Single Use Sterility Peristaltic Test Device Pump microbiology lab equipment

Winteam sterility test canister.PDF

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Sterility test

The USP <71> sterility test is any specific test capable of maintaining growth against two different types of media (aerobic organisms as well as aerobic and anaerobic organisms). Samples were prepared by direct inoculation or introduced into the medium by membrane filtration. If the media is transparent, the amount of sample required will depend on the type of product being tested and the size of the batch. The sterility test requires a 14 day incubation period. After 14 days of incubation, there was no evidence of microbial growth and the samples were considered sterile.

The Pacific Biology Laboratory Microbiology Laboratory provides sterility testing services for ISO Class 7 sterile kits in ISO 5 layered flood shields.

Available GMP Microbial Aseptic Testing Service

Bacteriostatic/fungal disease test

Sterility test

Direct transfer

Closed membrane filtration

Media fill and growth promotion

Sterility test

The sterility test is defined as a test to verify that the product does not contain live microorganisms. Sterility testing is important for medical devices, drugs, preparations, tissue materials, and other materials that claim to be sterile or infeasible.

Sterility Test Canister

The single-use fully enclosed bacteria culture incubator is composed of a protective cap, an air filter, a connector, a cylinder, a filter membrane, a base, a liquid outlet, and a parallel conduit. After more than forty procedures, each process is strictly inspected. 100% of the products pass the integrity test, and the quality traceability and quality are continuously improved according to the requirements of ISO9001 quality system certification. According to the traits and packaging of the inspection products, a variety of microporous membranes with different materials and different structures were selected, and 28 kinds of collection incubators were designed and developed to meet the needs of sterility inspection of various inspection products.

Features

• The elastic high-elastic pump tube is made of special materials and has long-term durability, wear resistance and pressure resistance to ensure complete detection.
• Transparent blister packs conform to international standards.
• Transparent composite packaging to reduce packaging waste and reflect environmental protection
• Imported medical dialysis packages from the United States can be used to rapidly degrade ethylene oxide and reduce ethylene oxide residues to ensure product sterility.
• Microbial microbial retention, microbial growth (sensitivity) and sterility testing ensure reliable and reliable results of sterility testing.
• Filter: bubble point method, bacterial retention test.
• Chewing stability test: The culture period is 14 days.

parameter

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

Pharmaceutical industry: sterility inspection and microbial limit inspection of purified water, water for injection, sterile preparations (large infusion, small injection, powder, biological products, blood products, ophthalmic preparations, maintenance liquid, etc.);

Medical device industry: sterility inspection and microbial limit inspection of purified water, water for injection, syringe, infusion set, blood transfusion device, intravenous catheter, etc.

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.