Dear all
Can you please suggest the teste to be carried out during OQ and Pq of the vial washing machine
It has to start with requirements. Parcel those out to IQ/OQ/PQ test objectives (possibly overlapping) then, if you have further, specific questions, post again.
When the Vials are earmarked for Injections filling, OQ must be designed as to cover the following:
1. Established Environment Minimum class D
2. Water Jets with Pressures specific to Vial Size.
3. Calibrated Pressure gauges
4. Defined No. of rinses, and defined quality of the final rinse
PQ must in addition to above be fully definitive for:
1.Capability to reduce Particulates - Viable and Non-viable
2.Demonstrating system filters integrity.
Thanks,
Musumba.
In addition you should challange 200 vials with NaCl and wash these vials with certain thosands (viz. 18000 )of the vial. Collect the vial and take the rinse sample with WFI after filling the vials up to 90% of the vials and analyse them for Ph, conductivity ,Microbiology and NaCl content take the acceptance criteria as per USP for WFI.
TARKESHWAR
Percentage of NaCl solution should be 20%.Fist of all take rinse sample from unwashed vials with WFI.In washed vial rinse sample the NaCl should be absent(i.e;Not detected).
Hi tarkeshwar can you please tell me three reference guidelines for using Nacl and the concentration of that.