Top 3 Single Use Mixing and Shaking Technologies for GMP Biotech Blending
Single use mixing for buffer prep, media prep, bioreactors, vaccine mixing and production, resin slurry blending and make up, is widely utilized in the biopharma manufacturing world. What technologies are efficient, sanitary, and suitable for GMP mixing and blending.
SINGLE USE MIXING AND BLENDING
Traditional mixtank systems for blending of 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 treatment of effluent so can be quite costly. With single use mixing systems, after the batch is complete you can dispose of the mixing bag (single use bag) or dispose of the single use carboy (USP VI PP carboy for blending is very popular) or poly vessel.
Some of the typical 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 detach from the in tank components via tri clamp connection. The drive is re-used, and the remainder of the system can be disposed of, or cleaned/sterilized for re-use if desired. Top entry mixers can be scaled down and scaled up effectively 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
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 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 can be used for any application a top entry stirrer or agitator is used for and scale up and scale down is very predictable.
What differentiates large capacity orbital shakers are the ability to handle large mixing applications where you do not want a stirrer (magnetic or shaft-driven propeller or mix impeller) into the material you need to mix or if you need to avoid propeller/impeller blade shear stress.
Orbital Shaking Systems can be used for small benchtop and large volume chromatography resin re-suspension, slurry resin makup 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.
Environmental enclosures
Shakers can incorporate temperature-controlled (heating and cooling) enclosures for orbital shakers, these enclosures can be used for large incubating applications, pharmaceutical thawing applications, or any application where you need to mix materials in a controlled environment.
Sensors
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 very good options for single use mixing and blending are top entry mixers, or orbital shakers, and both can be very effective.
