Figure 1. (click to enlarge) Effect of temperature on seal strength. The green bars represent samples created using low temperature. The orange indicates packages created using the high-temperature ...

Countless Warning Letters or FDA 483s include the following violations: “Failure to ensure, where the results of a process cannot be fully verified by subsequent inspection and test, that the process ...

Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...

FDA’s 21 CFR Part 820 — Quality System Regulation (QSR) has not been updated since it was first released in 1996 . . . until now. Are you ready? Part of a panel at the conference discussing the ...

Cover Story - Packaging Sterile Packaging: Sample Sizes and Statistics Determining appropriate sample sizes for operational qualifications can help manufacturers ensure sterility of medical device ...

Sterilization is, of course, a fundamental requirement in the medical field. Here are four common reasons for failing a sterile barrier packaging validation test, presented by MDDI Online. 1.