Requirements for single‐use sterilization papers and paper packaging used for medical devices

Abstract

The concept of using paper in medical packaging has been accepted widely. as it provides the essential permeability to allow ingress of the sterilising media whilst preventing the post‐penetration of bacteria. thereby maintaining sterility of the medical device itself. In Europe this widespread application of paper has demanded the introduction of proper standards for sterilization papers and converted items, such as bags and pouches. In this article these standards are discussed, i.e. British Standards, German DIN 58953, French Pharmacopoeia and Eucomed (European Confederation of Medical Suppliers Association). Comparisons of these standards, including results of our testing, also are presented t o underline the essential differences between specifications for the same grade of paper. In particular, special note is made in the case of air permeability of papers used for gas sterilization. The most reasonable solution is put forward by Eucomed, in which permeability performance is more fully addressed. The principles of various methods for the determination of microbial barrier performances of sterilization papers also are described and some comments in this respect are given.

Validation of Test Methods for Characterizing and Specifying Materials Used in the Construction of Sterilization Packaging

“…Sterilization packaging can take several forms, including bags, pouches and preformed packs, and is usually made from a combination of paper, plastic and nonwoven materials. Consequently, the materials used for sterile barrier systems must conform to requirements, which dictate a range of critical properties that include porosity, water resistance, heat sealability, acidity, and so on.…”