In-Depth 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 |
Specifications
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Item |
Discreption |
Usage |
| CP020028 |
D55A |
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| CPO20029 |
D90A |
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The collection incubator is meticulously crafted through a series of forty precision processes, each stringently adhering to the ISO9001 quality management system and the ISO14001 environmental protection standards. Every single product undergoes comprehensive integrity testing, ensuring unwavering quality traceability and continuous enhancement. Tailored to meet the diverse testing requirements across various dosage forms and packaging configurations, a selection of cups, filter materials, and compatible needles are carefully chosen. As a result, a diverse array of collection incubators is designed and developed to cater to the specialized needs of various sterilization assessments.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test is specifically designed for items with hollow tubes, such as infusion and transfusion sets, which are unsuitable for soaking but have a fluid pathway marked as sterile. This method is straightforward to execute, necessitating an adjustment of the FTM medium with liquid D rinse products. The resulting eluate is membrane filtered and subsequently placed in both FTM and SCDM. However, this technique is not commonly employed.
Bulk Pharmaceuticals / Biopharmaceuticals
Bulk pharmaceuticals (API) have been sterilized in strict compliance with USP 71 standards before their release into the manufacturing process.
Bulk biologics are meticulously tested for sterility according to the stringent 21 CFR 610.12 regulations, which mandate utilizing a medium (FTM) with sample test sizes as specified in the documentation, ensuring a minimum capacity of 10 ml.
Interpreting Sterility Test Outcomes
Technicians are required to be proficient in growth testing methodologies throughout the cultivation phase. Growth is ascertained by examining a medium that is typically clear and transparent against a light source, while the presence of a turbid (cloudy) area signifies microbial growth. Upon detection, the suspect container is rigorously tested to verify that the turbidity is indeed attributable to microbial presence and not due to sample degradation. Occasionally, the sample may become cloudy due to particle disintegration or a chemical reaction with the medium. Post-testing, samples are returned to the incubator for the remainder of the incubation period. Any samples exhibiting turbidity in the medium are transferred and observed over a span of four days on the 14th day of the assessment.
Label:
Laboratory Petri Dish
Cell Culture Dish Bulk Purchase
Petri Dish Product Range
Plastic Petri Dish
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