High Reliable laboratory sterility test kits ultrasonic welding SAL≤10^-6

Sterility Test Canister

3. Flow path sterility test

This sterility test method is suitable for products with hollow tubes (such as infusion sets and infusion sets) that are inaccessible and that the flow path is marked as sterile. In this sterility test method, the product is washed with liquid D, the eluate is subjected to membrane filtration, and then transferred 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.

4. The most robust membrane filtration

Steritest is a closed system membrane filtration sterilization test that maximizes safety and convenience.

5. Rapid sterility testing

Winteam Rapid System is based on adenosine triphosphate (ATP) bioluminescence for rapid sterility testing and rapid bioburden testing. With the fast sterility test system, you can get results in 5 days.

Official sterility test source used by the Gibraltar Institute:

USP <71> Sterility Test

According to AAMI / ANSI / ISO guidelines.

Sterility testing is an extremely important step before the release of sterile products. False-positive, false-negative experimental results, as well as experimental equipment failures and human error can cause significant time and money losses to the customer and directly affect the laboratory performance of the product. The combination of the Ai series collection instrument and the collection culture incubator provides a perfect solution. The test samples of different packaging forms are safely and uniformly transferred to the collecting culture incubator by the peristaltic pump of the collecting instrument, so that the sterility test results are more consistent and reliable.

Features

• Two layers of aseptic packaging facilitate cleanroom transfer and reduce contamination during transfer.
• Gamma sterilization, no residue, safe and reliable, to avoid false negative results.
• SAL 10 10-6, in line with the requirements of the 2015 Chinese Pharmacopoeia radiation sterilization method.
• The ultrasonic welding process ensures air tightness and pressure resistance.
• 100% passed the airtight performance test.
• Microbial microbial retention, microbial growth (sensitivity) and sterility testing ensure reliable and reliable results of sterility testing.
• 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.