I am currently establishing cleaning limits for a vaccine with serotypes and would appreciate some guidance? As vaccines do not have ADE values, we will use the 10ppm carryover criteria and we will use the limit based formula for our calculations. Should we do an individual calculation for all serotypes? We have recovery factors for all serotypes and the various soils and MOC’s. Do we apply the worst case recovery value for each serotype? Should the shared surface area be for each piece of equipment or each process module? Also we will need to apply a carbon factor and how do we determine this carbon factor for our vaccine?
1st off. Vaccines are about ug/mL so 10 ppm calculation does not apply and is not scientifically based.
2nd. All you have to is demonstrate compliance with PDA TR #49 (technical report on 'Points to Consider…)
3rd. This report does not apply to biologicals like Botox (an analog of Clostridium A Botulinum neurotoxin).
Think! How can the ‘carryover into the next lot’ of the vaccine which has a concentration of ppb occur when you are measuring in 10 ppm? It is too dilute!
The ‘problem’ occurs when a vaccine manufacturer changes his business plan and decides to make biologicals instead which require an ADE.
You need a ‘Site Cleaning Validation Master Plan (SCVMP)’ that states you are a vaccine manufacturing facility only and complies with PDA TR #49. This will mean you have separate SOPs on minimum air exchanges, humidity levels, HEPA filters, sterilization…