During the manufacturing process of injectable drugs, all pieces and parts need to go through a visual inspection process. The container, closure, product and final product all need to have individual inspections. Container closure integrity is extremely important, especially when involved with parenteral drugs. Parenteral drugs have the highest risk packaging application concern for closure integrity. Any damage or particle part of a container/ closure, could affect the sterility of the product. The drug could be effected due to oxidation, particulates, extra moisture entering the product, bacteria and more; all of which lead to serious concerns for the patients’ safety.
In USP <1207> “Package Integrity Evaluation—Sterile Products”, it focuses on the importance of container closure integrity, in addition to what could go wrong if an inspection process is not in place. Closures are often overlooked, or not inspected as precisely as they should be. More reliable testing is needed in order to keep parenteral drugs “essentially free” of particles and other toxins.
One solution to ensure container closure integrity is to move away from methods such as water baths, dye and microbial ingress testing—which are time consuming, and move towards vacuum decay, headspace analysis and high voltage leakage detection. Vacuum decay and high voltage leakage detection have been proven to be the most reliable non-destructive testing methods.
It is necessary to have the closures tracked and tested, so there is less of a chance for particulates to come into the container with the drug. If the rules from USP<1207> are violated, it could lead to ruining the process from USP<790> and <1790> visual inspections and particle defects in parenteral drugs.
Keeping track of all data information from these testing methods is important and necessary to prove the inspection process was correct. With InQuest Science’s Identifier Software, keeping track of all this data will be easy. Data can’t be altered or falsified.
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