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5 Ways to Optimize Your Bioprocess Results with Carboy Mixers

5 Ways to Optimize Your Bioprocess Results with Carboy Mixers

Biopharmaceutical Use,Pharmaceutical Use,Sanitary MixersNo Comments

At White Mountain Process (WMProcess), we understand that bioprocess optimization is at the forefront of achieving excellence in any biotechnological endeavor. One such way to ensure streamlined processes is by utilizing carboy mixers. These mixers play a crucial role in making processes like buffer prep, media prep, reagent and diagnostic blending, and product storage more efficient. Here are five ways to optimize your bioprocess results using carboy mixers:

1. Choose the Right Mixer for Your Needs

Different carboy mixers have diverse mixing abilities, which makes choosing the right one crucial. Direct drive mixers are ideal for light-duty low-viscosity mixing, while gear drive mixers are suited for heavy-duty mixing like resin slurry suspensions. By using the correct type of mixer, you can optimize your bioprocess by ensuring efficient mixing and preventing equipment damage, thereby saving time and resources. A variety of air and electric motors are also available to choose from.

2. Leverage the Benefits of Single-Use Systems

Consider using single-use carboy mixers to enhance productivity and reduce contamination risks by COP cleaning. Single-use systems are excellent for bioprocesses as they eliminate the need for cleaning and sterilizing, reducing turnaround time and increasing productivity. With single-use carboy mixers, you can also avoid cross-contamination, ensuring a higher purity level for your bioprocess.

3. Maximize Mixing Efficiency

Enhancing your mixing efficiency is a simple yet effective way to optimize your bioprocess. The primary way to achieve this is by determining the optimal mixing speed for your process and choosing the right impeller for the mixing service. With WMProcess’s carboy mixers, you can easily adjust the RPM (rotations per minute) to find the most efficient mixing speed. Efficient mixing ensures homogeneity and facilitates better cell growth and productivity.

4. Optimize Mixer Performance

The positioning of your carboy mixer can significantly impact the efficiency of your bioprocess. The mixer should be positioned to create a vortex in the carboy if you are adding solids that float. Mixers should never be undersized; having the ability to adjust speed and control the degree of agitation allows full-volume turnover, ensures complete mixing, and gives the ability to turn the speed down during pump out. Carboys have one mixer port, center-mounted, so a rectangular mixer acts as a baffled tank, where a round carboy has more swirling affect.

5. Monitor and Control Process Parameters

Process monitoring and control are crucial to the success of any bioprocess. This includes maintaining optimal temperature, pH, and dissolved oxygen levels. WMProcess’s carboy mixers can be equipped with sensors to monitor and control these parameters continuously. By doing so, you can ensure your bioprocess is always in the optimal range, improving the consistency and quality of your results. Carboys which are available in USP VI PP and FDA HDPE materials can be fitted with sanitary welded fitting for valves, vent filters, dip tubes, etc., tri clamp and quick disconnect sanitary connection are all available.

To sum up, carboy mixers are an integral part of bioprocess optimization. You can significantly enhance your bioprocess results by choosing the right mixer, leveraging the benefits of single-use systems, maximizing mixing efficiency, optimizing mixer positioning, and monitoring and controlling process parameters. Remember, the key to success in any bioprocess is having the right tools and knowing how to use them effectively.

With carboy mixers, you are one step closer to achieving bioprocess excellence.

The Best Sanitary Process Mixing Equipment for Biotech Blending Scalability

The Best Sanitary Process Mixing Equipment for Biotech Blending Scalability

Biopharmaceutical Use,Pharmaceutical Use,Sanitary MixersNo Comments

In the fast-paced world of biotech, sanitary blending processes are critical for producing high-quality pharmaceuticals, vaccines, and other life-saving products. Achieving consistent and uniform mixing and blending results is paramount to ensure product efficacy and safety. To meet the stringent demands of the biotech industry, choosing the right sanitary mixing equipment is crucial. In this blog, we’ll explore why WMProcess.com stands out as the go-to provider for top-of-the-line sanitary mixing equipment, enabling biotech companies to achieve exceptional blending process results.

1. Uncompromising Sanitary Standards:

In biotech applications, maintaining the highest sanitary standards is non-negotiable. WMProcess.com understands this critical aspect of biotech manufacturing and offers a range of mixing equipment that adheres to strict sanitary guidelines. Our equipment is designed to meet cGMP (current Good Manufacturing Practice) regulations, ensuring a contaminant-free and sterile blending environment. Most bioprocessing mixers would have 316L stainless steel wetted parts, with <20Ra polish and electropolish and passivation finish. USP VI elastomers such as EPDM, and PTFE are common. Exotic alloys include Hast C 276 wetted parts, AL6XN, and super duplex materials.

