and looks to establish the requirements, recommendations and methodology for microbiological contamination control in cleanrooms and how this control is demonstrated.
The old standards had been in place for over 15 years and came under scrutiny for being out of date. The new standard is not an international ISO standard and will only apply in Europe, therefore, a sense of confusion may well exist for international operations. Although it is understood that ISO will revisit 14698 parts 1 & 2 with the aim of revising them in line with this new CEN standard.
The new document certainly has more content, 51 pages, including sections on potential sources and routes of contamination, risk assessment, establishing a plan and interpreting results and data integrity.
There is also a section, Annex E, on microbiological measurement methods, covering: choice of method, air samplers, media and incubation. EN 17141 also has industry related informative annexes for life science and pharma, medical devices, healthcare, food; as well as guidance on culture media based methods and the new rapid methods. Within these sections, there are references to a number of other industry guidelines, such as GMP and Pharmacopoeia.
The new standard covers many areas and topics that were included in the old 14698, but in greater detail. Section 4 now focuses more on microbiological control, not ‘bio-contamination.’ It includes parts describing system attributes; potential sources that may lead to the risk of contamination; the use of the risk assessment approach and developing an effective EM plan. There is also a greater emphasis on data - not only recording, and alert and action limits - but the need to trend data and ensure data integrity; both key elements.
As mentioned, Annex E describes verification of culture media based measurement methods and air samplers. Notably, there are now sections describing the different types of air sampler – sieve, slit, centrifugal, and cascade, as well as a section on rapid (RMM) and alternative real-time methods (AMM) to reflect the growing use of new technologies within EM.
It will be interesting to observe how the new standard is received within the industry and how it is adopted within pharma as a reference document.
