As part of its comprehensive and complimentary service offering, CS Analytical has the expertise, equipment, and experience to help you address package seal integrity testing requirements. The CS Analytical team understands the challenges sealed packages – foil on foil bags, foil on poly pouches, trays with sealed lids, and other unique sealed package systems – present when seeking to evaluate integrity and meet regulatory compliance guidelines. The ASTM (American Society for Test & Measurement) provides a wide variety of approved and validated test methods that address sealing issues for package systems and the CS Analytical has the knowledge to assist you in defining the most optimal procedure that will help you meet the challenge you are facing.
The cGMP, FDA regulated laboratory has a HAUG Pack Vac Leak Tester Model PVCA 342620 custom built to address issues such as packaging material compatibility, sealing machine set-up, and seal reliability in in normal and high-altitude situations. This test system enables fast and reliable testing to ASTM standards. It is equipped with the ECAS electronic controller that improves test setting precision and enables fast and accurate results when multiple package systems must be tested.
CS Analytical team can perform a variety of ASTM test methods for detecting leaks and seal integrity regardless of package type or configuration. Common ASTM test methods requested and performed according to strict GMP standards include
- ASTM D3078 Determination of Leaks in Flexible Packaging by Bubble Emission
- ASTM D6653 Determining the Effects of High Altitude on Packaging Systems by Vacuum Method
- ASTM D4991 Leakage Testing of Empty Rigid Containers by Vacuum Method
- ASTM D5094 Gross Leakage of Liquids from Containers with Threaded or Lug-Style Closures
- ASTM F2096 Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
The CS Analytical team are experts when it comes to all types of seal integrity testing for Pharmaceutical, Medical Device and Biotechnology products and package systems. The team has the experience to understand all aspects of the relevant ASTM procedures and how they apply to these unique, and often sensitive, product types. All work is performed in a strict, FDA regulated environment that operates under a GMP quality system.