Hangzhou Winteam Scientific Instruments Co., Ltd.
THE MISSION OF WINTEAM IS PROVIDE BETTER STERILITY TEST PRODUCTION
|Place of Origin:||CHINA|
|Minimum Order Quantity:||ONE BOX|
|Packaging Details:||72sets/box,18sets/box, 48sets/box,12 sets/box|
|Supply Ability:||10000sets per day|
|Name:||Sterility Test Canister||Membrane Material:||MCE NYLON PP|
|Delivery:||At Stock||Needle:||304 Stainless Steel|
|Usage:||Filteration||Port:||Ningbo Or Shanghai|
sterility test kit canister,
sterility testing pump
Vial Bottle Sterility Test Canister large volume injection sterility test device
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
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.
|Schematic Diagram||Model||Inspection Style||Packing Spe.|
|Py220C||Glass Bottle Large Volume Injection||
|Ksf220C||Glass Bottle Large-Capacity Antibiotic Injection|
|Kapy220C||Ampoule Antibiotic Injection|
|Dgb220C||Vial Bottle Soluble Powder|
Vial Bottle Soluble Antibiotic Powder
|Sdy220C||Soft Bag Large Volume Injection|
|Nkf220C||Powder That Needs To Be Dissolved And Diluted|
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 Person: wong