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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The collection incubator is meticulously crafted through a rigorous process encompassing forty distinct stages, each executed in strict compliance with the ISO9001 quality management and ISO14001 environmental standards. Every product undergoes a thorough integrity test, ensuring exceptional quality traceability and continuous improvement. Tailored to meet the diverse testing requirements of varying dosage and packaging forms, an array of cups, filter materials, and compatible needles are carefully selected. Our state-of-the-art collection incubators are designed and developed to cater to the specific needs of sterilization testing, delivering unparalleled precision and reliability.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is meticulously designed for items featuring hollow tubes, such as infusion sets, where soaking is not feasible, and the fluid channel is designated sterile. This method offers effortless operation, requiring modification of FTM media with liquid D rinse products. The eluate is subjected to membrane filtration before being placed in FTM and SCDM. Although not commonly employed, this method provides a streamlined approach to testing sterility, ensuring robust results.
Bulk Drugs / Biopharmaceuticals
Bulk drugs (Active Pharmaceutical Ingredients, API) undergo sterilization according to USP 71 standards prior to entering the manufacturing process, ensuring utmost purity and safety.
Bulk biologics are rigorously tested for sterility in alignment with 21 CFR 610.12 regulations. This procedure mandates the use of FTM media, with specified sample test sizes and a minimum volume of 10 ml, guaranteeing comprehensive sterility assurance.
Interpretation of Sterility Test Results
Technicians are meticulously trained in growth testing methodologies during the cultivation process. Growth is assessed by examining a generally transparent medium under a light source, with any turbid areas indicating microbial presence. Upon detection, suspect containers are further tested to verify that turbidity originates from microbes, not from sample decomposition. Occasionally, sample cloudiness may result from particle shedding or a chemical reaction with the medium. Once testing is complete, samples are returned to the incubator for the remainder of the incubation period. Any turbidity observed is meticulously monitored and recorded over a four-day period on the 14th day of testing.
Tag:
Laboratory Petri Dish
Cell Culture Dish in Bulk
Petri Dish Products
Plastic Petri Dish
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