The Question posed on LinkedIn:
“Hi all, I need your support to find the answers of the following questions:
1. Using manual cleaning of glass vial before sterilization in dry oven in aseptic process for lyophilized product which means no depyrogenation , is it acceptable? and if yes, what is the requirement that should be provided to the inspector as evidence of no contamination (as documents / studies/ gown).
2. Is it mandatory to conduct viable and non-viable monitoring in the ascetic process during the capping and crimping?
Thanks in advance…“
My reply was this:
1. Validating rinsing your vials with WFI could show an acceptable endotoxin/pyrogen reduction. What auditors want to see is your processes are validated and capable of reducing the endotoxins by a certain log amount. Whether this is though cleaning followed by DHO, DHO only or WFI “dilution”. Ongoing data to show your in place systems are robust and operating under control is also needed.
You might find this useful: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-technical-guides/bacterial-endotoxinspyrogens
2. Your viable environmental monitoring program needs to show your clean rooms are operating within suitable defined parameters. This extends to all areas and activities so will include crimping and stoppering. Here I draw your alternation to PIC/S PE009-14 and the ISO 14644 series. As well as viable particles, non viable particles must not exceed stated levels.
Kind regards Paul“