ISO 80369-7 is the newly published standard that replaces the ISO 595 series of standards. The ‘Part 7’ standard is [...]
In package performance protocols, these vibration forces are incorporated into a regimen of other transport hazards such as handling (shock), compression, and environmental temperature and humidity extremes.
The debate in the industry is which standard to use for compliance with the ISO 11607 standard.
Significant product and package responses and interactions during shipment can be severe and may lead to package or product failure. Identification of critical frequencies and the nature of package stresses can aid in minimizing the effect of these occurrences.
Modern cleaning validation procedures must be implemented to prove that the equipment is reasonably free of any residue. It must be documented to be safe, causes no product quality concerns, and the process is contaminant-free in accordance with FDA, cGMPs, and USP guidelines.