- Human activity in the Cleanrooms is the primary reason for contamination. Therefore, gowning forms an important CCP. A list of apparel permitted in different classified areas is given in Table 4. Cleanroom garments shall comply with the guidelines provided by the Institute of Environmental Sciences and Technology (IEST).
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While several tests are described , the Helmke Drum test as per28 that verifies the particle shedding of garments, especially when it is washed multiple times, is critical. Other critical tests include verification of Moisture vapour transmission rate, air permeability, pore size, flammability, Surface resistivity, Static electricity decay, Particulate filtration efficiency [as per EN 143 (TSI 8130)] and Bacterial Filtration efficiency (as per ASTM F2101).
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The sterility assurance level of 10-6 after sterilization of the garments is tested as per ANSI/AAMI/ISO11137-1. It is crucial to ascertain the validity period of sterilized garments. Establishing the specific duration a garment can be worn before requiring replacement during a shift is essential. Training on the Gowning process is critical, and the process qualification shall comply with Annex -11.
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Continuous improvement is a core principle of ICH Q10. One such KPI that drives continuous improvement is monitoring CAPA (Corrective and Preventive Actions) closure times .
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Garments that pose a risk of contamination shall be discarded. Routine visual inspection is necessary before and after use to avert the risk of contamination during the process. An in-house laundry process is preferred. The number of wash cycles shall be validated. Detergents can be used, and the final rinse’s residual TOC shall be comparable with water for injection (WFI). Garments shall be autoclaved and frequently examined for the absence of lint. Garment material shall comply with IEST standards28.
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Personnel contribute significantly to the source of microorganisms . Personnel shall undergo qualification to enter the Grade B areas. Gowning qualification tests the operator’s proficiency to don and doff the garments correctly and conduct environmental monitoring while the operator is in the gown.
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Re-qualification, other than during annual frequency, is required whenever personnel return to the office after a vacation, recover from a long-term illness, are exposed to contaminating environments for reasons beyond the control of the company, results of an investigation confirm by hypothesis/proof that the inappropriate behaviour is the cause of the incident / OOS / OOT/deviation etc.
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No specified sampling locations were described in the guidance documents1; hence, this practice can vary across companies. Companies develop a risk-based approach to identify the locations for sampling. . Microbial sampling locations on the surfaces of the personnel covering gloved fingers, forearms, headgear, Facemasks, boots, etc, shall be performed as part of gowning qualification.
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Institute of Environmental Sciences and Technology, IEST-RP-CC003.4, “Garment System Considerations for Cleanrooms and Other Controlled Environments, 2011.
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Jan Eudy. “Fabric and Garment Testing for Cleanrooms, Flame Resistance, and Sterilization Compatibility. Available at https://www.agomat.com.ar/downloads/Fabric_and_Garment_Testing_for_Cleanrooms.pdf
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Ruchir, P. “Aseptic Processing: Behaviours, processes and controls”. Available at ,< https://www.ivi.int/wp-content/uploads/2023/02/Pansuriya-
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Ruchir_Aseptic-processing-behaviors-processes-and-controls.pdf> USP <1116> Microbiological Control and Monitoring of Aseptic Processing Environments
