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Bioreactors

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.

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
7 Deadly Sins of Mixing

7 Deadly Sins of Mixing

How To Use,Biopharmaceutical Use,Bioreactors,Industrial Use,Pharmaceutical Use,Sanitary MixersNo Comments

“Always use the right tool for the job.” “Take care of your tools and they will take care of you.” These classic words of wisdom certainly apply equally to manufacturing equipment. Mixing + Blending machinery mismatches and breakdowns cost you money due to downtime, scrapped poor quality batches, equipment repairs, and lost production. Optimized agitation equipment and perfected operating procedures bring successful mixtures and profits and a sense of satisfaction from a job well done. Mixers and agitators, are essential elements of complex processing systems, and should provide many years of valuable service if you avoid:

The 7 Deadly Sins of Improper Mixer Operation

The Underpowered Mixer

A wimpy mixer will get sand kicked in its face every day. Invest in a mixer you can be proud of! An undersized mixer typically will not provide enough flow, and enough agitation to successfully provide 100% uniformity in your tank. Other blending disasters from not enough flow and HP could result from solids settling at tank bottom, stratifications in tank, non-uniform heat transfer, ineffective mixing of viscous product, poor dispersion, and a host of other issues. This outcome is quite understandable, but then again, so is the desire to save money. You of course are in business to make money, not simply to try to save it. Spend some time consulting with mixing and blending experts like those at White Mountain Process. Any good agitator vendor should ask the right questions about your application, your tank, and your mixture. Your payoff will be a mixer with the muscle to thoroughly blend your ingredients in the shortest possible time. If the mixer lacks sufficient horsepower, it may not create the required flow in the vessel for proper mixing. SOLUTION– Mixer should be sized properly for the application, with enough HP and enough flow (mixing capability) to provide the proper uniformity in an acceptable time frame.

Improper Shear – “Too Much or too Little”

Shear stress is a force that acts on an object that is directed parallel to the object’s surface. Shear stress is imparted by the mechanical action of the mixer and is determined by factors such as the rpm of the mixer, tip speed, the impeller configuration, the clearance between the impeller and the mixing vessel, as well as the viscosity and rheology (change in viscosity vs. strain rate) of process fluids. Some fluids become less viscous (thinner) with increased shear strain rate and others become more viscous. The viscosity of a few other fluids, such as water, are unaffected by shear strain rate. Shear is a necessary condition in certain mixing applications, particularly in breaking apart particle agglomerations, creating emulsions, dispersions, particle size reduction, milling, and homogenizing. But as with many things, too much of a good thing can sometimes be a bad thing. Over-shearing sensitive particulate, mammalian cells, and shear sensitive solutions can destroy expensive batches of product. Low shear mixers are better suited here, with gear drive slow speed designs implementing low shear mixing impellers. Some process components–such as many minerals–are insensitive to high shear, while others–such as biomolecules–may be degraded under such conditions. Some materials may vary in sensitivity depending on factors such as temperature or pH. Be sure that you understand the shear requirements and sensitivities in your mixing application. It may be necessary to conduct experiments to determine optimal conditions of shear and the length of time the materials are subjected to that shear. SOLUTION – size the mixer to the proper low, medium, or high shear ranges required to achieve process results. Low shear mixers are typically slow speed, and high shear mixers are high speed and employ various impellers or mixing heads to impart large shear forces.

