The Benefits of Single-Use Solutions for Fluid Management in the Pharmaceutical Industry
Monday, February 06, 2023
The fluid management within biopharma has changed significantly over the past few years. Biopharmaceutical companies' manufacturing and supply chain divisions are experiencing significant changes due to advances in life science and healthcare adaptations.
FREMONT, CA: Biopharma fluid management has significantly transformed in recent years. Biopharmaceutical business manufacturing and supply chain divisions are undergoing a substantial paradigm shift due to life science developments and corresponding healthcare adjustments.
Innovative therapeutics such as gene and cell therapies (CGT) necessitate fundamentally novel approaches to drug manufacturing, as the supply chains frequently begin and end at the patient, as opposed to the distribution network in conventional pharmaceuticals. These business concepts are not easily scalable during commercialization on a larger scale. Collaborations bolster the sector with businesses that provide scalable solutions for workflow obstacles.
When to encounter fluid management systems in the biopharmaceutical industry
Since most stages involve liquids, such as feed media, buffer solutions, cell extracts, and product fractions, biotech businesses' manufacturing divisions are heavily involved with fluid management systems.
Process engineers distinguish between "greenfield" needs for fluid management, in which there are no strict limits in the process architecture, and "established plant floor" requirements, in which existing equipment specifies the process layout's boundary conditions. In the latter scenario, single-use equipment permits greater adaptability.
For instance, a facility that produces seasonal vaccines must frequently implement fresh operations. At such facilities with many manufacturing cycles, single-use systems can take advantage of their greatest benefits: the absence of cross-contamination hazards and cleaning or sterilization stages along the fluid path.
Process simulations aid in determining the flow diagrams, flow volumes, and daily and long-term storage requirements for the liquids involved.
The materials engaged in fluid transfer must possess the necessary mechanical and chemical properties, such as flexibility, durability, and solvent compatibility, to reduce the danger of leakage. In addition, they must be biocompatible and compliant with regulatory standards. Silicone, thermoplastic elastomers, and polytetrafluoroethylene (PTFE) are used to construct single-use equipment.
Challenges for liquid management systems
In biopharmaceutical production processes, liquid control systems' problems extend beyond meeting process logistics requirements. Regulatory authorities' stringent requirements must be met for biopharmaceutical goods to be safe. Biomanufacturing procedures are typically carried out in sterile or aseptic circumstances to reach bioburden levels that comply with the respective criteria, which is a fundamental aspect of current good manufacturing practice (cGMP).
Traditional procedures employing stainless steel pipes necessitate cleaning and sterilization operations (e.g., clean in place or sterilize in place) and corresponding validation before contact with process liquids. As a result, scalability and cost-effectiveness are restricted, as resources (labor, time, plant footprint) are tied to these phases.
Advantages of fluid handling with single-use systems for meeting high needs
There are various advantages to fluid handling with modern single-use systems, such as the rapid and precise movement of liquids between manifolds. Sterile connectors and tubing permit the transfer of fluid intermediates into single-use storage bags under sterile conditions without requiring SIP procedures. Innovative products, such as Single Use Support's IRIS single-use assemblies, provide highly flexible, easily scalable manifold solutions suited to the customer's needs in ISO 6 clean rooms and comprise sterilized components that comply with FDA, ISO, and other regulatory requirements. Single Use Support's RoSS.FILL technology, which allows for the scalable filling of single-use bags, is the ideal complement to IRIS's sterile consumables.
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