Ophthalmic preparations majorly consist of sterile liquid, semi-solid or solid preparations with active pharmaceutical ingredients. More than 70% of ophthalmic drug products are supplied in plastic container closure systems, which generally contain a month or longer supply of the drug. The liquid filled package formats are often soft containers with snap on or torque screw caps, but also include foil lidded blister packs for single use contacts. Any breach, channel, or micro leak in the container closure systems can greatly increase the risk of contamination of the ophthalmic solution. Therefore, in terms of product performance and safety, ophthalmic drug product packaging is considered to be more crucial than the packaging used for solid oral drug dosage forms.
Packaging defects are the key factors contributing to contaminated eye care solutions. For instance, the soft plastic containers and snap caps are typically blow molded plastics. The area for primary concern with both torque and snap on caps is the flange area of the bottle. Although traditional methods like visual inspection can detect many container failure modes of an uncapped container, inaccuracies or marks in the flange area can go unnoticed. However, such a defect can provide a clear path for bacteria and fungi to transfer into the product. This is both the most common and most difficult container defect to detect and remains hidden beneath the cap once it is applied. Hence, manufacturers require leak detection techniques capable of detecting even minute leaks for ensuring highly sensitive leak testing solutions.
PTI’s Vacuum Decay technology is a non-destructive leak testing method, capable of evaluating both liquid and air-filled containers and detecting defects as small as below 1 micron. Proven to be the most practical and sensitive vacuum-based leak test method, Vacuum Decay technology is an ASTM test method, FDA consensus standard, eliminating false positives and subjective results associated with manual visual inspection. Vacuum Decay technology is capable of identifying leaks in sealed rigid, semi-rigid and flexible packaging made of non-porous or porous materials. It provides reliable, accurate and repeatable test results that ensure deterministic package testing and leak detection.
PTI’s VeriPac 455 is a deterministic and quantitative package inspection solution for highly sensitive liquid filled containers making it ideal for ophthalmic package leak testing needs. This test method was developed using VeriPac leak test instruments. The VeriPac 455 features patented dual vacuum transducer technology, PERMA-Vac, which offers increased test sensitivity and produces repeatable, reliable results. Under this technique, the VeriPac 455 leak tester is connected to a test chamber that contains sample packages. Vacuum is applied to these packages and a dual transducer technology is used to monitor the test chamber for both the level of vacuum as well as the change in vacuum over a predetermined test time. The changes in absolute and differential vacuum indicate the presence of leaks and defects within the package. The test cycle takes only a few seconds, results are non-subjective, and testing is non-destructive to both product and package.
Benefits of Vacuum Decay technology
- Non-destructive, non-subjective, no sample preparation
- Defect detection down to 0.01 cc/min
- Results have proven superior to dye ingress
- Deterministic, quantitative test method
- Supports sustainable packaging and zero waste initiatives
- ASTM test method and FDA standard
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