Intricate and Comprehensive 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 |
Technical Specifications
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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Our meticulously crafted collection incubator undergoes a refined manufacturing process involving forty distinct stages. Each step adheres to the stringent standards of the ISO9001 quality system and the ISO14001 environmental system, ensuring unparalleled excellence. With a 100% pass rate in integrity tests, our commitment to continuous quality improvement is evident. By selecting diverse cups, filter materials, and matching needles tailored to various testing requirements across dosage and packaging forms, we have pioneered a range of collection incubators to satisfy the nuanced demands of sterilization testing.
Innovative Product Rinse Sterility Test
Ingenious Combination Product: Our Product Rinse Sterility Test is expertly designed for items featuring hollow tubes, like infusion and infusion sets, which cannot be submerged. This method is highly user-friendly, requiring a simple modification of FTM media with liquid D rinse products. The eluate is then meticulously membrane filtered and placed in both FTM and SCDM. Although this technique is straightforward, it is not commonly employed.
Bulk Pharmaceuticals / Biopharmaceutical Mastery
Our Bulk Drugs (API) are rigorously sterilized in compliance with USP 71 standards before they progress to the manufacturing stage, ensuring peak quality and safety.
Our Bulk Biologics undergo sterility testing as per the rigorous guidelines of 21 CFR 610.12. This process demands a medium (FTM) and mandates sample test sizes as delineated in the documentation, with a minimum capacity of 10 ml.10, ensuring comprehensive analysis.
Sterility Test Result Insights and Analysis
Mastering Growth Testing: Technicians are expertly trained in growth testing methodologies throughout the cultivation process. The growth is evaluated by examining a medium that is predominantly clear against a light source. Cloudiness signifies microbial growth. Upon detecting growth, the suspect container is diligently tested to ascertain that the turbidity is microbial rather than sample decomposition. Occasionally, cloudiness arises from particle disintegration or chemical reactions. Post-verification, samples return to the incubator for the remaining incubation period. Turbid samples are systematically transferred and observed over a four-day span, culminating on the 14th day of testing.
Categorization:
Precision Laboratory Petri Dish
Bulk Purchase Cell Culture Dish
Comprehensive Petri Dish Collection
Durable Plastic Petri Dish
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