Pharmaceutical Technology - March 2022

Pharmaceutical Technology March 2022

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26 Pharmaceutical Technology QUALITY AND REGULATORY SOURCEBOOK EBOOK MARCH 2022 P h a r mTe c h . c o m amount of contamination, both 0.5 microns and 5.0 microns, that were generated during activities, such as standing, sitting, walking, turning, etc. The test protocol utilized 48 particle counters at heights of 1 ft–6 ft 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—coverall, hood, and boots—is critical. Based on the tests conducted in 2015, it was appar- ent 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 particu- late contamination. • Improper gowning techniques cross-contami- nate the cleanroom garments. • Poor fitting garments increase the billowing effect and the particulate generation. PharmTech: What do you think were the most im- portant 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 opera- tions is affected by garment type. • Temperature increase can result in overheat- ing and result in greater microbial and par- ticulate risk. • Lifecycle of garments must be confirmed to re- duce the risk of contamination. These results demonstrated that there are major concerns during high activities in a cleanroom dur- ing operations and suggested that garments need to be changed after specific activities to reduce the risk. Challenges to the protocol PharmTech: What were the most challenging aspects of this testing protocol to perform? Have you tried any modifications/improvements since the first tests? Dixon-Heathman (Cleanroom Management Associ- ates): The test protocol was difficult. The num- ber of activities required were challenging to the operational staff. We have not done any further testing on garments in the body box, as the test- ing provided 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. PharmTech: As you shared the in-use testing pro- tocol at industry 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 assessments to deter- mine 5.0-micron particulate risk during set-up and interventions, especially in aseptic operations. Companies will have diff iculty in duplicat- ing these tests as they require 'body-box' testing within cleanrooms. However, users must assess gowning systems that meet the needs of contami- nation control in the intended applications. The thermal effect problem is seen daily. Com- panies are concerned about the comfort factor and the risk of microbial contamination because of ex- cessive heat. Temperature in cleanrooms have been Quality: Cleanrooms Contin. on page 39

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