Blogs CCIT

Aug 2021

Importance of OptiPac Leak Detection System in Blister Package Testing

Importance of OptiPac Leak Detection System in Blister Package Testing

Packaging plays a significant role in the drug delivery system. Packaging provides information regarding the manufacturer’s name, price, date of manufacturing and expiry, dose or strength, ingredients, etc. Blister packaging is a type of packaging format specially designed for tablets and capsules made by heating and shaping a plastic sheet into the 'blister,' which is entirely covering the object, into a bubble or a pocket. Several types of plastic materials like Polyvinyl chloride (PVC), Polyethylene terephthalate (PET), Amorphous polyethylene terephthalate (APET), High-density polyethylene (HDPE), etc. and aluminum sheets or foils are used in blister packaging. Blister packages can offer barrier protection and some tamper resistance to shelf-life requirements.

Tablets and capsules can be packaged in blister packaging in a regulated manner. The hard and solid-sized tablet or capsule is put in a rigid cavity and the flexible cover material is stamped to finish the package. The lines of tablets and capsules can usually handle the product with constant uniformity, making errors unusual. Interestingly, even though each cavity is independent, it also is reliant on blister packaging. If the seal is broken between two cavities, the sterility or quality of the product will not be affected until a blister cavity leaks outside the package.

Overview of OptiPac technology

OptiPac Leak Detection System is a non-destructive technology particularly intended for blister packages. To identify the existence and location of leaks, this technology uses volumetric imaging under vacuum with topographic imaging. Volumetric imaging is a next-generation technology that replaces expensive dye ingress methods of blister package inspection systems. The package is visually examined for blue dye penetration when submitted to a vacuum cycle immersed in dye during the dye ingress test. Although the approach appears uncomplicated, the method has several conditional factors which might contribute to inaccurate findings and less effective quality assurance.

The OptiPac is meant to accomplish a fast test cycle, without changing or sampling preparation, using One-Touch-Technology. The OptiPac applies controlled inputs and measurable outputs using concepts like those employed during a vacuum dye ingress test without the complications and the dependability challenges of the dye ingress procedure.

Simply place the blister package on the test plate and click START. The vacuum is drawn into a specified vacuum when the start button is pressed. The blisters spread under a vacuum and cause air to flow from the blister to leak. When the blister leaks, the air rushes into the chamber, leaving a blister packing deflated. A volumetric picture and measurement readings are used to detect which blister cavities are faulty during the dynamic vacuum test process. For each test package, there will be a clear pass/fail status and a quantifiable measurement

OptiPac benefits

  • A deterministic non-destructive technique
  • Auto-orientation of blister packs – test blister packs in any position
  • Auto calibration is an integrated one-touch function
  • No modification to test various blister formats
  • Completely tool-free
  • Identifies defective cavity
  • Preloaded Recipe Library with simple recipe creation and new blister forms validation
  • Advanced batch reporting with audit trail including image of blister pack and defect results
leak detection, optipac, leak testing, volumetric imaging, vacuum decay test

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