Quality control of medical consumables and devices

Sterility test on sterile medical consumables and devices (syringes, gauze, dressings, care sets). Testing of surgical gloves according to EN 455-1 and EN 455-2.

An analyst performing sterility testing of medical consumables inside an aseptic isolator.

The test looks for viable micro-organisms on consumables and medical devices presented as sterile: syringes, gauze, dressings, care sets.

It follows chapter 2.6.1 of the European Pharmacopoeia, by membrane filtration or direct inoculation depending on the article, with a fourteen-day incubation.

The sampling plan is defined with you, based on batch size and intended use. A sterility test covers a sample: it is not a guarantee that the whole batch is sterile, and that limit has to be understood before deciding what becomes of the batch.