β LACTAMASE MIXTURE SUPPLEMENT (STERILE) W/ (>500 Β I UNITS/VIAL ) & (>50 Β II UNITS/VIAL)

? Lactamase Mixture Supplement is a mixture of Penicillinases (? Lactamase I) and cephalosporinases (? Lactamase II) from Bacillus cereus 569/H9. The enzyme is presented as a freezedried powder containing buffer and zinc salt. Penicillinases and cephalosporinases are defined as a group of enzymes with varying specificity for hydrolysis of ?-lactam compounds. The use of ? -lactamase is specified by the US Pharmacopoeia (USP) in chapter 71 for monitoring of cephalosporin manufacturing facilities and sterility testing of bulk cephalosporins. USP has been harmonized with the European and Japanese pharmacopoeias.
There are four major uses of this preparation of enzymes.
1. Testing sterility of blood culture:
? Lactamase enzymes helps in inactivation of beta-lactam antibiotics in blood or other tissue samples prior to microbiological estimate of aminoglycosides or other non-lactam antibiotics and routine microbiological examination.
2. Environmental monitoring of antibiotic manufacturing areas:
In manufacturing facilities where antibiotics are produced, ?-lactamase enzymes such as penicillinase (penase) and cephalospopinase (Cephase) are contained in the monitoring media to inactivate ? -Lactam antibiotics. Produced antibiotics must also be inactivated prior to sterility testing to allow for the detection of potential contaminants which are sensitive to the antibiotic. Also, help in Assessment of the susceptibility of new beta-lactam antibiotics to inactivation by lactamase.
3. Testing for contamination of drugs by antibiotics:
?-lactamase enzymes help to check contamination of drugs by antibiotic such non penicillin drug shall be tested for the presence of penicillin.
4. Sterility Testing of Bulk Antibiotics:
US Pharmacopeia (USP) Chapter 71 and EP Section 2.6 describes sterility testing of bulk antibiotic, which should be free from microbial contamination