Exquisite Product Overview
| products appearance |
Light yellow, flat surface, no cracks, no visible impurities and bubbles |
| physicochemical property |
PH acceptable, gel strength 500-750g/cm2 |
| Sterility and water retention |
30-35ºC,Culture for 5 days, no bacterial growth,Culture for 5 days, no bacterial growth, no obvious water loss phenomenon |
| Packing |
Class A laminar flow production line automatic canning, to avoid the risk of personnel pollution |
| Growth experiment |
Inoculate the corresponding strains 50-100CFU according to the pharmacopoeia, and the ratio of the mean number of colonies on the test solid medium to the mean number of colonies on the control medium should be within the range of 0.5-2, and the size of the colonies should be consistent with the colonies on the control medium |
Specifications
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Each of these meticulously crafted collection incubators undergoes a rigorous creation process, consisting of forty precise steps. We adhere strictly to the esteemed ISO9001 quality system and the environmentally-conscious ISO14001 standards. With a flawless integrity test pass rate, our products exemplify excellence in quality traceability and continuous improvement. Catering to diverse testing needs—spanning various dosage and packaging forms—we’ve developed an array of incubators equipped with thoughtfully selected cups, filter materials, and needles to fulfill all sterilization testing requirements.
Sterility Assurance for Product Rinses
Integrated Solution: The Product Rinse Sterility Test is expertly tailored for hollow tube products such as infusion sets. Ensuring sterility without soaking, this user-friendly method involves modifying FTM media with liquid D rinse products. The rinsate is then membrane filtered and cultured in FTM and SCDM. It’s a specialized approach, not typically employed.
Bulk Pharmaceuticals / Biopharmaceutical Innovations
Bulk pharmaceuticals (API) undergo rigorous sterilization per USP 71 guidelines before advancing to the production phase.
Bulk biologics are subjected to sterility testing under the stringent 21 CFR 610.12 regulations, requiring FTM media with specified sample sizes and a minimum volume of 10 ml.10.
Deciphering Sterility Test Outcomes
In cultivating expertise, technicians are extensively trained in growth testing methodologies. Observing a normally clear medium under light, any turbidity indicates microbial growth. Upon detection, suspect containers are re-examined to ensure turbidity arises from microbial presence rather than sample decomposition. Occasionally, cloudiness results from particle shedding or chemical interactions. Post-testing, samples resume incubation. On the 14th day, turbid samples undergo detailed examination over four days.
Categories:
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Durable Plastic Petri Dish
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