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
  • 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 SizeAB
3 mL75 mm55 mm
10 mL90 mm60 mm
50 mL157 mm87 mm
100 mL179 mm92 mm
250 mL189 mm134 mm
500 mL226 mm155 mm
1 Litre275 mm200 mm
2 Litre350 mm200 mm
3 Litre378 mm247 mm
5 Litre410 mm319 mm
10 Litre620 mm322 mm
20 Litre520 mm580 mm
50 Litre860 mm582 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 < 0.125 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

Datasheet Download
Certificate of Quality Download

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