This paper uses the Boyle-Mariotte Law to restate a few general principles and applies them
to rationalise pressure holding tests on sterile installations. The authors offer a methodology …

High containment laboratories play an important role in modern society allowing for the
research and diagnosis of high-risk pathogens and infectious diseases whilst ensuring …

It has been ten years since the publication of a draft proposal, and now, many hundred
measurements without a binding standard for such a sensitive area later, the day has finally …

Objectives The objective is to check the maintaining performance of filter barrier in
sterilizations containers with the leakage rupture the junction tank/lid of the container. In …

The container closure system for pharmaceutical products intended to be sterile is critical
and this criticality relates to the physical properties of the container closure system in that a …

Validation is a documented procedure for obtaining, recording and interpreting the data
required to establish that a process will consistently comply with manufacture's predefined …

Pressure measuring instruments control process pressure; serve as leak detection; are used
to control pumps, filters and cleaning processes and to monitor fill levels. Joachim Zipp of …

* Josephus Pcm van Doornmalen, 3m Deutschland Gmbh, infection Prevention Division
Europe, middle East & africa, carlschurz-str. 1, 41453 neuss, Germany E-mail …