Lyophilization Technology Demonstration Facility

 

 

LyoHUB MISSION: The goal of the Advanced Lyophilization Technology Hub (LyoHub) is to advance the science and technology of freeze-drying/ lyophilization. LyoHub’s members include companies in the pharmaceutical and food processing sectors, equipment manufacturers and university researchers, who combine their expertise and resources to accomplish the goal. Immediate objectives are:  (i) to identify and disseminate Best Practices for lyophilization equipment performance, testing and validation and (ii) to conduct applied research to advance lyophilization processes and products.

 

In February 2016, LyoHUB opened the Lyophilization Technology Demonstration Facility located in the Birck Nanotechnology Center at Purdue Discovery Park. The facility, where collaboration on breakthrough technologies can be advanced with a goal of accelerating adoption and decreasing time to market, is equipped and supported by LyoHUB’s industry members. The facility also offers various hands-on training opportunities for academic and industry users.

 

The facility, located in BRK 2261, includes an 800 square foot laboratory space and auxilliary utilities corridor. This facility is a new recharge center in Birck Nanotechnology Center’s Biocore cluster and is being used for lyophilization research, development and pilot demonstration projects.

 

EQUIPMENT AND CAPABILITIES:

The demo facility provides training and access to lyophilization and analytical tools as described below. 

 

Development/Pilot-Scale Freeze-Dryer/Lyophilizer REVO by Millrock Tech

• 4 shelves (1 ft x 2 ft) with a total area of 0.74 m² 
• -45°C to +65°C shelf temperature range
• Hydraulic stoppering
• 6’’ chamber to condenser vapor duct
• 30L -85°C ice condenser
• FreezeBooster® controlled nucleation
• 16 Type-T thermocouples
• Heat flux sensors and LyoPAT® to determine vial heat transfer coefficient(Kv) and process design  
• Wireless product temperature monitoring
• Residual gas analyzer INFICON Transpector 200
• Electrical: 230V/1ph/60Hz/30A (-53°C)

 

Research & Development/Pilot-Scale Freeze-Dryer LYOSTAR^TM3 by FTS Systems/SP Scientific

• 3 shelves  with a total area of 0.4 m²
• -70°C to +60°C shelf temperature range
• Hydraulic stoppering
• 4’’ chamber to condenser vapor duct
• 30L -85°C ice condenser
• ControlLyo® controlled nucleation
• 16 Type-T thermocouples
• Two (2) 100 Ohm Resistance Temperature Detectors (RTDs) (i.e., for monitoring the shelf inlet and shelf outlet temperatures)
• Two (2) Capacitance Manometers (i.e. for monitoring vacuum in both the product and the condenser chambers)
• MTM® to determine vial heat transfer coefficient(Kv) and process design  
• Wireless product temperature monitoring
• Electrical: 230V/1ph/60Hz/40A

 

Development Freeze-Dryer/Lyophilizer MICROFD by Millrock Tech 

• Fast process setup and operation
• Simulates production/pilot lyos with just 19 vials using temperature controlled side walls
• LyoPAT-II to determine vial heat transfer coefficient(Kv) and process design  
• 8 Type-T thermocouples

 

Freeze-Drying Microscopy system by McCrone

• Optical microscope with digital camera for images and video
• Linkam FDCS196 / THMS350V vacuum stage 
• 130 °C/min maximum cooling rate under vacuum
• -196°C to 125°C temperature range

 

Sample preparation tools: analytical balances, micropipettes, high-purity excipients from Pfanstiehl.  

Equipment modifications can be made for specific projects.

 

Tools available on Website:

• LyoCalculator https://pharmahub.org/resources/lyocalculator
• Lyo Chamber Pressure Variation Calculator https://pharmahub.org/resources/pressurevar
• LyoHUB Best Practice Paper, Recommended Best Practices for Process Monitoring in Pharmaceutical Freeze Drying  http://link.springer.com/article/10.1208/s12249-017-0733-1

 

 

We are happy to assist with cost calculations for use of the LyoHUB Demonstration Facility.

Website: www.LyoHUB.org                                            Twitter: https://twitter.com/lyohub