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
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our meticulously crafted collection incubator undergoes a precise series of forty manufacturing processes, each strictly adhering to the stringent stipulations of the ISO9001 quality system accompanied by the rigorous ISO14001 environmental system standards. Each and every product passes the integrity test with flying colors, ensuring unyielding quality traceability and continuous enhancement. To accommodate the diverse testing requirements posed by varying dosage forms and packaging, a wide array of cups, filter materials, and matching needles were meticulously chosen. Consequently, we have innovatively designed and developed versatile collection incubators tailored to meet the multifaceted needs of sterilization testing.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is uniquely suited for products featuring hollow tubes such as infusion and infusion sets that cannot be soaked. The fluid channel of these products is distinctly marked as sterile. This streamlined method necessitates an adaptation of FTM media with liquid D rinse products, whereupon the eluate undergoes membrane filtration and is placed in FTM and SCDM. Although this approach is straightforward, it is not commonly adopted.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (Active Pharmaceutical Ingredients - API) are subjected to sterilization in strict compliance with USP 71 prior to their introduction into the manufacturing process.
For bulk biologics, sterility testing is performed in accordance with 21 CFR 610.12. This rigorous requirement calls for a medium (FTM) with sample test sizes explicitly specified in the documentation, ensuring a capacity no less than 10 ml.
Interpretation of Sterility Test Results
Technicians must be thoroughly trained in growth testing methodologies during the cultivation process. Growth identification is achieved through careful observation of the medium, which should be predominantly transparent in relation to the light source. The presence of turbidity in the medium signifies microbial growth. Upon detection of growth, the suspect container undergoes further testing to verify that the turbidity is indeed due to microbial presence rather than sample decomposition. Occasionally, cloudiness may result from particle shedding or a chemical interaction with the medium. Post-testing, the sample is returned to the incubator for the rest of the incubation duration. On the 14th day of testing, samples exhibiting turbidity are transferred and monitored for four additional days.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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