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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
  • Stability at very low temperatures of up to -20 °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 3mL, 10mL, 50mL, 100 mL, 250 mL, 500mL, 1 L, 2 L, 3L 5 L, 10 L , 20 L and 50 L
Operating Range
Operating Temperature -80°C to 45°C
Accuracy
Burst Pressure with Water >15 psi
Storage Temperature -20°C to 45°C
Freeze – Thaw Conditions
Minimum Temperature -80°C
Maximum No. of Freeze – Thaw Cycles 05
Materials of Construction
Bag Film AseptiFlex-D film type FBG-1
Connection Ports Polycarbonate
Clamps Polyester
Tubing Platinum cured silicone
Dimensions
Dimensions  

Bag Size A B
3 mL 75 mm 55 mm
10 mL 90 mm 60 mm
50 mL 157 mm 87 mm
100 mL 179 mm 92 mm
250 mL 189 mm 134 mm
500 mL 226 mm 155 mm
1 Litre 275 mm 200 mm
2 Litre 350 mm 200 mm
3 Litre 378 mm 247 mm
5 Litre 410 mm 319 mm
10 Litre 620 mm 322 mm
20 Litre 520 mm 580 mm
50 Litre 860 mm 582 mm
Specifications
Fill Volume
MDI AseptiBag Gold are designed for an overfill volume of > 10% over the specified bag size (volumes).
*Overfilling may result in leakages under freezing conditions.
Operational
Sterilization Gamma Sterilizable upto 50 kGy
Assurance
Bacterial Endotoxin Aqueous extracts exhibit < 0.25 EU/ml as established by Limulus Amebocyte Lysate (LAL) Test as per USP<85>
Fiber Release Passes microscopic test for fibers
Particle Release 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<661>)
Sterility The gamma sterilization process has been validated as per ISO 11137 to ensure a sterility assurance level (SAL) of 10-6
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>

AseptiBag™ Gold (For 3 mL Storage Bags)

Type
AseptiBag™ Gold ABDX
Bag Size
Code
3 ml U
Inlet Port
Code
Female Luer Lock M
X
XXX
Tube
Code
Platinum Cured Silicone X
X
Sterility
Code
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

     Example :

ABDX U M X XXX X X 3 02

AseptiBag™ Gold (For 10 mL and 250 mL Storage Bags)

Type
AseptiBag™ Gold ABDX
Bag Size
Code
10 ml T
50 ml S
100 ml A
250 ml B
Inlet Port
Code
Female Luer Lock M
Outlet Port
Code
Male Luer Lock L
XXX
Tube
Code
Platinum Cured Silicone X
X
Sterility
Code
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

     Example :

ABDX B M L XXX X X 3 02

AseptiBag™Gold (For 500mL to 50L Storage Bags)

Type
AseptiBag™ Gold ABDX
Bag Size
Code
500 mL V
1 L C
2 L D
3 L W
5 L E
10 L F
20 L G
50 L H
Inlet Port
Code
Male Quick Connector J
Female Luer Lock* M
Outlet Port
Code
Male Quick Connector J
Male Luer Lock* L
Sampling Port
Code
Needleless N
XX
Tube
Code
Platinum Cured Silicone X
X
Sterility
Code
Gamma Sterile 3
Pack Size
Pack Size Code
10 02

*Female Luer Lock and Male Luer Lock is available only for 500mL, 1L and 2L bag sizes

     Example :

ABDX C J J N XX X X 3 02

File Type Download
Datasheet Download
COQ Download

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