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 working solution, first add water (preferably hand-warm) to the tub or bucket, then sprinkle in and dissolve the product.
For example:
1 sachet (40 g) to 4 l = 1 % solution
Ensure complete wetting. Contact time has to be considered. Rinse surfaces intended to be in direct contact with final products. To prevent the build-up of residue on treated surfaces, keep residual moisture on surfaces to a minimum after wiping. perform® sterile concentrate OXY has excellent cleaning properties, therefore mixing it with cleaning boosters is not necessary. The composition of the active ingredient system in the use solution remains stable for one working day. If the active solution becomes very dirty, replace it earlier.
Product data
Composition:
100 g powder contains the following active substances:
45 g Pentapotassium bis(peroximonosulphate) bis(sulphate).
Labelling according to Regulation (EC) No. 648/2004: 5 - 15 % anionic surfactants, < 5 % non-ionic surfactants, < 5 % soap, < 5 % phosphonates, perfumes
Chemical-physical data
Special advice
Use disinfectiants safely. Always read the label and product information before use.
The bags are sterile (with radiation indicator) and doublewrapped in practical 5 sachets units. Do not store bags above room temperature.
The active solution may bleach textile dyes that are highly sensitive.