Product Description
Product Parameters
| item |
Model |
diameter |
aperture |
material |
color |
surface |
sterilization |
packing |
| CP020038 |
M47 |
47mm |
0.45μm |
MCE |
white |
smooth |
Gamma |
100pcs/box |
| CP020039 |
M47A |
47mm |
0.45μm |
MCE |
White |
grid |
Gamma |
100pcs/box |
| CP020040 |
M47B |
47mm |
0.45μm |
NYLON |
White |
smooth |
Gamma |
100pcs/box |
| CP020041 |
M47C |
47mm |
0.45μm |
PP |
White |
smooth |
Gamma |
100pcs/box |
| CP020042 |
M47D |
47mm |
0.45μm |
MCE |
White |
smooth |
Gamma |
100pcs/box |
| CP020043 |
M50 |
50mm |
0.45μm |
MCE |
White |
smooth |
Gamma |
100pcs/box |
| CP020044 |
M50A |
50mm |
0.45μm |
MCE |
White |
grid |
Gamma |
100pcs/box |
| CP020045 |
M50B |
50mm |
0.45μm |
NYLON |
White |
smooth |
Gamma |
100pcs/box |
| CP020046 |
M50C |
50mm |
0.45μm |
PP |
White |
smooth |
Gamma |
100pcs/box |
| CP020047 |
M60 |
60mm |
0.45μm |
MCE |
White |
smooth |
Gamma |
100pcs/box |
| CP020048 |
M60A |
60mm |
0.45μm |
MCE |
White |
grid |
Gamma |
100pcs/box |
| CP020049 |
M60B |
60mm |
0.45μm |
NYLON |
White |
smooth |
Gamma |
100pcs/box |
| CP020050 |
M60C |
60mm |
0.45μm |
PP |
White |
smooth |
Gamma |
100pcs/box |
Our collection incubator is a masterpiece crafted through forty meticulous processes, each aligning flawlessly with ISO9001 for quality and ISO14001 for environmental standards. With a 100% success rate in the integrity test, it embodies a continual enhancement in quality traceability and assurance. Tailored to meet the testing prerequisites of diverse dosage and packaging forms, an array of cups, filter materials, and compatible needles have been ingeniously selected. This innovation has led to the creation of various collection incubators, specifically designed and developed to cater to all sterilization test requirements.
Product Rinse Sterility Test
Combination Product: The product rinse sterility test, tailored for hollow-tube products like infusion and infusion sets, is unsuitable for immersion, especially when the fluid channel is denoted as sterile. This user-friendly method demands an adaptation of FTM media with liquid D rinse products. Following this, the eluate undergoes membrane filtration and is placed in FTM and SCDM. Notably, this method sees limited usage.
Bulk Drugs / Biopharmaceuticals
Bulk drugs, also known as Active Pharmaceutical Ingredients (API), undergo rigorous sterilization following the USP 71 standards before their release into the manufacturing process, ensuring the highest level of purity and safety.
Bulk biologics are meticulously tested for sterility in compliance with 21 CFR 610.12. This regulation stipulates that the medium (FTM) used must accommodate sample test sizes as defined in the documentation, with no less than a 10 ml capacity, underscoring the stringent quality assurance measures in place.
Interpretation of Sterility Test Results
During the cultivation process, technicians undergo comprehensive training in growth testing methods. The assessment of growth involves observing a medium that remains largely transparent against a light source, with turbid (cloudy) areas indicating microbial growth. Upon detecting growth, the suspect container undergoes rigorous testing to ascertain that the turbidity is microbial and not the result of sample decomposition; occasional cloudiness might stem from particle shedding or chemical reactions with the medium. Post-testing, samples are returned to the incubator for the remainder of the incubation period. Turbid samples in the medium are transferred and showcased for thorough evaluation on the 14th day of the test.
Tag:
Laboratory Petri Dish
Cell Culture Dish Bulk Buy
Petri Dish Products
Plastic Petri Dish
){kind=link}