Double layer packaging sterility test closed canister SS304 needle 50mm diameter filter

How does contamination occur?

There are many sources of contamination in the production of biopharmaceuticals. This includes raw materials, personnel, equipment, and manufacturing environments. Regulators will provide guidance to reduce the risk of contamination with bacteria or fungi, including the use of raw material disinfection techniques, ensuring sterility, and conducting GMP. However, despite these precautions, the risk cannot be completely eliminated. Therefore, sterility must be regularly tested during the manufacturing process.

Determination of sterility

Sterility testing guidelines are found in various pharmacopoeias around the world, including the US Pharmacopeia (USP) and the European Pharmacopeia (EP). IHC has adjusted this guide (3). The infertility test conducted by Sartorius STEDIM is a GMP specification, followed by EP (2.6.1. Infertility) and USP (<71> Sterility Test).

Characteristics of Sterility Test Canister

Ultrasonic welding process, smooth and fast, to achieve the best sealing performance.

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 transfer and reduce contamination during transfer.
• Gamma sterilization, no residue, safe and reliable, to avoid false negative results.
• Microbial microbial retention, microbial growth (sensitivity) and sterility testing ensure reliable and reliable results of sterility testing.
• Filter: bubble point method, bacterial retention test.

• Two layers of aseptic packaging facilitate cleanroom transportation and reduce contamination during transportation.

  Gamma ray sterilization, no residue, safe and reliable, to avoid false negative results.

  Sal 10-106, in line with the requirements of the 2015 Chinese Pharmacopoeia radiation sterilization method.

  The ultrasonic welding process ensures air tightness and pressure resistance.

  ll 100% passed the airtight performance test.

  Microbial microbial retention, microbial growth (sensitivity) and sterility testing ensure reliable and reliable results for sterility testing.

  Screening: bubble point method, bacterial retention test.

  Check the stability test: the cultural period is 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

Direct transfer sterility test

Combination product: This method is the preferred method for medical devices because the device is in direct contact with the test medium throughout the incubation period. Living microorganisms that may be present in or on the defective/sterilized product have an ideal environment in which disinfection can be carried out, especially for damaged microorganisms, which are caused by a sub-lethal sterilization process. All microorganisms have bioremediation mechanisms that can be directly transferred using environmental conditions conducive to growth, thereby benefiting these damaged microorganisms. The entire product should be immersed in the test solution; for large equipment, it should be immersed in the patient contact area; large catheters can be filled with the test medium with a syringe before immersion; cutting the catheter sample for complete immersion is the method of choice.

The United States Pharmacopoeia authors understand that because the size and shape of the test sample requires appropriate modifications, the method requires that the product be transferred to a separate container of FTM and SCDM, and then the product should be aseptically cut or transferred to the medium in its entirety. Fully immersed in the test medium, USP limits the volume of the media to 2500 ml and packages the sample for 14 days after transfer.