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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Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device

Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device

  • Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device
  • Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device
Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device
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
Delivery: At Stock Needle: 304 Stainless Steel
Usage: Filteration Port: Ningbo Or Shanghai
High Light:

sterility test kit canister

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sterility testing pump

 

Vial Bottle Sterility Test Canister large volume injection sterility test device

 

Winteam sterility test canister.PDF

 

Drug Sterility Test - USP <71>

Sterility testing of sterile drugs is an important part of GMP microbiology and can be used to ensure that pharmaceutical and biopharmaceutical treatments are truly sterile and safe for humans. USP <71> specifies sterility testing methods for pharmaceuticals and biological agents.

 

Sterility test capability test

A legal compliance test should be performed prior to initiating the sterility test. The suitability test for this method is called bacteriostatic and fungal testing. Bacteriostatic and bactericidal effects Combine less than 100 CFU of 6 different organisms with the sample and medium. If the microorganism can grow, it means that the sample will not inhibit its growth and can be tested for sterility.

 

After more than forty procedures, each process has undergone rigorous inspection. 100% of the products have passed the integrity test and the quality of traceability and quality is continuously improved according to the requirements of ISO9001 quality system certification.

 

  

Characteristics of Sterility Test Canister

 

  • High-precision rubber hoses are made of special materials with long-lasting tension, wear resistance and stress resistance to ensure maximum detection.
  • It uses medical dialysis packaging imported from the United States to ensure the sterility of the product, to quickly retain ethylene oxide and reduce ethylene oxide residues.
  • Transparent blister packaging, in line with international standards.
  • Transparent composite packaging to reduce packaging waste and reflect environmental protection
  • Pipe assembly lights are easier to use.
  • Two layers of aseptic packaging facilitate cleanroom transportation and reduce contamination during transportation.

 

Microbial retention, microbial growth (sensitivity) and sterility testing ensure that the results of the sterility test are authentic and reliable;
Filter membrane: bubble point method, bacterial retention rate test;
Ster Sterility Test: Culture for 14 days.

 

parameter

 

Schematic Diagram Model Inspection Style Packing Spe.
Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device 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
Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device 1 Apy220C Ampoule Injection
Apy330C
Kapy220C Ampoule Antibiotic Injection
Kapy330C
Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device 2 Dgb220C Vial Bottle Soluble Powder
Dgb330C
Kdgb220C

 

Vial Bottle Soluble Antibiotic Powder

Kdgb330C
Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device 3 Sdy220C Soft Bag Large Volume Injection
Sdy330C
Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device 4 Fsy220C Insoluble Liquid
Fsy330C
Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device 5 Nkf220C Powder That Needs To Be Dissolved And Diluted
Nkf330C

 

 

 

Vial Bottle Sterility Test Canister Large Volume Injection Sterility Test Device 6

 

Sterility test failure survey

 

For each positive sterility test (OOS), the laboratory should conduct an OOS survey to determine the effectiveness of positive growth.

 

 

1. Clean room environmental test (EER) data;

2. Media sterilization records;

3. Technical personnel training records;

4. The relative difficulty of the test procedure;

5. Control data (open and close media controls);

6. Technical sampling data (microbiological count on gloves and/or clothing after testing).

 

If there is convincing evidence that the initial sterility failure was caused by the laboratory, USP allows the product to be retested. Identification and species formation of isolates is an important factor in the final decision. If the first phase of the sterility test can be considered ineffective by the laboratory, the USP can perform a second phase of sterility testing. The second phase of the sterility test requires doubling the original sample size; if there is evidence that the test is not valid, the above-mentioned laboratory error can be repeated in the second phase of the test.

 

A detailed investigation may reveal circumstantial evidence supporting the final decision. It is recommended that the sterilization cycle data, environmental data and bioburden data be reviewed before making any decision to release the product.

 

Medical device manufacturers are advised to test non-sterile samples.

 

The John Lee formula can be used to calculate the probability of false positives 11 based on the diameter of the sample container, the amount of time the container was opened, and the number of particles in the room.

 

Sterility testing requires a high degree of control over GMP, Good Laboratory Practice 12, the environment (ISO Class 5 Sterile Cleanroom or higher) and employee specifications. The use of rigorous techniques in sterility testing practices is critical. This is an integral part of sterilization validation and routine quality control. Often, false positive results are rare when testing drugs in closed systems, and the challenges faced by combined products should be incorporated into a strong quality assurance program.

Contact Details
Hangzhou Winteam Scientific Instruments Co., Ltd.

Contact Person: wong

Tel: +8618968055427

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