UA-44035381-1
  • AseptiLink SC-γ

AseptiLink SC-γ

Single Use Systems (SUS) are increasingly being used in the biopharmaceutical manufacturing process. Aseptically connecting single use components to form a usable assembly or to connect a SUS to another single use or a reusable system, for example a sterile media bag to a bioreactor, is a critical requirement.

MDI Gamma Sterile AseptiLink SC-γ, genderless connectors are designed to provide a fast and convenient aseptic connection between two processing streams, such as a container to a sampling line, media bags to a bioreactor or a filtration assembly to a filling line, without the need of a biocontainment hood. In other words, it provides a validated robust connecting mechanism within sterile as well as non sterile environments, while eliminating the need for sophisticated and complicated hardware.

Aseptically connects:

  • Two gamma sterile single use systems
  • Gamma sterilized single use system and autoclavable stainless steel hardware
Construction
Seal Material Silicone
Proctective Cap Polypropylene
Peel away Film Polyester
Connection Polycarbonate
Operational
Burst Pressure > 4 bar (60psi)
Sterilization - By Irradiation Sterilizable upto 50 kGy. Autoclavable for 1 cycle at 125°C for 30 minutes after gamma irradiation. Do not steam in place.
Operating Temperature Range 4 - 40 °C
Assurance
Bacterial Endotoxin Aqueous extracts exhibit <0.25 EU/ml as established by Limulus Amoebocyte Lysate (LAL) test as per USP <85>
Bioburden Bioburden level is < 1000 cfu/device as per ANSI/AAMI/ISO 11737-1 : 1995
Fiber Release Passes test as per USP and comply with USFDA Title 21 CFR Part 210.3(b)(6) for fiber release
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Total Organic Carbon Meets the WFI requirements of USP <643> for Total Organic Carbon
Conductivity Meets the WFI requirements of USP <645> for Conductivity
Biosafety

Passes the Biological Reactivity Tests, In Vivo for Class VIplastics as described in USP <88>.
Passes the Biological Reactivity Tests, In Vitro forCytotoxicity as described in USP <87>.
Extractables Passes NVR test as per USP <661>
Type
AseptiLink SC-γ
Sterile Connector
ASCX
X
X
End Connection
Code
Single Step ½” Hose Barb Q
¼” Hose Barb B
3/8” Hose Barb I
XXX
XX
Sterility
Code
Gamma Sterile 3
Pack Size
Pack Size Code
10 03


     Example :

ASCX X X I XXX XX 3 02
Datasheet Download
Certificate of Quality Download

Write a review

Note: HTML is not translated!
    Bad           Good
  • Reliable aseptic connection even in non sterile areas
  • Fast and easy 3 step connection
  • Minimum inventory: Genderless design
  • Carefully selected materials of construction for minimum extractables