Enlightening Product Overview
| Name: |
Sterility Test Canister |
Membrane Material: |
MCE NYLON PP |
| Air Filter: |
0.22μm |
Needle: |
304 Stainless Steel |
| Usage: |
Filteration |
Tube: |
Pvc |
| High Light: |
sterility test kit canister,
sterility testing pump |
Introducing our innovative single-use closed sterile canister, meticulously designed for ChP, EP, JP, and USP compliance, ideal for your 100ml testing facility.
Choose Gibraltar Institute for Unrivaled Sterility Testing:
Revolutionary Membrane Filtration Sterilization Test
Experience unparalleled filtration precision with our membrane filtration sterilization test method, hailed as the pinnacle for drug filtration. Utilizing a 0.45 or 0.2 micron membrane, compliant with USP <71> sterility test standards, this method ensures optimal efficacy. Filters are meticulously rinsed with USP-sanctioned liquids to eradicate inhibitors, then transferred to nutrient-rich liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM). Incubated over 14 days, both anaerobic and aerobic growth are meticulously monitored, as recommended by USP <71>.
2. Cutting-Edge Direct Transfer Sterilization Test
Our direct transfer sterilization test offers an advanced solution for non-filterable medical devices, including solid dosage forms, powders, ointments, and creams. This method involves the direct transfer of test articles into nutrient-rich liquid thioglycolic acid medium (FTM) and soybean casein digestion medium (SCDM), with a 14-day incubation to ensure the highest levels of sterility.
Introducing Our Advanced Sterility Test Closed Canister.
Our sterility test canisters are crafted for impeccable pharmaceutical product testing via the membrane filter method, under stringent production conditions. Designed to seamlessly integrate with sterility test pumps.
Distinctive Features of Sterility Test Canister
- Filter Cartridge Options: Choose between 2 or 3 cartridges for tailored efficiency.
- Impressive Pressure Resistance: Engineered to withstand up to 0.5Mpa.
- Filter Cartridge Capacity: Generous 100ml volume for comprehensive testing.
- Versatile Filter Membrane Choices: Available in Mixed Cellulose Esters, Nylon, or PP membranes, with 47mm diameters and 0.45 μm pore size, catering to diverse testing needs.
- Precision Respirator Filter Membrane: Utilizes a PTFE hydrophobic membrane, 25mm in diameter with a 0.45 μm bore, ensuring top-quality filtration.
Technical Parameters
| Schematic Diagram |
Model |
Inspection Style |
Packing Spe. |
| |
Py220C |
Glass Bottle Large Volume Injection |
72Sets/Box
18sets/Box
48 Sets/Box
12sets/Box |
| Py330C |
| Ksf220C |
Glass Bottle Large-Capacity Antibiotic Injection |
| Ksf330C |
| |
Apy220C |
Ampoule Injection |
| Apy330C |
| Kapy220C |
Ampoule Antibiotic Injection |
| Kapy330C |
| |
Dgb220C |
Vial Bottle Soluble Powder |
| Dgb330C |
| Kdgb220C |
Vial Bottle Soluble Antibiotic Powder |
| Kdgb330C |
| |
Sdy220C |
Soft Bag Large Volume Injection |
| Sdy330C |
| |
Fsy220C |
Insoluble Liquid |
| Fsy330C |
| |
Nkf220C |
Powder That Needs To Be Dissolved And Diluted |
| Nkf330C |
Our collection incubator is the epitome of precision, crafted through 40 meticulous processes under ISO9001 and ISO14001 standards. Every product passes rigorous integrity tests, ensuring unrivaled quality and traceability. Tailored to diverse dosage and packaging forms, our incubators offer a versatile range of cups, filter materials, and needles for all sterilization testing needs.
Comprehensive Product Rinse Sterility Test
Innovatively designed for products with hollow tubes, like infusion sets, our product rinse sterility test offers unmatched ease, utilizing modified FTM media with liquid D rinse. The resulting eluate undergoes membrane filtration before incubation in FTM and SCDM, though not commonly employed, is remarkably suitable for specific applications.
Bulk Drugs and Biopharmaceuticals
Bulk drug substances (API) are meticulously sterilized in adherence to USP 71, ensuring impeccable quality before integration into manufacturing.
Our bulk biologics undergo stringent sterility testing as per 21 CFR 610.12, utilizing FTM media with documented sample test sizes, each with a minimum capacity of 10 ml, to guarantee absolute safety and reliability.
Deciphering Sterility Test Outcomes
To ensure optimal outcomes during the cultivation process, it is imperative that technicians receive comprehensive training in growth testing methods. Growth is assessed by observing a medium that maintains transparency, allowing light to pass through seamlessly. The presence of a turbid (cloudy) area within the medium is an indicator of microbial growth. Once growth is observed, it is essential to test the suspect container to ascertain that the turbidity is indeed due to microbial activity, rather than sample decomposition. Occasionally, cloudiness can occur due to particle shedding or a chemical reaction with the medium. Following confirmation, the sample is returned to the incubator for the remainder of the incubation process. Notably, samples displaying turbidity are further investigated and showcased for four days, specifically on the 14th day of the test, to ensure accurate results and maintain the integrity of the sterility testing process.
Tag:
sterility testing pump,
sterility test kit canister,
sterility test device
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