0.45μ Msterility Test Kit Canister ISO14001 MCE Nylon PP Membrance 0.22μM Respirator

0.45μ Msterility test kit canister ISO14001 MCE Nylon PP membrance 0.22μm Respirator

This article describes general concepts and issues related to sterility testing and various testing methods. Most USP <71> sections are in line with EP/JP.

Sterility testing is an important part of every sterilization validation, and sterility testing is an extremely difficult process that must be designed and implemented to eliminate false positive results. False positive results are usually caused by laboratory contamination or technician errors in the test environment. The test environment must be designed to meet USP requirements for microbial air and surface viable counts; growth media used in sterility testing must be carefully prepared and tested to ensure its ability to support microbial growth. Sampling, testing, and follow-up must be defined in the verification program.

Sampling plan

The official test USP (Vol. 30) recommends testing 40 units per production batch. Next, Table 2, "Minimum usage of each medium 2" is reprinted. Some quantities with EP / JP volume 3

For combination products, the ISO 11137/111354 standard recommends various sterilization verification sampling plans based on batch size and verification methods. In the case of small batches (> 1000), the sample size depends on the batch size.

Environmental issues related to sterility testing

A sterile test environment is described in USP General Information Section <1211>. This environment should be as tightly controlled as the aseptic processing environment. An aseptic processing environment (clean room) is used to dispense sterile drugs into pre-sterilized containers. Typically, the room provides laminar air that has been filtered through a microbiologically retained high efficiency particulate air (HEPA) filter. The room maintains a positive pressure and has specifications for indoor air changes per hour. The environment used for sterility testing should be designed similarly in an aseptic processing environment; there should be a vestibule for storing the robes and a separate area for actual sterility testing; the test area should meet ISO Class 5 particle control requirements (specified in USP Chapter (1116)). The lass must be carried out under a laminar flow hood in a room that does not meet ISO C requirements. In addition to particle testing in the environment, laboratories must also test for ubiquitous living bacteria and fungal organisms. Sterility test technicians must wear appropriate anti-virus clothing to prevent microbes from entering the room. Laboratories must have validation and training programs for robes and sterility testing.

Characteristics of Sterility Test Canister

• Unique Septum Version
• Low Adsorption
• High Mechanical Stability
• l 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.
• l 100% passed the airtight performance test.
• Microbial microbial retention, microbial growth (sensitivity) and sterility testing ensure reliable and reliable results of sterility testing.

Application range

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.;

Food and beverage industry;

Environmental protection industry.

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

The USP <71> sterility test consists of two qualifying tests that must be performed prior to sterility testing, "adaptive testing" (promoting growth testing) and "validation testing" (antibacterial and fungal disease testing).

The suitability test is used to confirm that each growth medium used in the sterility test procedure will support the growth of less than 100 viable microorganisms, which will fail if the medium does not support the growth of the indicator organism. According to the culture parameters (time, temperature) determined by the method, a part of each medium batch must be specially sterilized, and if the medium is not sterilized, the test fails.

The verification test is used to determine whether the test sample inhibits the growth of microorganisms in the test medium. Microbiological retention means that the microorganism cannot grow and proliferate in the microbial medium, and the bacteriostatic medium does not necessarily kill the bacteria; it may It only hinders the growth and reproduction of bacteria. Each product must be tested for validation prior to and/or during the sterility test to determine if the media volume is valid for a particular product. Certain medical products contain bacteriostatic and fungistatic compounds and may require special procedures and special media for testing. This test is similar to the suitability test described above, but the product sample is placed in the medium along with the microorganisms. It was compared to a control without a test sample. If microbial growth is present in the sample and control containers, the next step is to perform an actual sterility test that allows for simultaneous suitability, validation, and sterility testing.