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.
	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

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.