Process Validation & Equipment Qualification Services
Critical equipment to be considered
Integrity Testing Equipment
In the biopharmaceutical industry, implementing new equipment with respect to Quality rules and guidelines in a GMP environment can be challenging, The filter integrity test instrument is a piece of critical equipment which should be controlled in the environment in which it will be used.
To help you stay ahead in today’s demanding and competitive production environment, our Provantage® Services group provides unparalleled support for implementation of our production equipments in your processes.
Our Integrity Testing Services are designed to:
Optimize installation:
- Site Acceptance Testing (SAT): make sure your instrument is fully operational after arrival and verification at the pharmaceutical production
Accelerate validation:
- Installation Qualification and Operational Qualification (IQOQ): we can qualify the filter integrity test instrument on-site and ensure it will function as specified in GMP environment.
- Determination of drug product specific integrity testing specifications
Increase operator efficiency:
- Automatic Operator Certification Training: satisfy cGMP for operators performing in-process filter integrity testing.
Ensure optimum performance and longevity:
- Equipment service agreements meet the need for preventive maintenance, spare parts supply and calibration.
Document Links:
- Drug Product-Based Integrity Testing: Establishing a Product/Filter Test Minimum Value
- Establishing Product Specific Bubble Point Specifications For Sterilizing-Grade (0.22 µm) Durapore® Filters
- Integritest® 4 System qualification protocol and services
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