Authors: T. Appel, D. Diedrich, S. Eberhardt, B. Früh, M. Kamer, S. Krüger, M. Schick-Leisten, E. Schmidt, T. Schwibbe, K. Wiese
Sterile barrier system
Each sterile barrier system used must be taken into account at the time of validation of
the steam sterilization processes. Mixed loads are assembled to create the reference
loads and these include the entire range of ➜ STERILE BARRIER SYSTEMS used.
In addition, the packaging processes must be validated separately.
The packaging includes foil/paper packaging, containers, non-woven packaging.
The packaging system must be specified for the MDs and must comply with ISO 11607-1
and ISO 11607-2  (see ISO/TS 17665-1 Section 7.2).
These ➜ PACKAGING SYSTEMS have specific properties to be borne in mind when
–– Containers – additional weight/condensate
–– Foil/paper and non-woven packaging – porous items – risk of overheating
–– Foil/paper and non-woven packaging – no thermal capacity to promote condensate evaporation.
–– All packaging types – steam penetration
This recommendation is Part 2 of Recommendation No. 99 by the Quality Task Group entitled Recommendations for validation preparation of steam sterilization processes in large sterilizers.
Download the recommendation here: AKQ_en_ZT_5_16