It can be used in clinical drug development and commercial manufacturing. The bag has been validated through a complex testing plan, including freezing, handling, and transportation testing. Fully compliant with GMP standards, strict quality control measures have been implemented, 100% integrity testing has been carried out, ensuring a 10-6 level of sterility assurance during product use. The length and connector of the tubing can be customized, and the surface of the shell can be easily wiped and disinfected for entry into the production area from the thawing point. The shell design allows for stacking during freezing and storage operations.
SPECIFICATIONS
| Membrane (Product wetted layer) |
ULDPE |
| RTS Sterile Connector |
PSU |
| CPC AQG Sterile Connector |
PC |
| CPC MPC Quick Connector |
PC |
| Boat Connector |
LDPE |
| Luer Connector |
PP |
| Needle Free Sampling Valve |
PC |
| Tube |
TPE |
| Shell |
HDPE |
| Screw and Nut |
PA |
| Sterile Sealing Ring |
Copper-Nickel |
| Clamp |
POM/TPU |
Ordering Information
| CAT. NO. with PuRobust membrane |
FZS12RTS01 |
FZS12GSS01 |
FZS12MPC01 |
| CAT. NO. with PureSupply membrane |
FZS12RTS01PS |
FZS12GSS01PS |
FZS12MPC01PS |
| Maximum working volume |
12L |
| Suggestion minimum working volume |
3L |
| Inlet and outlet connectors |
3/8” RTS Sterile connector (2 male) |
3/8” AQG Sterile |
MPC Quick Connector (1 male + 1 female) |
| Inlet and outlet disconnect |
Sterile Sealing Ring |
| Sampling |
Needle Free Sampling Valve |
| Sterile by |
Gamma |
| Process Temperature |
-80°C ~ 60°C |
| Size (Length*Width*Height) |
755*565*130mm |
| Empty Weight |
3KG |