Technical sterile filtration

Hygiene specialists and doctors face the very serious challenge of the spread of Gram negative, resistant bacteria. Without a comprehensive prevention plan it will be almost impossible to meet this challenge.

Water supply points contribute to the risk of infection in medical facilities. The causes are manifold and are not only based on the original water quality. When reprocessing medical devices such as endoscopes that are used within the human body, high quality cleaning and disinfection are vital. Reprocessing must conform to DIN EN ISO 15883. The specifications for the quality of the water used for final rinsing need particular attention so that residues of cleaning and disinfectant solutions can be removed as completely as possible from the exterior and interior of the endoscope.

The Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Devices (BfArM) have issued hygiene specifications for the reprocessing of medical devices; they recommend the use of validated processes and also provide details of threshold values for water quality to avoid transmission of pathogenic microorganisms on reprocessed endoscopes.

In the last 15 years, sterile filtration has become established as a fundamental component of prevention. 1,2

Reliable sterile filters for use on cleaning noozles for rinsing medical devices (such as endoscopes) and inline filters as sterile barriers on the inlet pipe of medical devices which use water (such as birth pools and cleaning and disinfection devices for endoscopes) should fulfil the following criteria:
1. Bacterial retention in accordance with ASMT F383-15A: LRV (Brevundimonas diminuta) > 7 per cm2
2. Bacteriostatic additive in the plastic of the housing to prevent biofilm formation3
3.  Quick and safe installation.

With 15 years' experience in this area, i3 Membrane has employed ion-supported technology to develop a very compact high performance sterile filter from the formulated requirements. The filter is manufactured in a modern pharmaceutical production process as a non-returnable product. Because of its small and compact construction it is superior to returnable systems in ecological terms. As a manufacturer of medical devices, i3 Membrane has a quality management system that is certified in accordance with DIN EN ISO 13485 and thus complies with demanding requirements relating to the safety and reliability of its products and services and to risk minimisation for its products.


1: Recommendation by Deutsche Gesellschaft für Krankenhaushygiene: "Gesundheitliche Bedeutung, Prävention und
     Kontrolle Wasser-assoziierter Pseudomonas aeruginosa-Infektionen" in
     HYGIENE & MEDIZIN, 41. Jahrgang, Supplement 2, 2016, page 16

2: Recommendation by Deutsche Gesellschaft für Krankenhaushygiene: "Anforderungen an die 
     Hygiene   bei der medizinischen Versorgung von immunsupprimierten Patienten".

3: Measurement acc. to JIS Z 2801/ISO 22196