| New demands in R+D centres are related to scale-up feasibility and quality of procedures and research methods. FDA investigators consider that transfer of technology from R+D departments to clinical trials and later commercial production is carried out with lack of strictness and poor documentation practices. |
 |
Therefore, they are emphasising on the concept
of GxP as a quality oversight, comprising all practices in R+D and production
processes. The new Series LyoBeta lyophilisers are laboratory units that have
been designed specifically for advanced research centres, keeping in mind
that initial development of new drugs is one of the most critical issues for
its final commercial success.
| DESIGN FEATURES |
| The LyoBeta is a compact unit with castors, constructed in a steel stove enamelled cabinet. The equipment is supplied fully assembled, including the vacuum and refrigerating system and all necessary elements, ready for operation after connecting to the utility services. |
| Efficient Design |
|
The design of this unit offers the best capabilities for R+D activities. The LyoBeta has been equipped with the appropriate components, devices and sensors to control processing conditions: temperature, pressure and time. This allows defining the process variables to achieve adequate control and reproducibility. The equipment includes brazed plate heat exchangers, when used in combination with other high quality components, yields cooling and heating rates of 1ºC/min as per our production freeze-dryers. Optimisation of process recipes is easily performed by means of the chamber to condenser valve, which allows for pressure rise testing and thermodynamic control. This valve also permits proceeding with the product loading and unloading without defrosting the condenser if it has not reached full capacity. The refrigeration system is capable of reaching –80ºC in the condenser and -50ºC on the shelves. It only uses HFC gases, which are authorised for use both at the moment and in the long term. |
| Flexibility of Use |
|
By using the stoppering device, the distance between the shelves can easily be modified, so the unit can be adapted to difand/ ferent product fill volumes, vial sizes or vial types. Moreover, a lateral inlet port allows the connection of a three way valve manifold for the freeze-drying of CN 29/32 open flasks. |
| High quality and superior craftmanship |
|
The chamber and shelves have been constructed with the same philosophy than production units. They are made entirely from stainless steel AISI 316 L and they are fully accessible inside for cleaning purposes. The condenser, which is also made of AISI 316 L, has a rapid ice-defrosting device, which works by means of a group of external electrical resistors. Both the chamber and the condenser have transparent acrylic door to facilitate viewing of the process. |
| Precise control and temperature uniformity |
|
The thermal fluid circulates inside the sandwich type channels of the shelf. This allows prior product freezing and later heating during sublimation phase. An additional shelf thermally balances the equipment. This feature for laboratory lyophilisers guarantees uniform heat transfer at all the shelves. Research lyophilisers often have the pressure sensors located on the vacuum line, reflecting the pressure of the line to the vacuum pump rather than in the chamber. The LyoBeta has the vacuum sensor in the chamber, which makes possible monitoring and controlling the pressure which comprises the environment where the product is exposed. This allows studying and obtaining finest scale-up results. |
| CONTROL SYSTEM |
| Based on PLC and user friendly touch-screen |
|
One of the main new feature of the Series LyoBeta lyophilisers is the incorporation of a non-proprietary PLC instead of the classic microprocessor, much commonly used in this type of equipment. This system, fully proven in the industrial models, guarantees maximum reliability and reproducibility in the process, totally adapting the equipment to cGLP. The system allows control of the freeze-dryer functions via a graphic HMI (Human Machine Interface) user interface, which offers the following possibilities: |
|
| The user interface presents information in an attractive and intelligible manner on a graphic 6” touch screen, through which different data screens can be accessed by means of touch zones. |
 |
| Optionally, the equipment can be connected to different peripherals, such as a chart recorder, printer or PC. When connected to a PC, we offer two possibilities to work under Windows environment. |
| WINDOWS ENVIRONMENT |
| LyoLogger |
| A data logging programme wich enables collection of data such as graphs, events, alarms and history (ASCII files) through a serial port. |
| LyoStar/lab |
| A SCADA software program designed specifically for scientific R+D studies. It allows designing, loading and store recipes, generate reports, historics, lists of alarms, etc. |
 |
| SPECIFICATIONS | |||
|
Unit
|
LB25
|
LB35
|
|
| No. of shelves |
ud.
|
4+1
|
6+1
|
| Shelves dimensions (WxD) |
(mm)
|
380x450
|
380x450
|
| Useable shelf area |
m2
|
0.68
|
1.03
|
| Interdistance |
mm
|
100
|
60
|
| Shelf temperature range |
°C
|
-55 to +80
|
-55 to +80
|
| Condenser capacity |
kg
|
25
|
35
|
| Final condenser temperature |
°C
|
< -80
|
< -80
|
| Vacuum pumpflow |
m3/h
|
18
|
18
|
| Electrical power |
kW
|
6.5
|
8.1
|
| Power supply |
V/Hz
|
220 / I / 50/60 (Others under request)
|
380 / III / 50/60 Others under request)
|
| Weight |
kg
|
1,050
|
1,100
|
| Dimensions (WxHxD) |
mm
|
1,260 x 1,975 x 1,100
|
1,260 x 1,975 x 1,100
|
| AVAILABLE OPTIONS |
|