Comprehensive and Detailed Product Insight
| 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 Specifications
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our collection incubator is a masterpiece crafted through an exacting sequence of forty meticulous processes, each aligned with the highest standards of the ISO9001 quality system and the ISO14001 environmental system. We take pride in achieving a flawless 100% pass rate in integrity testing, reflecting our relentless pursuit of quality improvement and traceability. With a keen understanding of diverse testing requirements across various dosage forms and packaging, we've engineered an array of cups, filter materials, and precision needles. These innovations are designed to fulfill the comprehensive needs of sterilization tests, ensuring each product meets the highest standards of safety and effectiveness.
Rigorous Product Rinse Sterility Test
Combination Solution: The product rinse sterility test is specifically tailored for products featuring hollow tubes, such as infusion and transfusion sets. Ideal for those fluids marked sterile but unsuitable for soaking, this method simplifies operations by utilizing liquid D rinse products in conjunction with FTM media modifications. Post-rinsing, the eluate undergoes membrane filtration before being placed in FTM and SCDM. Although straightforward, this method sees limited application.
Bulk Pharmaceuticals / Advanced Biopharmaceuticals
Bulk pharmaceuticals (API) undergo rigorous sterilization as mandated by USP 71, ensuring complete safety before entering the manufacturing phase.
Bulk biologics are scrutinized under stringent sterility testing guided by 21 CFR 610.12. The protocol demands the use of FTM medium, with specified sample volumes reaching a minimum of 10 ml.
In-depth Interpretation of Sterility Test Outcomes
Proficient technicians are essential for executing growth testing during cultivation. Growth is identified by inspecting the medium, where clarity against a light source is disrupted by turbid areas, signaling microbial presence. Upon detecting growth, further investigation confirms whether turbidity stems from microbial activity or other factors like sample decomposition or particle shedding. Post-confirmation, suspect samples are incubated for the test's duration, with any turbidity observed being transferred and monitored over a four-day period on the 14th test day.
Classification:
Innovative Laboratory Petri Dish
Cell Culture Dish Bulk Purchase
Diverse Petri Dish Product Range
Durable Plastic Petri Dish
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