can any one provide me the reference or notes for isolater validation?
PDA Technical Report 34, (TR 34) Design and Validation of Isolator Systems for the Manufacturing and Testing of Health Care Products
Price: 150$
[COLOR=“purple”]Isolator used for production or Sterility test
Process scheme for validation[/color]
User Requirement Specification —> Risk Assesment–>Validation master plan–> Functional specification --> Design specification–> Regulatory assessment—> Building or Fabricating–> Factory acceptence test—>Delivery & Installation–>
[COLOR=“blue”][b]–>Site acceptence test—>
Installation Qualification–>
Operational Qualification—>
Cycle development -->
performance qualification–>
Environmental monitoring PQ–>
Integrity testing of Gloves & Containe[/color]r—>[/b]
Qualification of Room ( This step is done depending up on organization—>
Process validation in Production Department or Sterility method validation in QC
CLOUR — Done by fabricator and Buyer
Colour --Done at factory or buyers site
Colour-- Its company’s philosophy when to perform
Colour – This is critical step to prove earlier procedure is very robust
Kindly let me know the details about Isolation validation
in this i want to know
- Glove port integrity
- Material transfer to isolator of vial filling machine
- sterilisation of isolators by means of VHP
If anybody have more than this kindly post the details.
You must validate your gloves for integrity each and every run.
You must ensure that your VHP has 6 log reduction
You must ensure that your ports are air tight.
The isolator validation is again dependent on design, size and features.
Everything is not common in that.
I would like to one more step it is aeriation after completion of cyles.
Can anyone share expierence about sterility holding time study for biodecotaminated isolator?
Best Regards!
Tiger