Top 3 Single Use Mixing and Shaking Technologies for GMP Biotech including Resin Slurry Prep
Blending Single-use mixing for buffer prep, media prep, bioreactors, vaccine mixing and production, resin slurry blending, and makeup are widely utilized in biopharma manufacturing. What technologies are efficient, sanitary, and suitable for GMP mixing and blending.
SINGLE-USE MIXING AND BLENDING
Traditional mix tank systems for blending buffers, media, and bioreactors have included 316L stainless steel sanitary tanks, with top entry biopharma-ready mixers or agitators. After running a batch, clients would CIP clean in place the system, nitrogen purge to dry, and then run another batch. CIP requires utilities, cleaning and rinsing agents, and effluent treatment, so it can be quite costly. With single-use mixing systems, you can dispose of the single-use mixing bag or the single-use carboy after the batch is complete. (USP VI PP, or ply vessel carboy for blending, is very popular).
Some of the standard technologies for single-use mixing are:
TOP ENTRY SINGLE-USE MIXERS
For carboys, a top entry mixer is used with an autoclavable design, so the motor/drive quickly detaches from the in-tank components via tri clamp connection. The drive is re-used. The remainder of the system can then be disposed of or cleaned/sterilized for re-use. Top entry mixers can be scaled up or down to handle small liter batches to several thousand liters of mixtures. Systems are available for manual cleaning or COP clean out of place, autoclaving, CIP, gamma radiated and sterile packaged, completely single use, customized to suit, etc.
ORBITAL SHAKERS FOR BIOTECH
Shakers are ideal and can utilize single-use bags to provide efficient and robust mixing uniformity without any intrusion of mixing impellers or without having to use custom mixing bags. Complete systems are available, including ISO manufacturing, UL listing, CE certifications, IQ and OQ documentation packages, FATs on-site for equipment inspection, SATs at the plant site for startup assistance, and complete automated PLC systems to meet your exact needs. Orbital shakers are used for gentle (low shear) circular swirling action for mixing buffers, salts, proteins, blending in protein purification, tissue culture work, vaccine production, and general mixing procedures.
Large capacity orbital shakers
Large capacity orbital shakers can be used for any application that typically suits a top entry stirrer or agitator. Scaling up and down is very predictable. Large-capacity orbital shakers are different because they can handle large mixing applications. They are perfect when you do not want a stirrer (magnetic or shaft-driven propeller or mix impeller) in the material you need to mix or if you need to avoid propeller/impeller blade shear stress.
Orbital Shaking Systems can be used for many size applications, including small benchtop and large volume chromatography resin re-suspension, slurry resin makeup and prep, protein expression, protein purification, cell culture, fermentation, yeast propagation, blending in small and large single-use bags, thawing or product, and any liquid to liquid mixing, or solids dissolving into liquid type applications.
Environmentally Enclosed Orbital Shakers can incorporate temperature-controlled (heating and cooling) enclosures that can be used for large incubating applications, pharmaceutical thawing applications, or any application where you need to mix materials in a controlled environment.
Many different types of sensors are available, from temperature sensors to CO2 sensors, humidity sensors, and more.
Mixing system certifications ISO manufacturing plant, UL listing and stamp, CSA for Canada, CE for Europe.
Hazardous location ratings, PLC automation, and we offer IQ, OQ, FATs, and SATs.
So two excellent options for single-use mixing and blending are top entry mixers or orbital shakers. Both can be very effective.