Alternative Method: H²O² more
effective than Steam for Sterilisation of Freeze Dryers
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 degree Celsius to 121 degree Celsius.
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.
The Alternative
Technology GEA Lypohil has looked for a less expensive solution
and found a way to sterilise freeze dryers at vacuum and at room temperature:
The H
²O
² –Sterilisation. We developed the VAPOVAC
H
²O
² –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
H
²O
² – 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 from GEA Lyophil 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:
- Drying: The freeze drying chamber and condenser are dried before feeding
hydrogen peroxide into the equipment.
- Evacuation: The freeze dryer is evacuated to a very low pressure.
- Injection: When the injection set pressure is reached, the
H²O² –solution is lead into the freeze dryer.
- Residence Time: After injection the residence time of the hydrogen peroxide
is monitored and can be adjusted to ensure effective sterilisation.
- 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
The 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:
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