Central Service - Issue 4/00

EDITORIAL

A Summer Void

NEWS UPDATE

What's new in Standardisation: Operation of Large Steam Sterilizers in the Healthcare Sector Erratum
A New Department - Industrial Forum
Reuse of Single-Use Medical Devices: Towards a Definite Standpoint in Belgium

MAIN ARTICLES

J. Fereres, B. Peláez (CEDEST):
Sterilization and Validation in Europe and Spain

S. Schaffer, I.J. Pflug:
Vaporized Hydrogen Peroxide at Low Pressures as an Agent to Kill Bacterial Spores

Abstract
The design, construction, and testing of an apparatus to quantify the death kinetics of bacterial spores subjected to vaporized hydrogen peroxide, at temperatures of the order of 50 °C and at absolute pressures of the order of 3 to 9 Torr are described and test data reported. Survivor curves, logarithm of the number of surviving microorganisms as a function of the exposure time to the hydrogen peroxide vapor were, in general, straight lines. The mean D-values obtained were: 37.0 seconds at 1.4 mg/L, 10.8 sec at 2.96 mg/L, and 2.4 sec at 6.0 mg/L.

V. Herzog:
Desorption of Ethylene Oxide for Compliance with Limit Values

DISCUSSION

D. Achterberg:
Operating Steam Sterilizers: State of the Art

FORUM

M. Kleebauer, R. Wilken:
Bowie & Dick Test Sheets: Independent Accredited Test Institute in Munich

Abstract
The Bowie Dick test is a well-established method for routine checking of steam sterilisers. The Bowie & Dick Test Sheets must meet very stringent requirements which are outlined in detail since 1997 in EN 867 Part 3. However, such performance requirements are useful only if there also exists a generally accessible means of verifying them, i.e. a test method for those Bowie & Dick test sheets already on the market or also for prototypes still in the development phase - but in any case for those that meet the requirements of the Standard and wish for confirmation of this. By modifying a commercially available steam steriliser with high-grade, certified measurement and control technology, a test instrument was devised for Bowie & Dick test sheets permitting verification of the performance requirements according to validated and accredited procedures for manufacturers and users alike. Proposals for acceleration of the test sequence, enabling practice-oriented monitoring of the production of Bowie & Dick test sheets, have been formulated. Hence the prerequisites for conformity testing of Bowie & Dick test sheets as per EN 867 Part 3 have been established at an independent institute.

MAILBOX

CJ Programmes

EDUCATION

P. Heeg
Tuberculosis (1)

RECOMMENDATIONS BY THE QUALITY TASK GROUP (AK »QUALITÄT«)

Programmes for Automated Processing (Part II)