Flexboy® 2D Pre-Designed Solutions for Storage Best Performance, Assurance of Supply and Single Use System Integrity for All Process Steps

Table of Contents Please click on the headline to go to the selected page Digital Selection Map Please click on the box to select the right solution with the right connection for your process step Sterile Weld to Biostat STR® and RM Single-use Bioreactors Media Formulation Buffer Formulation Sterile Connection Sterile Weld Steaming Connection to Stainless Steel Bioreactors Sterile Connection to other Single-use Bioreactors Cell Harvest & Downstream Intermediates Drug Substance Purification Drug Product Formulation Sterile Connection to Downstream Systems Sterile Connection Sanitary or Aseptic...

Drug Substance Drug Product Back to Table of Content Unprecedented Performance and Assurance of Supply Flexboy® 2D Storage Solutions for All Process Steps Drug Product Formulation Building on more than 20 years of experience in designing Single-use Fluid Management Solutions, we have established proven Pre Designed Solutions (PDS) for every media, buffer, harvest & downstream intermediates, drug substance and drug product process steps. The performance and assurance of supply of Flexboy® PDS are based on the complete control of our manufacturing process for the resins, the film, the bags, the...

Drug Substance Drug Product Back to Table of Content Material Science and Film Extrusion Expertise The S71 EVA film of Flexboy® 2D bags is the result of combining material science and film extrusion expertise in collaboration with our resin suppliers and film partner. Such partnerships ensure a full under tanding of the resins formulation s and the film manufaturing process. Following the principles of QbD, we have selected the raw materials to achieve best quality attributes and superior assurance of supply. We have established the resin specification, extrusion design space and process controls...

Drug Substance Drug Product Back to Table of Content Control of the Entire Manufacturing Process Assurance of Supply Long-term supply contracts and quality agreements with suppliers and partners guarantee the traceability and control of the raw material and the film formulation. The control of the entire manufacturing process provides consistent quality, change control and business continuity. Proven Robustness The strength and flexibility of Flexboy® bags make them robust and suitable for all process steps. Combining material science and film expertize in partnership with our suppliers, we have...

Drug Substance Drug Product Back to Table of Content Assurance of Quality Supply for Fluid-Contact Components Component Quality, Change Control and Business Continuity Critical fluid-contact components used for Flexboy® PDS are secured by long term contracts and quality agreements to offer the best assurance of supply. Critical fluid-contact components are also available off-the-shelf to offer the best delivery reliability. Material Qualification Flexboy® PDS components are evaluated for conformity against the EP and USP standards after reviewing technical documentation and certificates of quality...

Drug Substance Drug Product Back to Table of Content Validation and Quality Assurance Flexboy® PDS are qualified against extensive biological, chemical, physical, extractable and cell growth testing to provide reliable validation data applicable to a wide range of process conditions. For the most critical drug product process step bioburden, sub-visible particulates and endotoxin testing is performed on actual product samples for every production batch. Sartorius Quality Systems for single-use products follow applicable ISO 9001 and FDA regulations and ISO 13485 for Medical Devices. Because single-use...

Drug Substance Drug Product Back to Table of Content Validation and Quality Assurance Media, Buffer, Harvest & Downstream Intermediates Drug Substance Weekly testing of bioburden, particles and endotoxin on representative sample Drug Product ¹ Lot release testing of bioburden, particles and endotoxin on actual product sample ¹ None of the Flexboy® PDS for Drug Product are yet released on the basis of a lot release testing Certificate of Release Statement Particles Prevention Program USP Class VI USP<87> and ISO 10993: Biological reactivity tests, in Vitro USP<88>: Biological reactivity tests,...

Drug Substance Drug Product Back to Table of Content Assurance of Container Single Use System Integrity The assurance of container Single Use System Integrity of Flexboy® 2D bags is proven along the entire product life cycle. Quality by design principles, process qualification, process control and quality control first ensure integrity of the film, the welds and the bag chamber. A 100% bag chamber leak test is then performed in-process before line assembly for all Flexboy® 2D bags. In addition, and upon request we have developped a Supplier Integrity Test (SIT) for the complete bag and line assemblies...

Filtration & Storage for All Process Steps Filling and draining lines EVA and Clear C-Flex® tube EVA and Silicone Tuflux® tube Outlet Sterile Connections Opta® SFT male C-Flex® tube for sterile weld with Biowelder® TC Silicone Tuflux® tube for sterile disconnection with Clipster® STCII Steamthru™ valve Sampling Clave needleless sampling port Outlet Sanitary or Aseptic Connections CPC Quick coupler male Tri-Clamp Drug Substance EVA tube for sterile weld with Vante™ sealer Drug Product Back to Table of Content Inlet Filters Sartopore® 2 0.45 | 0.2 μm Sartopore® 2 XLG 0.8 | 0.2 μm Sartopore® 2 XLM...

Inlet Filters and Connectors Flexboy® 2D PDS are available with four sterilizing filtration options. Sartopore® 2 sterilizing-grade filter with 0.45 | 0.2 μm membranes optimized for buffer filtration Sartopore® 2 XLG sterilizing-grade filter with 0.8 | 0.2 μm membranes optimized for media filtration, cell harvest & downstream intermediates Sartopore® 2 XLM filter with advanced 0.2 | 0.1 μm pore size distribution and asymmetric prefilter membrane optimized for mycoplasma retention in media Sartopore® Platinum sterilizing-grade filter with 0.45 | 0.2 μm membranes optimized for drug substance and...