Product Description
Product Parameters
| Item |
Model |
description |
culture |
usage |
| CP020028 |
D55A |
PETRI DISH |
TSA |
Surface microbial sampling without disinfectant and antibiotic residues |
| CP020029 |
D55B |
PETRI DISH |
TSA with Lecithin and Tween 80 |
Surface microbial sampling of residual disinfectant |
| CP020030 |
D55C |
PETRI DISH |
TSA with Lecithin and Tween 80,Penicillin G |
Sampling of surface microorganisms from residual penicillin antibiotics |
| CP020032 |
D55E |
PETRI DISH |
SDA |
For fungal detection on surfaces |
| CP020033 |
D90A |
PETRI DISH |
TSA |
Microbial detection of airborne settling bacteria and floating bacteria without disinfectant and antibiotic residues |
| CP020034 |
D90B |
PETRI DISH |
TSA with Lecithin and Tween 80 |
Microbial detection of airborne settling bacteria and floating bacteria in residual disinfectants |
| CP020035 |
D90C |
PETRI DISH |
TSA with Lecithin and Tween 80,Penicillin G |
Microbial detection of airborne settling bacteria and floating bacteria with residual penicillin antibiotics |
| CP020037 |
D90E |
PETRI DISH |
SDA |
For airborne fungal detection |
| CP020075 |
D90F |
PETRI DISH |
TSA with Cephalosporinase |
Microbial detection of airborne sedimentation bacteria and floating bacteria with residual cephalosporin antibiotics |
| CP020109 |
D90G |
PETRI DISH |
EMB |
Isolation and identification of Escherichia coli and Aerogenes |
| CP020110 |
D90H |
PETRI DISH |
NA |
Generally used for bacterial culture, transfer, rejuvenation, bacterial enhancement |
| CP020116 |
D90R |
PETRI DISH |
R2A |
For the determination of the total number of colonies in purified water |
Our collection incubator is a masterpiece of precision, skillfully crafted through a meticulous forty-step process, each aligned with the rigorous ISO9001 quality system and ISO14001 environmental standards. With unwavering commitment to excellence, every single product undergoes a comprehensive integrity test, ensuring impeccable quality and traceability throughout. Catering to diverse testing requirements, whether it be varying dosage forms or packaging needs, we have meticulously selected a range of cups, filter materials, and compatible needles, leading to the creation of innovative collection incubators, expertly designed to address a wide spectrum of sterilization testing needs.
Product Rinse Sterility Test Overview
Combination Product: The Product Rinse Sterility Test is specifically tailored for products with hollow tubes, such as infusion and infusion sets, where soaking is unsuitable and the fluid channel is designated as sterile. This method, known for its simplicity, involves a straightforward modification of FTM media with liquid D rinse products. The eluate undergoes membrane filtration and is subsequently placed in both FTM and SCDM. While effective, this method is often reserved for particular cases.
Bulk Drugs and Biopharmaceutical Insights
Bulk drugs (API) are expertly sterilized as per the stringent USP 71 guidelines before being released into the manufacturing process, ensuring the utmost integrity and quality.
Bulk biologics undergo rigorous sterility testing in compliance with the precise 21 CFR 610.12 standards, which mandate the use of a medium (FTM) and specify sample test sizes with a minimum capacity of 10 ml.10, ensuring thorough and reliable testing outcomes.
Understanding Sterility Test Results
Technicians must be proficiently trained in growth testing methods during the cultivation process to ensure accurate results. Growth is identified by examining a medium that is typically clear and transparent when held against a light source; any turbid (cloudy) area signifies microorganism growth. Upon detecting growth, the suspect container is meticulously tested to ascertain that the turbidity is due to microbial presence, rather than sample decomposition; occasionally, cloudiness may result from particle shedding or chemical interactions with the medium. Post-testing, samples are returned to the incubator to complete the incubation period. For samples showing turbidity, they are closely monitored and analyzed over four days, culminating on the 14th day of the test.
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