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Single-Use Mixing Systems: Cut Costs, Reduce Risk & Increase Flexibility

Single-Use Mixing Systems: Cut Costs, Reduce Risk & Increase Flexibility

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A recent General Electric Healthcare Life Sciences study discovered that single-use mixers “exhibit lower environmental impacts” compared to their multi-use counterparts. As pharmaceutical and biotechnology manufacturers jump on the single-use mixer bandwagon, it’s likely that multi-use mixing technology will eventually become a thing of the past – at least in the highly sensitive, carefully sterilized spheres of biopharmaceuticals.

Single-use mixers are the way of the future when it comes to cutting costs, streamlining efficiency, and boosting output in the biopharmaceutical realm. Single-use mixers, which are comprised of pre-sterilized, disposable, usually polymer-based materials, are replacing stainless steel and glass mixers nationwide. Because single-use technology effectively reduces risks of cross contamination, it can significantly cut operational costs and reduce the corporate environmental footprint for the long term. Big savings over traditional mixing tanks are the reduced time and costs associated with CIP, clean in place, cleaning of equipment between batches.

Single-use mixers require users to dispose of all fluids and the disposable single use bag and mixer after each use. So how does this save money and streamline efficiency? The irony is that replacing the fluids every time actually saves cleaning and waste output, because multi-use mixers must be painstakingly cleaned and rinsed with the typical CIP cycle, purified water, washed with any number of cleaning solvents or acids, and then treated with air or pressurized steam if SIP is required. Cleaning products, chemicals, solvents, water and the heat used to produce steam all equate to added costs, extra time and an increased environmental impact.

Single-use mixers consist of an in-bag impeller, which creates a mixing action inside a hermetically sealed bag (the bag is disposable and often gamma radiated). Boasting results that include economic and operational efficiency, single-use mixers are ideal for media prep, buffer prep, product mixing, certain botanical oils and concentrates, drug formulation mixing, pH and conductivity adjustments, and compounding.

With the reduced cleaning demands inherent to the single-use mixer approach, CIP (Clean-In-Place) and SIP (Sterilize-In-Place) technologies – and their associated problems and risks – are also undermined when single-use mixing is implemented. Because CIP and SIP processes demand so many steps, from multiple “flushes” to solvent washes to “air blows,” the time and energy it takes to clean multi-use mixers is not insignificant. Enter the single-use mixer, which erases the need for constant cleanings as well as the concern that raw materials might become contaminated over the course of multiple agitations within the same enclosure.

The data is in, and it’s overwhelming: Single-use mixers are streamlined, simple, and practical. With slashed validation costs and cleaning times, you’ll find that single-use mixers enable increased operational flexibility across the board, because you’ll suddenly find yourself with more time and resources available to devote to other areas. And single-use mixers drastically reduce the risk of cross contamination, because fresh raw materials will always be entering a brand-new, sterile environment.

For sensitive or sterile operations, single-use mixers are the solution. With less wastewater output, less product waste, and a proven track record for reducing the company’s environmental footprint, a single-use mixer is the efficient, logical choice. Already, single-use mixers are appearing across a number of sectors and not only being used in biotech and pharmaceuticals.

7 Deadly Sins of Mixing

7 Deadly Sins of Mixing

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“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

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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

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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

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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

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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.

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