production freeze dryers
for the pharmaceutical
The pharmaceutical production freeze dryers line, Lyopharm, is specifically designed for pharmacological products in large batches. We provide customized solutions, developing projects for new processes or improving the existing ones, adapting them to our customer needs. We offer the Factory Acceptance Test (FAT), the equipment transportation and the Acceptance Test at customer Site (SAT).
Compact pharmaceutical freeze drying solutions are provided for loading surfaces below 10m2. In the same bench (frame) the product chamber and the condenser are integrated together with all the components. For equipment larger than 10m2, the vacuum and refrigeration systems are typically provided in a separated bench. For the larger Lyopharm models the equipment is typically integrated with the building in more than one floor and taking part of the pharmaceutical plant project.
The Lyopharm freeze dryers are manufactured by freeze drying COOLVACUUM experts in freeze drying applications for the pharmaceutical industry. The Lyopharm line is a first-class choice if what is sought is a pharma production freeze dryer.
- Shelve temperature range: -55ºC to +80ºC
- Cooling rate in shelf: 20ºC to -40ºC in <60 min
- Heating rate in shelf: 1ºC/min
- Condenser final temperature: <-75ºC
- Final vacuum: <0.01mbar
- Removal rate: 1000mbar to 0.1mbar<30min
- Leak rate:<0.03 mbar•L/s
- Cleaning system CIP
- Sterilization system SIP (by steam or by hydrogen peroxide)
- Hydraulic vial closing
- PLC control system 21CFR part 11 and cGAMP
- Automatic loading system
SIP sterilization systems
The sterilization needs in pharma production freeze dryers has increased in the last decades. Its objective is the biological contaminant reduction below the detectable levels on the most resistant microorganisms. From COOLVACUUM we offer equipment with sterilization by steam or by hydrogen peroxide.
Steam sterilization is the most common means of sterilization today. The process of steam sterilization raises the temperature and pressure of the freeze dryer to 121ºC and 2bar(a) for a period of time and number of cycles.
This method entails designing the freeze dryer not only to work in vacuum, but also as a pressure vessel. The chamber will need to be reinforced to withstand the stresses caused by the positive pressures.
The vapor hydrogen peroxide sterilization VHP is performed at vacuum conditions. The peroxide diluted to 35% and heated to 70ºC is connected to the vacuum chamber causing its evaporation and its homogeneous distribution in all the volume. The superficial microorganisms structures (proteins, carbohydrates and lipids) are destroyed by oxidation and consequently causing its dead. Finally, the peroxide is decomposed in oxygen and water, without generating any residue.
Automatic loading systems
The automatic loading systems are necessary to assure the integrity of the pharmacological products. The pharma standards are increasingly leading to control measures to stablish a physical barrier between the operator and the product.
From COOLVACUUM, freeze drying experts in the pharmaceutical industry, we study each case individually to provide the most convenient solution for satisfying the customer needs. We can offer simple solutions as transfer trolleys with laminar flux included, or sophisticated fully automatic loading systems.
LYOPHARM TECHNICAL DATA
|Shelves useful surface||m2||2.16||3.24||5.40||7.56||9.72||12.96||14.40||19.73||24.59||29.6||41.86|
|Condenser ice capacity||Kg||40||60||100||150||200||250||300||400||500||600||800|
|10ml vials capacity||vials||4900||7300||11400||17100||22000||29400||32700||44800||55800||67200||95100|
|5 ml vials capacity||vials||9200||13900||21500||32400||41700||55600||61800||84700||105600||127000||179000|
|Number of shelves||–||4+1||6+1||5+1||7+1||9+1||9+1||10+1||11+1||11+1||11+1||14+1|
|Total dimensions (length)||mm||3600||3900||4500||4700||5200||6500||6500||7300||7300||7600||8000|
|Total dimensions (width)||mm||1750||2200||2300||2300||2200||2300||2300||3000||3000||3000||3200|
|Total dimensions (height)||mm||2850||3100||3100||3400||3800||3900||3900||4200||4200||4200||4600|