Exquisite Product Description
| 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 |
Technical Specifications
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our state-of-the-art collection incubators are crafted with meticulous attention to detail, going through forty precise production stages. Each stage adheres strictly to the esteemed ISO9001 quality management system and the rigorous ISO14001 environmental management standards. We ensure 100% product integrity through comprehensive testing, allowing for seamless traceability and exceptional quality enhancement. Tailored to meet diverse testing requirements of various dosage and packaging forms, we offer a wide selection of cups, filter materials, and corresponding needles. This enables us to design and innovate multiple collection incubators tailored to fulfill all sterilization testing needs.
Sterility Assessment of Product Rinse
Combined Product Application: Our product rinse sterility test is specifically designed for products featuring hollow tubes, such as infusion and transfusion sets. This method is perfectly suited for items not amenable to soaking, where the fluid pathway is marked as sterile. The procedure is straightforward and entails the adaptation of FTM media with liquid D rinse products. The resulting eluate undergoes membrane filtration before being placed in FTM and SCDM. While effective, this method is not commonly employed.
Pharmaceuticals / Biopharmaceuticals
Before entering the manufacturing process, bulk drugs (Active Pharmaceutical Ingredients) undergo comprehensive sterilization as per the stringent guidelines of USP 71.
Bulk biologics are meticulously subjected to sterility tests in alignment with 21 CFR 610.12. This ensures the medium (FTM) is adequately matched with sample test sizes as specified in the documentation, maintaining a minimum capacity of 10 ml.10
Comprehensive Analysis of Sterility Test Outcomes
Our expert technicians undergo extensive training in growth testing methodologies during cultivation. Growth observation is conducted on a generally transparent medium against a light source; the presence of turbid areas within the medium signifies microbial proliferation. Upon detecting growth, the suspect container undergoes further testing to ascertain if the turbidity is due to microbial presence rather than sample decomposition. Occasionally, sample cloudiness results from particle shedding or chemical interactions with the medium. Post-testing, the sample returns to the incubator for the incubation duration. Turbid samples are systematically transferred and monitored over a four-day span, concluding on the 14th day of the test.
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