perform® sterile wipes IPA

Sterile, ready to use 70 % (v/v) IPA impregnated wipes for surface disinfection in cleanrooms.
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  • fast, effective and residue free
  • pouch of 20 ready to use alcohol impregnated wipes
  • (Gamma-Ray irradiated) and double wrapped
  • suitable for cleanrooms grade A/B, ISO class 5/6
  • low particle release
  • colour and perfume free
  • efficacy tested according to European norms (EN)

Source of supply

 

Further information

Fields of Application

Disinfection of surfaces and equipment / devices in cleanrooms, in particular for class A and B cleanroom areas, according to:
  • Annex 1 of EU Guide to Good Manufacturing Practice Manufacture of sterile medicinal products, March 2009.
  • FDA Guidance for Industry: Sterile drug products produced by aseptic processing - current Good Manufacturing Practice; U.S. Department of Health and Human Services, Food and Drug Administration, September 2004.

Instructions for use

For professional use only. Clean the surface carefully before use. Remove excess water from the surface before disinfection, if necessary. Ensure complete wetting. Used wipes must be disposed of in a sealed container. Disinfect after each production and cleaning cleaning process or if required according to SOP. Wipe the surface thoroughly with a cloth and leave at room temperature (20± 2°C) for at least 5 minutes. Application for PT02: Disinfection of clean non-porous surfaces such as small work surfaces in medical and non medical areas as well as surfaces in clean rooms (class A/B). Effective against bacteria and yeasts.

Microbiological efficacy

Recommended use concentration*
Test methodready-to-use
Bacteria, Yeast and Mycobacteria
bactericidalsuspension + carrier test/ EN 1650; EN 16615 clean conditions5 min.
yeasticidalsuspension + carrier test/ EN 1650; EN 16615 clean conditions5 min.
* including phase 2 step 1 as well as phase 2 step 2 tests
Note: Description of the test method you will find on our website.

Product data

Composition:
100 g solution contains the following active substances: 63.1 g Propan-2-ol (equates 70% (v/v)).

Special advice

Use disinfectants safely. Always read the label and product information before use.

The alcohol used within the perform® sterile wipes IPA comprises alcohol of pharmaceutical quality in accordance with the Ph. Eur.

EU-0023656-0002 1-2

Information for order

ItemDelivery formItem
perform® sterile wipes IPA 20 pc bag20 / carton(s)on request
These products are not available in every country. For more information please contact our local subsidiary or distributor.

Environmental information

schülke manufactures products economically and with advanced, safe and environmentally friendly production processes while at the same time maintaining out high quality standards.

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