Hangzhou Winteam Scientific Instruments Co., Ltd.

Hangzhou Winteam Scientific Instruments Co., Ltd.

THE MISSION OF WINTEAM IS PROVIDE BETTER STERILITY TEST PRODUCTION

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Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility

Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility

    • Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility
    • Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility
  • Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility

    Product Details:

    Place of Origin: CHINA
    Brand Name: WINTEAM
    Certification: ISO9001
    Model Number: KSY

    Payment & Shipping Terms:

    Minimum Order Quantity: ONE BOX
    Price: Negotiable
    Packaging Details: 72sets/box,18sets/box, 48sets/box,12 sets/box
    Supply Ability: 10000sets per day
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    Detailed Product Description
    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

     

    single-use closed sterile canister ChP EP JP USP 100ml for testing facility

     

    Select the Gibraltar Institute for sterility testing:

    Membrane filtration sterilization test

    The membrane filtration sterilization test method is the best method for filtering drugs. The product was filtered through a 0.45 or 0.2 micron membrane filter according to the USP <71> sterility test method. The filter is then rinsed with a suitable USP liquid to remove the inhibitor and then transferred to liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM). Both media were incubated for 14 days and microbial growth was examined daily. The USP <71> sterilization test recommends the use of liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM). These can promote the growth of anaerobic and aerobic microorganisms.

     

    2. Direct transfer sterilization test

    The direct transfer sterilization test method is a method of selecting medical devices (such as solid dosage forms, powders, ointments, and creams) that cannot be filtered. In this sterility test method, the test article is transferred directly to liquid thioglycolic acid medium (FTM) and soybean casein digestion medium (SCDM). Both media were incubated for 14 days and microbial growth was examined daily.

    We are offering sterility test closed canister.
    Sterility test canisters are used for pharmaceutical product sterility test by the membrane filter method which produced in very strict condition. Working together with sterility test pump.

      

     

    Characteristics of Sterility Test Canister

     

    • Quantity of Filter Cartridge: 2 or 3
    • Pressure Resistance of Filter Cartridge: 0.5Mpa
    • Volume of Filter Cartridge: 100ml
    • Filter Membrane: Mixed Cellulose Esters Membrane / Nylon Membrane / PP Membrane (according to different types) with diameters of 47mm and bore diameter of 0.45 μm
    • Respirator Filter Membrane: PTFE hydrophobic membrane with diameter of 25mm and bore diameter of 0.45 μm

     

     

    parameter

     

    Schematic Diagram Model Inspection Style Packing Spe.
    Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility 0 Py220C Glass Bottle Large Volume Injection

    72Sets/Box

    18sets/Box

     

    48 Sets/Box

    12sets/Box

    Py330C
    Ksf220C Glass Bottle Large-Capacity Antibiotic Injection
    Ksf330C
    Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility 1 Apy220C Ampoule Injection
    Apy330C
    Kapy220C Ampoule Antibiotic Injection
    Kapy330C
    Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility 2 Dgb220C Vial Bottle Soluble Powder
    Dgb330C
    Kdgb220C

     

    Vial Bottle Soluble Antibiotic Powder

    Kdgb330C
    Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility 3 Sdy220C Soft Bag Large Volume Injection
    Sdy330C
    Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility 4 Fsy220C Insoluble Liquid
    Fsy330C
    Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility 5 Nkf220C Powder That Needs To Be Dissolved And Diluted
    Nkf330C

     

     

     

    The collection collection incubator is carefully manufactured by forty processes, each in strict accordance with the ISO9001 quality system and ISO14001 environmental system requirements. 100% of the products passed the integrity test, achieving continuous improvement in quality traceability and quality. According to the testing requirements of different dosage forms and packaging forms, various cups, filter materials and matching needles were selected, and various collection incubators were designed and developed to meet various sterilization tests. need.

     

     

    Single Use Closed Sterility Test Canister ChP EP JP USP 100ml For Testing Facility 6

     

     

    Product rinse sterility test

    Combination product: Product rinse sterility test is only applicable to products with hollow tubes, such as infusion and infusion sets, which are not suitable for soaking and the fluid channel is marked as sterile, this method is easy to operate and requires modification of FTM media with liquid D rinse products, The eluate was membrane filtered and placed in FTM and SCDM. This method is usually not used.

     

     

    Bulk drugs / biopharmaceuticals

    Bulk drugs (API) have been sterilised according to USP 71 prior to release to the manufacturing process.

     

    Bulk biologics are tested for sterility according to 21 CFR 610.12, which requires a medium (FTM) with sample test sizes listed in the document and a capacity of not less than 10 ml.10

     

     

    Interpretation of sterility test results

    Technicians must be trained in growth testing methods during the cultivation process. Growth is determined by observing a medium that is generally transparent and transparent with respect to the light source, and the turbid (turbid) area of ​​the medium indicates the growth of microorganisms. Once growth is detected, the suspect container is tested to confirm that the turbidity present is due to microbes, not due to decomposition of the sample; sometimes, the sample becomes cloudy due to particle shedding or chemical reaction with the medium. After testing, return to the incubator for the remainder of the incubation period. Samples turbid in the medium were transferred and displayed for four days on the 14th day of the test.

    Contact Details
    Hangzhou Winteam Scientific Instruments Co., Ltd.

    Contact Person: wong

    Tel: +8615869109373

    Send your inquiry directly to us (0 / 3000)