H2O2 Gas Sterilization more effective than Steam Sterilization


Why?
The production of many pharmaceuticals requires sterile conditions. Therefore freeze dryers are equipped with SIP-Systems (Sterilisation-in-Place) working with steam, which means that the freeze dryers are exposed to different stresses and strains. During a freeze drying process the plants undergo pressures of 5 x 10-3 mbar up to 2,5 bar and temperatures ranging from -80°C to 121°C. Consequently the chamber, condenser and the related piping have to be built pressure proof making those freeze dryers much more expensive than the non-steam sterilisable executions.

Alternative Technology
GEA Lyophil has looked for a less expensive solution and found a way to sterilise freeze dryers at vacuum and at room temperature: The H2O2 Sterilisation. We developed the VAPOVAC™ H2O2 Steriliser which at the same time reduces the investment costs and furthermore the sterilisation cycle time. GEA Lyophil is the only manufacturer that offers this technology.

The H2O2 Sterilisation is faster, safer, more efficient and more environmentally friendly than using steam. This technology is available for new plants and as a retrofit option to existing installations.

The VAPOVAC™ steriliser uses VHP technology to sterilise equipment under vacuum at room temperature. Only a very small quantity of hydrogen peroxide is used to penetrate the freeze dryer vessels and all associated piping of the equipment. This method effectively eliminates all residual contamination. The freeze dryer is then fully vented, leaving no harmful residues.

The Process
This consists of five steps:

  1. Drying: The freeze drying chamber and condenser are dried before feeding hydrogen peroxide into the equipment.
  2. Evacuation: The freeze dryer is evacuated to a very low pressure.
  3. Injection: When the injection set pressure is reached, the H2O2 solution is lead into the freeze dryer.
  4. Residence Time: After injection the residence time of the hydrogen peroxide is monitored and can be adjusted to ensure effective sterilisation.
  5. Removal of H2O2: After sterilisation, the hydrogen peroxide is completely and safely removed from the chamber.

Benefits
The VHP systems have many advantages over other sterilisation methods:

  • Shorter sterilising times
  • Lower investment costs
  • No complex pressurized vessel needed
  • Simplified piping systems
  • Less energy consumption
  • Longer service intervals
  • No cooling needed before re-use.


Increased plant availability
The faster turnaround results in greater efficiency. The entire sterilization operation takes place at room temperature – meaning that sterilization can be performed in approximately 3 hours for an average production freeze dryer, compared with approximately 8 hours for steam sterilization. This allows the plant operators to increase productivity and make the whole system more efficient.

Low cost and kind to the environment
Very little energy is needed to operate the VAPOVAC™ steriliser, making it cheaper and, therefore, kinder to the environment. The chamber, condenser and connecting pipes are used at atmospheric pressure, which makes them less expensive and easier to install. The elimination of high-pressure hoses also makes the process safer and reduces operational wear – meaning that plant system lifetimes are extended.

Increased safety
H2O2 system meets GAMP, cGMP, FDA, DIN, ISO and all other European and US codes. The residence time of the hydrogen peroxide can be varied as the system is monitored and can be adjusted to ensure effective sterilisation. After sterilisation, the hydrogen peroxide is completely and safely removed from the chamber – the operator having to positively confirm to the control system that H2O2 evacuation has been achieved successfully in order to complete the sterilisation process.

Retrofit maximization and application support
Retrofitting a freeze dryer with the H2O2 sterilisation system offers operators a way to increase the lifespan of existing equipment. In addition to gaining a highly efficient and cost-effective method of sterilisation, GEA Lyophil can, at the same time, enhance plant performance through a range of new systems, in addition to the H2O2 system.

GEA Lyophil’s experts can recommend various methods and equipment in increase productivity of existing plant. For example, new shelf packages and GEA Lyophil’s ALUS® (automated loading/unloading system) give plant a new lease of life and extend the operational usefulness of the entire plant.

For our German speaking customers:
Lesen Sie auch den Online-Artikel in process.de: Bitte hier klicken.
In Kürze hier auch als PDF zum Download erhältlich.

 Back  Top of page