Sterile Filter Validation
We provide professional sterile filter integrity testing and validation services for sterile vent filtration membrane systems, ensuring regulatory compliance, optimal filter performance, and the safety of your personnel, manufacturing processes, products, and environment.
Why Sterile Filter Integrity Testing?
PRI Service Solutions offers integrity testing and validation service for your sterile filter membrane systems to ensure proper functionality for the safety of your staff and the environment. PRI technicians are Pall factory-trained and utilize the Palltronic® Flowstar integrity testing instrument. Testing capabilities include water intrusion test, forward flow test, bubble point test, and combined forward flow and bubble point test.
Upon completion of the test, electronic and paper reports are generated for documentation and regulatory compliance indicating a status of “Pass” or “Fail.”
Testing Provides Validation of the Following:
- Filters Meet Manufacturer Specs
- Filter Is Installed Correctly
- Filter Assembly Integrity
- Filter Is Proper Grade for Application
- Compliance with Regulatory Requirements
- Filters Meet Biosafety Needs
Two Ways to Handle Logistics:
Onsite Validation at Your Facility:
Ideal for users with sterile vent filters used on biowaste treatment systems where the filters need to be validated post-use, as well as pre-use. We can validate the used filters, and if they need replaced we can test the new one prior to putting it into service.
- We ship testing equipment to you.
- We travel to your facility.
- We perform testing on the filters AND housings “in-situ.”
- We provide documentation.
- We can replace filters with new ones if necessary.
Offsite Validation at PRI Lab:
Ideal for users with sterile utility filters which need to be validated post-use prior to disposal. You can pull the filters out of service, ship them to us and put new ones in. We will test the old filters, and provide documentation to you.
- You sterilize the old filters and remove them from service.
- You ship filters to PRI (we can provide you a hardshell shipping case if desired).
- We validate filters in our lab.
- We provide documentation.
- We dispose of filters or send them back to you if desired.
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