single-use closed sterile canister ChP EP JP USP 100ml for testing facility

Select the Gibraltar Institute for sterility testing:

Membrane filtration sterilization test

The membrane filtration sterilization test method is the best method for filtering drugs. The product was filtered through a 0.45 or 0.2 micron membrane filter according to the USP <71> sterility test method. The filter is then rinsed with a suitable USP liquid to remove the inhibitor and then transferred to liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM). Both media were incubated for 14 days and microbial growth was examined daily. The USP <71> sterilization test recommends the use of liquid thioglycolic acid medium (FTM) and soy casein digestion medium (SCDM). These can promote the growth of anaerobic and aerobic microorganisms.

2. Direct transfer sterilization test

The direct transfer sterilization test method is a method of selecting medical devices (such as solid dosage forms, powders, ointments, and creams) that cannot be filtered. In this sterility test method, the test article is transferred directly to liquid thioglycolic acid medium (FTM) and soybean casein digestion medium (SCDM). Both media were incubated for 14 days and microbial growth was examined daily.

We are offering sterility test closed canister.
Sterility test canisters are used for pharmaceutical product sterility test by the membrane filter method which produced in very strict condition. Working together with sterility test pump.

Characteristics of Sterility Test Canister

• Quantity of Filter Cartridge: 2 or 3
• Pressure Resistance of Filter Cartridge: 0.5Mpa
• Volume of Filter Cartridge: 100ml
• Filter Membrane: Mixed Cellulose Esters Membrane / Nylon Membrane / PP Membrane (according to different types) with diameters of 47mm and bore diameter of 0.45 μm
• Respirator Filter Membrane: PTFE hydrophobic membrane with diameter of 25mm and bore diameter of 0.45 μm

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 collection collection incubator is carefully manufactured by forty processes, each in strict accordance with the ISO9001 quality system and ISO14001 environmental system requirements. 100% of the products passed the integrity test, achieving continuous improvement in quality traceability and quality. According to the testing requirements of different dosage forms and packaging forms, various cups, filter materials and matching needles were selected, and various collection incubators were designed and developed to meet various sterilization tests. need.