Aseptic processing personnel monitoring

To demonstrate the control of aseptic operations maintained by well-trained personnel, defined procedures, and appropriately designed equipment and facilities. Media filling in conjunction with comprehensive environmental monitoring will be conducted three times to demonstrate that the aseptic processing of lyophilized powder is functioning as intended. 

All documents of batch numbers 001, 002, and 003 (process simulation of 24-hour duration) of media-fill study 1, study 2, and study 3 for aseptically filled A-ml vials were reviewed and found to meet the media-fill qualification requirements per current USP monograph and ISO 13408-1 1998 (E), including process simulation, environmental and personnel monitoring results. 

It is easily understood that if the aseptic operation is performed in a separated small space from which personnel have been completely excluded, the necessity for room classification based on particulate and environmental microbiological monitoring requirements may be significantly reduced. In other words, critical operations in an aseptic area should be performed in the smallest space, and intervention by personnel should be minimized by indirect means through the use of protective glove ports and/or half suits. Application of these methods can minimize the chance of contamination. Following are such systems currently in place to reduce the contamination rate in aseptic processing. 

There are items that must be transferred into the aseptic processing area that cannot be treated within a sterilizer/oven. These include portable tanks, electronic equipment, and containers of sterile materials (ready-to-use items, sterile powders, environmental monitoring media, etc.). Air locks, pass-throughs, and similar designs are employed in which the exterior surfaces of the items are disinfected. The disinfection process may be completed by personnel outside and/or inside the aseptic area depending upon the specifics of the design. 

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