UA-44035381-1
  • AseptiBag Gold

AseptiBag Gold

AseptiBag Gold is made from AseptiFlex-D film offering multiple advantages such as:

  • Very low extractable profile for low ‘Product’ risk
  • Long term storage of media and cell growth
  • Stability at very low temperatures of up to -80 °C
  • Higher strength and flexibility

  • 100% integrity tested with pressure leak test
  • High barrier properties for protection of product molecule, product pool and media components
  • Robust and flexible with high burst strength
  • Easy inlet and outlet quick connections
  • User friendly easy to hold/hang design
  • Custom designed to suit user specific process applications

mdi AseptiBag Gold systems are used for critical biopharmaceutical process steps such as:

  • Long term aseptic storage of sterile media, buffers and drug substances at low temperatures
  • Transfer of sterile media to bioreactors
  • Transfer of process intermediates between process areas
  • Aseptic transfer of drug substance to formulation facilities
Size
Available Sizes 100 mL, 250 mL, 1 L, 2 L, 5 L, 10 L , 20 L and 50 L
Operational
Sterilization Gamma Sterilizable upto 50 kGy
Accuracy
Burst Pressure with Water >15 psi
Storage Temperature -80°C to 45°C
Materials of Construction
Bag Film AseptiFlex-D film type FBG-1
Connection Ports Polysulfone/Polycarbonate
Clamps Polyester
Tubing
Thermoplastic Elastomer
Platinum cured silicone
Dimensions
Dimensions

Bag SizeAB
100 mL154 mm86 mm
250 mL189 mm134 mm
1 Litre246 mm200 mm
2 Litre350 mm200 mm
5 Litre375 mm319 mm
10 Litre590 mm322 mm
20 Litre490 mm580 mm
50 Litre775 mm582 mm
Assurance
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test
Fiber Release Passes test as per USP and comply with USFDA 21 CFR Part 210.3(b)(6) for fiber release
Particle Release The filtrate complies with USP <788> test for particulate matter in injections
Extractables with WFI Does not affect the quality of Water for Injection (passes tests as per USP)
Biosafety
Passes the Biological Reactivity Tests, In Vivo for Class VI plastics as described in USP <88>
Passes the Biological Reactivity Tests, In Vitro for Cytotoxicity as described in USP <87>
Sterility The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6

AseptiBag Gold (For 100 mL and 250 mL Storage Bags)

Type
AseptiBag Gold ABDX
Bag Size

Code
100 ml A
250 ml B
Inlet Port
Code
Female Luer Lock M
Male Luer Lock L
Outlet Port
Code
Female Luer lock M
Male Luer Lock L
XXX
XX
Sterility
Code
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

     Example :

ABDX B M L XXX XX 3 02

AseptiBag Gold (For 1L to 50L Storage Bags)

Type
AseptiBag Gold ABDX
Bag Size
Code
1 L C
2 L D
5 L E
10 L F
20 L G
50 L H
Inlet Port
Code
Male Quick Connector J
Female Quick Connector O
Outlet Port
Code
Male Quick Connector J
Female Quick Connector O
Sampling Port
Code
Yes R
No X
XX
XX
Sterility
Code
Gamma Sterile 3
Pack Size
Pack Size Code
10 02


    * Sampling port is available in 2 liter to 50 liter bags. It is not available in 1 liter bag.

     Example :

ABDX C J J R XX XX 3 02

Datasheet Download

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