Penase (Penicillinase) 3300

Penase (Penicillinase) 3300

Formulation: Freeze-dried powder
Sales Unit: 10 vials
Activity: >3 300 IU ßl/vial
Store at 2-8°C
For in vitro use only.

Specifications
Penase is a Penicillinase with a specific substrate range solely against all relevant penicillins. Penase is available as a freeze-dried powder in vials, containing buffer salts.

Unit definition
One International Unit (IU) of ßl (Penicillinase) activity will hydrolyze 1.0 μmole benzylpenicillin per minute at pH 7.0 at 25°C.
One IU BI corresponds to 600 Levy Units or 100 000 Kersey Units, respectively.

Sterility
The freeze-dried powder is not sterile but has been filtered through a 0.45 μm filter prior to freeze-drying. We recommend filter-sterilization after reconstitution.

Storage & Stability
Penase is stable in unopened vials for 24 months from date of analysis when stored at 2-8°C. After reconstitution and sterile filtration, Penase is stable for at least two weeks at 2-8"C.

Application

Penase can be applied for sterility testing of penicillins according to US and European Pharmacopeia. It can be easily incorporated into existing standard operatingprocedures by addition of the reconstituted sterile- filtered enzyme solution to all buffers and media. To validate complete inactivation of the penicillin, a
challenge test (using less than 100 colony-forming units of Staphylococcus aureus ATCC 6538 or Bacillus subtilis ATCC 6633) with an appropriate quantity of enzyme has to be performed under the custom specific settings.
Further applications include environmental monitoring of manufacturing areas and sterility testing of blood cultures.

Recommendations for use
We recommend dissolving the content of one vial in 10 ml of purified water. After reconstitution, filter- sterilize through a 0.2 μm low-protein binding membrane.
For preparation of agar plates, Penase should be added to the medium at a temperature of < 50"C.

This product was originally developed by EUCODIS Bioscience GmbH, now Biosynth.