Penase concentrate is an high purified enzyme based product specifically designed for the inactivation of Penicillins. The product does not contain animal derivatives thus is TSE/BSE free and is non-toxic. Penase concentrate has been processed in aseptic condition and the product is certified as a sterile product as it has passed a sterility test. The process has not been validated to the level required for an injectable drug. Before use or preparation observe the product for signs of deterioration. The recommendation of CFR 436 Subpart B, “Sterility Test Methods” should be followed, i.e. “Prior to use, or at the time of test, a representative number of the tubes containing added penicillinase are incubated at 3’-32°C for 24 to 48 hours, and are examined for sterility”.
Formulation and pack size
Penase concentrate is available in the following pack size:
- cod. PEN-LQS: pack of 1 x 100 ml bottle
- cod. 6 PEN-LQS: pack of 6 x 100 ml bottle
- cod. 6 PEN20-LQS: pack of 6 x 20 ml bottle
Potency1: 20,000 Levy Units/ml/min Inactivation of Pen G2: 10,000,000 IU/ml/min
1. Levy Unit (LU): amount of penicillinase that inactivates 593 IU (International Units) of Sodium Penicillin G per minute at 25°C and pH 7.0
2. Not all penicillins are comparable to Penicillin G in regards to their inactivation by penicillinase. Some may require as much as 20 times more penicillinase than does Penicillin G
Penase concentrate is a product specifically designed for the inactivation of penicillins, thus finds its application in beta-lactams (Penicillins) sterility testing (either environmental and antibiotics sterility testing). Penase concentrate can be used for the inactivation of beta-lactams from blood or tissue sample prior to routine microbiological examination. For this last application Penase concentrate is intended only for IDV manufacturer.
Penase concentrate is an optimized ready to use solution that can be directly added to the test samples. The amount of product to be added to the test sample should be determined and set-up case by case depending on the application, concentration of antibiotic that should be inactivated, and depending on the specific beta-lactam that should be inactivated.
Before to sample the product disinfect the cap septum with a suitable disinfectant.
Penase concentrate is intended for in vitro use only
Stability of Reagents
Penase concentrate has a stability of 24 months from manufacturing date. The product should be stored at + 2°C/+8°C.