The ability to resist microbiological ingress and the entrance or escape of substances is necessary for the packaging of sterile pharmaceutical products to maintain their quality. Pharmaceutical package integrity standards are quite strict since any packaging defect might have a direct influence on the health and safety of patients. USP 1207 explains how to ensure the integrity of non-porous containers used to transport sterile pharmaceuticals. Syringes, cartridges, flexible bags or pouches, plastic or glass ampules, capped vials or bottles, and containers for drug/device combination products are examples of pharmaceutical packaging.
How to ensure pharmaceutical package sterility with Vacuum Decay Technology?
The most feasible and sensitive Container Closure Integrity test method has been proven to be vacuum decay. The test measurement yields a quantitative result that is both dependable and accurate, as well as a pass/fail determination. Vacuum Decay technique works by enclosing sample packages in a tight-fitting evacuation test chamber with an external vacuum source. The test chamber is monitored for both the level of vacuum and the change in vacuum during a set test duration using single or dual vacuum transducer technology. The existence of leaks and defects within the package is indicated by variations in absolute and differential vacuum.
As it is a non-destructive test method, it saves money by not wasting product during leak tests and produces a return on investment in under 6 months for most of the products. Vacuum Decay has shown to be a non-destructive alternative to the blue dye leak test. Vacuum Decay is an ASTM Test Method F2338, which is also recognized by the FDA as a Consensus Standard for Package Integrity Testing. It is referenced as a deterministic test method for container closure integrity testing in the new USP 1207 Chapter Guidance.
Advantages of Vacuum Decay Technology
- Non-destructive, non-subjective, no sample preparation
- Pass/fail results backed by quantitative test data
- Cost effective with rapid return on investment
- Deterministic, quantitative test method
- Identifies which cavity is defective
- ASTM test method and FDA standard
- Repeatable, rapid and reliable testing
Package integrity must be evaluated as part of a sterility program in order to determine the risk of new leaks occurring during pharmaceutical storage. After understanding the mechanism and the rationale for guaranteeing no contamination, it is recommended that test techniques with detection ability as near as feasible to the maximum permitted leakage limit be utilized.
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