Detailed 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 |
Parameter
| Products code |
Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The collection incubator, a masterpiece of precision engineering, emerges from a meticulous journey through forty distinct processes, each upheld by the stringent standards of the ISO9001 quality system and ISO14001 environmental system. Every single product, a testament to flawless craftsmanship, triumphs in the integrity test, reflecting our relentless pursuit of quality excellence and traceability. Tailored to fulfill the diverse testing requisites of various dosage and packaging forms, a curated selection of cups, filter materials, and complementary needles coalesce to birth an array of collection incubators. These are exquisitely designed and innovatively developed to cater to the nuanced demands of sterilization testing.
Product Rinse Sterility Test
Combination Product: The Product Rinse Sterility Test is a specialized procedure reserved for products featuring hollow tubes, such as infusion and infusion sets. It's expertly crafted for scenarios where soaking is impractical, and the fluid channel is designated as sterile. The method, celebrated for its simplicity, involves the modification of FTM media with liquid D rinse products. Subsequently, the eluate undergoes membrane filtration, after which it's nurtured in FTM and SCDM environments. Despite its effectiveness, this method is not the standard choice in most instances.
Bulk Drugs / Biopharmaceuticals
Bulk Drugs (API): Sterilized meticulously in adherence to the illustrious USP 71 guidelines, bulk drugs are deemed pristine before embarking on the manufacturing journey.
Bulk Biologics: In alignment with the rigorous stipulations of 21 CFR 610.12, bulk biologics are subjected to a sterility test regimen. This entails using a specially formulated medium (FTM) with sample test sizes as outlined in the regulatory document, maintaining a minimum capacity of 10 ml.10 to ensure comprehensive evaluation.
Interpretation of Sterility Test Results
Technicians, proficiently trained in the art of growth testing methods, embark on a meticulous cultivation process to interpret sterility test results. The growth of microorganisms is evidenced by the emergence of turbidity in an otherwise transparent medium, contrasting starkly against the light source. Upon detecting growth, diligent testing of the suspect container ensues to ascertain whether the observed turbidity is attributable to microbial activity or is an artifact of sample decomposition. Occasionally, cloudiness may arise from particle shedding or chemical interactions with the medium. Following this critical evaluation, the sample returns to the incubator for the duration of the incubation period. To substantiate any findings, samples exhibiting turbidity are transferred and observed for a duration of four days on the 14th day of the test.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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