Microbiological Contamination Control Standards As They Exist Today
This can be a convoluted topic, so it is best to gain some clarity up front on who is making what decisions – and which standards impact you.
ISO/TC209 is the technical committee in the ISO community who makes decisions related to cleanrooms and associated controlled environments. They manage the ISO 14644 family of cleanroom related standards, including ISO 14698-1 and -2, the standards around biocontamination control.
On the other hand, CEN/TC243 is the technical committee in CEN. It often does mirror work of ISO/TC209, as it has shared members. The Vienna Agreement allows for sharing standard work between the two committees, as well as parallel voting.
From 2009 to 2014, a committee attempted to address the issues within ISO 14698, but there were too many internal clashes over the purpose of the document. Some wanted to focus on classification, while others maintained the emphasis needs to strictly be on monitoring. They were not able to resolve this conflict and, after 5 years, the committee disbanded. (Spoiler alert: this work is now being continued and the emphasis has been placed on monitoring – not classification).
Currently, ISO 14698-1 and -2 were last revised in 2003. In March 2020, there was a Systematic Review (SR) vote to withdraw ISO 14698-1 and -2. In Europe, this was replaced by EN 17141 in August 2020. There has been a push for ISO to adopt these standards at an international level to avoid confusion and consolidate standards into one publication.
In response to this request, ISO/TC209 has resumed the work of the original committee from 2004 in cooperation with CEN/TC243 to put forth an international, cohesive standard.
Challenges That Come With Microbiological Contamination Control Standards
The journey to get to a comprehensive, singular standard is not simple. While particle counting is far from easy, microbiological contamination is a different level of complexity. It deals with living organisms that are not easy to recover, measure, or observe in the first place. We call these the unseen enemies.
Microbiological contamination also presents a wide range of issues that depend on a number of variables, including how the cleanroom functions. Humans are the primary contributor to this issue, accounting for 70% to 80% of contamination within a cleanroom. Even with a shift of focus towards robotics and automation, with less human presence in the cleanroom, it is inevitable that some level of human influence will be present.
Moreover, different stakeholders and industries present a number of unique challenges. The life science industry is looking for sterility, but the food industry needs safety. The healthcare industry, on the other hand, is primarily concerned with infection control.
There is no one size solution to solve all these problems, which is why the new technical committee has stakeholders from every industry, as well as subject matter experts, to represent the unique difficulties their division is facing.
Issues Found In EN ISO 14698
While the very topic of microbiological contamination control is complex, EN ISO 14698 presented its own host of contradictions and problems. The lack of updates over the last 17 years in the face of new regulations, guidelines, and technological advances did not help.
For example, ISO 14698 is not in line with the current ISO 14644 approach. There are no principles for establishing and demonstrating control, as well as a lack of clarity on classification vs monitoring. There is a profound lack of checklists for “things to consider”, as well as a slew of challenges in real time measurement versus traditional indirect methods for sampling, recovery, incubation, and enumeration. ISO 14698 also does little to help the different industries with their wide array of problems.
EN 17141’s New Approach To Biological Contamination Control
With these issues and complications in mind, EN 17141 proposes a revised standard with the goal to find international acceptance. It focuses heavily on control and monitoring, not classification. This is done through a risk assessment and a plan that focuses on establishing then demonstrating control. It provides an easier and more practical standard to use in different industries, reinforcing best practices while leveraging existing guidelines.
Most importantly: it creates a single standard.
This standard keeps what works from ISO 14698 while reinforcing risk assessment, impact, and mitigation (this is Quality Risk Management or QRM). It aligns with the changes in the recently published GMP Annex 1 and adapts to evolving technologies. It removes unnecessary materials, including liquids, biocontamination in textiles, and validation in laundering. It also removes some issues, such as endotoxins, viruses, and prions. Meanwhile, it adds guidance for medical device manufacturers.
The standard also…
- Reviews scope of microbiological continuum.
- Gives an independent review and assessment of current indirect measurement methods, which includes the importance of the d50.
- Recognizes the roles of other standards without replicating them.
- Distinguishes between culturable and viable.
- Highlights the differences between cleanrooms and controlled environments, with according guidance.
But how does EN 17141 differ from EN ISO 14698? How does it provide customized support to different industries? We’ll answer those questions (and more) in our next blog! Create your free Knowledge Center account to be the first to see that blog.