This standard applies specifically to European cleanrooms in the pharmaceutical and biopharmaceutical, hospital, and food industries, as identified in the annexes with specific suggestions.
EN 17141 is composed of 6 parts, with sections 1 through 3 outlining the purpose of the document and definitions. Those 6 sections are followed by annexes with industry specific information and details for measurement methods and sampler verification. Today, we’re going to break down the 3 critical sections of EN 17141, including EN 17141-4, EN 17141-5, and EN 17141-6, which essentially address how to establish and demonstrate an effective microbiological contamination control plan in a cleanroom.
EN 17141-4: Establishment of Microbiological Control
This portion of EN 17141 has a few major points: what your contamination control system should address, sources of contamination, risk assessments, and establishing your environmental monitoring plan. Essentially, EN 17141-4 outlines the importance of a contamination control plan (or system) and how to enforce it.
The first thing section 4 dictates is that there should be a system to maintain microbiological contamination control put into place and maintained. This system needs to be able to:
- Identify sources of microbial contamination and their routes in the cleanroom.
- Assess sources’ and routes’ risks and then address those risks.
- Establish a schedule for monitoring microbiological contamination, including valid sampling methods.
- Establish appropriate alert and action levels, and measures to be taken when the levels are exceeded.
- Continually verify it is meeting standards and performance parameters through review of product contamination rates, monitoring results, risk assessments, control methods, and monitoring limits.
- Establish and maintain documentation.
- Include training and education for all staff involved in the use of the cleanroom or controlled environment.
Section 4 goes on to outline different sources of microbiological contamination, such as people, supply air, product materials, utilities, and machines. As a part of your system, as previously dictated, you should be able to identify these sources and have plans to address each risk if contamination is present.
Lastly, EN 17141-4 goes on to outline how to establish an environmental monitoring plan, including monitoring locations, monitoring frequencies, alert and action limits, documentation system, and personnel education and training. These factors should be determined by the risk assessment, which should take into consideration the application of the cleanroom and the products and materials used or developed within.
EN 17141-5: Demonstration of Microbiological Control
The backbone of an excellent contamination control system or plan is the ability to prove its efficacy. This is not only integral to the function of the system, but also to audits and verification of the system. EN 17141-5 outlines how to properly demonstrate the control through effective records.
According to section 5, results of monitoring for biological contamination should not only be cataloged, it should also be analyzed and the data should be trended.
The authors go on to outline the principles of verification of the control system. To maintain verification and ensure proper function, the results should regularly be examined and investigations done for out of specification (OOS) results. All audits, checks, observations, etc. should be made on record, which should identify the personnel making the record, preparation, testing, evaluation, and reporting. These records should appropriately cultivate an audit trail.
All testing should be done with integrity, which includes the consideration of:
- Application,
- Identification of application-specific parameters,
- Data collection locations,
- Limit of detection and sensitivity of test measurement,
- And data collection.
EN 17141-5 also dictates methods for recording, evaluating, and trending data.
EN 17141-6: Microbiological Measurement Methods
In the last section of EN 17141, aside from the annexes, the authors cover how to determine your microbiological measurement method, as well as appropriate methods of measurement. Your chosen method should consider:
- The application of the cleanroom, including how long the activities take.
- How accessible the cleanroom environment is for the sampling tool.
- What effect the sampling device might have on your cleanroom’s environment or your process.
- The efficiency and precision of the method.
This portion specifically addresses three sampling methods: volumetric air samplers, culture media and incubation, and incubators. The authors give guidance that volumetric air samplers should follow manufacturer’s specifications, including validation by the manufacturer before use.
They go on to list considerations for culture media and incubation methods, including:
- Justifying the media you choose and the incubation conditions associated with it.
- Establishing controls so the media won’t contaminate the environment and will remain accurate.
- The ability of the media to sustain growth.
- Validating the condition of the media for air sampling.
- The media’s ability to identify both fungi and bacteria.
Finally, the authors address incubators directly, including proper qualification before use. The temperature should be plus or minus 2.5C to the target temperature and qualification should be carried out at least once every three years.
Are You In Compliance?
EN 17141’s annexes go on to describe specific considerations for a variety of industries to ensure compliance. We recommend conducting a gap analysis if you are currently following ISO 14968-1:2003 and ISO 14968-2:2003 to ensure compliance.
As always, we recommend working exclusively with vendors who take these regulations and guidelines seriously, integrating them into the development of their devices. Here at Lighthouse, we integrate compliance into the essence of our devices, while setting industry standards and advancing technology.
Take our ActiveCount100H as an example. This air sampler is a powerful example of compliance, specifically with ISO 14698-1, and maintains requirements often overlooked, such as the HEPA filtered exhaust.
The best way to stay in compliance is to work with vendors who live, breathe, eat, and sleep compliance.
If that’s your goal, talk to one of our experts today.
