The FDLS series commercial pharmaceutical freeze dryers are designed to perform industrial freeze drying processes in the biopharmaceutical industry. For freeze drying medical vaccines, antibiotics, serum, penicillin, hormones and reagents etc.
The FDLS freeze dryers are complete with hydraulic stoppering system which can close vials after freeze drying is finished and is under vacuum environment, also can use as a shelf freeze dryer to dry bulk goods. The range lyophilizers can integrate CIP and SIP system to satisfy commercial aseptic production needs.
The FDLS freeze dryers available in shelf area from 1.08m2 to 45.9m2, can meet production demand of clinical trials, pilot test and commercial production.
Technical Specifications
| Model | FD-1LS | FD-2LS | FD-3LS | FD-5LS |
|---|---|---|---|---|
| Shelf Area | 1.08m2 | 2.16m2 | 3.24m2 | 5.4m2 |
| No. of Shelves | 4+1 | 6+1 | 6+1 | 5+1 |
| Shelf Size | 600*450mm | 600*600mm | 600*900mm | 900*1200mm |
| Shelf Temp. | -55C~+70C | -55C~+70C | -55C~+70C | -55C~+70C |
| Condenser | 10Kgs/24Hrs | 20Kgs/24Hrs | 30Kgs/24Hrs | 50Kgs/24Hrs |
| Condenser Temp. | -85C | -85C | -85C | -85C |
| Final Vacuum | <1Pa | <1Pa | <1Pa | <1Pa |
| Power Install | 13.5Kw | 18Kw | 21Kw | 28Kw |
| Size W*L*H | 1200*2200*2300 | 1500*2350*2500 | 1500*2800*2500 | 1600*4000*2800 |
| Model | FD-10LS | FD-20LS | FD-30LS | FD-40LS |
|---|---|---|---|---|
| Shelf Area | 9.72m2 | 19.8m2 | 29.7m2 | 40.5m2 |
| No. of Shelves | 9+1 | 11+1 | 11+1 | 15+1 |
| Shelf Size | 900*1200mm | 1200*1500mm | 1500*1800mm | 1500*1800mm |
| Shelf Temp. | -55C~+70C | -55C~+70C | -55C~+70C | -55C~+70C |
| Condenser | 100Kgs/24Hrs | 200Kgs/24Hrs | 300Kgs/24Hrs | 400Kgs/24Hrs |
| Condenser Temp. | -85C | -85C | -85C | -85C |
| Final Vacuum | <1Pa | <1Pa | <1Pa | <1Pa |
| Power Install | 60Kw | 85Kw | 98Kw | 125Kw |
| Size W*L*H | 1900*6000*3200 | 2200*7500*3600 | 2500*9000*3800 | 2500*9000*4000mm |
Technical Details
Vekuma has been designed and manufactured production scale lyophilizers for the pharmaceutical and biotechnology industry. Which is carried out in accordance with the guidelines of GMP, FDA and CE. We support your drugs development from very beginning lab research development, to process optimization, pilot production and final success in commercial and industrial mass production.
All FDLS pharmaceutical freeze dryers are modular engineered with standardized sub-systems that can be flexible configured as per user’s reqirement, such as CIP, SIP, redundant compressors, vacuum pumps and fluid pumps. Fit both aseptic and non-aseptic production.
Meet International Regulations and Directives
With science advances, pharmaceutical industries require higher level freeze drying equipment to meet the production needs, and relevant departments have published regulations and directives to guide manufacturers who involve with production of bio and pharma products.
Vekuma well understand the challenges and our FDLS series pharma freeze dryers can be designed fully meet these regulatory standards include but not limited to GLP, GMP, FDA, GB150.
Configurable System
The FDLS pharmaceutical freeze dry system is modularly engineered, easy to configure, install and maintain. Each subsystem as an individual module and is linked together by the control system. A wide range of accessories can be installed to match the particular needs of users, for example CIP, SIP, redundant system etc.
Flexible to Use
The FDLS freeze dryer comes with flexible shelves coupling with a top-to-bottom, hydraulic stoppering device which capable of capping vials after freeze dry. So, it can be used as a stoppering freeze dryer for bottled products drying, or as a shelf freeze dryer for bulk goods drying.
Solution For All Stages
The FDLS freeze dryers available in shelf area from 1.08m2 to 45.9m2, various models selectable to perform clinical trials, pilot test and commercial production. And all FDLS machines have the same technical features and system performances, easily technology transfer and scale up.
Rectangular Drying Chamber
The FDLS pharmaceutical freeze dryers feature rectangular drying chamber which have the highest space using rate. The drying chamber is stainless steel fabricated, design as per GB150 pressure vessel directive, inner wall polished roughness better than 0.8um and wall external cover up to 150mm thick PUF for insulation.
Heat Transfer Fluid Based Shelves
The heat-plates in shelf module are heat transfer fluid based and are always temperature controlled. Fluid based shelves ensures the smallest temperature deviation between shelves and shelf points: <+/-1C. The heat-plates bellows are braided, stainless steel material. Shelves flexibly move up or down, for vials sealing or assist CIP.
Individual Ice Condenser
The vapor collect condenser is external type, large capacity and is stainless steel fabricated. It is installed behind the product chamber, connect to product chamber by a stainless steel pipe, an isolation valve is installed to isolate and to perform pressure rise test.
The ice condenser is coils type, cooled by refrigerant direct expansion. Each compressor has an independent circuit and each circuit has a coolant distributor that evenly distribute coolant to coils to guarantee the condenser temperature uniformity and enhance the vapors collect performance.
Industrial Versatile Control System
The control system is PLC and HMI based, the PLC is use to perform interlock checks, execute freeze drying processes and generate alarms; the touch screen HMI is use to monitor system working status and check drying data. The control interface has the following functions.
- Alive display system working status and key parameters.
- Recipes management.
- Real time freeze drying trend.
- Data logging and can be exported via USB.
- Automatic and semi-automatic working.
- CIP/SIP parameters set.
- System setting and sensors calibration.
- System log-out and password enter.
- System protection setting.
