Exquisite 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 stands as a testament to meticulous craftsmanship, forged through forty precise processes that adhere rigorously to the ISO9001 quality system and the environmental standards of ISO14001. Every single product passes a thorough integrity test, ensuring an unbroken chain of quality and reliability. To cater to diverse testing requirements, whether involving various dosage forms or packaging types, we have curated a selection of cups, filter materials, and precision-engineered needles. These elements combine harmoniously within our collection incubators, tailored meticulously for an array of sterilization test scenarios.
Meticulous Product Rinse Sterility Examination
Integrated Solution: The Product Rinse Sterility Test is explicitly designed for products featuring hollow tubes, such as infusion assemblies, where soaking is impractical, and the fluid path is sterile-marked. This method boasts ease of execution, necessitating the adaptation of FTM media with liquid D for rinse applications. The resultant eluate undergoes membrane filtration, subsequently incubated in FTM and SCDM. This approach is not typically employed.
Primary Pharmaceuticals / Advanced Biopharmaceuticals
Prior to their pivotal role in manufacturing, Bulk Drugs (API) undergo stringent sterilization in alignment with the rigorous standards of USP 71.
Bulk Biologics undergo rigorous sterility scrutiny per 21 CFR 610.12, mandating a medium (FTM) with defined sample test sizes and a minimum capacity of 10 ml, ensuring uncompromised sterility standards.
Nuanced Insights into Sterility Testing Outcomes
Expert technicians, trained meticulously in growth monitoring methodologies, evaluate the cultivation process. Growth is discerned by scrutinizing the medium's transparency against a light source, identifying turbid (cloudy) regions indicative of microbial proliferation. Upon detecting growth, the suspect vessel undergoes further testing to ascertain that turbidity is microbe-originated and not due to sample decomposition; occasionally, turbidity arises from particle disintegration or chemical reactions within the medium. Post-assessment, samples are returned to incubation to complete the growth cycle. Turbid samples are transferred and monitored for four additional days on the 14th day of testing.
Characteristics:
Precision Laboratory Petri Dish
Cell Culture Dish wholesale
Petri Dish Collection
Durable Plastic Petri Dish
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