Incompatible Materials of Construction

Mixer shafts and blades are commonly produced from various grades of stainless steel (SS) for high strength and corrosion resistance.  But stainless steel can corrode, causing pits that may form cracks, which in turn may lead to mechanical failure of the part. The corrosion resistance of SS is imparted by the addition of chrome at a level of at least 10.5%.  Nickel is also often added.  The chrome forms an extremely thin barrier layer of chromium oxide on the surface, which protects against corrosion such as common rust. However, the barrier layer may be degraded by chlorine (a component of table salt), fluorine, iodine, and certain fatty acids. Type 316 SS contains 2% molybdenum, making it considerably more resistant to solutions of sulfuric acid, chlorides, bromides, iodides and fatty acids at high temperature than the 304 SS alloys.  In the production of certain pharmaceuticals, SS grades containing molybdenum are required in order to reduce metallic contamination. It is important to note that 316 SS, although more corrosion resistant than the 304 alloys, may not be sufficient for some conditions. Various specialty metals and polymers offer a higher level of corrosion resistance than SS alloys.  These include: a)      Hastelloy® C22 and C276 b)      Titanium c)      AX6LN d)      Polymers such as Teflon® PTFE, Halar® ECTFE, Kynar® PVDF, rubber, PVC, polyethylene (PE), and polypropylene (PP) Highly abrasive process materials may erode the electro-polished finish on metal parts, degrade the barrier layer on SS, and cause pits that are difficult to thoroughly clean. SOLUTION – Mixer Agitator materials of construction should be specified to handle the application, temperatures, abrasiveness, cleanliness, and acceptable materials if mixing pharmaceuticals.   Special polishing, passivation, electropolishing, or coatings (Teflon, Kynar, Polypro) should be specified for mixer shaft and impeller assemblies and if any material certs, FDA or USP VI documentation is required that should be noted.

Insufficient Cleanability – Dirty Mixers are Bad News

There is substantial diversity in mixer designs and materials, and a wide range in the ability of these mixers to be cleaned and sterilized. Add to this the variability in cleanliness required by the array of industries and processes in which mixers are used, and it becomes apparent that this factor must not be the subject of guesswork.  Insufficient cleanability must be avoided at all costs, whereas it may make little sense to spend money on designs far exceeding the process requirements. Parameters affecting cleanability include corrosion and erosion resistance of the mixer component materials, as well as equipment design parameters including crevices and the ability of parts to be disassembled and removed. For efficiency, some mixing systems are constructed so that they may be cleaned in place (CIP) or sterilized in place (SIP).  This means that the unit does not require disassembly for cleaning or sterilization.  For CIP/SIP, special spray-cleaning equipment is designed to clean all areas, and all materials are able to withstand the heat of sterilization. Metals of course will withstand sterilization temperatures, whereas certain polymers may not.   Kynar® PVDF and polypropylene are two polymers that can stand up to many heat-sterilization processes. Another important consideration in cleanability is the type of connector or seal used at the point where the mixer shaft penetrates the vessel wall.  Sanitary connectors such as Tri-clamp® (TC), NovAseptic® (NA),and TerraportTM allow optimum drainage of process materials and are fully cleanable.  Sanitary mechanical seals offer similar advantages. For CIP, should the impeller be submerged in fluid?   Do you want to CIP the mechanical seal debris well?   Is the impeller set screwed to shaft, or welded/polished/electro-polished? SOLUTION – If a mixtank will be CIP and/or SIP proper good design practices should be implemented for the agitator.   The mixtank design is crucial for good cleaning, and properly specified spray balls/nozzles to accommodate full coverage and complete cleaning of tank/mixer/accessories.

 Unsuitable Documentation Package

“In God we trust.  All others bring data.” Your supplier may have told you that you purchased a mixer meeting the requirements of FDA, USP, and other regulatory or standards bodies; your mixer may in all aspects of its design and manufacture meet those requirements.  But if you do not have the proper documentation to back up that claim, then your mixer does not in fact meet the requirements. In order to ensure that sanitary mixers are designed and manufactured to stringent quality standards, including materials of composition, relevant oversight bodies have stipulated various specifications and documentation requirements.  Among these are: Food & Drug Administration (FDA)

  • Certificate of Conformity
  • A Certificate of Conformity offers little data, and usually just says the product or material meets the purchaser’s specifications or those of some standard.
  • Certificate of Analysis
  • A Certificate of Analysis provides data, including the specifications of the product or a confirmation that they fall within a certain range. A Certificate of Analysis also normally provides information about known deviations or contaminants. The FDA normally prefers Certificates of Analysis over Certificates of Conformity.
  • Current Good Manufacturing Practices (cGMP)
  • The FDA requires that equipment used in pharmaceuticals production be manufactured in facilities meeting cGMP standards, and the purchaser of high-purity mixing equipment may require that the supplier provide a copy of its FDA cGMP manufacturing facility certification.

U.S. Pharmacopeia (USP)

  • USP VI
  • The USP defines six plastics classes, from I to VI, with VI the strictest. Plastics manufacturers may have their plastic resins certified as USP Class VI. A plastic resin material that has passed Class VI certification is expected to be biocompatible.
  • The USP Class VI conforming equipment must be made from materials with clear histories of biocompatibility that meet tight requirements for leachates.

