Specifically,

(A) Your aseptic operators disinfect ISO 5 surfaces prior to environmental monitoring sample collection. This practice can yield false-negative results. For example:

1. On July 18, 2023, your aseptic operator applied disinfectant to the ISO 5 repeater pump and weigh scale prior to surface sampling while spraying disinfectant onto their gloves and a sterile wipe within the ISO 5 hood. Your aseptic operator proceeded to collect three samples from the repeater pump lid and touch pad, and weigh scale after the surfaces had been sprayed with disinfectant.
2. On July 28, 2023, your aseptic operator applied disinfectant to the ISO 5 hood surface and repeater pump prior to surface sampling while spraying disinfectant onto a sterile wipe within the ISO 5 hood. Your aseptic operator proceeded to collect two samples from the hood surface and repeater pump touch pad after the surfaces had been sprayed with disinfectant.

(B) Your quality personnel in the cleanroom perform their own personnel bioburden sampling. This practice contradicts your procedure, SOP-CAPS-5000582, Environmental Monitoring – 5038, which states quality personnel must be sampled by another qualified person. For example, on July 28, 2023, your quality technician collected their own glove fingertip samples after preparing sterility test samples within the ISO 5 hood.

(C) Environmental monitoring of ISO 5 equipment does not include disinfectant spray bottles stored within the hoods. Disinfectant spray bottles, which may be stored in the hood for up to *** days, are handled by multiple aseptic operators. Your procedure, SOP-CAPS-5000582, Environmental Monitoring – 5038, instructs monitoring of equipment stored in the ISO 5 hood, including pumps, shakers, scales, and balances.

(D) Environmental monitoring of cleanroom personnel does not reflect activities and associated bioburden within your clean room. Your procedure, SOP-CAPS-4000582 Environmental Monitoring – 503B, instructs monitoring, including glove fingertips, for technicians, pharmacists, and quality personnel working in the clean room, but your monitoring for pharmacists and supervising technicians is not representative of their activities within the cleanroom, which can include opening doors between rooms, handling the telephone, touching tablet screens, and moving containers holding materials. For example, on July 18, 2023, after performing activities described above the glove fingertips of your Supervising Technician were sampled after disinfection and performance of “aseptic manipulations” in an ISO 5 hood. These manipulations consisted of moving three items from one side of the hood to the other side.