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Single Use Mixing Options

Optimizing Buffer Preparation with Single Use Mixing and Lab Carboys, a Detailed Guide.

Optimizing Buffer Preparation with Single Use Mixing and Lab Carboys, a Detailed Guide.

Single Use Mixing OptionsNo Comments
Optimizing Buffer Preparation

Optimizing Buffer Preparation with Single Use Mixing and Lab Carboys:

Buffer preparation is a critical step in many laboratory, biotech, and pharmaceutical GMP blending processes.    The right buffer preparation can ensure that the process is successful and that the desired results are achieved, but 100% mixing uniformity of all ingredients is mandatory.   What mixing and blending systems are used for buffer and media prep:

  1. Mag drive stirrers – simple Teflon coated magnets go into a beaker and spin using a mag drive unit, these are simple and inexpensive mixing devices, although cannot be scaled up to production mixing tanks
  2. Carboy Mixers – off the shelf HPDE and USP VI PP carboys can be fitted with top entry carboy mixers which can quickly and efficiently provide homogeneous blending, with unform pH throughout the mixture
  3. Single use bag mixing, or single use carboy mixers – single use mixing systems work really well for waterlike mixing of buffer solution, and can be mixing impeller based or bag shaking type platforms
  4. Large scale buffer preparation is typically performed in traditional stirred tank systems, with a top entry agitator with single or dual mixing impellers

 

 Many laboratories are now turning to single use mixing and lab carboys to streamline and optimize buffer preparation. 

Overview of Buffer Preparation

Buffer preparation is a process that involves mixing together a solution of chemicals and water to create a solution with a specific pH and ionic strength. Buffers are used to maintain the pH of a solution, and they are essential in many laboratory processes, such as cell culture, protein purification, and chromatography. The process of buffer preparation can be time-consuming and complicated, and it can be difficult to get the right concentrations and pH values. That’s why many laboratories are now turning to single use mixing and lab carboys to streamline and optimize buffer preparation.

Understanding Single Use Mixing and Lab Carboys

Single use mixing systems are systems that are designed to quickly and easily mix and dispense buffer solutions. They are typically composed of a mixer, a carboy, and a dispenser. The mixer is used to stir and homogenize the buffer solution, and the carboy is a container for the buffer solution. The dispenser is used to dispense the buffer solution into containers or other vessels.

Lab carboys are containers that are used to store and transport buffer solutions. They are typically made of polypropylene and are designed to be lightweight and durable. They are available in various sizes and shapes, and they can be used in a variety of applications.

Advantages of Using Single Use Mixing and Lab Carboys

Single use mixing and lab carboys offer several advantages for buffer preparation. First, they are quick and easy to use, so you can prepare buffer solutions in a fraction of the time it would take to do it manually. Second, they are accurate and reliable, so you can be sure that the buffer solutions you prepare will meet the desired specifications. Third, they are cost-effective, so you can save money on materials and labor costs. And finally, they are safe and easy to use, so you can be sure that your laboratory is working in a safe and efficient manner.

Types of Single Use Mixers and Lab Carboys

When it comes to single use mixers and lab carboys, there are several types available. Depending on your needs, you can choose from static mixers, dynamic mixers, and recirculating mixers. Each type has its own advantages and disadvantages, so it is important to choose the one that best suits your laboratory’s needs.

Static mixers are the simplest and most economical type of single use mixer. They use a static mixing element to mix and homogenize the buffer solution, and they are ideal for smaller volumes of buffer solution.

Dynamic mixers are more complex and expensive than static mixers, but they are more efficient and better suited for larger volumes of buffer solution. They use a rotating mixing element to mix and homogenize the buffer solution.

Recirculating mixers are the most complex and expensive type of single use mixer, but they are the most efficient and are well suited for large volumes of buffer solution. They use a recirculating mixing element to mix and homogenize the buffer solution.

When it comes to lab carboys, there are several types available as well. The most common types of lab carboys are carboys with handles, carboys with spouts, and carboys with lids. Carboys with handles are the most common type and are well suited for storage and transport of buffer solutions. Carboys with spouts are ideal for dispensing buffer solutions into containers or other vessels. And carboys with lids are ideal for storing and transporting buffer solutions.

How to Choose the Right Single Use Mixer and Lab Carboy For Optimizing Buffer Preparation 

When it comes to choosing the right single use mixer and lab carboy, there are several factors to consider. The first is the size of the buffer solution you need to prepare. For smaller volumes, a static mixer is usually the best option. For larger volumes, a dynamic or recirculating mixer is usually the best option.

The second factor to consider is the type of buffer solution you need to prepare. If you need to prepare a solution with a certain pH or ionic strength, you may need a more complex mixer. If you are just preparing a solution with a simple pH or ionic strength, a static mixer will usually be sufficient.

The third factor to consider is the type of lab carboy you need. If you need to store and transport buffer solutions, a carboy with handles is usually the best option. If you need to dispense buffer solutions into containers or other vessels, a carboy with a spout is usually the best option. And if you need to store and transport buffer solutions, a carboy with a lid is usually the best option.

