Comprehensive and Detailed 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 and Parameters
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our state-of-the-art collection incubator boasts precision craftsmanship, undergoing a meticulous forty-step manufacturing process. Each step aligns seamlessly with the stringent ISO9001 quality management and ISO14001 environmental standards, ensuring excellence. Every single product triumphs in the integrity test, achieving unparalleled traceability and quality enhancement. To cater to diverse testing needs across varied dosage and packaging forms, we offer an array of specially curated cups, filter materials, and compatible needles, crafting bespoke collection incubators that fulfill intricate sterilization testing requirements.
Advanced Product Rinse Sterility Testing
For combination products featuring hollow tubes like infusion and infusion sets, our Product Rinse Sterility Test stands as the pinnacle of reliability. Ideal for scenarios where soaking is unsuitable and sterile fluid channels must be maintained, this method transforms complexity into simplicity. By integrating specially modified FTM media with liquid D rinse products, the eluate undergoes membrane filtration before residing in FTM and SCDM. Though this method is not frequently employed, its precise applications ensure unmatched sterility assurance.
Expertise in Bulk Drugs and Biopharmaceuticals
Bulk pharmaceutical ingredients (API) receive rigorous sterilization in strict adherence to USP 71 guidelines, ensuring they are impeccably prepared before advancing to the manufacturing stage.
Bulk biologics undergo comprehensive sterility testing as mandated by 21 CFR 610.12. This protocol necessitates the use of a fitting medium (FTM) with designated sample test sizes, mandating a minimum capacity of 10 ml.10 to ensure thorough examination and compliance.
In-Depth Analysis of Sterility Test Outcomes
During cultivation, technicians receive specialized training in advanced growth testing methods. Observations hinge on a medium that should be crystal-clear under a light source, with any cloudy areas signaling potential microbial growth. Upon detecting growth, a suspect container is scrutinized to ascertain that turbidity arises from microbial presence rather than sample decomposition. Occasionally, sample cloudiness occurs due to particulate shedding or a chemical reaction with the medium. Post-evaluation, the sample resumes its incubation phase. Medium-turbid samples undergo further transfer and display on the 14th day, extending over a four-day observation period.
Identifying Tags:
Precision Laboratory Petri Dish
Bulk Purchase of Cell Culture Dishes
Exceptional Petri Dish Product Range
Durable and Reliable Plastic Petri Dishes
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