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 collection incubator is meticulously crafted through a rigorous process involving forty distinct steps, each adhering strictly to the ISO9001 quality management and ISO14001 environmental standards. Every product is subjected to comprehensive integrity testing, ensuring excellence in quality traceability and continual enhancement. To accommodate the diverse testing requirements of various dosage forms and packaging styles, we have curated a selection of cups, filter materials, and compatible needles, resulting in the innovative design and development of a range of collection incubators tailored to meet diverse sterilization test needs.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is specifically designed for items featuring hollow tubes, such as infusion and transfusion sets, where soaking is unsuitable, and the fluid channels are marked as sterile. This method is renowned for its simplicity, requiring the modification of FTM media with liquid D rinse products. The resulting eluate is subjected to membrane filtration before being placed into FTM and SCDM media. Although not commonly employed, this method offers a streamlined approach.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (Active Pharmaceutical Ingredients, API) undergo rigorous sterilization as per USP 71 standards prior to their introduction into the manufacturing process, ensuring impeccable quality and safety.
Bulk biologics are subjected to stringent sterility testing in accordance with 21 CFR 610.12. This involves the use of a suitable medium (FTM) with specifically documented sample sizes, ensuring a minimum capacity of 10 ml. This rigorous process guarantees the microbiological integrity of biologics.
Interpretation of Sterility Test Results
Technicians are required to be adept in growth testing methodologies during cultivation. Microbial growth is identified by observing a medium that becomes turbid against a light source, indicative of microorganism presence. Upon detection, the suspect container undergoes testing to ensure that observed turbidity is microbial and not due to sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical interactions with the medium. Post-testing, samples are returned to the incubator for the remainder of the incubation period. Turbidity detected is documented and displayed over a four-day span on the 14th day of testing.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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