American Society for Testing & Materials (ASTM)

  • Mill test report (MTR)

This is a test report used for metals that certifies that the metal material meets certain standards set by organizations such as the ASTM, ASME, or ANSI, etc. SOLUTION – Any documentation required for mixer materials of construction, motor/gearbox, mechanical seal, etc., should be specified with your mixer inquiry to assure complete compliance with the final turnover package. Mixing Vessel is Not Suitable A mixer is part of an interdependent system including the vessel or tank into which the mixer is inserted. Parameters of the vessel that affect mixing efficiency and effectiveness include:

  • The presence and placement of baffles to direct the process fluid toward the mixer impeller(s)
  • The position of the mixer in the vessel: top, bottom, or side mounting. Bottom-mounted mixers offer greater efficiency than top- or side-mounted designs.
  • Number, location, and design of the mixer impeller(s)
  • The presence and effectiveness of a vortex breaker
  • The design and location of the vessel outlet valve
  • The presence and design of a recirculation loop
  • Single- or multi-shaft mixing
  • Open or closed vessel and temperature/pressure rating
  • Material of construction, such as SS or poly
  • Sanitary connectors for all connected pipes and equipment if necessary
  • The ability of the system to be CIP/SIP

SOLUTION – Mixing tank geometry, features, and design are as crucial to mixing performance as the HP and speed of the actual agitator. Careful attention to process vessel design to meet all your needs (mixing, cleaning, instrumentation, self-draining, heat transfer…) will help make the mixer perform as expected.

Mixer Options are Not Dialed-in

There are a number of options in mixers. Be sure to thoroughly evaluate those available or seek expert advice regarding your application. Some of these are:

  • Variable speed and its range
  • Tachometer to monitor actual mixer shaft speed
  • Mechanical seals for sanitary applications
  • Special finishes
  • Low level mixing
  • Multiple or customer impellers
  • Split mixer shaft

SOLUTION – Carefully choose the options required with keeping financial impact within your range.

AVOID the 7 Deadly Sins of Improper Mixer Operation

Stay away from high risk and painful experiences. Take the time to get expert assistance, and purchase the correct high-quality mixing system to make your next mixer installation a good one. We at White Mountain Process assume that is your goal, and we know it is ours. A properly selected mixer, sized for your tank and process conditions, when further combined with a flawless installation, delivers a happy day for all of us. Some good reference documents: Mixer buyers guide Mixer data sheet Mixtank concept drawing Contact White Mountain Process for an engineering consultation; we love creating solutions!

Proven Techniques for Preventing the Contamination of Food and Pharmaceuticals

Proven Techniques for Preventing the Contamination of Food and Pharmaceuticals

Sanitary Mixers,Biopharmaceutical Use,Bioreactors,How To Use,Industrial Use,Pharmaceutical UseNo Comments

Bacteria, contaminants and other microbes and microscopic particles are not picky about where they make an entrance. Even a slight lapse of diligence or attention can therefore throw an entire production run into jeopardy.

That means keeping a close eye on things right from the beginning is required. Providers of sanitary mixing equipment make it possible to ensure that contamination-prone foodstuffs, beverages, pharmaceuticals and other goods will not become corrupted even while they are being processed, an important ability that contributes greatly to the safety of the public at large.

In order to achieve this goal, aseptic mixing equipment makes use of a number of techniques and technologies. Many such pieces of equipment are designed from the ground up to stand up to the temperatures and pressures of an autoclave, so that they can be sterilized thoroughly whenever that might be advantageous.

Even once sterilized, though, an aseptic mixer or other device will still be susceptible to contamination. Production environments that focus on delivering sterile output normally take a number of effective measures to cut down on the presence of foreign life forms and substances, but these will inevitably still allow some problematic intrusions.

Because of this, aseptic equipment of this kind must still be designed to keep out bacteria and other potentially dangerous kinds of contamination. This typically means making use of high-grade seals that form nearly impenetrable barriers wherever a microbe or other particle might make an entrance. For a number of reasons, these seals are often made of silicone, a versatile material in several respects. For one thing, silicone of the right formulations can often stand up to an autoclave just as well as stainless steel and the other materials used to build most mixers might. That saves time and effort when it becomes necessary to sterilize a mixer, allowing for a nearly direct transfer from the production floor.

