5.0 Cleanliness Requirements
“Cleanliness is not an absolute. It is a relative condition denoting the degree to which a product can be isolated from or cleaned of contaminants. The level of required cleanliness must first be established for the end product before the level of cleanliness for packaging or containers can be determined.
The cleanliness requirements should be based on individual company manufacturing specifications.”
NVR Testing: The filtered solvent from particle testing is heated and analyzed for total non-volatile residue.”
The analysis of volatile chemicals typically uses gas chromatography / mass spectroscropy. The packaging material sample is heated in a closed container, driving off volatile components. The collected sample is then analyzed by weight. This outgassing is caused by a combination of vacuum and/or high temperatures in the test environment that may be well beyond what can be expected in real handling and shipping situations.”
5.1.4 Ionic Contamination
Ionic contamination is defined as chemical species that are not electrically neutral, but are either charged positively or negatively. Ionic contaminants are anions (e.g. fluorine, chlorine, bromides, nitrates, nitrites, phosphates, and sulfates) and cations (e.g. lithium, sodium, ammonium, potassium, magnesium, and calcium). The presence of ionic contamination may cause corrosion. Ionic contaminants are determined by ion chromatography. The user must define the level of ionic contamination based on product requirements.”