Thoroughly 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 |
Key Parameters
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our collection incubators are masterfully crafted through an intricate process consisting of forty meticulous stages, each designed to uphold the rigorous standards set by the ISO9001 quality management system and the ISO14001 environmental guidelines. Every single product undergoes a stringent integrity test, ensuring top-notch quality traceability and continuous improvement. Tailored to meet the specific testing requirements posed by varying dosage forms and packaging strategies, we have carefully selected an array of cups, filter materials, and compatible needles. This thoughtful assembly has led to the innovation and development of diverse collection incubators that cater to the distinct needs of various sterilization tests.
Product Rinse Sterility Testing Protocol
Combination Product Insight: The product rinse sterility test is finely tuned for products featuring hollow tubes, such as infusion and transfusion sets. It is notably unsuitable for immersion tests, particularly where the fluid pathway is designated as sterile. This method shines in its simplicity, requiring only the modification of FTM media with a liquid D rinse. The process involves membrane filtering the eluate before immersing it in FTM and SCDM. Although effective, this method is not commonly employed.
Bulk Drugs and Biopharmaceuticals Overview
Before entering the manufacturing phase, bulk drugs (APIs) undergo a comprehensive sterilization process per the rigorous standards of USP 71.
Bulk biologics undergo sterility evaluation in accordance with 21 CFR 610.12, which stipulates the use of a suitable medium (FTM) along with specifically outlined sample test sizes, ensuring a minimum capacity of 10 ml.
Comprehensive Interpretation of Sterility Test Outcomes
Laboratory technicians are required to possess adept training in growth detection methods during the cultivation phase. Growth is determined by scrutinizing a generally clear medium against a light source, where any turbid area signifies microbial proliferation. Upon detection, the suspect sample is rigorously tested to ascertain if turbidity results from microbial presence rather than sample degradation; occasionally, turbidity may arise from particle shedding or chemical interactions with the medium. Post-testing, samples return to the incubator to complete the incubation cycle. Any medium exhibiting turbidity is placed on display for observation on the 14th day, continuing for an additional four days.
Tags:
Laboratory-Grade Petri Dish
Wholesale Cell Culture Dishes
Innovative Petri Dish Products
Durable Plastic Petri Dishes
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