Detailed 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 |
Parameter
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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 testament to precision and quality excellence. Crafted meticulously through forty stages, it adheres stringently to the ISO9001 and ISO14001 standards, ensuring not only superior quality but also environmental responsibility. Each unit undergoes a rigorous integrity test, guaranteeing unwavering quality traceability and continual enhancement. Tailored to meet diverse testing demands across different dosage and packaging formats, our selection of specialized cups, filter materials, and needles forms the backbone of our versatile collection incubators, designed to cater to various sterilization testing needs.
Product Rinse Sterility Test
Combination Product: This method is designed specifically for products featuring hollow tubes, such as infusion sets. Not suitable for soaking, it efficiently confirms sterility in fluid channels marked as such. Simplifying processes, it necessitates the use of FTM media modified with liquid D to rinse products. The elution is then membrane-filtered and examined in both FTM and SCDM media. While operationally straightforward, it is not the most commonly employed technique.
Bulk Drugs / Biopharmaceuticals
Before advancing to the manufacturing phase, Bulk Drugs (API) undergo meticulous sterilization as per the rigorous USP 71 guidelines, ensuring they meet the highest safety and efficacy standards.
Bulk Biologics adhere to the stringent sterility testing protocols outlined in 21 CFR 610.12. This entails utilizing a specified medium (FTM), with a documented minimum sample test size of 10 ml, fortifying the product's quality assurance.
Interpretation of Sterility Test Results
Technicians undergo comprehensive training in growth testing methodologies during cultivation. Growth is confirmed by inspecting the medium against a light source; any turbidity indicates microbial activity. Upon detection, further tests on suspect containers ascertain whether the turbidity stems from microbial presence or other factors like sample degradation. Occasionally, cloudiness is due to particle shedding or chemical reactions. Post-testing, samples are returned to incubation to complete the cycle. Samples showing turbidity in the medium are transferred and monitored over four days on the test’s 14th day.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulkbuy
Petri Dish Products
Plastic Petri Dish
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