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 & Characteristics
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The collection incubator undergoes an exquisite crafting process, meticulously manufactured through forty stages, each stringently adhering to the highest ISO9001 quality standards and ISO14001 environmental regulations. Every product undergoes a rigorous integrity test, ensuring unmatched quality traceability and continual enhancements. Tailored to accommodate diverse testing necessities across dosage and packaging forms, an array of cups, precision filter materials, and customized needles are expertly selected. This innovative design and development of various collection incubators cater to a vast range of sterilization testing requirements.
Comprehensive Product Rinse Sterility Test
Specialized Combination Product: The Product Rinse Sterility Test is meticulously designed for hollow-tube products, such as infusion and infusion sets. Not intended for soaking applications, this test is ideal for products with sterile-marked fluid channels. Simple operation is facilitated by modifying FTM media with liquid D for rinsing products. The eluate undergoes membrane filtration before placement in FTM and SCDM, offering a streamlined solution. Though generally uncommon, this method is a precise option for specific needs.
Bulk Pharmaceuticals and Biotech Products
Prior to entering the manufacturing process, bulk drugs (API) are meticulously sterilized following the stringent USP 71 guidelines, ensuring their pristine quality and safety.
Bulk biologics are rigorously tested for sterility in full compliance with 21 CFR 610.12 standards, requiring an FTM medium with specified test sample sizes, maintaining a minimum capacity of 10 ml to ensure thorough assessment.
Sterility Test Results Interpretation
To ensure precision in growth testing, technicians undergo comprehensive training. Growth is assessed by examining a typically transparent medium against a light source, where a turbid (cloudy) area signals microbial growth. Upon detection, the suspect container is meticulously analyzed to determine whether the turbidity results from microbial presence rather than sample decomposition. Occasionally, cloudiness may arise due to particle shedding or chemical reactions with the medium. Post-testing, samples return to the incubator to complete the incubation period. Turbid samples are subsequently transferred and evaluated over a four-day period on the 14th day of testing.
Product Categories:
Laboratory-Grade Petri Dish
Bulk Purchase of Cell Culture Dishes
High-Quality Petri Dish Solutions
Durable Plastic Petri Dish
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