Hangzhou Winteam Scientific Instruments Co., Ltd.

Hangzhou Winteam Scientific Instruments Co., Ltd.

THE MISSION OF WINTEAM IS PROVIDE BETTER STERILITY TEST PRODUCTION

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Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance

Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance

  • Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance
  • Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance
Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance
Product Details:
Place of Origin: CHINA
Brand Name: WINTEAM
Certification: ISO9001
Model Number: KSY
Payment & Shipping Terms:
Minimum Order Quantity: ONE BOX
Price: Negotiable
Packaging Details: 72sets/box,18sets/box, 48sets/box,12 sets/box
Supply Ability: 10000sets per day
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Detailed Product Description
Name: Sterility Test Canister Membrane Material: MCE NYLON PP
Pakcing: Paper Box Needle: 304 Stainless Steel
Usage: Filteration Port: Shanghai
High Light:

sterility test kit canister

,

sterility testing pump

 

Reliable sterility test kit Gamma Ray Sterilization AS cup 0.45μm membrance

 

Our verification program requires technicians to continuously test membrane filtration and direct immersion of 40 simulated samples under unfavorable environmental conditions without false positive results. Isolation technology is used to create conditions for a sterile environment for testing drugs. The qualification conditions for the isolator are extensive and the isolator is typically sterilized using a chemical sterilizer.

 

The robustness of the sterilization process involves many problems. Eligibility and maintenance of isolation and identification of sterile systems may require a significant amount of work. Isolators may not be the best cost method for solving environmental problems when testing drugs in closed systems such as winteamTM. Standard aseptic processing GMP can avoid most environmental problems. 5

  

Characteristics of Sterility Test Canister

 

  • Conforms to the requirements of radiation sterilization of CP2010.
  • Double-layer sterile packaging.
  • Sterility testing: 14 days incubation, conforms to EP/USP
  • Filter: bubble point method, bacterial retention test.
  • Chewing stability test: The culture period is 14 days.
  • l Ultrasonic welding process, the welding is smooth and sturdy, to achieve the best sealing performance.
  • Material of Filter Cartridge or Base: AS
  • Material of Filter/ Clamping Piece/ Needle Base: ABS
  • Material of Needle Case / Canister Base Stopper: PP
  • Canister Cap: silica gel

 

100% passed the airtight performance testing;Passed the bacterial challenge experiment and sterility test, which ensures reliable of the sterility test.The united use of them keeps all process carrying out in complete closed condition, including transfer, filter and incubate, which avoids exogenous contamination.Product sterility performance has been maintained and able to dialyze the ethylene oxide quickly, its residues and packaging waste are reduced, which fully reflects the corporate philosophy of environmental protection;

 

 

 

parameter

 

Schematic Diagram Model Inspection Style Packing Spe.
Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance 0 Py220C Glass Bottle Large Volume Injection

72Sets/Box

18sets/Box

 

48 Sets/Box

12sets/Box

Py330C
Ksf220C Glass Bottle Large-Capacity Antibiotic Injection
Ksf330C
Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance 1 Apy220C Ampoule Injection
Apy330C
Kapy220C Ampoule Antibiotic Injection
Kapy330C
Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance 2 Dgb220C Vial Bottle Soluble Powder
Dgb330C
Kdgb220C

 

Vial Bottle Soluble Antibiotic Powder

Kdgb330C
Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance 3 Sdy220C Soft Bag Large Volume Injection
Sdy330C
Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance 4 Fsy220C Insoluble Liquid
Fsy330C
Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance 5 Nkf220C Powder That Needs To Be Dissolved And Diluted
Nkf330C

 

 

Reliable Sterility Test Canister Gamma Ray Sterilization AS Cup 0.45μM Membrance 6

 

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.

Contact Details
Hangzhou Winteam Scientific Instruments Co., Ltd.

Contact Person: wong

Tel: +8618968055427

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