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 |
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 |
This meticulously crafted collection incubator undergoes a rigorous 40-step manufacturing process, adhering to the stringent guidelines of the ISO9001 quality system and the ISO14001 environmental system. Each product is subjected to a thorough integrity test, boasting a flawless pass rate, ensuring exceptional quality traceability and continual advancement. Tailored to meet the diverse requirements of various dosage forms and packaging types, a wide array of cups, filter materials, and compatible needles have been selected. Consequently, we have innovatively designed and developed an array of collection incubators to fulfill the diverse needs of sterilization tests.
Sterility Test for Product Rinse
Combination Product: The product rinse sterility test is exclusively designed for items with hollow tubes, like infusion and transfusion sets, where soaking is not feasible. If the fluid channel is labeled as sterile, this method offers ease of operation. It involves the modification of FTM media with liquid D rinse products, followed by membrane filtration of the eluate, which is then placed in FTM and SCDM. However, this method is not typically employed.
Bulk Pharmaceuticals / Biopharmaceuticals
Prior to entering the manufacturing process, bulk drugs (API) are sterilized in compliance with USP 71, ensuring they meet the highest safety and quality standards.
Bulk biologics undergo sterility testing as per 21 CFR 610.12, which mandates the use of a medium (FTM) with sample sizes specified in the documentation and a minimum capacity of 10 ml.
Comprehensive Analysis of Sterility Test Outcomes
During the cultivation process, technicians, who are rigorously trained in growth testing methodologies, determine growth by examining the medium's transparency against a light source. The appearance of turbidity indicates microbial proliferation. Upon detecting growth, the suspect container is further examined to ascertain whether the turbidity is due to microbial presence or other factors like sample decomposition. Occasionally, cloudiness arises from particle shedding or chemical reactions with the medium. Post-testing, samples are returned to the incubator for the remaining incubation period. Samples exhibiting turbidity in the medium are transferred and observed for four days by the 14th day of testing.
Labels:
Laboratory Petri Dish
Cell Culture Dish Bulk Purchase
Petri Dish Product Line
Plastic Petri Dish
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