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Overlooked Considerations from EN 17141:2020 Clause 5

Most medical products require some level of microbiological control. For many products that means production in a controlled environment. EN 17141:2020 was recently published to give manufacturers guidance on controlled environments and biocontamination control. EN 17141:2020 supersedes the older ISO 14698-1:2003 and ISO 14698-2:2003. An important new requirement of EN 17141:2020 is found in clause 5 “Demonstration of microbiological control” which states “A suitably competent microbiologist should review the data to identify any possible issues. . . .”

The designation of “suitably competent” is not defined by standards. However, such requirements are nothing new. The United States of America Code of Federal Regulations (CFR) for quality system regulation of medical devices, section 820.25, states among other requirements, that personnel shall have the necessary education, background, training, and experience. These CFR requirements can serve as guidance for what is considered suitably competent. In most cases suitably competent is addressed via training records, certifications, a CV, or other applicable records.

One of the first options to achieve compliance is to have a suitably competent microbiologist on staff. However, having a dedicated microbiologist on staff is not a practical or viable option for many organizations. Additionally, there is a finite number of microbiologists available.

A more practical option for many companies may be to utilize an external microbiologist, such as a consultant. External microbiologists perform such evaluations on a regular basis and are able to interpret the data independent of organizational pressures. Additionally, external microbiologists perform evaluations for a wide variety of sponsors, which can give them additional experience and insights.

Regardless of whether the microbiologist is a full-time employee or a contracted consultant, the necessary data for trending and review should be obtained for a comprehensive review by the microbiologist. As noted by clause 5 the purpose of the review is “. . . to identify any possible issues, for example an unexpected quantitative or qualitative shift in the types of microorganism recovered due to changes such as seasons, disinfection programs, operator population, training, raw materials and or facility controls.” A suitably competent microbiologist will have the knowledge and experience needed to understand the relationships between microorganisms and the environment. If the data is insufficient for comprehensive review, a gap analysis may be necessary to ensure that the necessary testing is performed, and the proper data is collected.

In addition to being a requirement, having a suitably competent microbiologist perform the data review can aid in detecting potential contamination before it affects finished product, reducing risk to the end user and the manufacturer. If having your own microbiologist is not a viable or cost-effective option, consider partnering with Nelson Laboratories Expert Advisory Services. Our experts can provide the necessary data review and will work with you to identify possible issues.