Î²-Lactamase (penicillin amido-b-lactam hydrolase E.C.188.8.131.52.) is sold as a freeze dried powder containing buffer and zinc salts. For the Î²-Lactamase bulk powder, manufacturing starts the formulation (pre freeze-drying) with 251.39g Trizma pH7.5, 2.175g ZnSO4 and 100g BSA per Million units of BII activity.
Is AG Scientific's Beta-Lactamase pure?Our beta-Lactamase (penicillin amido-b-lactam hydrolase E.C.184.108.40.206.) is sold as a freeze dried powder containing buffer and zinc salts. Our beta-lactamase bulk powder manufacturing starts the formulation (pre freeze-drying) with 251.39 g Trizma, pH 7.5, 2.175 g ZnSO4 and 100 g BSA per million units of BII activity. There will be some loss in activity during freeze drying, but this can be variable. We then re-suspend the bulk powder to dispense into the vials and again there will be some losses in activity as these are freeze dried. Therefore, it is not really possible to determine the final actual concentration of the Tris, ZnSO4 or BSA with any precision. Additionally, we certify that the aforementioned product is derived from a microbial fermentation process, which contains no solvents in either the fermentation or formulation processes. Although the material has not been specifically tested, we are confident that there will be no organic volatile material contained in the beta-lactamase product.
SterilityThe beta-lactamase vialed products are bacteriologically sterile. They are sterilized by gamma-irradiation. The sterility testing that we perform at Manufacturing facility is not according to USP chapter 71, which is very strictly defined. Manufacturer makes a 1.3% (w/v) nutrient broth (Oxoid GM1 or equivalent), it is autoclaved at 121°C and then 5 mL of this is added to a vial. This is then subject to a 14 day incubation at 37°C and examined for the presence of any growth.
StabilityThe beta-lactamase bulk powders are stable for at least 2 years at -20°C in the presence of a desiccant. The vialed products are stable, when unopened, for up to 2 years at 4°C, and for up to 4 weeks at 0-4°C after reconstitution in sterile water.
TESTING STERILITY OF BLOOD CULTURESBlood cultures are routinely prepared in order to test for bacterial infection. False negative results might be obtained where the blood sample contains antibiotics. Incorporation of β-Lactamase in the culture medium will overcome this problem when cephalosporins/penicillins are present
TESTING FOR CONTAMINATION OF DRUGS BY ANTIBIOTICSUS Code of Federal regulations states that “If a reasonable possibility exists that a non-penicillin drug product has been exposed to cross-contamination with penicillin, the non-penicillin drug product shall be tested for the presence of penicillin” (21 CFR 211.176, Penicillin Contamination, FDA, BY-Lines No. 8 November 1977)
ENVIRONMENTAL MONITORINGMonitoring within antibiotic manufacturing areas
STERILITY TESTING OF BULK ANTIBIOTICSAs described by US Pharmcopeia (USP) Chapter 71 and EP Section 2.6
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