For another thing, silicone is extremely resilient and conducive to forming tight seals. While it may take several such silicone barriers to fully prohibit the entry of microbes and microscopic particles, this is still quite often a more attractive choice than the alternatives. Thanks to design and construction decisions like these and others, consumers today can generally be sure that the foods and medicines they depend upon will not do them harm.

Mixer-Agitator Bending Moment and Shaft Deflection

Mixer-Agitator Bending Moment and Shaft Deflection

How To Use,Biopharmaceutical Use,Bioreactors,Industrial Use,Pharmaceutical Use,Plastic Agitator and Tank Options,Stainless Steel Agitator and Tank OptionsNo Comments

Bending Moment is the Hydraulic Force (FH) acting on a shaft at a length away from the bearings perpendicular to the axis of rotation. Bending Moment causes the shaft to bend away from the central rotational axis and is critical to determine the shaft material, diameter and bearing design. Excessive bending moments or weak materials of construction can lead to catastrophic failures. The bending moment for each impeller is calculated using the applied Horsepower (HP) and impeller distance from the load bearings. The speed of the mixer and diameter of the impeller is also taken into account as well as whether or not the impeller is submerged or at the liquid surface (important for filling and emptying). After the bending moment is established, the amount of shaft deflection can be estimated using the shaft diameter and the material’s Modulus of Elasticity.

Single Use Mixers

Single Use Mixers

Single Use Mixing Options,Biopharmaceutical Use,Bioreactors,Industrial Use,Pharmaceutical Use,Sanitary MixersNo Comments

Add some innovation to your next batch with single use mixers and disposable mixers from White Mountain Process – and save valuable processing and validation time!

Our single use mixers offer a better way to cut mixing time and significantly reduce cross contamination for aseptic processes such as mixing food, beverage, cosmetics, biopharma and other mixing processes in cGMP environments.

Eliminate cross contamination and speed up turnaround time with single use mixers from the specialists at White Mountain Process. Disposable mixers offer major advantages, such as increasing production while reducing labor costs, as well as other benefits like:

  • Cut cleaning time
  • No CIP or SIP issues
  • Reduce validation costs
  • Less wastewater
  • Less product waste
  • Great for sensitive or sterile materials
  • No impellers

Mix powder, liquids and liquid solutions with mixing bags engineered with film flaps and slots designed to thoroughly mix media throughout the mix bag.

Available in sizes ranging 30 to 5,000 liters, our single use mixer provides truly scalable mixing action and can combine process operations. Your mixing lab will appreciate faster start-up times and shorter cycle times.

Ideal in environments where portability is key, single use mixing systems offer scalable, fast and efficient mixing in one economic package.

While disposable, single use mixers are manufactured to meet cGMP criteria, with the primary expectation of creating a helpful product for the bioprocessing industry.

How Single Use Mixers Work

While single mixers vary depending on the application and size, they generally consist of an in-bag impeller which creates mixing action inside a hermetically sealed bag. No dynamic seals are required and the shaft does not go inside the mixing bag. This system allows for easier mixing of multiple batches in bags – even if the bags are different sizes – with a single use mixer.

Single use mixing bags, while disposable, are designed for rigorous mixing, as well as the media’s exposure to the bag (generally using only a TK8 bioprocesses film where bag is in contact with media). Using a medical-grade poly resin, the bag is generally laminated to create a very strong, ADCF-compliant bag which meets medical-grade requirements.

Applications for Single Use Mixers

Why use a single use mixer for mixing biopharma, buffer and media prep? Mainly for economic and operational efficiency. Labs using single use mixers save valuable processing and validation time.

  • Media prep
  • Buffer prep
  • Product mixing
  • Drug formulation mixing
  • pH / conductivity adjustment
  • Compounding
  • Difficult mixing applications
  • Dense powers, high viscosities
  • Applications requiring repeated, fast-mixing processes

Some industries that do not have cGMP requirements to meet may still benefit greatly from single use mixers, simply because of the fast set-up and clean up time.

Also known as sealed mixing vessel technology or disposable mixers, single use mixers are becoming increasingly popular in industries such as nanomaterial mixing, coating granules or pellets, incorporating liquids into powders and mixing dissimilar powders.

