In pharmaceutical and biotechnology manufacturing environments where beta-lactam antibiotics (specifically cephalosporins) are handled, residual antibiotic activity can carry over onto monitoring plates and inhibit the growth of environmental flora. This leads to false-negative results and an underestimation of microbial contamination. The cephalosporinase enzyme in this medium effectively neutralizes residual cephalosporin residues, ensuring that any recovered microorganisms can grow and be accurately counted.
Intended Use
This product is intended for surface sampling in controlled environments. It is particularly suitable for:
- Active pharmaceutical ingredient (API) manufacturing facilities handling cephalosporins.
- Cleanrooms and isolators where beta-lactam residues are a concern.
- Monitoring of equipment surfaces, walls, floors, and personnel gloves/gowns.
- Packaging material bioburden checks.
Composition (per Liter)
- Pancreatic Digest of Casein: 15.0 g
- Papain Digest of Soybean Meal: 5.0 g
- Sodium Chloride: 5.0 g
- Agar: 15.0 g
- Cephalosporinase: 4,000,000 IU
- Distilled Water: 1,000 mL
- Final pH: 7.3 ± 0.2 at 25°C
Performance Characteristics
The product meets stringent quality control criteria:
- Appearance: Light yellow, convex, smooth surface, free from cracks, visible impurities, and bubbles.
- Gel Strength: 500–650 g/cm².
- Sterility: No growth observed after incubation at 20–25°C for 3 days and 30–35°C for 2 days.
- Growth Promotion: Validated for robust growth of Escherichia coli, Pseudomonas aeruginosa, Bacillus subtilis, Staphylococcus aureus, Candida albicans, and Aspergillus niger.
Packaging and Storage
- Format: 55mm × 10 plates per pack.
- Fill Volume: 15–20 mL per plate.
- Packaging: Three-layer vacuum packaging (designed to facilitate safe entry into cleanrooms).
- Shelf Life: 60 days from the date of manufacture.
- Storage: Store at 2–8°C in the dark. Do not freeze.
Q: Why is cephalosporinase included in this medium?
A: Cephalosporinase is an enzyme that hydrolyzes and inactivates residual cephalosporin antibiotics. Without it, any antibiotic residue on the sampled surface could leach into the agar and inhibit the growth of sensitive environmental bacteria, leading to false-negative results in facilities producing beta-lactam products.
Q: Can I use this plate for general environmental monitoring if I don’t manufacture antibiotics?
A: Yes. While it is specifically formulated for beta-lactam facilities, TSA with cephalosporinase is a rich, general-purpose medium that will support the growth of a wide range of bacteria and fungi. However, for standard non-antibiotic environments, a standard TSA plate without the enzyme may be more cost-effective.
Q: How should I dispose of the plates after use?
A: This is a single-use product. After incubation and enumeration, plates must be disposed of as biohazardous waste. It is recommended to autoclave the plates (or place them in a biohazard bag and autoclave) before final disposal to ensure sterilization.
Q: The plate has condensation inside the packaging. Is it still usable?
A: Slight condensation is normal due to temperature fluctuations during shipping. If there is excessive water on the agar surface, you may carefully pour off the excess liquid in a clean environment (laminar flow hood) and allow the plate to dry slightly before use. Do not use plates if the agar has shrunk significantly from the sides of the dish or shows signs of contamination.
