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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Our state-of-the-art collection incubator is the epitome of precision, crafted through a meticulous 40-step manufacturing process. Each stage aligns rigorously with ISO9001 and ISO14001 standards, ensuring unwavering quality assurance and environmental responsibility. Achieving an impeccable 100% pass rate in integrity tests, our incubators exemplify superior quality and traceability. Tailored to the diverse testing requisites of various dosage and packaging forms, we offer a range of specially designed cups, filter materials, and needles. These are expertly crafted to cater to the stringent sterilization requirements of multiple collection incubators.
Product Rinse Sterility Test
Combination Product Insight: Our advanced product rinse sterility test is meticulously crafted for products featuring hollow tubes, such as infusion sets. This method is ideal when the fluid channel is marked sterile and unsuitable for soaking. Emphasizing ease of operation, this technique involves modifying the FTM media with liquid D rinse products. The eluate is then membrane-filtered and suitably placed in FTM and SCDM. While this innovative approach offers enhanced simplicity, it is not commonly employed.
Bulk Drugs / Biopharmaceuticals
Before entering the manufacturing phase, all bulk drugs (API) undergo stringent sterilization, adhering to the rigorous standards of USP 71. This ensures that they meet the highest safety and quality criteria.
Our bulk biologics are subjected to thorough sterility tests in strict compliance with the 21 CFR 610.12 regulations. This mandates the use of a suitable medium (FTM) and sample sizes clearly defined in the documentation, with a minimum capacity of 10 ml, ensuring precise and reliable results.
Interpretation of Sterility Test Results
Our skilled technicians are adept in growth testing methods, pivotal during the cultivation process. Growth is ascertained by examining a typically transparent medium against a light source, where any turbid area signals microbial growth. If detected, the suspect container undergoes further testing to discern if turbidity stems from microbial activity, sample decomposition, or potential chemical reactions. Occasionally, cloudiness results from particle shedding. Post-testing, samples return to the incubator for the remainder of the incubation period. On day 14, turbid samples are transferred and displayed for four days, ensuring comprehensive analysis.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
Audited Supplier 
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