How to Optimize Buffer Preparation with Single Use Mixers and Lab Carboys

Once you have chosen the right single use mixer and lab carboy for your needs, there are several steps you can take to optimize your buffer preparation. First, make sure the buffer solution is properly mixed and homogenized. This can be done by adjusting the speed and duration of the mixing process. Second, make sure the concentration and pH levels of the buffer solution meet the desired specifications. This can be done by adjusting the concentration of the chemicals and water in the buffer solution. Third, use a reliable and accurate dispenser to dispense the buffer solution into containers or other vessels. And finally, store the buffer solution in the appropriate lab carboy for easy transport and storage.

Benefits of Using Single Use Mixers and Lab Carboys

Using single use mixers and lab carboys for buffer preparation offers several benefits. First, it helps to streamline and optimize the process, so you can prepare buffer solutions quickly and accurately. Second, it reduces the risk of errors, so you can be sure that the buffer solutions you prepare are of the highest quality. Third, it helps to save time and money, so you can reduce labor costs and materials costs. And finally, it helps to ensure a safe and efficient laboratory environment, so you can be sure that everyone is working in a safe and productive manner.

Where to Find Single Use Mixers and Lab Carboys

If you are looking for single use mixers and lab carboys, you can find them at most laboratory supply stores. You can also find them online, but it is important to make sure you are buying from a reputable distributor. You should also make sure the single use mixer and lab carboy you choose is of the highest quality, so you can be sure it will meet your laboratory’s needs.

Conclusion

Buffer preparation can be a time-consuming and complicated process, but it doesn’t have to be. With the right single use mixing and lab carboy system, you can streamline and optimize buffer preparation and ensure that the buffer solutions you prepare are of the highest quality. Single use mixers and lab carboys are quick and easy to use, accurate and reliable, cost-effective, and safe and easy to use. So, if you are looking for a way to optimize your buffer preparation, single use mixing and lab carboys are the way to go.

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

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

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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.

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

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

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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.

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
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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

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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

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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.

Mixing Tanks Designed for Process Results

Mixing Tanks Designed for Process Results

Biopharmaceutical Use,Bottom Entry Mixers,Industrial Use,Plastic Agitator and Tank Options,Sanitary Mixers,Single Use Mixing Options,Stainless Steel Agitator and Tank Options,Top Entry MixersNo Comments
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White Mountain Process is a premier supplier of mixing tanks and blending systems. There is no one tank that fits all applications. We offer a variety of tank materials and styles, with the appropriate mixing system to give you the results desired. Pre engineered tanks with quick deliveries are available. Tanks can be customized to suit including instrumentation and automation.

Looking for the perfect blending system?
Optimize your mixing tank system with choices and perfection.

A variety of mixers are available including top entry agitation, bottom entry mixer, mag drive top and bottom entry mixing, multimotion style blenders, and single use mixers for GMP use.

Mixing Tanks Designed for Process Results

  • Plastic Mixing Tanks (Poly / Non-Metallic mixing)
  • Sanitary Mixtanks
  • Stainless steel and exotic alloy blend vessels
  • Single use mixing tank
  • Carboy mixing tank
  • Bottom and top entry slurry mix tanks
  • Extraction tanks
  • Glass reaction jacketed tanks

Contact White Mountain Process sales@wmprocess.com for consults on choosing the right mixing tank.

Carboy Mixers & Agitation Systems

Carboy Mixers & Agitation Systems

Sanitary Mixers,Biopharmaceutical Use,Industrial Use,Pharmaceutical Use,Single Use Mixing OptionsNo Comments

White Mountain Process announces the most extensive offering of carboy mixers and agitators for the sanitary and biopharma markets. Catering to biotech, pharmaceutical, and sanitary manufacturers these carboy mixers are available for mixing applications like buffer prep, media prep, diagnostics, and dissolving powders into liquids.

Carboys can be customized to suit with nozzles, dip tubes, vent filters, instruments, and any accessories desired.

Available in:

  • Sealed carboy and mixer
  • Mag drive carboy stirrer
  • Single use carboy blending system
  • Open top carboy agitator

Carboy mixers provide customers simple ways to mix, disperse, and blend liquids and solids into liquids.

White Mountain Process offers help to customers for any mixing application including design, engineering, computational fluid dynamics, lab mixer testing, scale up and scale down services.

The Versatility of Bottom Entry Mixers

The Versatility of Bottom Entry Mixers

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

Bottom entry mixers provide manufacturers in the pharmaceutical, biopharmaceutical and food processing industries with viable alternatives to top entry solutions. These mixers provide efficient mixing and blending of products, and can be custom designed to suit the specific speed, shear and agitation requirements for various applications.