2. Customizable Solutions:

Each biotech blending process is unique, requiring tailored solutions to meet specific requirements. WMProcess.com offers a diverse portfolio of sanitary mixing equipment that can be customized to fit the needs of individual biotech companies. Whether it’s high-shear mixing, very dense resin slurry, emulsification, or powder dispersing into liquid, their expert team can design equipment that precisely matches the application’s parameters.

3. Cutting-Edge Technology:

Staying ahead in the biotech industry necessitates embracing the latest technological advancements. WMProcess.com offers cutting-edge sanitary mixing equipment with state-of-the-art features for mixing impellers, mechanical seals, and various motor drive options. Our equipment ensures optimal blending efficiency and product consistency, from advanced control systems to innovative blending techniques.

4. Optimal Efficiency and Scalability:

Biotech companies often deal with large-scale production, and their equipment must handle the workload. WMProcess.com’s sanitary mixing solutions are efficient at small volumes and easily scalable for high-volume production. This adaptability allows biotech manufacturers to increase production capacity without compromising blending quality.

5. Reliability and Durability:

Downtime is costly, both financially and in terms of production delays. WMProcess.com recognizes the importance of reliable equipment in biotech manufacturing. Our sanitary mixing equipment is built to last, using robust materials that can withstand the demands of continuous operation and harsh cleaning procedures.

6. Superior Customer Support:

Biotech companies require a responsive and knowledgeable support team that can address their concerns promptly. WMProcess.com prides itself on providing superior customer support, with experts available to assist clients throughout the equipment selection, installation, and maintenance processes.

Conclusion:

In the world of biotech blending, choosing the right sanitary mixing equipment is vital for achieving consistent and reliable results. WMProcess.com stands out as the leading provider of top-quality, customizable, and cutting-edge sanitary mixing solutions that meet the stringent requirements of the biotech industry. Our commitment to uncompromising sanitary standards, efficiency, scalability, and exceptional customer support makes us the go-to choice for biotech companies seeking optimal blending process results. To elevate your biotech blending operations to the next level, trust WMProcess.com as your partner in success.

5 Key Benefits of Sanitary Plastic Mixing Tanks for Biotech Manufacturing

5 Key Benefits of Sanitary Plastic Mixing Tanks for Biotech Manufacturing

Biopharmaceutical Use,Pharmaceutical Use,Plastic Agitator and Tank OptionsNo Comments

In the world of biotech manufacturing, the choice of equipment plays a crucial role in ensuring optimal production processes and product quality.

One such essential piece of equipment is the sanitary plastic mixing tank. These tanks offer numerous advantages over traditional alternatives, making them a preferred choice for biotech manufacturing facilities. In this blog, we will explore the top five benefits of using sanitary plastic mixing tanks in biotech manufacturing.

1. Superior Sanitary Standards:

Maintaining high sanitary standards is paramount in biotech manufacturing. Sanitary plastic mixing tanks are designed with this requirement in mind. Made from FDA-approved materials such as high-density polyethylene (HDPE) or polypropylene (PP), these tanks are inherently resistant to corrosion and microbial growth. Unlike metal tanks, plastic tanks do not rust or corrode, ensuring that no contaminants are introduced into the manufacturing process. Moreover, the smooth surface of sanitary plastic tanks prevents the accumulation of residue and facilitates easy cleaning, further reducing the risk of contamination.

2. Chemical Compatibility and Versatility:

Biotech manufacturing often involves working with a wide range of chemicals and compounds. Sanitary plastic mixing tanks offer excellent chemical compatibility, making them suitable for handling various substances without the risk of chemical reactions or degradation. Plastic tanks can be customized to meet specific requirements, including temperature resistance, UV protection, and resistance to specific chemicals. This versatility allows biotech manufacturers to choose the ideal tank material and design that best suits their unique needs.

3. Cost-Effective Solution:

Investing in sanitary plastic mixing tanks can provide significant cost savings for biotech manufacturing facilities. Plastic tanks are generally more affordable than their stainless steel counterparts, making them a cost-effective option for both startups and established biotech companies. Additionally, plastic tanks are lightweight and easier to install, reducing labor and transportation costs. Their durability and low maintenance requirements further contribute to long-term cost savings.

4. Excellent Thermal Insulation:

Temperature control is critical in biotech manufacturing processes. Sanitary plastic mixing tanks excel in this aspect by offering excellent thermal insulation. Compared to metal tanks, plastic tanks have lower thermal conductivity, which helps maintain consistent temperatures inside the tank. This feature is especially crucial when handling heat-sensitive biotech materials or conducting temperature-sensitive reactions. The superior insulation properties of plastic tanks reduce energy consumption and ensure precise temperature control, resulting in improved process efficiency.

