Products and Services
Micro Leak Testing Pharmaceutical BPC And API Containers
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•Product Sheet: VeriPac Leak Testers
•Application Note: VeriPac Technology Statement
•FDA Recognized Standards: ASTM F2338-05
The VeriPac 325 has proven to be the ultimate all around leak testing solution for the pharmaceutical industry. Using non-destructive vacuum decay leak testing technology, VeriPac testers are designed to accommodate a full range of container and package types including BPC (Bulk Pharmaceutical Chemical) and API (Active Pharmaceutical Ingredient) containers and bags as well as unit dose bottles, cups, vials and ampoules. This versatility offers a tremendous advantage to companies looking for a non-destructive, reliable leak testing solution that can be implemented at various stages of the drug manufacturing process.
VeriPac micro leak testers can help reduce the number of recalls due to defects that compromise package integrity, sterility and container closure integrity. It's a superior alternative to using destructive testing methods that are time consuming and unreliable, producing results that are dependent on technique, sample preparation and operator variablility.
The VeriPac 325 utilizes an ASTM approved vacuum decay leak test method (F2338-05) recognized by the FDA as a consensus standard for package integrity testing. This test method was developed using PTI's VeriPac leak test instruments. Test components are optimized according to the type of package being tested and the level of sensitivity required.
VeriPac 325
- For high resolution requirements for pharmaceutical packages
- Leak detection for packages with defect profile typically >5 microns
- Micro leak detection of vials, ampoules and other rigid containers
- BPC (Bulk Pharmaceutical Chemical) and API (Active Pharmaceutical Ingredient) containers and bags
- Absolute vacuum & differential vacuum transducers
- Measures differential pressure & vacuum decay in Pa/sec.
- ASTM approved test method F2238
- FDA Recognized Consensus Standard #014; Item 168.
- Non-destructive and non-invasive
- No sample preparation
- Allows for increased sampling
- Quantitative results
- Repeatable
- Rapid test time
- Eliminates cost and waste of destructive testing
- Test results can be easily validated
- SPC laboratory testing or online applications
•Product Sheet: VeriPac Leak Testers
•Application Note: VeriPac Technology Statement
•FDA Recognized Standards: ASTM F2338-05
Click here to request information or to discuss active projects.
