Package Integrity Testing – VeriPac Series
Tyvek® gives the premium microbial barrier protection for sterilized medical instruments and pharmaceuticals. Apart from protecting the medical devices and pharmaceutical products from physical damages, medical and pharmaceutical packages also should provide an effective microbial barrier and help to maintain the sterility of the products. Bacteria and viruses with sizes varying from 0.002 to 100 microns are a constant threat to pharmaceuticals and medical devices which in turn can be hazardous to the patients.
Tyvek® has been known to provide superior microbial barrier under the most rigorous, highly contaminated conditions. Tyvek® is made of continuous, randomly oriented high-density polyethylene (HDFE) filaments. This unique structure gives Tyvek® greater resistance to microbial penetration than other packaging materials.
Extensive research work has been done on the microbial barrier performance of porous medical packaging materials. Conventionally, water bath/bubble leak testing method were used where the packaging is placed into a water bath. Bubbles will be seen coming from the pack in case of any leakage, which is a destructive, subjective test method. PTI’s VeriPac package integrity testing method is a non-destructive alternative to the conventional water bath leak test or bubble leak testing method. VeriPac leak test systems can be utilized for non-destructive package integrity testing for Tyvek and porous packaging.
VeriPac inspection systems are based on the ASTM approved vacuum decay test method F2338. It is listed in ISO 11607 USP <1207> and is an FDA recognized consensus standard for package integrity testing. This technology has been proven under the GMP regulatory guidelines. The ASTM F2338 method was developed using VeriPac leak test instruments. VeriPac Series have been used in the leak detection of high-risk applications that require the highest level of reliability and accuracy.
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VeriPac Series - Non-destructive Alternative to Water Bath Leak Test Method
Specifications
| Application |
- Non-destructive leak detection for packages with defect profile typically >15 microns
- Altitude package testing
|
| Package Type |
- Filled & sealed pouches, cups, trays
- Empty trays
- Tyvek® lidded blisters
- Pouches
|
| Package Materials & Combinations |
Tyvek®, Paper, Foil, Film, Aluminum, Plastic & Laminated Materials |
| Offline or Online |
Offline lab instrument |
| Test Configuration |
- Offline laboratory
- Production line applications
|
| Test System |
Single Transducer PERMA-Vac Technology* |
|
Test Method*
|
Vacuum Decay |
| Operator Interface |
10" color touch screen |
|
Test Parameter Storage
|
Up to 20 packages |
| Test Sensitivity |
2 ccm (approximate hole size 15 microns) |
|
Test Results/Resolution
|
Pass/Fail Result in mBar units |
| Security Password |
Yes |
| Remote Internet Access |
Yes |
| Data Collection |
View on touch screen and electronic data log collection |
| Test Chamber |
Manual or semi-automatic |
| ASTM Test Method |
ASTM F2338-09** and ASTM D6653-13 |
| Test Instrument Enclosure |
Stainless steel |
| Test Dimensions |
14.5” W – 22” D – 12” H |
| Weight |
35 lbs |
| Power |
100-240 VAC; 50/60 Cycles |
| Air |
90 psi |
| Options |
- Validation Qualification Package (IQ/OQ/PQ)
- Microcalibrator Flowmeter
|
* U.S. Patents 5,513,516 6,513,366 8,544,315.
** ASTM Test Method F2338-09 - www.astm.org based on VeriPac leak testers.
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| Test results may vary according to application and package specifications. |
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Seal Quality Inspection of Tyvek® and Porous Packaging
Seal-Scan® and Seal-Sensor
Airborne ultrasound technology has been established as one of the most effective methods for non-destructive testing of flexible packages. Ultrasound technology is an ASTM Test Method F3004-13.
Complementing the high cost of medical device manufacturing, there is a high value placed on the sterility and quality of the final product which are the main reasons for successful integration of Seal-Scan® airborne ultrasound seal inspection for medical device packaging.
Seal-Scan® and Seal-Sensor technology characterize seals that appear visually acceptable yet possess defects that affect product quality and shelf-life. Seal-Scan® is an offline inspection system used for the detection of seal defects, seal characterization and material analysis. Seal-Scan® is an excellent tool to analyze the sealing process that is ultimately the key to a good quality seal.
Seal-Scan® technology provides advanced digital imaging software tools for process control which offers in-depth seal quality analysis. Seal-Sensor is the online configuration for automated inline scanning of pouch seals that will find defects 100% online.