Penicillinase (β-lactamase Type I) is a member of the β-lactamase family. Our company has obtained high-efficiency penicillinase through biotechnological fermentation followed by chromatographic separation and purification. This product is characterized by high purity, high activity and strong specificity. Its purity was analyzed by three methods, namely reverse-phase high-performance liquid chromatography (RP-HPLC), size-exclusion high-performance liquid chromatography (SEC-HPLC) and reducing and non-reducing sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE). The purity determined by all the above methods is over 90%.
Applications
1. It can effectively hydrolyze the following penicillins: sodium penicillin, ampicillin, amoxicillin, pivampicillin, carboxypenicillins (e.g., carbenicillin, ticarcillin) and ureidopenicillins (e.g., furbenicillin, mezlocillin). Note: First-generation cephalosporins are not penicillins and are not hydrolyzed by this enzyme.
2. Sterility testing of injectable penicillin antibiotics.
3. Microbial limit testing and control bacteria examination in the quality inspection of oral penicillin antibiotics.
4. This product is ineffective against compound preparations containing β-lactamase inhibitors (e.g., clavulanate potassium, sulbactam, tazobactam), such as amoxicillin-clavulanate potassium.
5. It can also be used to eliminate antibiotic residues in pipelines during the simulated filling process of penicillin formulation production lines (only to be added after medium filling and before incubation).
6. Adding penicillinase to petri dishes containing environmental monitoring medium can reduce the risk of false negatives. The specific enzyme dosage per petri dish shall be subject to validation results.
Usage Instructions
1. Before entering the sterile room, wipe the outer wall of the vial with a disinfectant. This operation is also applicable to the surface sterilization of isolators.
2. The lyophilized powder can be reconstituted with culture medium, rinsing solution or normal saline (liquid formulations do not require reconstitution).
3. Adding enzyme to rinsing solution: Use a sterile syringe or other sterile devices to draw an appropriate amount of enzyme solution and add it to the sterilized rinsing solution.
4. Adding enzyme to culture medium: Use the built-in needle of the fully enclosed bacteria collection incubator to draw an appropriate amount of enzyme solution, and add it separately to each tube of the incubator. The enzyme can be added either before or after introducing the culture medium.
Recommended Dosage
The dosage of penicillinase for each batch of samples shall be not less than 15 million units. The dosage can be appropriately adjusted according to the antibacterial activity of the tested product and the volume of rinsing solution. The specific dosage shall be subject to methodological validation.
B2602319