5. Scalability and Flexibility:

Biotech manufacturing is often subject to changes in production volume and process requirements. Sanitary plastic mixing tanks offer excellent scalability and flexibility to accommodate such fluctuations. Plastic tanks can be easily resized or added to existing setups without the need for extensive modifications. Moreover, plastic tanks are lighter and easier to maneuver, allowing for seamless reconfiguration of the production floor layout as needed. This adaptability enables biotech manufacturers to scale their operations efficiently and respond to market demands with ease.

Conclusion:

Sanitary plastic mixing tanks provide a wide range of benefits for biotech manufacturing facilities. From ensuring superior sanitary standards to offering chemical compatibility, cost-effectiveness, thermal insulation, and scalability, these tanks are a reliable and versatile choice. Biotech companies can enhance their manufacturing processes, improve product quality, and optimize their operations by embracing the advantages of sanitary plastic mixing tanks. With their proven track record and numerous benefits, it’s no wonder that these tanks have become an indispensable tool in the biotech industry.

Single-Use Mixers – Benefits and Types of Mixing Systems For Bioprocess Applications

Single-Use Mixers – Benefits and Types of Mixing Systems For Bioprocess Applications

Biopharmaceutical Use,Bottom Entry Mixers,Pharmaceutical Use,Single Use Mixing OptionsNo Comments
single-use-mixers

Benefits of and Types of Single-Use Mixing

This is part one of a multi-part blog covering the benefits and types of single-use mixers for bioprocess applications.

Some advantages of using a single-use mixer include the following:

  • Single-use mixers tend to be user friendly
  • Decreased risk of cross-contamination
  • Smaller financial investment
  • Ends cleaning validation and sterilization concerns
  • Faster production times
  • Increased accuracy
  • Convenient and readily available storage
  • Reduction in personnel costs
  • Ready to use
  • Adjustable output
  • Elimination of the need for tank and impeller cleaning

Many significant benefits accompany the implementation of single-use mixing systems within the biological and pharmacology industries.

The development, testing, and manufacture of preparations such as vaccines, an array of specific cell cultures, pharmacological research, buffers formulation, and cell culture media prep require precise mixing.

Any process involving suspension, dissolution, dispersion, and homogenization depends upon accurate and thorough mixing. Incorporating single-use mixers into bio-therapeutic development and production ensures superior mixing and a more uniform end product.

There is a wide variety of single-use mixing systems on the market, most of which can be customized to address specific mixing needs.

Types of Single-Use Mixing Systems

Single-use mixers come in a wide range of designs. Both open and closed systems are standard, and each category offers several variations, each best suited for a specific type of application.

Sub-categories include:

SINGLE-USE BOTTOM-ENTRY MIXERS

Single-use mixers using traditional disposable bags with a bottom entry mixer design that is guaranteed not to shed or fail. There are no moving parts in this blender design which provides:

  • More uptime.
  • Zero chance of failure.
  • Reduced chance of particulate shedding, which can be an issue with traditional plastic mag mixer designs.

WMProcess bottom mount mixer design is a new innovative Single Use Mixing System. Because it uses a single-use pump head, this disposable blending equipment becomes a multi-purpose bioprocessing system for:

  • Single-use mixing of solutions by recirculation without rotating wetted mixer parts.
  • Integrated filling and emptying of the bag
  • Post-mixing processes like sterile filtration, TFF, flow through chromatography, and others
  • Optional integration of inline single-use sensors (including sensors for pH, conductivity, temperature, and UV)
  • Optional integration of a heat exchanger for cooling and heating the media
  • Excellent disposable mixing system for buffer, media, and sterile processing

Principle: the QuattroMix Single-Use Mixing System has an inlet and outlet port, which both are connected to a pumping device. The media will be pumped out of the bag through the outlet port, circulated through the pump (and other possible post-mixing processes), and pumped back into the bag through 16 nozzles with a smooth fluid stream.

WMP Mixing Bags are available from 10liters to 2000liters.

To be continued in part two.

Tri Clamp Sanitary Mixing Applications For Bioprocesses

Tri Clamp Sanitary Mixing Applications For Bioprocesses

Biopharmaceutical Use,How To Use,Sanitary MixersNo Comments
tri-clamp-mixer

Tri Clamp Mixers to mount to TC connections (mixer for Tri Clamp sanitary ferrule) are popular for sanitary mix tanks and biopharma mixing vessels.

