Tyvek® & Porous Packaging

tyvek

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.

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.
Test results may vary according to application and package specifications.

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VeriPac 355
airborne-ultrasound for medical device leak test
 
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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.

Seal Quality Inspection of Tyvek
914.337.2005
ContactUs
ptiusa

Our technologies conform to ASTM and other regulatory standards.

ContactUs
914.337.2005

Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

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Get in Touch

 

Packaging Technologies & Inspection

PTI offers inspection systems for package leak testing, seal integrity and container closure integrity testing (CCIT). Our technologies exclude subjectivity from package testing, and use test methods that conform to ASTM standards. PTI's inspection technologies are deterministic test methods that produce quantitative test result data. We specialize in offering the entire solution including test method development and equipment validation.

Sales Channel Partner Portal Login

ptiusa

Our technologies conform to ASTM and other regulatory standards.

ContactUs
914.337.2005

Get in Touch

 
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