The Benefits of Bottom Entry Over a Top Entry Mixer

Bottom entry mixers are ideally suited to mixing and blending applications in the pharmaceutical and biopharmaceutical industries. Although generally more expensive, they offer significant benefits over a top entry mixer:

  • Low level mixing. The ability to mix to very low levels, and blend during drawdown makes bottom entry agitators perfect choice for high value product mixtures.
  • Improved process purity. These mixers do not have to contend with the possibility of contamination from particulate matter falling into the tank from overhead bearings and seals used in top entry mixers, although top entry mixers can be outfitted with a debris well to prevent this.
  • Easy installation. Very easy to install, and simple to maintain the mixer drive/gearbox since its at the bottom of the tank. Top entry mixers with long shafts need special rigging often times to install. The bottom entry mixer is easier to install than its top entry counterpart. The top entry mixer requires sturdy infrastructure to support its heavy overhead motor.
  • More efficient mixing. The design of a bottom entry mixer promotes the formation of a vortex which ensures more efficient and effective blending. It also provides 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.
  • 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.
  • Easier handling and operation. These mixers are much easier to handle and operate in tight spaces or where headspace is limited.
  • 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.

Applications for the Use of Bottom Entry Mixers

Bottom entry high shear mixers are especially suited for:

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

Mixers can be fitted to either stainless steel or polypropylene tanks and can be designed to conform to cGMP specifications for biopharmaceutical production. Users can choose from other options including mixer speed control, a double mechanical seal, multi-motion agitation and multi-shaft mixing. These mixers can also be designed to operate in tanks under pressure or vacuum.

Types of Bottom Entry Mixers

  • Flange or Tri clamp mount with mechanical seal
  • Welded design, flush mount, with mechanical seal
  • Mag drive mixer sealless design
  • Single use bottom entry mixer with disposable bag and mixing assembly

Bottom Entry Magnetic Drive Mixers for Sanitary Applications

Traditionally, all mixers have some type of mechanical seal at the point where the impeller shaft enters the tank. These can be single or double seal arrangements in the attempt to provide a sterile barrier between the interior of the vessel and the outside environment.

The problem with mechanical seals is that they all fail sooner or later. The sanitary magnetic mixer has been developed to do away with the need for 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.

The use of mag mixers in bioreactors is of critical importance, as seal failure can have catastrophic consequences. Other typical uses for bottom entry mag mixers are for aseptic mixing, buffer preparation mixing and media make up agitation.

These mixers can be custom designed to include mixer speed control, multi-motion agitation or multi-shaft mixing, if a combination of top and bottom entry mixing is required. They can be fitted to stainless steel or polypropylene tanks.

White Mountain Process launches new line of bioreactors

White Mountain Process launches new line of bioreactors

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

White Mountain Process, LLC, catering to sanitary, biopharmaceutical and high purity users of agitators & mixing tanks, launches new line of laboratory bioreactors and fermenters. Configured for research, development, pilot plant and production, these fully configurable single-use bioreactors include the choice of cell-vessels for cell culture or bacto-vessels for fermentation.

Complete with precise electrical heating for accurate and gentle heat transfer, and temperature control for cell culture and microbial fermentations, these double wall vessels include a stainless steel head plate and are designed to the latest GMP requirements. All options include pre-programmed, ready-to-use configurations for fermentation and cell culture and include interchangeable mag drive and direct drive options, a variety of impellers, and multiple industry standard head plate ports.

Bioreactor Applications:

  • Cell culture and microbiology Research & development
  • Laboratory and pilot scale fermentation of aerobic and anaerobic bacteria, yeasts, and fungi
  • Mammalian, insect, and human cell line cultivation
  • Stem cell culture or biofuel/biopolymer development
  • Vaccine production in anchorage and non-anchorage dependent cell lines
  • Suitable for batch, fed-batch, and continuous processes
  • Validation packages available for GMP-regulated processes
Single Use, CIP & COP Carboy Mixers

Single Use, CIP & COP Carboy Mixers

Industrial Use,Plastic Agitator and Tank Options,Sanitary Mixers,Single Use Mixing Options,Top Entry MixersNo Comments

White Mountain Process offers world class single use mixing systems for a variety of carboys and plastic process vessels. These mixers can be used over and over and cleaned via traditional CIP/COP methods. Although single use bag mixing dominates the disposable blending market, using USP VI PP carboys and single use poly mixing assemblies can be extremely cost efficient. Mixing is via traditional TOP ENTRY AGITATION so scale up to larger production batches is very easy, and scale down to microliters is easily duplicated.

Download our carboy mixer PDF to see a variety of mixers used on off the shelf poly carboy tanks. Containers are customized to suit your requirements including dip tubes, sterile vent filters, solvent filters, inlet/outlet connections, volume markers, custom tagging, private labelling, etc.

Carboys are available in HDPE, PP, PETG as well as Polycarbonate, which provide a see thru container option. Carboy mixers are available in open top, sealed vapor tight, and magnetic drive designs. Materials of construction are available in a wide range of poly materials, 316LSS, Hastelloy C and exotic alloys. We offer a variety of mixing impeller designs to optimize blending performance depending on your mixing application. Low shear and high speed designs are available.

Full GMP documentation packages are standard, and all mixers are test run at QC to assure simple and easy mixing startups. All mixers are guaranteed to run flawlessly out of the box.

Contact White Mountain Process at sales@wmprocess.com for any assistance or price quotes.

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