Case Study Request

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Case Studies

01. Using AdvantaSil™ High Pressure Unreinforced Silicone Tubing for Bulk Fluid Transfer

The objective of this study was to identify tubing that would minimize the time required for fluid transfer by maximizing flow rate. The capability of the tubing to withstand pumping flow rates between 5 to 50 LPM and resultant changes in pressure drop until point of failure (tubing collapse) at the suction line was studied.

This case study describes the performance of AdvantaSil High Pressure Unreinforced Silicone Tubing (APHP) used in a Monoclonal Antibody process for the transfer of buffers in purification.

02. AdvantaPass® Cleanroom Portal for Aseptic Fluid Transfer

The aseptic transfer of liquids between two areas of different grade classification poses a challenge in Single-Use facility design and operation. The main objective of the customer was to quickly transfer fluid from one area to another while minimizing the risk of contamination. In addition, the customer was looking to maximize efficiency and reduce operator error.

This case study describes the implementation of the AdvantaPass® Cleanroom Wall Pass-Through System used to aseptically transfer fluid between areas of different grade classification in a fully Single-Use cGMP facility.

03. AdvantaPure BioClosure® System for Drug Substance Filling and Storage

The are many different approaches to filling and storage of protein bulk drug substance in biologics production. The primary objective of the customer was to develop a closed system that was leak proof under operating conditions and maintained container closure integrity during storage at -70°C. Additionally, the customer was concerned about foaming that occurred when filling the container. AdvantaPure’s engineering team worked with the customer to design a custom system for their production needs.

This case study illustrates the performance of AdvantaPure’s custom BioClosure systems for bulk drug substance.

04. AdvantaPure Molded Assemblies for Final Filling

In Single-Use design and implementation, integrity and robustness of the system are critically important in assessing risk, especially where no sterile filtration is possible as part of the processing step.

This case study describes the design and implementation of a custom AdvantaPure molded filling assembly used in final fill.

 


 

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