White Mountain Process offers many small-footprint sanitary mixers for sealed tank applications.

We can fit a compact and ergonomic sanitary top entry agitator on a 1.5″ Tri Clamp (TC) connection for 5-100liter mixing tanks and up to 8″ Tri Clamp connection on the top entry blender for larger production tanks.

These stainless mixers are typically biopharma ready and include 316Lss polished wetted parts (typically to the 10-20Ra polish range), polished and electropolished impeller assembly (usually passivated in addition to EP), cGMP mixer mechanical seal, can be supplied with all stainless electric or air operated agitator motor, and have a Gold Standard documentation package with traceable certs on every component, and USP VI certs with o-rings for the mechanical seal.

WMP’s small footprint Tri Clamp mixers are available in 2″ -8″ TC connection ports. The seal can be a simple vapor-tight USP VI lip seal, a single dry-running mixer seal, or a more sophisticated double liquid or gas-purged agitator mechanical seal.

Typical applications for these tri-clamp mixers are buffer prep, media prep, vaccine production, salt/saline dissolving, resin slurry mixing for makeup before feeding chromatography columns, fermentation, cell culture, and other liquid or powder into liquid mixing and blending manufacturing steps at a facility.

Some of a typical sanitary mixer highlights are:

  • Mixer Wetted Surfaces: mixer shaft and impeller are typically 316Lss with polished and electropolished mixer-wetted parts
  • Non-Wetted: food grade epoxy painted mixer pedestal and motor/gearbox or all stainless steel housing and motor is available
  • Motor: all stainless electric and air motors, or steel IT painted motors for an economical solution
  • Sanitary Impellers: polished and electropolished impellers such as Hydrofoil, Hydroflow, Turbine, fabricated marine prop, multi-props, Teflon, mass flow impellers
  • Vessel Connection: Sanitary Tri-Clamp (TC ferrule), Flanged
  • Sanitary Single dry run mixer seal, Double Mechanical Seals, or FDA lip seal for low-pressure applications

Other options available

  • Variable speed mixer controller, Explosion proof motors available
  • RPM indication – mixer tachometer assemblies available
  • Quickly removable motor assembly for easy cleaning & autoclaving
  • Dual bearings low profile pedestal arrangement
  • Mixer Debris well for mechanical seal with NPT or tri-clamp flush connections
  • Various Elastomer selections for mechanical seals
  • Vessel tank mount, tri-clamp or flanged
  • Shaft sizes: 1/2″, 3/4″, 1″, and larger
  • In tank shaft coupling for split shaft (pool cue style mixer shaft)
  • Independent vessel mount system for glass and plastic mixing tanks

Please email us at sales@wmprocess.com with your process details. We can help size a mixer to fit your mixing needs.

Single-Use Mixing and Shaking Equipment for GMP-Biotech Resin Slurry Prep

Single-Use Mixing and Shaking Equipment for GMP-Biotech Resin Slurry Prep

Biopharmaceutical Use,Industrial Use,Pharmaceutical Use,Single Use Mixing Options,Top Entry MixersNo Comments

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.

Incubator Shakers

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.

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 excellent options for single-use mixing and blending are top entry mixers or orbital shakers. Both can be very effective.

Chromatography Resin Slurry Mixing & Blending for Biopharma

Chromatography Resin Slurry Mixing & Blending for Biopharma

Biopharmaceutical Use,Bottom Entry Mixers,Pharmaceutical Use,Sanitary Mixers,Stainless Steel Agitator and Tank Options,Top Entry MixersNo Comments
Single-Use Mixers – Benefits and Types of Mixing Systems For Bioprocess Applications
Biopharmaceutical Use,Bottom Entry Mixers,Pharmaceutical Use,Single Use Mixing Options

Single-Use Mixers – Benefits and Types of Mixing Systems For Bioprocess Applications

Many significant benefits accompany the implementation of single-use mixing systems within the biological and pharmacology industries. The development, testing, and manufacture of preparations such as vaccines, an array of specific cell cultures, pharmacological research, buffers formulation, and cell culture media prep require precise mixing.
How To Use a Carboy Mixer
Biopharmaceutical Use,Air Mixers,Bottom Entry Mixers,How To Use,Industrial Use,Plastic Agitator and Tank Options,Sanitary Mixers,Single Use Mixing Options,Stainless Steel Agitator and Tank Options,Top Entry Mixers

How To Use a Carboy Mixer

For those in the biopharmaceutical industry, handling the preparation of large volumes of solutions comes with its fair share of challenges. A seamless process is crucial to the quality of the end product, and that means ensuring homogeneous mixing and blending with zero contamination. A balance of sanitation and efficiency is key, especially when it […]
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The Benefits of Bottom Entry Mixers

