Fields of Application
- EU Guidelines to Good Manufacturing Practice for medicinal products, Annex 1: 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
To prepare the active solution, fill a tub or bucket with water of an appropriate quality, add the correct volume of perform® sterile concentrate QB and stir gently.
For example:
1 bottle (40 ml) for 8 L water = 0.5 % solution. Wipe surfaces so they are well moistened and observe contact time. If necessary, rinse surfaces that have come in contact with the product.
Product data
Composition:
100 g solution contains the following active substances:
30 g Alkyl (C12-16) dimethylbenzyl ammonium chloride (ADBAC/BKC (C12-C16)), 3 g Polyhexamethylene biguanide (monomer: 1.5-bis(trimethylen)- guanylguanidinium monohydrochloride).
Chemical-physical data
Special advice
Use disinfectants safely. Always read the label and product information before use.
The practical 40 ml single-use bottles are easy to open without having to use a device. They are stable and easy to empty. perform® sterile concentrate QB features excellent material compatibility.
IE: PCS No. 95506