Fill/Filtration-Freeze/Thaw

Advanced Fluid Management and Freeze/Thaw Logistics

Automated processes for aseptic fluid management and controlled cold chain management optimize manufacturing of drug substance to a large extent. Different drug substances have one necessity in common: control and reproducibility. cGMP-compliant single-use technologies enable standardization in critical process steps where a large technology gap exists in biopharmaceutical production.

Reduced product loss when handling single-use bioprocess containers, highly accurate and automated filtration and aliquotation and controlled freezing and thawing improve bioprocess steps for all modalities; increased cost-effectiveness, higher drug product quality, rapid performance and limitless scalability. 

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Scalable Single-Use Technologies for Biopharma Processes

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Primary Packaging

Single-use bag protections system with RoSS shell

Protect

Single-use aseptic bag filling machine RoSS.FILL

Filtration and Filling

Plate freezer Biopharma large scale with RoSS.pFTU

Freeze & Thaw

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Cold storage

Shipping drug substances in single-use bag containers safely with RoSS.SHIP

Ship, Track & Trace

Primary Packaging

IRIS Single-Use Bag (2D or 3D)

Store and ship anything from cell culture samples to large drug substance volumes reliably and on time. 2D or 3D single-use bioprocess containers in any size.

Single-use bioprocess container by Single Use Support

Protect

RoSS® Shell

With the RoSS Shell system, the sensitive single use bag is covered in 3D foam, which is held by a highly robust plastic frame. Bottom and top are made of stainless steel – ideal for the freezeing process and absolutely robust.

Single use bag protection for drug substances in bulk stream with RoSS shell by Single Use Support
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RoSS.KSET

Single use bags with a volume of less than 250ml are covered with a first layer of soft 3D foam which is complemented by an innovative and intuitive locking mechanism. Its robust stainless steel frame protects the single use bag during freezing and shipping.

Industry 4.0 biomanufacturing RoSS.KSET for CGT bag protection
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Filtration and Filling

RoSS.FILL Bag

With RoSS.FILL, the RoSS shell systems contained in the bag rack can be filled with a speed of up to 300 liters per hour in a fully automated manner. RoSS.FILL is compatible to all single use bags and bottles and can be scaled up by attaching multiple racks.

RoSS.FILL Bag - single use bag filling and draining system machine
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RoSS.FILL CGT

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

RoSS.FILL - aseptic single-use filling and draining system for Cell & Gene therapies
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RoSS.FILL Base

Fully automated filling & draining system. Up to 12 single use bags ranging from 50mL to 50L. Filling of 1000L 3D single use bags possible.

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Freeze & Thaw

Freeze Thaw Platform

The freeze & thaw system RoSS.pFTU is a fully automated and scalable plate-based freezing unit. Both economically and in terms of product stability we have reached the next level. The plate-based platform RoSS.pFTU Large Scale is completely adapted to RoSS shell system for a batch sizes of up to 400L and more.

RoSS.pFTU large-scale
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RoSS.pFTU Lab Scale

Controlled freezeing and thawing of small batches - more important than ever for cell & gene therapies and clinical studies! The plate-based freeze & thaw platform for labs RoSS.pFTU Lab Scale is the perfect solution for one or multiple single use bags of up to in total 10L. GMP-compliant computerized system optional.

Laboratory freezer RoSS.PFTU Lab Scale
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RoSS.pFTU Large Scale

Up to 400L of controlled freezing in the RoSS.pFTU large scale

RoSS.pFTU large-scale

Cold storage

RoSS.FRDG | Cold Storage

Ultra-Cold Storage for frozen drug substances in different sizes. RoSS.FRDG keeps the desired set point temperature down to -80°C.

Ultra-cold storage RoSS.FRDG

Ship, Track & Trace

RoSS.SHIP

RoSS.SHIP offers the your tailored solution for 100% protection from external mechanical influences for RoSS shell systems. Different possible sizes will fulfil your individualized need. With passive cooling, it maintains its ultracold temperatures for international shipments over multiple days. With its measurements it complies with international logistcis standards. Also monitoring temperature and tracking its location is no problem.

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More information

Single-use filtration systems impact on process integrity biopharma

Single-use filtration systems and their impact on process integrity for biopharma

The big names in the pharmaceutical industry are increasingly switching from immobile systems based on bulky stainless steel tankers to scalable single-use filtration systems. But why is this so?

Drug substance filling: manual versus automated systems

Streamlining drug substance filling with automated systems

Biotechs and CMOs alike are investing in novel bioprocessing approaches to meet the changing needs of a rapidly evolving market that requires bioprocessing approaches that will increase manufacturing supply chain flexibility and scalability. SUSupport can help – learn more!
 

Ice front growth speed in single-use bags

How to achieve scalable freezing & thawing of biopharmaceuticals

What do you need for scalable freezing of biopharmaceuticals in single-use bags? 
Check out our Scalability Guide.