100ml Consumable Steritest System , Sterility Test Kit ChP EP JP USP SS304 Needle

100ml Consumable steritest system ChP EP JP USP SS304 needle for testing facility

Methodology

The United States Pharmacopoeia is a compilation of validated medicines and medical device methods and official monographs, divided into the following sections: monographs, general information chapters, and general requirements. The <1000> series of general information sections are not legal requirements. The sterility test (USP <71> part) falls under the “general requirements” and is therefore a legal requirement.

For combination products, the ISO Radiation Sterilization Microbial Method (11737-2 1998) 6 describes an improved sterility test for the USP method that is specifically designed to detect aerobic organisms exposed to a sublethal sterilization cycle. This ISO sterility test method is recommended to verify gamma ray and electron beam sterilization processes.

The selection method for EO7 sterilization products is the official USP <71> program.

Characteristics of Sterility Test Canister

Quality check: each device is subjected to rigorous in-process and release quality checks including 100% membrane and canister integrity tests as well as intense physical and microbiological testing.

The sterility test canister is elaborately manufactured through more than 40 procedures, which are strictly controlled respectively. The products fully passed integrality inspection. According to requirement of ISO 9001, each test can be traced and the quality has being improved continuously. According to the various characters and packaging formats of the samples, we match many kinds of microporous filter membranes which are different in materials and structures, and then design and develop 28 kinds of incubate container which can meet all requirements in the sterility testing for all kinds of the samples.

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

Process flow

Before performing the actual sterility test, please carefully send the sample samples to the test lab so that the lab can determine the appropriate test procedure. Each product should have a unique test procedure specification, which should be very specific to the project. Specific (or vial/syringe) for testing. The procedure must indicate that the sample portion (SIP) sample portion is the percentage of the complete product being tested. Because the medical device has various shapes and sizes, it is difficult to test. Therefore, the test laboratory will determine the sample portion, which is the fraction A portion of the sample is represented (ie, 0.1 for 10% of the sample).

The SIP portion should be verified by a sterility test for the gamma and electron beam dose setting method.

The combined product faces a unique challenge, the combination product is defined as a product with a pharmaceutical ingredient in a medical device, such as a drug-coated stent, and the agency's Office of the Combined Products (OCP) will determine which regulatory authority (CDRH, CDER or CBER) ) is the main product of this product. All sterile drugs require a formal USP sterility test on the combined product. Sterile pharmaceutical ingredients pose the greatest challenge to laboratory personnel. Biologics must be aseptically processed and cannot be terminally sterilized. We will see more biologics, which are combination products, and radiation-sterilized combination products are usually treated as medical devices in accordance with ISO 11137. In all combinations, pharmaceutical GMP will take precedence over 820 QSR8. GMP9 requirements will ensure a reduction in the number of bioburdens and consistent locations in the microbial population manufacturing process.