Subscribe to our Newsletters !!
Infections pose an everpresent threat to society a
Biotech Fluidics has introduced a durable dual sta
A new COVID-19 variant, BA.3.2, informally called
The sustained tensions between Iran and the United
For a number of years now, healthcare systems glob
Tofu used to be associated with Asian cuisine, but
Dear Readers, Welcome to a fresh and forward-lo
The importance of mixing systems in modern biopharmaceutical manufacturing is undeniable; they play a key role in managing sterility, ensuring the consistency of products, and aiding in the efficiency of manufacturing processes. As the industry rapidly shifts towards single-use technologies, mixer bag systems have emerged as a novel and dependable option for all upstream and downstream processes.
The biopharmaceutical and single-use disposable industries have engineered systems specifically designed for them by crafting these systems in cleanroom facilities (ISO Class 7 / ISO Class 8), where a high degree of quality is maintained for every aspect, from the selection of the initial materials to the fulfillment of the final product.
Single-use mixing systems play a vital role in:
Ensures the uniform dissolution of powdered nutrients in WFI, which is directly linked to improved cell growth and productivity.
Ensures precise and uniform mixing for the pH adjustment during cell culture and fermentation.
Guarantees the sterility and uninterrupted consistency of media preparation and storage.
Process & Fluid Transfer
Allows for safe and uncontaminated transfer of process liquids.
Mixer systems are also essential in:
Used in the purification steps to hold and mix intermediate bulk solutions.
Ensures consistent interaction between the product and the inactivation agents.
Mixing of APIs and excipients is done in a controlled and gentle manner to reduce shear stress and protein aggregation.
Ensures the mixture is homogeneous prior to sterile filling into vials or syringes.
These certifications provide assurance for the safety of materials, biocompatibility, and market clearance in compliance with global regulations.
Maintaining sterility and chemical compatibility is critical, and high-performance polymer components like silicone tubing, single-use assemblies, gaskets, and custom molded parts are crucial in achieving this.
Ami Polymer offers cutting-edge polymer solutions for the biopharmaceutical industry, enabling safe, scalable, and compliant mixing technologies.
By Sreedhar Chirra Assistant Manager (Business Development)