The Benefits of Bottom Entry Mixers

Bottom Entry Mixers,Biopharmaceutical Use,Industrial Use,Sanitary MixersNo Comments
photo of Bottom entry mixer and top mount agitator
Photo of Bottom Entry Mixer and VFD

The Benefits of Bottom Entry Mixers over Top Entry Mixers from White Mountain Process

Southbridge, MA – White Mountain Process offers Bottom Entry Mixers that are ideally suited to mixing and blending applications in the pharmaceutical and beverage industries. The company offers standard mixers and agitators, which are bottom mounted to the tank via weld pad, ANSI flange, or TC tri clamp sanitary connection. Mixers are available in high flow/low shear blending designs, or bottom agitators are also available for high speed and high shear dissolving.

The benefits of Bottom Entry Mixers:

  • Low level mixing. The ability to mix to very low levels, and blend during drawdown and tank pump out.
  • Ease of installation. Very easy to install and simple to maintain the mixer drive/gearbox since it is at the bottom of the tank.
  • More efficient mixing. The design of a bottom entry mixer promotes uniform mixing of the batch that continues until the vessel is almost completely drained.
  • More available headroom. Top entry mixers can take up valuable room on the tank top. Bottom mount mixing design eliminates that issue.
  • Easier access for maintenance. Their low entry point makes them more accessible for maintenance. This also reduces safety concerns, which are always an issue when dismantling top entry mixers for maintenance and repair.
  • More efficient cleaning-in-place (CIP). Mixer design enables more efficient CIP than the cleaning process of the agitator and shaft associated with a top entry mixer. 
  • Bottom Entry Magnetic Drive Mixers are ideal for sanitary applications. The bottom mount sanitary magnetic mixer is a standard for sealless mixing and the elimination of a mechanical seal. A drive unit connected to the bottom of the tank is fitted with a magnet.  When the drive turns, it locks onto a magnet on the mixer impeller to make it turn. The impeller is mounted on a spindle that is welded to a mounting plate inside the tank. Because there is no breach of the tank wall in this design, there is no need for a seal and sterility is almost guaranteed.

Applications for the Use of Bottom Entry Mixers:

  • Buffer prep and Media prep
  • Dissolving of solids such as salts
  • Blending and dissolving difficult- to- wet powders and gums into liquids
  • Low shear and high shear applications
  • Filtration product hold tanks
  • Yeast propagation
  • Chromatography slurry

For more information view https://www.wmprocess.com/bottom-entry-mixer/

Mike Matton

mike@wmprocess.com 

www.wmprocess.com

About White Mountain Process

White Mountain Process is a USA based company that supplies sanitary mixing and blending equipment throughout the world. The company prides itself in offering real, experienced help to solve elaborate mixing problems with a goal of optimizing your blending process. We offer extensive engineering support and application assistance for any mixer, agitator, mechanical seal, mixing tank, or complex automated blending system.

Carboy Mixtank Systems

Carboy Mixtank Systems

Biopharmaceutical Use,Air Mixers,Industrial Use,Plastic Agitator and Tank Options,Sanitary Mixers,Single Use Mixing Options,Top Entry MixersNo Comments
carboy mixer parts

Engineered Solutions with Poly CARBOY Mixing + Blending Systems from White Mountain Process…


A common problem in the biopharma industry is a lack of choices for mixing and blending in smaller vessels. You can now improve batch consistency, increase productivity, improve ergonomics for mixing in carboy containers, and eliminate non-conforming equipment documentation issues.


Southbridge, MA – White Mountain Process provides a wide range of CARBOY MIXERS + AGITATORS and CARBOY BLENDING SYSTEMS for sanitary and cGMP mixing applications. These mixer systems can be single use design, used with CIP/COP cleaning protocols, and autoclave sterilization situations. The carboy agitators and stirrers range from economical mag drive top entry blending to more sophisticated mixing arrangements with custom ports, dip tubes, vent filter, and instrumentation for a complete engineered mixing system for lab mixing, R&D, or production blending.

White Mountain Process engineers sanitary mixers to meet all biopharma clean ability standards. The carboy mixers have gold documentation packages for GMP requirements.


Carboy tanks and vessel availability:

  • HDPE polyethylene – USP VI and FDA certified materials
  • PP polypropylene – USP VI and FDA certified materials
  • PETG – USP VI and FDA certified materials
  • PC polycarbonate – USP VI and FDA certified materials
  • Mixers to fit any carboy cap including 83B cap, 38mm, 45mm, 53mm, 83mm, and 120mm cap sizes.

