Fill & Finish

The final step in biopharmaceutical manufacturing is known as aseptic Fill & Finish. The final drug product is filled into vials, (pre-filled) syringes or single-use bags before it is ready for its distribution globally.

At this stage the liquid product is of the greatest value and this is one of the most critical steps. Any product that is contaminated or packaged incorrectly can result in safety issues, production failure and loss of valuable product. Therefore, maintaining sterility and quality of the final drug product is of utmost importance. 

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Single-Use Technologies

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Mostly fully automated and highly sensitive processes are used for efficient product formulation and filling into vials and syringes. Prior to final filling at the Fill & Finish site, single-use applications ensure the safe and sterile receipt of drug products at frozen or cooled state. Various single-use technologies come into play for reliable biopharmaceuticals handling:

  • Controlled Thawing to secure highest product quality and stability
  • Refrigerators to store frozen drug substances at highest storage density
  • Shaking Applications to restore optimal homogeneity
  • Automated Draining of drug products from single-use bioprocess containers
  • Single-Use Assemblies to safeguard smooth fluid flow

Products

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RoSS.pFTU Mid-Scale

Our mid scale freezer is a plate-based Freeze/Thaw unit designed for RoSS shells, to protect your preferred single-use bag during cryogenic applications. 

RoSS.pFTU mid scale is compatible with single-use bioprocess containers of all sizes and manufacturers and shows best product stability results for your biopharmaceuticals up to 70L. 

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RoSS.DRAI

Drain your single use bags at Fill & Finish site. This standalone draining rack enable controlled fluid flow while draining single-use bags. Connected peristaltic pumps enable lowest holdup volume. Multiple racks can be attached for simultaneous and continuous pooling thanks to inclination of all shelves. All disconnection types possible.

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ROSS.SHAK | Shaker

RoSS.SHAK is your reliable shaker to regain highest quality and homogeneity of your biopharmaceuticals.

RoSS.SHAK enables constant shaking of your protein to regain homogeneity and product quality after freezing. Shakes up to 70L per run in 3 pre-defined speeds.

Customized single-use assemblies

No matter if upon customized request or off-the-shelf, single-use assemblies can be assembled to ensure tailored fluid flow. Also at Fill & Finish production lines the product undergoes different process steps during fluid management, be it in isolators, filters, shakers or other final process steps. For small scale fill finish pre-filled syringes can be attached to the sterilized assembly. Single Use Support helps you to build your single-use assembly by means of its online configurator or direct inquries.

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