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.