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 collection incubator exemplifies unparalleled craftsmanship, undergoing a meticulous manufacturing process encompassing forty distinct stages. Each stage adheres rigorously to the stringent guidelines of the ISO9001 quality management system and the ISO14001 environmental system standards. Impressively, every product triumphantly sails through the integrity test, facilitating a relentless pursuit of elevated quality traceability and excellence. To cater to the diversified testing requisites of various dosage forms and packaging styles, an array of cups, specialized filter materials, and precision-engineered matching needles are meticulously chosen. Consequently, an innovative range of collection incubators is conceptualized and crafted to meet the diverse needs of sterilization testing.
Product Rinse Sterility Test
Combination Product: Our product rinse sterility test is meticulously designed for products endowed with hollow tubes, like infusion and infusion sets. While these are not ideal for soaking, the sterile fluid channel ensures seamless operation. The process requires an adaptation of FTM media with liquid D rinse products. The eluate undergoes membrane filtration before being placed in FTM and SCDM. Notably, this method, while straightforward, is sparingly utilized.
Bulk Drugs / Biopharmaceuticals
For bulk drugs (API), an unwavering commitment to sterility is exemplified by adherence to USP 71 standards, ensuring absolute purification before integration into the manufacturing process.
For bulk biologics, rigid sterility testing as per 21 CFR 610.12 is paramount. This necessitates using a medium (FTM) with sample sizes explicitly described in the document, ensuring a minimum capacity of 10 ml.
Interpretation of Sterility Test Results
Technicians are meticulously trained in growth testing methodologies during cultivation. Growth assessment involves scrutinizing a typically transparent medium against a light source, where any turbidity signals microbial proliferation. Upon detecting growth, further tests on the suspect container confirm the presence of microbes rather than sample decomposition. Occasionally, cloudiness arises from particle shedding or a chemical reaction with the medium. Post-testing, samples return to the incubator for the continuation of the incubation phase, with cloudy samples being observed further over the 14-day test period.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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