In-Depth 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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Our collection incubator is a masterpiece, crafted meticulously through a series of forty precise processes. Each step adheres strictly to the stringent ISO9001 quality system and ISO14001 environmental system standards, ensuring a flawless final product. Every single item undergoes thorough integrity testing, paving the way for continuous innovation in quality traceability and enhancement. Tailored to accommodate the diverse testing requirements of various dosage and packaging forms, our selection includes an array of cups, filter materials, and matching needles. Each design is born out of the necessity to meet the diverse demands of sterilization testing, bringing excellence and reliability to the forefront.
Innovative Product Rinse Sterility Test
Product Suite: Our ingeniously designed product rinse sterility test is crafted specifically for products featuring hollow tubes, such as infusion and infusion sets. Ideal for applications where soaking is unsuitable and the fluid channel is designated sterile, this method shines with its simplicity and efficiency. Utilizing an altered FTM media with liquid D rinse products, the eluate undergoes membrane filtration before being placed in FTM and SCDM. This technique, while generally not utilized, exemplifies ease of use and precision in adaptation.
Comprehensive Bulk Drugs / Biopharmaceuticals
Bulk drugs, also known as Active Pharmaceutical Ingredients (API), undergo meticulous sterilization according to the rigorous standards of USP 71 prior to their journey into the manufacturing process. This ensures that the highest quality and safety standards are upheld, readying them for further production stages.
Bulk biologics undergo stringent sterility testing as mandated by 21 CFR 610.12. This involves the use of a fortified medium (FTM) with sample test sizes detailed within the documentation, ensuring a minimum capacity of 10 ml to achieve accurate results.
Comprehensive Interpretation of Sterility Tests
During the cultivation process, technicians must be expertly trained in growth testing techniques. Growth is evaluated by closely observing a medium that remains generally transparent against a light source, while any turbid areas indicate microbial proliferation. When growth is detected, further testing of the suspect container is imperative to confirm that turbidity is due to microbial presence rather than sample degradation. Occasionally, cloudiness may result from particle shedding or chemical interactions with the medium. Post testing, samples are returned to the incubator for the remainder of the incubation period. On the 14th day, any samples displaying turbidity in the medium are transferred and meticulously monitored for four days.
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