B Lactamase 1401 1431 Ds

ENZYMES
-Lactamase
Catalogue no. BELA-70-1401, BELA-70-1431
E.C. Number 3.5.2.6
ORIGIN
Bacillus cereus 569/H9
SPECIFICATIONS
-Lactamase is a freeze-dried product containing buffer salts and zinc and is has a broad range of
activity against both penicillins (I activity) and cephalosporins (II activity).
TABLE 1 The Specifications of -Lactamase
FORMULATION UNITS CATALOGUE NO.
Freeze dried bulk powder >2 II Units/mg BELA-70-1431

(also contains approx. 20 I Units/mg)
Sterile product in vials >500 I Units/vial BELA-70-1401

>50 Il Units/vial
UNIT DEFINITION
One Sekisui (International) unit of Penicillinase (-Lactamase I) activity is defined as the amount of
enzyme that will catalyse the hydrolysis of 1.0 micromole of benzylpenicillin per minute at 25C and
pH 7.0.
One Sekisui (International) Penicillinase unit is equivalent to 600 Levy Units, 75 Pollock Units or 91200
Kersey Kinetic Units.
One Sekisui (International) unit of Cephalosporinase (-Lactamase II) activity is defined as the
amount of enzyme that will catalyse the hydrolysis of 1.0 micromole of cephalosporin C per minute
at 25C and pH 7.0.
STERILITY
The -Lactamase vials are sterilised by gamma-irradiation. There is no detectable growth in
Tryptone Soya Broth at 30-35C for 14 days. The bulk powder is not sterile but has been filtered
through a 0.45 micron filter prior to freeze drying
sekisuienzymes.com AP0239.5.0
ENZYMES
RECONSTITUTED STABILITY
-Lactamase vials are stable for 4 weeks at 2-8C after reconstitution in water.
FIG. 1 -Lactamase Liquid Stability
120
100
RECOVERY (%)
80
60
40
20
0
0 5 10 15 20 25 30 35 40
TIME AFTER RECONSTITUTION (DAYS)
I UNITS II UNITS
EFFECTIVENESS
Sekisui Enzymes -Lactamase has been demonstrated to inactivate the following;
Penicillins: Amdinocillin, Amoxicillin, Ampicillin, Azlocillin, Benzylpenicillin, Carbenicillin, Cloxacillin,

Flucloxacillin, Methicillin, Mezlocillin, Nafcillin, Oxacillin, Piperacillin, Ticarcillin.
Cephalosporins: Cefaclor, Cefadroxyl, Cefalexin, Cefaloridine, Cefalothin, Cefamandole,

Cefazolin, Cefdinir, Cefixime, Cefonicid, Cefoperazone, Cefotaxime, Cefpodoxime, Cefprozil,
Cefsulodin, Ceftazidime, Ceftiofur, Ceftizoxime, Ceftriaxone, Cefuroxime.
Sekisui Enzymes -Lactamase has also been demonstrated to inactivate Carbapenems.
APPLICATIONS
1. 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 -Lactamase/Penicillinase
in the culture medium will overcome this problem when cephalosporins/penicillins are present.
2. 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).
ENZYMES
3. Environmental monitoring of antibiotic manufacturing areas

Contact plates, settle plates and air monitoring systems for testing of aseptic conditions in antibiotic
manufacturing facilities need to be manufactured with agar medium for neutralisation of antibiotic.
This is achieved by the addition of Penicillinase or -Lactamase to the medium. In this way any
antibiotic residues are hydrolysed and microbial contamination can be detected.
4. Sterility Testing of Bulk Antibiotics

US Pharmacopeia (USP) Chapter 71 and EP Section 2.6 describe sterility testing of bulk antibiotics,
which should be shown to be free from microbial contamination. The testing requires the removal
of significant amounts of active antibiotic from solution by combined filtration and the use of
Penicillinase or -Lactamase. The resulting solution is tested for the (lack of) growth of microbes. USP
specifies that the amount of Penicillinase or -Lactamase used in this removal process should be
verified using a microbial challenge solution in a control sample.
OTHER AVAILABLE PRODUCTS
CATALOGUE NO. FORMULATION UNITS SPECIFICATIONS
BELA-70-1491 Freeze dried bulk powder >2 II Units/mg

Active against penicillins
and a wide range
BELA-70-1461 Sterile product in vials >50 II Units/vial of cephalosporins
PENI-70-1541 Freeze dried bulk powder >15 I Units/mg

Active against penicillins only
PENI-70-1545 Sterile product in vials >3000 I Units/vial
Note: Sekisui Enzymes -Lactamase is for in vitro use only.

(1) Waterworth PM; An enzyme preparation inactivating all penicillins and cephalosporins, Jour Clin Path 26: 596, 1973
(2) Newsome SWB, Walsingham BM. The use of -lactamases in the clinical laboratory. Med. Microbiol. 1972 Jul;6:59-66
(3) Winley C et al ; Neutralisation of Beta Lactam Antibiotics in an environmental monitoring medium, PDA Jour Pharm Sci & Tech, 52 (6); 344-345, Nov-Dec 1998
(4) S erge Ohresser, Stphanie Sacherer, Millipore Molsheim; Development of a culture media for microbiological air monitoring in antibiotic production area
(http://mail.google.com/mail/html/load.htmlantibiotic production area; 2001.htm)
(5) Haberer K, Schulz H, Romeyke Y, Sauer D. Validation of enzymatic inactivation of cephalosporins adhering to enviromental monitoring samples. Eur. J.
Parenteral Sciences 1996;3:79-81.
EMEA AMERICAS JAPAN AND ASIA GROUP

Sekisui Diagnostics (UK) Ltd Sekisui Diagnostics, LLC Sekisui Medical Co., Ltd.
50 Gibson Drive 4 Hartwell Place 13-5, Nihonbashi 3-Chome
Kings Hill, West Malling Lexington Chuo-ku, Tokyo
Kent, ME19 4AF, UK MA 02421 103-0027 JAPAN
Tel: +44 (0)1732 220022 Tel: 800 332 1042 Tel: +81-3-3272-0828
Fax: +44 (0)1732 220024 Fax: 800 762 6311 Fax: +81-3-3272-0907
Email engage@sekisuienzymes.com

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ENZYMES

TABLE 1 The Specifications of -Lactamase

FORMULATION UNITS CATALOGUE NO.

Freeze dried bulk powder >2 II Units/mg BELA-70-1431

Sterile product in vials >500 I Units/vial BELA-70-1401

FIG. 1 -Lactamase Liquid Stability

Penicillins: Amdinocillin, Amoxicillin, Ampicillin, Azlocillin, Benzylpenicillin, Carbenicillin, Cloxacillin,

Cephalosporins: Cefaclor, Cefadroxyl, Cefalexin, Cefaloridine, Cefalothin, Cefamandole,

Sekisui Enzymes -Lactamase has also been demonstrated to inactivate Carbapenems.

2. Testing for contamination of drugs by antibiotics

3. Environmental monitoring of antibiotic manufacturing areas

4. Sterility Testing of Bulk Antibiotics

OTHER AVAILABLE PRODUCTS

CATALOGUE NO. FORMULATION UNITS SPECIFICATIONS

BELA-70-1491 Freeze dried bulk powder >2 II Units/mg

PENI-70-1541 Freeze dried bulk powder >15 I Units/mg

Note: Sekisui Enzymes -Lactamase is for in vitro use only.

EMEA AMERICAS JAPAN AND ASIA GROUP

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