Enriching the Product's Detailed 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 |
Cutting-Edge Parameters
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Meticulously crafted, our collection incubator undergoes a rigorous forty-step manufacturing process, adhering strictly to ISO9001 quality and ISO14001 environmental standards. With a commitment to excellence, 100% of our products pass the integrity test, ensuring a superior standard of traceability and quality enhancement. Designed to cater to diverse testing requirements across various dosage forms and packaging types, we offer an array of cups, filter materials, and compatible needles. Our diverse collection of incubators has been developed to meet the precise needs of sterilization testing.
Innovative Product Rinse Sterility Testing
Combination Product Insight: Our Product Rinse Sterility Test is tailored for items with hollow tubes, such as infusion and infusion sets, which cannot be soaked. Ideal for those marked with sterile fluid channels, this method is both straightforward and efficient. It involves a modification of the FTM media with liquid D to rinse the products. The eluate is then meticulously membrane filtered and placed in FTM and SCDM. Note that this method is typically reserved for specific use cases.
Advanced Solutions for Bulk Drugs and Biopharmaceuticals
Our Bulk Drugs (API) are sterilized in full compliance with USP 71 standards before entering the manufacturing phase, assuring top-notch quality and safety.
Ensuring the highest standards, Bulk Biologics undergo comprehensive sterility testing as per 21 CFR 610.12. This involves using a medium (FTM) with specified sample test sizes and a capacity not less than 10 ml, guaranteeing stringent sterility checks.
Excellence in Interpreting Sterility Test Results
Our technicians receive thorough training in growth testing methodologies throughout the cultivation process. Growth is identified by examining a typically clear medium against a light source, where any turbidity signals microbial presence. Should growth be observed, meticulous testing confirms whether the turbidity is due to microbes or other factors like particle shedding or chemical reactions with the medium. After testing, samples are returned to the incubator for the remainder of the incubation period, ensuring comprehensive observation. On the 14th day of testing, samples showing turbidity are transferred and observed for an additional four days.
Distinguished Tag:
Precision Laboratory Petri Dish
Cell Culture Dish Bulk Purchase
Comprehensive Petri Dish Products
Durable Plastic Petri Dish
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