Carboy Mixers availability:

  • Electric variable speed mixer with USP VI vapor tight seal. Autoclave design, easy remove motor.
  • Top mount air operated agitator (pneumatically driven air motor mixer style) with all stainless steel air motor
  • Mag drive top entry poly mixer (nonmetallic mixing with top mount magnetically driven stirrer)
  • Single use carboy mixer, we mixer drive you re-use
  • COP/CIP agitation setup – easy to clean in place or via parts washer
  • Carboy CIP cleaning stations

Typical applications:

  • Resin slurry make up, using high torque carboy mixer
  • Buffer prep and salt dissolving
  • Media preparation blending
  • Mixer designs for low shear simple blending or high shear and high speed dissolving
carboy_mixer_options_14may_edit-1

Contact the specialists at White Mountain Process to discuss an engineered solution for your application.

For more information View Here


Mike Matton

mike@wmprocess.com

www.wmprocess.com


 

About White Mountain Process:

White Mountain Process is a USA based company that supplies sanitary mixing and blending equipment throughout the world. The company prides itself in offering real, experienced help to solve elaborate mixing problems with a goal of optimizing your blending process. We offer extensive engineering support and application assistance for any mixer, agitator, mechanical seal, mixing tank, or complex automated blending system.

How To Use a Carboy Mixer

How To Use a Carboy Mixer

Biopharmaceutical Use,Air Mixers,Bottom Entry Mixers,How To Use,Industrial Use,Plastic Agitator and Tank Options,Sanitary Mixers,Single Use Mixing Options,Stainless Steel Agitator and Tank Options,Top Entry MixersNo Comments

For those in the biopharmaceutical industry, handling the preparation of large volumes of solutions comes with its fair share of challenges. A seamless process is crucial to the quality of the end product, and that means ensuring homogeneous mixing and blending with zero contamination. A balance of sanitation and efficiency is key, especially when it comes to mass production—and the mixing and blending equipment you use plays a significant role in this process. 

 

White Mountain Process’s carboy mixers are specifically tailored to pharmaceutical and sanitary manufacturing, offering simple ways to mix, disperse and blend liquids and solids. With a diverse product lineup—including a selection of mixers and carboys in any standard volume—and customization options, we have the unique capability of catering to a wide range of industry needs.

What we offer: 

Our carboy mixers come in electric, air and magnetic drive models and all are available as single-use, clean-in-place (CIP), clean-out-of-place (COP) or autoclave. Carboys can be customized to your specifications with dip tubes, sterile vent filters, solvent filters, inlet/outlet connections, volume markers, custom tagging, private labelling and more. 

Designed with the sanitary and biopharmaceutical markets in mind, our line of carboy mixers and agitators are ideal for a range of applications like buffer preparation, media preparation, diagnostics and dissolving powders into liquids.

Carboy mixers and agitation systems are available as:
  •   Sealed carboy and mixer
  •   Mag drive carboy stirrer
  •   Single use carboy blending system
  •   Open top carboy agitator
How to use the mixer, agitator or tank

The best part of using a carboy mixer, agitator or tank is this: it doesn’t require a lengthy manual to figure out. In fact, it’s as easy as 1, 2, 3: add your ingredients, turn the mixer on, and pump them out—and just like that, you’ve simplified your mixing process. We promise, there’s no catch!

 

Why you should use our carboy mixers for your mixing tank system


With the most extensive offering of carboy mixers and agitators for sanitary and biopharmaceutical purposes, we have myriad options to suit your manufacturing processes. Here are some of the features and services we offer that make our products exceptional in these industries.

Customization options
Almost everything we offer can be customized to deliver exactly the product you need. That means carboys in any standard volume, designed to your specifications. Our ability to customize the materials used offers flexibility with solutions and solvent compatibility, limiting leachables. 

Sanitary mechanical seals
Our carboy mixers feature sanitary mechanical seals for closed mix tank applications, which can limit bioburden and endotoxins.

Speed control
If your goal is precision mixing, we can help you achieve it. Our electric and air mixer motors include options for speed control, offering the ability to perform precision mixing that can be validated.

Single-use availability
In the past several years, biopharmaceutical manufacturing has seen a shift toward single-use bioprocessing equipment. White Mountain is prepared to meet that need, with all of our carboy mixers available as single-use for disposable facilities. 

