perform® sterile alcohol IPA

Our Plus

fast, effective and residue free
sterile (X-Ray irradiated) and microbial filtrated (0.2 μm)
suitable for cleanrooms grade A/B, ISO class 5/6
ready to use in a handy, sterile 500 ml- and 1L- spray system
optional with WFI (Water for Injection)
colour and perfume free
efficacy tested according to European norms (EN)

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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

Apply perform® sterile alcohol IPA to objects and surfaces and allow to take effect. Clean the surface carefully before use. If necessary, remove excess water from the surface before disinfection. Do not apply more than 25 ml/m². Ensure complete wetting. Used wipes must be disposed of in a sealed container. Disinfect after each production and cleaning process or as required by the standard operating procedure (SOP). For professional use only. perform® sterile alcohol IPA is also suitable for glove disinfection. Surfaces that are particularly sensitive to alcohol, such as acrylic glass, must not be treated. Optionally, perform® sterile alcohol IPA is available with WFI (Water for Injection).

Spraying: Spray the ready-to-use product onto the surface and leave to act for at least 1 minute at room temperature (20± 2°C).
Wiping: Spray or pour ready-to-use product onto the surface and then wipe with a cloth or wipe the surface with a cloth that has first been pre-soaked by spraying or pouring. Leave to act for at least 5 minutes at room temperature (20± 2°C).

Microbiological efficacy

Efficacy	Concentration	Contact time
bactericidal EN1276, EN13697	ready-to-use	1 min.
yeasticidal EN1650, EN13697	ready-to-use	1 min.

Product data

Composition:
100 g solution contains the following active substances: 63,1 g Propan-2-ol (equates 70 % (v/v)).

Chemical-physical data

Density:approx. 0,88 g/cm3 / 20 °C

Viscosity, dynamic:> 2,5 mPa*s / 20 °C / Raw material

Flash point:22 °C / Method : DIN 51755 Part 1

Form:liquid

Color:colourless

pH:Not applicable

Special advice

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

The sterile 500 ml- and 1 L- spray system offers the following advantages:

convenient size for handling and storage
ergonomically shaped spray pump for ease of use
remains sterile after opening

The bottles are sterile (with irradiation indicator) and doublewrapped individually. perform® sterile alcohol IPA comprises alcohol of pharmaceutical quality in accordance with the Ph. Eur. EU-0023656-0001 1-1

Information for order

Item	Delivery form	Item no.
perform® sterile alcohol IPA 500ml bottle	10/Carton	on request
perform® sterile alcohol IPA 1l bottle	6/Carton	on request

These products are not available in every country. For more information please contact our local subsidiary or distributor.

Application aids

Item	Item no.
perform® spray bottle holder	693540
perform® spray bottle holder - plate	693541

Environmental information

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