- 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
| Operating Range |
| Operating Temperature |
-80°C to 45°C |
| 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 |
| Operational |
| Sterilization |
Gamma Sterilizable upto 50 kGy |
| Accuracy |
| Burst Pressure with Water |
>15 psi |
| Storage Temperature |
-20°C to 45°C |
| 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 | 490 mm | 580 mm | | 50 Litre | 775 mm | 582 mm |
|
| 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>) |
| 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 3 mL Storage Bags)
| | | | Inlet Port | | Code | | Female Luer Lock | M | | | | | Tube | | Code | | Platinum Cured Silicone | X | | | | Sterility | | Code | | Gamma Sterile | 3 | | | Pack Size | | Pack Size | Code | | 10 | 02 | |
Example :
AseptiBag Gold (For 10 mL and 250 mL Storage Bags)
| | | 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 | | | | Tube | | Code | | Platinum Cured Silicone | X | | | | Sterility | | Code | | Gamma Sterile | 3 | | | Pack Size | | Pack Size | Code | | 10 | 02 | |
Example :
AseptiBag Gold (For 500mL to 50L Storage Bags)
| | | 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 | | Needless | N | | | | Tube | | Code | | Platinum Cured Silicone | 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
