Robust Storage and Shipping of bulk drug substance in single use bags

• Single use bag covered in 3D foam, protected in robust frame and stainless steel lids for consistent and quickest possible freezing and defrosting times
• Single Use Bag independent: any size, any supplier
• Product loss towards 0%
• Highest achievable storage density to reduce required freezer space capacity
• Freedom and space to use sterile connectors, long hoses, satellite samples
• Scalable platform for single use bags
   

Robust Storage and Shipping of bulk drug substance in bottles

• Bottlenecks incl. attached connectors are covered and immobilized in 3D foam and protected by a PE shell
• Bottle independent: any size, any supplier
• Product loss towards 0%
• Freedom and space to use sterile connectors, long hoses or other
• Scalable platform for single use bags
   

Fully automated system for filling, draining and filtration of drug substance into single use bags and bottles

• Filling of up to 10 liters of drug substance in less than 1 hour
• Filling of one or multiple single use bags, bottles and vials ranging from 30ml to 10l
• Highest possible filling accuracy with individual weighing cells
• Modular system with separate control unit and pumping station
• Option to take samples

Fully automated system for filling, draining and filtration of multiple small single use bags in cell & gene therapies at highest accuracy.

• Filling of up to 36 small single use bags per rack
• Filling of any single use bags ranging from 10mL to 1000mL
• Highest possible filling accuracy
• Modular system with separate control unit and pumping station
• Fully GMP-compliant
• Option to take samples

Fully automated system for filling, draining and filtration of drug substance into single use bags

• Filling of up to 200L of substance at highest throughput speed – variable depending on bag size and individual preferences
• Filling of any single use bags ranging up to 20L
• Highest possible filling accuracy with individual weighing cells per bag
• Modular system with separate control unit and pumping station
• Option to take samples

Fully automated system for filling, draining and filtration of drug substance into single use bags for bulk drug substance.

• Used for filling of single use bags for bulk drug substance, protected by SUS RoSS shells
• Contains 1 control unit + 1 valve tower with one floor scale for bags and/or bottles
• Up to 12 single use bags ranging from 50mL to 50L. Filling of 1000l
• 3D single use bags possible.
• Optional MES integration

Fully automated system for filling, draining and filtration of drug substance into single use bags

• Filling of up to 200 litres of substance in less than 1 hour – variable depending on bag size and individual preferences
• Filling of any single use bags ranging from 10ml to 20l
• Highest possible filling accuracy with individual weighing cells
• Modular system with separate control unit and pumping station
• Option to take samples

The plate-based freeze/thaw platform is completely adapted to the RoSS Shell System

• Freeze/thaw unit adapted to RoSS shells, protecting your preferred bag
• Single Use Bag independent: any size up to 5l, any supplier
• At highest possible freezing velocity & accuracy
• Best product stability results
• Scale-up: freeze/thaw recipe for lab scale also transferable for large scale
• Freezes down to -60°C – optionally to -80°C
  Rental option 
• Next level both, economically and in terms of product stability

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The plate-based freeze/thaw platform is completely adapted to the RoSS Shell System

• Freeze/thaw unit adapted to RoSS shells, protecting your preferred bag
• Single Use Bag independent: any size, any supplier
• At highest possible freezing velocity & accuracy
• Best product stability results
• Best product stability results
• Capacity of up to 5 bags of 20L, depending on bag size.
• Freezes down to -90°C

The plate-based freeze/thaw platform is completely adapted to the RoSS Shell System

• Freeze/thaw unit adapted to RoSS shells, protecting your preferred bag
• Single Use Bag independent: any size, any supplier
• At highest possible freezing velocity & accuracy
• Best product stability results
• Scale-up to 200l per batch with different sizes of single use bags
• Freezes down to -90°C
• Next level both, economically and in terms of product stability

The hybrid plate-based freeze/thaw platform RoSS.pFTU Large Scale is suitable for both, single use bags and bottles.

• Freeze/thaw unit for up to 21 bottles of 4L per batch run
• Bottle independent: any size, any supplier
• At highest possible freezing velocity & accuracy
• Best product stability results
• Scale-up to 67L per batch with different sizes up to 4L bottles
• Freezes down to -90°C
• Next level both, economically and in terms of product stability

100% protection from external mechanical influences during shipping

• Keeps low temperature for shipping for up to 6 days
• For all drug substance primary packages
• Complies with international logistics standards
• GPS/G-Force for monitoring temperature and tracking its geographical location at all times

100% protection from external mechanical influences during shipping

• Keeps low temperature for shipping for up to 8 days
• For all drug substance primary packages
• Complies with international logistics standards
• GPS/G-Force for monitoring temperature and tracking its geographical location at all times

SUS provides fully leverageable qualification services to its customers based on current GMP requirements. The standard service includes

• Specifications
• Technical documentation
• FAT/SAT.

Furthermore, installation and operational qualification packages including documentation and test execution are offered optionally and will be tailored to customer- and application-specific requirements. (More info in our FAQ sheet.