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Repower your production

Enhance the performance of your LYO and loading/unloading systems, remove obsolescence, extend their lifespan, and achieve environmental and cGMP compliance with a comprehensive set of upgrade services covering machine componentry, refrigeration and vacuum technologies, equipment controls, and all other ancillary systems.

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COMPLIANCE DATA INTEGRITY LOADING & UNLOADING SYSTEM SUSTAINABILITY RELIABILITY ANNEX I CONTROL SYSTEM PERFORMANCE
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  • Compliance
  • Data Integrity
  • ANNEX I
  • Reliability
  • Sustain Ability
  • Loading & Unloading
  • Control System
  • Perfor Mance

Ensure compliance with the latest requirements and regulations.

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.

Service Products

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

  • 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

Add new features to your SCADA system.

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.

Service Products

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

  • 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

Compliance.

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.

 

Service Products

  • 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.
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Value and benefits

  • 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

Renew your equipment to avoid obsolescence.

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.

Service Products

  • 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)
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Value and benefits

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

     

Reduce the impact on the environment.

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.

Service Products

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

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

The LYO-ReGen package refers to a complete upgrade program for loading and unloading systems for freeze dryers that allows for:

– 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.

Service Products

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

 

Value and benefits

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

Get the updated SCADA interface to back up your data.

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. 

Service Products

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

  • 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

Restoration or improvement of the original performance.

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.

Service Products

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

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