Freeze-Drying

Apply LYO-ReGen to your freeze dryer to ensure compliance with the latest and most stringent regulations. Improve the environmental performance and protection of your equipment and increase productivity through sequential cycling cycles and customization of loading and unloading systems.

• Recipe versioning
• SQL reporting
• Autowithin
• Instruments redundancy
• Control system SCADA
• Control system SCADA & PLC
• Safety device/interlocks
• Non acqueous solvent
• Refrigerant retrofit

• CRF 21 compliance
• Data integrity and cyber security
• Reduce operator intervention
• Reduce equipment downtime
• Fit the reports generated by equipment’s SCADA
• Enhance process robustness and data collection recording
• Enhanced compliance with the most recent requirements for open product handling as per Annex I
• Enhanced compliance with the current environmental and safety regulations

Upgrade your machine with new features that are only available in the “new generation” of freeze dryers. Control and optimize all production phases by connecting to the plant database.

• SQL reporting
• Integration in domain
• Instruments redundancy
• SCADA redundant architecture
• OSI  PI – WERUM – MES system

• Continuous Data collection
• Ehnanced uptime
• Batch Report can be generated again at a later time from SQL database,
with indication COPY as water mark
• System under customer IT policy

Be ahead of the curve and ensure full compliance with the new Annex I requirements by upgrading the control system, critical instrumentation, and lyophilizer loading and unloading systems to meet the latest and most stringent environmental control standards and regulatory expectations.

• Instruments redundancy
• Control System upgrades
• Fully automatic Water Intrusion Test for sterilizing filters
• Continuous automatic monitoring and alarming of the sterile boundary of the lyophilization process
• Cycle queuing to enable the fully automatic unattended execution of all service cycles (defrosting, CIP/SIP, Filter integrity test and Unit leak test)  to minimize equipment downtime between two consecutive manufacturing cycles while meeting the most recent GMP best practices.
• Unique batch report for freeze drying and services cycles
• Upgrade of the loading/unloading systems (from fully manual to enclosed and ventilated semi- or fully automatic loading/unloading systems) and implement physical barrier technologies around your unsealed containers to support the achievement of Grade A conditions throughout the handling of the partially closed/unsealed containers.

• Enhance your Aseptic process robustness by minimizing the risk of biological
contamination at this crucial step of your aseptic processes
• Automate parts of the handling to minimize equipment/Operator interactions
• Achieve full compliance to Annex I’s requirements and most recent GMP best practices with a reduced capital investment and downtime

The LYO-ReGen package makes it possible to upgrade any machine and eliminate the risk of obsolescence of old components by improving performance or adding features that are only available in “new generation” equipment.

• Mycom
• Cumulus
• Hydraulic power unit & cylinder Control system
• Pneumatic valve manifold from pressure switch to pressure trasmitter
• Vacuum pump (oil or GV to GXS)
• Refrigerant retrofit
• ETV (sporlan to danfoss)

• Reduce unexpected equipment failure
• Improve troubleshooting capability
• Predict downtime due obsolescence of failing items
• Reduce Global warming potential impact
• Customize the stoppering pressure based on vials size 

LYO-ReGen reduces energy consumption and limits the impact on the greenhouse effect. If you use non-aqueous solvents, it also helps with liquid separation and waste management.

• Cumulus
• Refrigeration leak detector
• Safetherm HX
• Non acqueous solvent
• Refrigerant retrofit

Reduce environment impact
Immediately detect leakage
Comply with E&S regulation
Prepare for new technology product

– Upgrading existing control systems (PLC and SCADA) to meet the latest requirements and make use of the latest technologies.
– Machine upgrades that eliminate the risk of obsolescence of old components, improve performance, and add features only available in “new generation” equipment.
Improved GMP solutions for existing loading and unloading operations between existing filling and capping equipment and existing freeze dryers.
– Introduction of the latest EM equipment and improved ergonomics and monitoring of RABS access on existing equipment.

The same LYO service products are applicable to the vial loading and unloading systems. However, the following specific features exclusively apply to the vial loading and unloading systems LYO-ReGen package:

Reliability:
• Components (motors, drivers, gearboxes and sensors,
E-cabinet)
• Mechanical disconnect between infeed starwheel and conveyor
• Laser safety scanner
• Laser distance measurement

Performance:
• Mechanical disconnect between infeed starwheel and conveyor
• Laser safety scanner
• Laser distance measurement

Annex 1:
• Semi-Automatic solutions between existing equipment
• Reduced operator activities during loading and unloading of LYO
Optimize Grade A path
• Improved RABS access
• Latest EM devices

Same value and benefits as the freeze dryers. See all benefits listed in the other categories.

The LYO-ReGen package includes a complete update of the control system. The freeze dryer is upgraded to take advantage of the new recipe version management and SQL-based report generation features, as well as all the additional features typical of the “new generation” LYO. Plus, you’ll never again have to worry about potential hardware failures causing a “gap” in automatic cycle reports. 

• Virtualization
• SQL reporting
• Integration in domain
• Full control system upgrade
• Redundant architecture
• Multiple freeze dryers
• Stratus server

• ANNEX I compliance
• Batch report can be generated again at a later time from SQL database, with indication COPY as water mark
• Process data for data table and chart(s)
• Alarm filtering for audit trail
• Continuous data collection
• Ehnanced uptime
• Disaster recovery & business continuity
• System under customer IT policy

LYO-ReGen is the upgrade program that allows you to improve the efficiency of your equipment and bring it back to its original performance. It shortens production cycles by automating filter testing and incorporating it into sequential cycles.

• Mycom (from bitzer)
• Cumulus
• Autowithin
• Refrigerant retrofit
• ETV upgrade

• Enhance performance
• Enhance reliability
• Improve equipment up time
• Comply with E&S regulation