Blogs

Blister packs are pre-formed packaging that are commonly used for tablets, capsules and certain consumer goods. They are made up of two primary components - a cavity made from a form of plastic or aluminum and a covering made from aluminum, paper or a lamination of soft foil. The cavity holds the product while the covering seals the product in the package.

While filling tablets into blister packs, the product is first fed into the desired cavities followed by sealing the cavity covering. Manufacturers of sterile pharmaceuticals highly depend on package integrity testing to verify product quality and safety.

Package Inspection Techniques

1. OptiPac Leak Detection System

OptiPac Leak Detection System is a non-destructive container closure integrity testing method developed specifically for multi-cavity blister packs. This leak detection method uses One-Touch Technology to achieve a rapid test cycle without requiring any changeover or sample preparation. Practical operation, sensitivity and reliability are the key features that make OptiPac technology ideal for blister package inspection.

To conduct the test, the operator places the blister pack on the test plate and presses the start button. The next step involves pulling vacuum to the desired vacuum level. The blisters expand under vacuum, driving air out of the blister through any leaks present. If the pack is defective, the air escapes into the chamber leaving a collapsed blister cavity. Depending on the blister cavity, OptiPac technology provides rapid detection of upto sub-5-micron defects. Additionaally, the technology displays a definitive pass/fail result along with quantitative measurement for each package tested.

2. VeriPac 410 Series

The VeriPac 410 inspection system utilizes a combination of Vacuum Decay technology and differential force measurement for container closure integrity test (CCIT) and leak detection of blister packs, sachets, and pouches with low headspace, such as transdermal patch packaging and suture packs. This technology can be used to test multiple packages in a single test cycle based on the package specifications. Additionally, it can also precisely identify which package or blister cavity is defective. VeriPac 410 inspection systems are proven to provide quantitative test results with a definitive pass/fail result. Being a non-destructive technique, VeriPac 410 allows tested products to be returned to the production line. This eliminates the cost and waste associated with destructive leak test methods. The ROI for the VeriPac 410 makes this a powerful solution for the pharmaceutical industry.

Benefits of VeriPac 410 Series

• Non-destructive, non-invasive, no sample preparation
• Non-subjective, accurate and repeatable results
• Capability to test multiple packages in a single test cycle
• Identifies which package is defective
• Simplifies the inspection and validation process
• Supports sustainable packaging initiatives
• ASTM test method and FDA standard
• Cost effective with rapid return on investment
• Scalable to automated inline testing.

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