C R I T I C A L R AW MATERIALS

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-Lactamase and Penicillinase

Sekisui Diagnostics is the prime manufacturer of both -Lactamase and Penicillinase for inactivation of all classes of -Lactam antibiotics; cephalosporins up to 5th generation, carbapenems and penicillins.

In light of the over-use of -Lactam antibiotics and resulting resistance, new and novel broader spectrum antibiotics have been developed. For environmental and sterility monitoring of antibiotic manufacturing facilities under FDA (21 CFR211.176 and CFR436.20), broader spectrum -lactamase is now an essential tool. Sekisui has a new addtion to its range - -LACTAMASE-ES (EXTENDED SPECTRUM) ENHANCED FEATURES FROM OUR STANDARD -LACTAMASE
4 Full inactivation of a broad range of -Lactams including the more resistant cephalosporins: Cefepime, Cefoxitin, Cefradine and Ceftaxidime which other commercially available enzymes do not degrade as efciently. 4 Highly stable, retaining >90% of its activity after 4 hours at 50C, means no need to compensate for loss of enzyme activity during media preparation for applications using sterile plates.
Penicillinase 100 90 80 % Inhibition 70 60 50 40 30 20 10
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-Lactamase-ES

-Lactamase

-Lactam Antibiotic

Agar diffusion test on Tryptone soy agar (TSA) plates containing 500IU Cephalosporinase activity/L

THe Americas

iNterNatiONal

DIAGNOSTI C S

Sekisui Diagnostics, LLC 31 New York Avenue Framingham, MA 01701-9400 Phone: 800 332 1042 Fax: 800 762 6311 Email: questions@sekisuidiagnostics.com

Sekisui Diagnostics (UK) Limited 50 Gibson Drive Kings Hill, West Malling, Kent, ME19 4AF, UK Phone: +44 (0) 1732 220022 Fax: +44 (0) 1732 220024 Email: info@sekisuidiagnostics.com

AP0246.3.0

C R I T I C A L R AW MATERIALS
EFFECTIVENESS

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Penicillinase Sekisuis Penicillinase products have been demonstrated to inactivate the following: Penicillins: Amdinocillin, Amoxicillin, Ampicillin, Azlocillin, Benzylpenicillin, Carbenicillin, Cloxacillin, Flucloxacillin, Methicillin, Mezlocillin, Nafcillin, Oxacillin, Penicillin, Piperacillin, Ticarcillin. -Lactamase In addition to the above penicillins, Sekisuis -Lactamase products inactivate the following:
CEPHALOSPORINS CA R BA P E N E M S

1ST GENERATION CEFADROXIL* CEFALEXIN* CEFALORIDINE CEFAZOLIN* cEFRADINE*

2ND GENERATION CEFAcLOR CEFAMANDOLE CEFMETAZOLE* CEFONIcID CEFOTETAN* CEFOXITIN* CEFPROZIL CEFUROXIME* CEFDINIR CEFIXIME

3RD GENERATION CEFTIOFUR* CEFTIZOXIME* CEFTRIAXON * MOXALAcTAM*

4TH GENERATION CEFEPIME* CEFPIROME*

5TH GENERATION CEFTOBIPROLE CEFTAROLINE ERTAPENEM IMIPENEM MEROPENEM

CEFOPERAZONE* CEFOPDOXIME CEFOTAXIME* CEFSULODIN CEFTAZIDIME* CEFTIBUTEN*

* use of -Lactamase-ES is recommended for these antibiotics

APPLICATIONS
4 Testing sterility of blood cultures to remove false negatives caused by antibiotics in the blood sample 4 Testing for contamination of drugs by antibiotics as required by US Code of Federal regulations (21 CFR 211.176, Penicillin contamination, FDA, BY-lines No.8, Nov., 1977) 4 Environmental monitoring of antibiotic manufacturing areas 4 Sterility testing of Bulk antibiotics as described by US Pharmcopeia (USP) Chapter 71 and EP Section 2.6

Product details and ordering information

For more detailed information on the following products or any other enzymes, substrates or immunodiagnostics from our critical raw material range please contact us or visit our website at www.sekisuidiagnostics.com
F O RMULATION C E P H A L O S P O R I N A S E ( II ) UNits P E N Ic I L L I N A S E ( I ) EN Q U I R E EN Q U I R E > 500 UNITS/VIAL > 15 UNITS/MG > 3 , 0 0 0 U N I T S /V I A L catalOG N umB er

BELA- 7 0-1491 BELA- 7 0-1431 BELA- 7 0-1401 PENI- 7 0-1541 PENI- 7 0-1545

-LACTAMASE - E S -LAcTAMASE -LAcTAMASE S T E R I L E V I A L S

PENI cILLINASE PENI cILLINASE S T E R I L E V I A L S

> 2 UNITS/MG > 2 UNITS/MG > 5 0 U N I T S /V I A L -

NE W

1 IU dened as the amount of enzyme needed to hydrolyse 1 mole of Penicillin G (Penicillinase) or 1 mole Cephalosporin C (Cephalosporinase) per minute at 25C and pH 7.0

PRODUCT FORMATS
4 Sterile, pre-dispensed vials, in packs of 10, for speed and ease-of-use 4 Bulk powder, for when larger volumes are required, which although not sterile, has been ltered through a 0.45 micron lter prior to freeze drying