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.
Some examples of changing requirements and the retrofit solutions:
| 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? |
1. New shelf package
2. New compressor or LN2 refrigeration unit
3. LN2 booster
4. 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.
Would 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.