Documentation options
A bonus: we make it as easy as possible for our customers to access the information they need for lab mixing by providing good manufacturing practice (GMP) documents, such as FDA, USP Plastic Class VI and Material Test Reports (MTR) on all polished stainless steel.
Sanitary Mixers for Biopharma Blending

Sanitary Mixers for Biopharma Blending

Biopharmaceutical Use,Industrial Use,Pharmaceutical Use,Plastic Agitator and Tank Options,Sanitary Mixers,Single Use Mixing Options,Stainless Steel Agitator and Tank OptionsNo Comments

The sophistication of biopharmaceuticals is enormous, but the development of innovative biopharmaceutical products is often plagued by technological and operational challenges. The manufacturing capabilities required to reliably reproduce molecules at an industrial scale are enormous. While the mixing and blending required for biopharmaceutical formulation may appear straightforward – and have been undertaken for over a century – the sanitary features of mixers can make or break their long-term utility in the operations process. An agitator used on a mixing tank (blending system) must be designed and operated to provide the process results required, and have the documentation and ability to be properly cleaned per the in house procedure or SOP (typical cleaning is via CIP and/or SIP – clean in place and/or steam in place).

Sanitation is Critical for High-Quality Biopharmaceutical Products

Sterility and cleanability on blending equipment for drug makers is of course of the utmost importance, and several aspects of sanitation and relevant outcomes must comply with U.S. Food and Drug Administration (FDA) regulations. These regulations change in response to the needs of the industry and its stakeholders and tend to get stricter over time. The technology of mixers used in the food industry may not always differ significantly from mixing technology in the pharmaceutical and biotechnology industries. However, in the latter case, it is critical to have ultra-sanitary mixing equipment that is built specifically to meet the demands of pharmaceutical and biotechnology products. More recently, as food allergies have been on the rise, the risks associated with cross-contamination have increased the importance of sanitation in the food industry as well.

Sanitation Standards

The FDAs Current Good Manufacturing Practice regulations (CGMPs) helps to ensure that biopharmaceuticals are not only high-quality products but that they are also free of contamination. Sterility is vital for any associated drug, including its quality, purity, safety, strength, efficacy, or identity. Particularly with new viruses such as Covid-19 coronavirus pandemic, it shows the urgent importance of sterility in every way, shape, and form. Any processing equipment, including mixing and blending tanks and systems must be cleaned and sterilized accordingly.

Meetings Sanitation Requirements Can Be Time Consuming and Laborious

While sanitation has always been emphasized in biopharmaceutical industries, the process for sanitation has faced limitations and caused workflow bottlenecks for biopharmaceutical operations. For instance, production systems of the past have been cleaned manually, requiring time consuming and laborious processes, such as system disassembly, scrubbing, and rinsing. An added critical weakness of these systems has been the potential to introduce contamination and potentially damage the system.

Clean-in-Place Technology Helps to Ensure High-Quality and Efficient Blending

The use of clean-in-place (CIP) techniques – which is used extensively in the biotechnology and pharmaceutical industries, as well as in the food industry – offers a modern approach to mixing and blending that enables comprehensive cleaning without the need to disassemble the different pieces and sections of the equipment. CIP technology can help to maintain clean surfaces through the spraying or recirculating of fluids. These methods often employ spray balls that spray various cleansing and sanitizing liquids at high flow rates and at high temperatures.

Not only do CIP systems remove system fouling in a highly effective way, but they are also conducive to automation. These features associated with CIP technologies have made them readily adopted by leaders in biopharmaceutical manufacturing and food production.

CIP Strategies Add Value to Biopharmaceutical Processes Like Buffer and Media Prep

The CIP approach enhances quality and efficiency wherever cleaning and sanitation is required. For frequent or high batch processes, such as buffer preparation and media preparation, CIP is particularly valuable. Not only can this strategy increase cleaning quality and efficiency, but it can help ensure that the development of these batches is repeated in a uniform way and that each product is reproducible and scalable.

Mixer and Blending Tank Designs Must be CIP and SIP friendly

Any sanitary agitator, and blending vessel should be specified and designed to allow proper cleaning and sterilizing per GMP and BPE standards. Mixing tanks are generally fabricated in USP VI PP (polypropylene) or FDA PE (Polyethylene) materials, or stainless steel 316Lss grade, with polished surfaces <20ra and post fabrication passivation and electropolishing. all materials must be traceable and proper gmp documentation part of the mixer turnover package. often times these mixing tanks will be riboflavin cip tested to assure complete coverage in the vessel, and proper cleaning of all the agitator components including the mechanical>

Takeaway: Given the critical importance of sanitation for biopharmaceutical products and the immense labor that can be involved in ensuring sanitation standards are met, those producing these products need technologies that can achieve the highest levels of sanitation while enhancing the efficiency of the sanitation process. Clean-in-place (CIP) technologies are an ideal way to meet these challenges and produce high-quality, reliable products without regularly replacing or supplementing equipment.

