Fields of Application
- 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).
Product data
Composition:
100 g solution contains the following active substances: 63,1 g Propan-2-ol (equates 70 % (v/v)).
Chemical-physical data
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 | GTIN |
|---|---|---|---|
| perform® sterile alcohol IPA 500ml bottle | 10 / carton(s) | 136406 | 4032651976027 |
| perform® sterile alcohol IPA 1l bottle | 6 / carton(s) | 136408 | 4032651976010 |