The Vikumer FDL-TP stoppering freeze dryers are mainly use in pharmaceutical industry, for vaccine freeze drying, so it also calls pharmaceutical lyophilizer. Vaccines in vials are dried in drying chamber, later will be stoppered in lyophilizer (under vacuum environment), to guarantee the drug stability and extend its shelf life.
Meet GMP is the essential requirements of a pharmaceutical freeze dryer, whatever the design, control or document. Vikumer FDL-TP fully meet GMP and are designed beyond the directives.
CIP Clean in place and stoppering system are the standard config. in FDL-TP, SIP Sterilize in place is optional. For all models we provide complete document package (OQ, PQ, FAT, Drawings etc.) and can be fully customization, as per user functions request.
- Meet GMP.
- LYO-Mega Control system meet 21CFR Part11.
- PLC and user-friendly touch screen control system, PC connectivity.
- Control of the freeze dryer via a graphic HMI.
- Alive display freeze dry system working status.
- Freeze drying steps management.
- Real-time freeze drying curve.
- Drying data can download to USB memory.
- Automatic and semi-automatic working.
- In-place lyophilization, shelves -55C ~ +70C and chilling and heating efficiency >1C/min.
- Stainless steel 316L material.
- CIP Clean in place function.
- SIP Sterilize in place optional.
- Various combination types of drying chamber and condenser.
- Documents and validation package provide.
- Drying chamber and condenser are designed according to GB150 pressure vessel code and are fabricated from high quality stainless steel. Chamber inner wall and shelves surface roughness Ra<0.4um, corners are rounded for easy cleaning.
Precise Temperature Control and Uniformity
- Rectangular drying chamber with PUF insulation layer, plus the delicate designed shelves energy balance system, can guarantee plates temperature variance <+/-1C, which is the insurance of high-quality freeze drying.
- Plates temperature range -55C to +70C, heating and chilling rate >1C/min, enables flexible program freeze drying steps.
- Can use for bulk material freeze drying or vaccine lyophilization.
- Shelves Temp. -55C to +70C.
- Shelves cooling +20C to –40C within 60min.
- Shelves heating –40C to +20C within 60min.
- Condenser final -85C.
- Condenser cooling +20C to –40C within 30min.
- Vacuum final <1Pa
- Vacuum atm. to 0.1mbar within 30min.
- Vacuum leakage ≤5x10-2mbarL/s.
- Plates surface polish Ra<0.4um
- Plates surface flatness <+/-0.5mm/m
*Shelves Temp. -55C to +70C, couple with condenser -75C, Vacuum <1Pa.