What is the approach for cleaning validation of a facility where viral vaccines are manfactured on campaign basis.
Please suggest.
Viral vaccines cleaning validation should be done on Risk based assessment.
[COLOR=“blue”]1.Identification of Critical Points
2.Identification of sources that virus might escape out when performing a cleaning or sterilization(Decontamination).
3.Cleaning of work benches and Biosafety cabitens after incubation of virus if you perform in Eggs.
4.Cleaning validation of inoculum fermenter.
5.Cleaning validation of Production fermenter.
6.Cleaning validation of harvesting systems
7.Cleaning validation of diafiltration systems
8.Cleaning validation of Chromatography and validation of virus inactivation methods.
9.Cleaning validation of adjuvant mixing tanks.
10.Cleaning validation of incubation vessels.
11.Cleaning validation of filling tanks or vessels after use.
12.Enumeration of wastes in the all above cleaned effulents : all of these should go into a Kill tank and then the sample from Kill tank must be enumerated and identified.
13.Environmental monitoring methods in all critcal areas after disinfection of these areas. Especially swab techniques must be used where access is limited or difficult.[/color]
The scope of work, scienctific methology ,documentation & Risk assessment is bigger and massive than its written here.
You must follow standard guides or booklets for such methodologies.
You can ask our moderator regarding guide for cleaning validation and purchase.
Regards
Thanks for your reply.can I have a template of protocol for cleaning validation of any Viral vaccine with respect to finished product(Formulation & Filling).
Hi,
I work at Biological Company, and we have the same doubts, would be necessary validate the cleaning process, if the sterilization cyle is already validated? For example, in the fermenter I have the descontamination cycle validated, so is it necessary?
Any regulatory agency request that?
Thanks in advance