Beta-lactamases are enzymes produced by bacteria (Also known as Penicillinase) that provide resistance to β-lactam antibiotics such as penicillins, cephamycins, and carbapenems (ertapenem), although carbapenems are relatively resistant to beta-lactamase. Beta-lactamase provides antibiotic resistance by breaking the antibiotics structure. Beta-Lactamase ensures sterility of bacterial infections by eliminating false negatives via the removal of antibiotics in blood samples
These antibiotics all have a common element in their molecular structure: a four-atom ring known as a β-lactam. Through hydrolysis, the lactamase enzyme breaks the β-lactam ring open, deactivating the molecule's antibacterial properties. Beta-lactam antibiotics are typically used to treat a broad spectrum of Gram-positive and Gram-negative bacteria. Beta-lactamases produced by Gram-negative organisms are usually secreted, especially when antibiotics are present in the environment.
• Testing sterility of blood cultures - Blood 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 antibiotics - US 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 monitoring of antibiotic manufacturing area
• Sterility testing of bulk antibiotics as described by US Pharmcopeia (USP) Chapter 71 and EP Section 2.6
• Sterile, gamma-radiated, pre-dispensed, vacuum-sealed vials (in packs of 10) for speed and ease-of-use
• >50 units/vial (at pH 7.0, 25°C)
• Bulk powder is not sterile, but has been filtered through a 0.45 μm filter prior to freeze drying.
Not for human therapeutic use or for medicinal purposes. For research applications only.
|Handling||Avoid contact with skin and eyes. Avoid formation of dust and aerosols. Provide appropriate exhaust ventilation at places where dust is formed.|