i3 FIVESterile filter

The i3 FIVE filter is used as a sterile barrier in the inflow pipe of medical devices through which water flows. These devices include endoscope cleaning and disinfecting equipment and also birthing pools and relaxation tubs.

High quality cleaning and disinfection are especially important in the reprocessing of medical devices such as endoscopes that are used within the human body. Reprocessing must conform to DIN EN ISO 15883. Users need to take particular note of the specifications for the quality of the water used for final rinsing in order to remove residues of cleaning and disinfectant solutions from the exterior and interior of the endoscope as completely as possible. In their specifications for hygiene in the reprocessing of medical devices, the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute (RKI) and Germany's Federal Institute for Drugs and Medical Devices (BfArM) recommend that validated processes be used. They also provide information on water quality threshold values to prevent reprocessed endoscopes from transmitting microorganisms.

The reprocessing of endoscopes usually involves 8 stages. Immediately after the examination the endoscope is wiped down. It is then tested for leaks and cleaned with a brush before being rinsed and disinfected. After a last rinse, which removes residues of cleaning and disinfecting agents, the endoscope is dried and finally tested for error-free functioning. The reprocessing itself can be carried out manually, partly automatically or fully automatically. However, automatic reprocessing is preferable to manual and part-automatic reprocessing with regard to the microbiological quality of the final rinsing water.

Modern cleaning and disinfecting devices for endoscopes are able to treat their own water in order to guarantee high quality final rinsing water. They disinfect the water by means of heating, UV irradiation or the use of sterile filters. This is because, for thermolabile endoscopes in particular, the final rinse must always be carried out with microbiologically pure water of drinking water quality to ensure that no new microbes are introduced into the endoscope after all the remaining disinfectant has been rinsed out. The rinsing water should not contain Legionella bacteria, Pseudomonas aeruginosa and atypical mycobacteria; its overall bacterial content must be less than 10 CFU / 100 ml. Depending on how the endoscope is to be used, the amount of endotoxins in the final rinsing water must also be checked in accordance with DIN EN ISO 15883-4:2016. It is not sufficient to use unfiltered tap water or non-sterile distilled water as these are frequently contaminated with microbes.

Manual pre-cleaning
- Testing for leaks
- Brushing
- Rinsing     -> Use of i3 FOUR sterile filter is optional

Cleaning and disinfection
- Rinsing
- Cleaning
- Rinsing
- Disinfection
- Final rinsing     -> Use of i3 FIVE sterile filter recommended

Drying
- Approval and documentation

 

It is also important to ensure adequate water hygiene when using birthing pools and relaxation pools in clinical settings. During a water birth it is possible for blood, urine and feces to be carried into the pool. There is also a risk of infection from microbes in the water supply system in hospitals and clinics.

For a water birth, it is advisable to use an i3 FIVE sterile filter when filling the birthing pool. This protects mother, infant and attending staff from infections caused by waterborne bacteria such as Legionella pneumophila, Pseudomonas aeruginosa or atypical mycobacteria. The filter contains a 0.2 µm membrane which holds back waterborne microbes and thus ensures that the water is pure.

Properties:

  • The i3 FIVE filter meets all the requirements referring to a medical device; the usage duration is up to 50 days (7 weeks)
  • The filter housing contains a bacteriostatic additive
  • The LRV (log reduction value) for the bacterium Brevundimonas aeruginosa is > 7
  • The integrated Rectus plug and associated quick-release coupling ensure that the i3 FIVE sterile filter can be installed rapidly and safely
  • The filter length without connections is 140 mm and the filter diameter is only 40 mm
  • The membrane has a nominal pore size of 0.2 µm. This conforms to the definition of sterile filtration¹ and allows a stable through-flow
  • The water filter provides lasting protection against waterborne pathogens for immune compromised and immunosuppressed patients

 Contact us on +49 40 25767480 or send us your question. We'll be glad to send you an individual quote for our i3 FIVE sterile filter.

¹ Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good  
   Manufacturing Practice September 2004, Pharmaceutical CGMPs

 

 

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Specification

Data

Diameter

40 mm

Length (without connections)

140 mm

Weight

115 g

Flow rates

> 20 l/min. at 5 bar (20° C)

Max. operating temperature

60° C (max. 30 min. at 70° C)

Operation pressure

max. 5 bar

Shelf life

max. 1 year

Pore size of membrane

0.2 µm

Membrane area

720 cm2

Housing material

Polypropylene

Packaging

Double-walled PE-foil, vacuumed