Exquisite 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
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The meticulously crafted collection incubator is the result of forty precise processes, each adhering strictly to the esteemed ISO9001 quality standards and the rigorous ISO14001 environmental system criteria. With unwavering commitment to excellence, 100% of these products triumphantly pass the integrity test, ensuring consistent enhancements in traceability and quality. Tailored to meet the diverse testing requirements for varying dosage and packaging forms, an array of cups, filter materials, and compatible needles has been expertly curated. This has led to the innovation and development of collection incubators designed to fulfill a multitude of sterilization test demands with utmost precision.
Revolutionary Product Rinse Sterility Test
Innovative Combination Product: The Product Rinse Sterility Test is specifically crafted for products featuring hollow tubes, such as infusion and infusion sets. When traditional soaking is unsuitable and the fluid channel is designated as sterile, this streamlined method comes into play. It necessitates a modified FTM media along with liquid D rinse products. The eluate undergoes meticulous membrane filtration and is subsequently placed in FTM and SCDM. While typically not a standard method, its ease of operation offers a unique solution.
Leading Bulk Drugs / Biopharmaceuticals
Prior to the manufacturing process, Bulk Drugs (API) undergo a sterilization process meticulously aligned with USP 71, ensuring they are pristine and ready for release.
Bulk biologics undergo rigorous sterility testing as per 21 CFR 610.12, requiring a medium (FTM) with meticulously documented sample test sizes. The specified capacity ensures that it isn't less than 10 ml, guaranteeing compliance and safety.
Insightful Interpretation of Sterility Test Results
Technicians, well-versed in growth testing methodologies, play a crucial role during the cultivation process. Growth is discerned by examining a medium that remains generally transparent with respect to a light source, where any turbid areas signal the presence of microorganisms. Upon detection of growth, a thorough examination of the suspect container is conducted to ascertain that the turbidity is indeed due to microbial presence and not sample decomposition. Occasionally, cloudiness may arise from particle shedding or chemical reactions with the medium. Post-validation, the specimen is returned to the incubator for the remainder of its incubation period. Samples exhibiting turbidity in the medium are transferred and showcased for four days on the 14th day of the experimentation period.
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