Wintema Sterility Test Closed Canister for Lab/ for Microbial Limit Test/ Medicine

Product Description

Product Description

 

Name:	Sterility Test Canister	Membrane Material:	MCE NYLON PP
Air Filter:	0.22μm	Needle:	304 Stainless Steel
Usage:	Filteration	Tube:	Pvc
High Light:	sterility test kit canister , sterility testing pump

 

 

Features

 

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

Product Parameters

 

 
 

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.
 

 

Product rinse sterility test
Combination product: Product rinse sterility test is only applicable to products with hollow tubes, such as infusion and infusion sets, which are not suitable for soaking and the fluid channel is marked as sterile, this method is easy to operate and requires modification of FTM media with liquid D rinse products, The eluate was membrane filtered and placed in FTM and SCDM. This method is usually not used.
 
 
Bulk drugs / biopharmaceuticals
Bulk drugs (API) have been sterilised according to USP 71 prior to release to the manufacturing process.
 
Bulk biologics are tested for sterility according to 21 CFR 610.12, which requires a medium (FTM) with sample test sizes listed in the document and a capacity of not less than 10 ml.10
 
 
Interpretation of sterility test results
Technicians must be trained in growth testing methods during the cultivation process. Growth is determined by observing a medium that is generally transparent and transparent with respect to the light source, and the turbid (turbid) area of the medium indicates the growth of microorganisms. Once growth is detected, the suspect container is tested to confirm that the turbidity present is due to microbes, not due to decomposition of the sample; sometimes, the sample becomes cloudy due to particle shedding or chemical reaction with the medium. After testing, return to the incubator for the remainder of the incubation period. Samples turbid in the medium were transferred and displayed for four days on the 14th day of the test.

 

Tags

 

 

sterility testing pump,

sterility test kit canister,

sterility test device