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www.biopharminternational.com Quality and Regulatory Sourcebook eBook March 2022 BioPharm International 11 surrounding an operator at 18 inches and 36 inches. The study showed that proper movement and training were important for operations. But this is not the entire solution. The 'fit' of the garment—cov- erall, hood, and boots—is critical. Based on the tests conducted in 2015, it was apparent that more studies were needed to determine if the garment became contaminated during wearing and the impact of that contamination on the cleanroom and operations. Testing of operational staff while working was required. Data from those further stud- ies indicated that: • Untrained personnel generate higher particulate contamination. • Improper gowning techniques cross-contaminate the cleanroom garments. • Poor f itting garments increase the billowing effect and the par- ticulate generation. BioPharm: W hat do you think were the most important conclusions to come out of the research you did in developing this new testing protocol? Dixon-Heathman (Cleanroom Management Associates): The requirement of garments is protection for the product, process, and cleanroom from particulates generated by people. The testing identified three major items: • Particulate generated over time during operations is affected by garment type. • Temperature increase can result in overheating and result in greater microbial and particulate risk. • Lifecycle of garments must be conf irmed to reduce the risk of contamination. These results demonstrated that there are major concerns during high activities in a cleanroom during opera- tions and suggested that garments need to be changed after specific activities to reduce the risk. CHALLENGES TO THE PROTOCOL BioPharm: What were the most chal- lenging aspects of this testing protocol to perform? Have you tried any modifica- tions/improvements since the first tests? Dixon-Heathman (Cleanroom Management Associates): The test protocol was difficult. The number of activities required were challenging to the operational staff. We have not done any further testing on garments in the body box, as the testing pro- vided the data we needed. However, we are currently testing other sources of 5.0-micron particulates in critical areas of the cleanroom that could also create potential product concerns. BioPharm: A s you sha red t he in-use testing protocol at industr y events, what type of response have you heard? Do you think more companies will begin to employ these tests? Dixon-Heathman (Cleanroom Management Associates): The industry was generally surprised by the data. Companies are using impact assess- ments to determine 5.0-micron particu- late risk during set-up and interventions, especially in aseptic operations. Companies will have diff iculty in duplicating these tests as they require 'body-box' testing within cleanrooms. However, users must assess gowning sys- tems that meet the needs of contamina- tion control in the intended applications. The thermal effect problem is seen daily. Companies are concerned about the comfort factor and the risk of micro- bial contamination because of excessive heat. Temperature in cleanrooms have been reduced where possible. Fabric selection is key in reducing this risk. FUTURE TRENDS AND PRACTICES BioPharm: Are there any plans for industry or regulatory to consider the test protocol for future good practice guidelines? Dixon-Heathman (Cleanroom Management Associates): Standards today research types of testing models to allow for continuous improvement. I am hopeful that the standards organi- zations will review this type of testing and begin to add this test to standards. This testing could be performed by gowning designers to determine better fitting garment systems that reduce the risk of the billowing effect. Billowing risk could become a test that is required for gowning selection. Quality and Regulatory Sourcebook Quality: Cleanrooms Contin. on page 29 "The garment system must ... manage the particulate and ... microbial risk to the product and process." —Anne Marie Dixon-Heathman Cleanroom Management Associates "The requirement ... is protection for the product, process, and cleanroom from particulates ... " —Anne Marie Dixon-Heathman Cleanroom Management Associates