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
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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 is a masterpiece of engineering, expertly crafted through a meticulous forty-step process. Each stage of fabrication is executed with precision, adhering strictly to the ISO9001 quality system and ISO14001 environmental system requirements. Our commitment to quality ensures that 100% of our products pass the stringent integrity tests, embodying our promise of ongoing enhancement in quality traceability and assurance. Tailored to the diverse testing needs of varying dosage forms and packaging configurations, we offer an array of cups, filter materials, and accompanying needles. This comprehensive design and development of collection incubators cater to a multitude of sterilization test demands.
Comprehensive Product Rinse Sterility Test
In our innovative combination product line, the product rinse sterility test is specifically designed for items featuring hollow tubes, such as infusion and infusion sets marked as sterile in fluid channels. This method, ideal for items unsuitable for soaking, is straightforward and involves the modification of FTM media with liquid D rinse products. The eluate undergoes membrane filtration and is subsequently placed in both FTM and SCDM. While typically not the conventional approach, this method is purposefully adapted for unique applications.
Exceptional Bulk Drugs / Biopharmaceuticals
Our bulk drugs (API) undergo rigorous sterilization in compliance with USP 71 standards before being integrated into the manufacturing process, ensuring utmost reliability and safety throughout the production cycle.
Bulk biologics are scrutinized for sterility following the stringent guidelines of 21 CFR 610.12. This necessitates the use of FTM medium with specific sample test sizes, with a minimum capacity of 10 ml, as delineated in the official documentation.
Expert Interpretation of Sterility Test Results
Technical personnel receive specialized training in growth testing methodologies during the cultivation process. Growth is meticulously assessed by examining a medium generally clear and transparent under a light source. A turbid region indicates potential microbial proliferation. If growth is detected, it is imperative to test the suspect container to verify that the observed turbidity is attributable to microbial presence rather than sample decomposition. Occasionally, samples may become turbid due to particulate shedding or a chemical reaction with the medium. Post-testing, the samples are returned to the incubator for the remaining incubation duration. Samples exhibiting turbidity on the 14th test day are transferred and displayed for a subsequent four-day observation period.
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Petri Dish for Laboratory Use
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