Extending the life of the freeze dryer – Adapting to changing requirements
and regulations
Freeze dryers are designed to run for decades. During this time many
things can happen: Authorities tighten up regulations, you have developed a new
drug and are ready to go into production, production requirements have changed
- and the freeze dryer installed many years before does not meet these
requirements any longer. Then time for a retrofit has come. Retrofits help you
to cope with changing requirements at low investment costs.
Changing requirements – Retrofit solution – Some Examples
|
Requirement: |
Retrofit Solution |
|
Do you need to sterilise your
freeze dryer and you only have a non-sterilisable
one? |
H2O2 –
Sterilisation by our VAPOVAC
Steriliser |
|
Do you need to proof sterility
of your equipment? |
Integrity
test |
|
Do you want to increase the
performance? |
New shelf package,
New compressor or LN2
refrigeration unit
LN2
booster
New vacuum pump
system |
|
Do you need to use other vial
sizes? |
New shelf package with other
interdistances |
|
Do you need to increase
product and operator protection, increase contamination
prevention? |
ALUS® Automatic Loading and
Unloading System |
|
Does the supply of spare parts
for an older control system has become a problem? |
Upgrading to Siemens S7 or
Rockwell ControLogix |
|
Do you need to comply to 21
CFR Part 11 |
Upgrading to Siemens S7 or
Rockwell ControLogix Implementation of WinCC, InTouch or iFix for
SCADA |
|
Re-Validation
|
IQ/OQ Documentation and
execution
support |
GEA
Lyophil offers retrofits of our own and of non GEA Lyophil freeze dryers. Our
experts start with a thorough examination of the current situation and your
specific needs. Based on our long experience in the freeze drying business, we
are able to offer customer-specific
solutions. That way you are able to
meet your production goals with the existing equipment and be competitive for
some more years. Of course all changes will be fully documented according to
GMP.
Do you like some more information? Do you like to check what would
be feasible for your freeze dryer? Our experts will be ready to propose your
specific retrofit solution. Please click on the contact box to the right.