Comprehensive Product Overview
| 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 |
Specifications
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Crafted with meticulous precision, our collection incubator undergoes an astounding forty-step manufacturing process, rigorously adhering to both the ISO9001 quality standards and the ISO14001 environmental regulations. Notably, each product triumphs in the integrity test, ensuring an exceptional trajectory of quality and traceability. Tailored to the testing requisites of diverse dosage and packaging forms, the selection of varied cups, filter materials, and compatible needles results in the creation of collection incubators designed to fulfill a gamut of sterilization testing needs.
Product Rinse Sterility Examination
Integrated Solution: The product rinse sterility test, specifically crafted for products featuring hollow tubes like infusion sets, is tailored for efficiency. While unsuitable for soaking and requiring a sterile fluid channel, this method involves an effortless procedure where FTM media is adapted with liquid D to rinse products. The eluate undergoes membrane filtration before being placed in FTM and SCDM. Although not frequently deployed, this method is highly effective for specific applications.
Bulk Pharmaceuticals / Biopharmaceuticals
Prior to entering the manufacturing process, bulk drugs (Active Pharmaceutical Ingredients or API) undergo sterilization in strict compliance with the rigorous standards of USP 71.
In accordance with 21 CFR 610.12, bulk biologics are subjected to a sterility test which mandates the usage of a medium (FTM) with specified sample test sizes, ensuring a minimum capacity of 10 ml, thereby upholding stringent safety protocols.
Analysis of Sterility Test Outcomes
It is crucial for technicians to be meticulously trained in growth testing methodologies during cultivation. Growth is meticulously observed through a medium that remains predominantly clear and transparent against a light source, with any turbid regions indicating microbial proliferation. Upon detecting growth, a suspect container undergoes further testing to ascertain that the observed turbidity is microbial in nature, rather than a result of sample degradation. Occasionally, cloudiness may be attributed to particle shedding or chemical interaction with the medium. Post-testing, the sample returns to the incubator for the remaining incubation period, with turbid samples being transferred and observed for four days by the 14th day of testing.
Keywords:
Laboratory Petri Dish
Bulk Purchase Cell Culture Dish
Petri Dish Collection
Plastic Petri Dish
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