The Versatility of Bioreactors in Bioprocessing

The Versatility of Bioreactors in Bioprocessing

Biopharmaceutical Use,Bioreactors,How To Use,Industrial Use,Pharmaceutical Use,Sanitary Mixers,Single Use Mixing Options,Stainless Steel Agitator and Tank OptionsNo Comments

Bioreactors are vessels that are used to grow microorganisms and are employed in many industries. They are critical pieces of equipment in the biopharmaceutical industry where they are used to propagate cell cultures from mammalian and plant tissue. During this process, the bioreactor produces a range of products including medicines, antibodies and vaccines. They are also used extensively in tissue engineering for in vitro growth of new tissue for transplantation.

A bioreactor can also be used as a fermenter. Fermentation is a biochemical process whereby an organism such as yeast breaks down carbohydrates to produce alcohol, gases and other compounds, depending on the controlled environment. In medical applications, fermenters are often used to manufacture products like antibiotics and hormones.

Bioreactors play a vital role in environmental engineering and the operation of sewerage and waste water treatment plants. They can be used in aerobic or anaerobic digestion processes to break down undesirable waste material in effluent. This makes the treatment process more efficient, producing higher quality water for reuse.

Stainless Steel vs. Single-use Bioreactors

While there is healthy debate raging about the use of stainless steel versus single-use bioreactors, each has its advantages and disadvantages. There are a number of manufacturers who have opted to implement a hybrid of the two technologies.

The advent of single-use technology has seen proponents highlighting the ease of deployment, fast changeover and plant flexibility, which makes it attractive for CMOs. It also requires reduced capital outlay for plant and equipment. However, this is new technology which has a number of drawbacks as it:

  • Is not suitable for large-scale production.
  • Requires operator training in the acquisition of new skills.
  • Imposes greater responsibility on operators which adds to the risk of things going wrong.
  • Calls for meticulous planning to ensure availability of consumables.
  • Carries the risk of damage to single-use bags, causing leakage or contamination.

The use of stainless steel bioreactors is well established and workers are well-versed in plant operation. Detractors point to their inflexibility, higher maintenance cost and increased risk of cross-contamination. However, stainless steel vessels do offer the following advantages:

  • Reactors are available in larger capacities, suitable for large-scale, commercial production.
  • There is a reduced risk of operator error.
  • Manufacturers have complete ownership of process quality.
  • This option can accommodate more advanced measurement and control technology.

The Future of Stainless Steel Bioreactors

A survey conducted of current facilities for cGMP commercial manufacturing showed that over eighty percent of companies are using stainless steel technology. In addition, with more than 75% of respondents stating a preference for stainless steel in their new facilities, it is clear that stainless steel is here to stay for the foreseeable future.

In acknowledgement of the challenge posed by single-use reactors to their market share, stainless steel equipment manufacturers are developing innovations in design that will allow more modularity and flexibility in operation. These are benefits that are most often attributed to single-use technology.

Designers are also looking at making changes to system design that will enable biopharmaceutical manufacturers to incorporate single-use equipment as part of a hybrid solution. For large-scale manufacturing, stainless steel vessels are more cost-effective and it is envisaged that reusable equipment will retain its dominance in this market.

Basic Bioreactor Design

Bioreactors can be classified according to their mode of operation as continuous, batch or fed batch systems. A fermenter is used to nurture and grow microorganisms by maintaining a constant temperature throughout the process. Bioreactors are used to produce different chemical substances by varying the temperature during the process. This makes a bioreactor more versatile than a standard fermenter in terms of the variety of products that can be produced.

Vessels are usually made from 316L stainless steel and are designed using biochemical engineering principles, which can be complex. Bioreactor designers need to take several process parameters into consideration, including temperature, pH, nutrient concentration and the amount of dissolved gases necessary for fermentation or biochemical reaction.

Many bioreactors are fitted with agitators to facilitate mixing and even temperature distribution within the vessel. Cooling jackets or coils are used to maintain temperature. In some applications, like exothermic fermentation, external heat exchangers are used to cool the product. Gases required for biochemical reaction need to be controlled when added to the vessel. By-product gases also need to be released from the bioreactor.

State-of-the-art bioreactors include re-sterilizable valves for additions, sampling and harvesting. They are also fitted with tube spargers for oxygen, air and carbon dioxide. The entire system is controlled using a process controller using SCADA software. Leading process equipment manufacturers will supply bioreactors mounted on a skid and suitable for turnkey installation and commissioning.

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