In-Depth 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 |
Specifications and Parameters
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our innovative collection incubator boasts a meticulous assembly of forty intricate processes, each stringently adhering to the ISO9001 quality system and ISO14001 environmental standards. With a commitment to excellence, every single unit undergoes a comprehensive integrity test, elevating quality traceability and consistent enhancement. Catering to diverse testing requisites across various dosage forms and packaging, we meticulously select from an array of cups, filter materials, and precision-engineered needles. This allows us to craft a wide range of collection incubators, meticulously tailored to meet the unique demands of sterilization tests with unparalleled precision and reliability.
Sterility Testing through Product Rinsing
Combination Product Insight: The product rinse sterility test is meticulously designed for hollow tube products such as infusion and infusion sets, where soaking is impractical, and sterile marking is imperative for the fluid channels. This user-friendly method necessitates a careful modification of the FTM media using liquid D to rinse products, followed by membrane filtration of the eluate, which is then incubated in FTM and SCDM media. It is a specialized approach, infrequently employed yet tailored for specific applications.
Bulk Pharmaceuticals / Biopharmaceutical Solutions
Prior to integration into the manufacturing process, bulk drugs (Active Pharmaceutical Ingredients or API) undergo rigorous sterilization in compliance with USP 71 standards, ensuring unmatched safety and purity.
In accordance with 21 CFR 610.12 regulations, bulk biologics undergo stringent sterility assessments, utilizing a specified medium (FTM) with documented sample test sizes and a minimum 10 ml capacity, guaranteeing comprehensive and reliable results.
Analysis of Sterility Test Findings
Our expertly trained technicians employ advanced growth testing methodologies during the cultivation phase. Growth detection involves examining a typically clear and transparent medium in relation to a light source, where turbidity indicates microbial proliferation. Upon detecting such growth, further tests are conducted to verify that the turbidity is microbial and not a result of sample decomposition. Occasionally, cloudiness may arise from particle shedding or chemical reactions with the medium. Post-verification, samples are returned to the incubator for the completion of the incubation cycle, with turbid samples undergoing additional examination on the 14th day, illuminating our commitment to accuracy and reliability.
Product Tags:
Precision Laboratory Petri Dishes
Bulkbuy Cell Culture Dishes
Exceptional Petri Dish Product Range
Premium Quality Plastic Petri Dishes
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