The manufacture of biopharmaceuticals requires multiple operations in order to deliver a product of appropriate quality and potency to the patient. Operations such as fermentations and chromatography are technically complex requiring considerable understanding and control.
Throughout the process it is necessary to ensure either sterility or the control of disburden within process streams. Conditions that are commonly encountered within bioprocesses are conductive to the growth of microorganisms within process solutions. These solutions are often moderate with respect to temperature, pressure, acidity and osmolarity and in addition can contain carbon sources required for microbial growth.
Preventing contaminations within manufacturing process requires consideration to be given to many facets of facility design and operation. The operating philosophy of the facility can change the approach to contamination control. For example, a facility which is being operated "24/7" and in which equipment is adequately sized to maximize throughput can rapidly product being harvested from the bioreactor and minimize the risk of microbial contamination by reducing to a minimum the time product is being held in intermediate pool tanks. In cases where facilities are not being used so intensively a manufacturer might utilize sterile filtration in order to protect intermediate product pools from bioburden.
Sterilization filtration process
MS Experience in Sterilization Filtration & Bioburden Control
Sterile liquid, gas or effluent is often required in biological and pharmaceutical processing. Membrane filters are commonly used to validate to produce sterile fluid. Fluidsthat would be damaged by heat irradiation or chemical sterilization can be only sterilized by microfiltration using membrane filters. This method is commonly used for heat label pharmaceuticals and protein solutions in medicinal drug processing. Commonly filter with pore size 0.2um will effectively remove microorganisms. In processing of biologics viruses must be removed or inactivated, Nanofilter with smaller pore size of 20-50 nm is used. The smaller the pore size the lower the flow rate.
Membrane Solutions is able to supply a broad range of sterilizing-grade filter products that vary sufficiently in size. Design and materials of construction to satisfy the differences between these applications whether required in the laboratory, or in a GMP (Good Manufacturing Practices) manufacturing environment.
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Features-Benefits of MS Filters for Sterilization Filtration
Recommended MS® Products
MS® SteriPure PES Pleated Cartridge Filter is manufactured with advance hydrophilic, asymmetric polyethersulfone membranes. The PES membrane provides accurate particle cut-offs and is compatible with a broad range of chemicals.
MS® PolyPure Cartridge Filter is constructed of micro polypropylene and ideally suited for removing agglomerated particles and gels. Deep, wide pleats for long service life and construction optimized for consistent performance under variation in flow.
MS® capsule filters are designed for critical, small volume filter applications in the coatings, fine chemicals, pharmaceuticals and microelectronics markets. They contain pleated, absolute-rated, filter media providing excellent retention of particles at fast flow rates. The all polypropylene construction offers superior chemical resistance and durability in demanding process applications.