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:
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
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.
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.
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.
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.
You can get standard designs, or customize your air operated mixer as a bottom entry mag drive mixer or top entry pneumatic agitator with sanitary stainless steel motor. Customization is our game, if you want a tachometer, titanium or Hast wetted parts, electropolish/passivation, all poly shaft/impeller, we can do it!
These mixers are very common for pharmaceutical mixing equipment which are used on poly blending tanks or stainless steel process vessels.
Benefits of these stainless steel pneumatic mixer motors:
- All stainless steel, sanitary, no painted surfaces or coatings
- Intrinsically safe, and Atex certified
- Ultra lightweight and ergonomic, great for compact mixing vessels
- Sleek look to the motors, along with our classic sanitary mixer appearance these mixers are right at home in biopharma suites
- No overheating
- Variable speed by simple adjustment of air flow going into motor
- Great torque ability with these gear drive air motor designs
The top entry agitator version can have a mechanical seal or vapor tight USP VI lip seal and a tri clamp or ansi flange connection is most popular. For bottom mount mag drive the mixer is sealless, so no mechanical seal is required.
These mixer air motors can be used in explosion proof environments, as they are intrinsically safe, non-sparking, and in compliance with the European Union’s ATEX directive 94/9/EC. For equipment used in potentially explosive environments.
Air operated mixers have a lot of features and benefits to users depending on the mixing application. For fast assistance and free consultation contact sales@wmprocess.com and ask for applications assistance for air operated mixers.
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.
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, 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
Who We've Worked With