Additional Applications Include:

  • Gases, liquids, powders, solids and pastes
  • Adhesives, sealants and caulks
  • Inks and pigments
  • Cosmetics
  • Advanced materials
  • Polymers
  • Electronic pastes and inks

Major Cost & Time-Savings Benefits

The benefits of single use mixers are clear – they eliminate the need for tank cleaning, significantly reduce cycle times and eliminates the risk of cross contamination. Additionally, single use or disposable mixers significantly reduce start-up costs.

Highly suited for buffer prep and media prop, in addition to cell harvest, buffer exchange and inactivation. Single use mixers also keep lab technicians safer by minimizing exposure to inhalable powders. Other benefits include:

  • Very easy to set-up and use
  • Easy to transport
  • Can increase production capability, especially in multi-product mixing labs
  • Decreases or eliminates risk of cross-contamination
  • Reduces downtime for cleaning validation
  • Good Engineering Practice (GEP) compliant designs available for super-efficient mixing performance

Single use mixers can be customized with connectors, filters and tubing, to suit your process or lab environment.

Reduce the risk of contamination while improving your costs! Contact White Mountain Process for a consultation to discuss your process and mixing needs.

Stay in the Lead with Your cGMP Process

Stay in the Lead with Your cGMP Process

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

What may have been high-end equipment 20 years ago may cause your company serious problems now. While it may function reliably, if your drug manufacturing process isn’t cGMP compliant, you risk regulatory action from the FDA. Ensure your system meets FDA standards now, by contacting a White Mountain Process specialist to review your current mixing system.

Current Good Manufacturing Practices (cGMP) are necessary guidelines for drug manufacturing. While people assume all manufacturers adhere to these practices, remarkably some manufacturers have not upgraded equipment to current processes and standards.

When it comes to drug products, cGMPs provide a solid foundation for good product quality. Our trained specialists can help you determine current weaknesses in your production and mixing equipment so you can remedy any potential problems quickly. We offer design assistance, necessary documentation, and can help you create a cGMP compliant manufacturing process in your lab to certify product purity.

With the proper systems in place, your manufacturing can guarantee product quality, thanks to strict quality management systems and solid operating procedures. We can help you take your drug manufacturing to the next level by assisting you with critical upgrades in equipment and record keeping strategies. Your company will enjoy the two-fold benefits of smarter production processes – including greater efficiency and a better end product.

Are contamination issues, product mix-ups, waste and errors a problem for your drug mixing production? Be sure your products meet quality standards with the latest in high performance equipment. Introduce the latest mixtank equipment designed for CIP and SIP processes, mixing designed for portability and improve your overall mixing processes and results.

Is your goal to apply more internal stringent requirements?

If quality is your company’s number one goal, let us introduce you to modernized systems which will greatly exceed minimum FDA standards. We build quality into your mixtank, taking into account your specific mixing procedures so you can develop reproducible processes and measurable results to guarantee the safety and effectiveness of the products you manufacture.

Have the assurance that your systems will pass critical inspections by following cGMP standards and regulations with robust mixing systems from White Mountain Process. Contact us to help with:

  • Solid to liquid applications requiring aggressive mixing
  • Efficient mixing for a wide variety of applications
  • Single-use mixing systems, single-use mixing bags
  • Buffer and media prep
  • Design assistance for setting up your cGMP certified cleanroom
  • CIP and SIP mixtank systems
  • Individual accessories, or complete, turn-key mixtank solutions
  • High shear mixers and granulators
  • Bulk containers, wash stations and blenders

Since the pharmacological and pathophysiological implications for cGMP drug production are many, White Mountain Process stays abreast of all changes and modifications, as well as the demands in the industry by major players in the drug manufacturing industry. Put our experience to work for you with engineering assistance, processing tips and valuable advice from the professionals who deal with high-end mixing every day.

With properly designed mixing systems tailored to your process and application, your products can make a difference in the life of your end customer, as well as your bottom line. The professionals at White Mountain Process can help you improve your mixing processes, from start to finish, including reporting and cleaning routines. It’s our goal to help your company provide advanced mixing processes and thereby helping you to assure your pharma or biotech mixing department is providing consistent quality to customers, every time.

Call us today to help your company stay ahead of the curve by developing effective and safe batches consistently.