Container Closure Integrity Systems For Pharmaceutical Drug Packaging

While in the early development stage of packaging, the supplier is obliged to ensure that the packaging is by design capable of ensuring sterility. Therefore, the packaging must to be tested for defects in the range of 0.2 µm, respectively 6 * 10-⁶ mbar*l/s („maximum allowable leak level“; MALL). Based on a study from Kirsh, this is the defect size where the microbial ingress failure rate is 0 %. Integrity tests are mainly performed in the range of 2 to 20 µm defect size. The main reason for this is the feasibility of the available methods to detect smaller defects in a reasonable test time. When dealing with 100 % inspection of the production line that operates at speeds for 120 to 600 parts per minute, the allowed defect size is sometimes even increased to a significantly higher level. To compensate on the risk-based approach, additional off-line sample testing is performed to a tighter specification in the range of 1 to 10 µm. This also applies to stability testing which is performed in laboratory tests. Here again the sensitivity is more important than the test time.