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According to USP1207, the headspace inside a sterile pharmaceutical or medical device packaging is an important part of a product. Therefore, it should comply with corresponding quality-relevant attributes. The attributes may vary depending on the product. For instance, the residual oxygen concentration is one of the attributes for oxygen-sensitive formulations. Testing low headspace packages like sachets and blister packages can be quite challenging for manufacturers. Read on to know how PTI's VeriPac 410 ensures package integrity of low headspace packages.

Leak testing using VeriPac 410 series.

Over the years, manufacturers of multi-cavity blister packs and low headspace packaging have been using destructive test methods to evaluate the integrity of such packages. However, such traditional test methods lacked accuracy and produced subjective, and unreliable results. In order to overcome the limitations of destructive test methods, PTI has developed VeriPac 410 inspection system - a non-destructive seal and leak detection technology for blister packs, sachets, and pouches with low headspace.

The VeriPac 410 employs a mix of vacuum decay technology and differential force measurement to identify defects in packages. Multiple packages can be tested in a single test cycle, depending on package specifications. The non-deterministic nature of the test produces accurate and reliable results, removes subjectivity and the operators can get a definite pass/fail outcome. Additionally, being a non-destructive test method, the VeriPac 410 allows tested packages to be returned to the production line and eliminates the cost and waste associated with destructive leak test methods. This test method has a wide range of applications including low volume flexible and semi-flexible package leak testing.

Technology Overview

The VeriPac 410 tester is connected to a specially designed drawer-style test chamber. A custom package insert that conforms to the package shape increases test sensitivity. Certain types of packages can be tested in multiple during a single test cycle. The location of the defective package or cavity is identified. Vacuum levels are monitored during the test cycle to evaluate the package using the ASTM F2338 vacuum decay leak test method. Decay of the vacuum level indicates that air is leaking from the package into the test chamber.

Once the vacuum testing phase is complete, a pressure plate maps the surface pressure of the flexible package lidding. The pressure plate system recognizes the pressure pattern exerted by the package when it is not defective, and the lack of pressure exerted on the pressure plate by a defect, allowing for both defect detection and location of the defective package or cavity.

Benefits of VeriPac 410 system