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Biopharmaceutical manufacturers have traditionally implemented bulk final filtration and bulk dispensing as two separate unit operations – with multiple operators assigned to carrying them out. However, this approach can be inefficient in a number of ways.
Drug product needs to be transported between the two unit operations. This movement of product and materials not only wastes operators’ resources but also increases the time taken to complete the final stage of the manufacturing process. There is also a risk of product loss and contamination during the transition between two unit operations.
Implications for biopharmaceutical manufacturers
The manual nature of bulk final filtration and bulk dispensing as two separate unit operations also has implications for biopharmaceutical manufacturers.Involving multiple operators in the process increases the potential for variability and human error. This can lead to product losses and in the event of contamination, the loss of entire batches – with the resulting financial losses, reputational damage and market shortages of life-changing drugs.
Human error can also lead to inaccuracies; for example, more product being transferred to a bottle or bag than is required can have a significant impact on production and can be financially damaging too – especially given the high value of the product when it reaches this stage.
There are also cost implications of the man-hours dedicated to the two unit operations – as well as the fact that specialist staff may be more effectively employed elsewhere in a process, rather than being used to manually operate pumps and valves.
Using a separate open process for bulk filling after filtration can expose a sterilized batch to potential contamination and given the product is in its most concentrated and valuable format at this time, the consequences can be grave.
How can efficiency be improved?
Parker’s SciLog® FD (Filter and Dispense) System automates, standardizes and encloses final bulk filtration and dispense operations. The system brings bulk final filtration and bulk dispense into one unit operation, which is optimized for both functions.
The SciLog® FD System removes the variability and potential for human error that is inherent in manual processes and it allows manufacturers to apply pre-defined recipes for dispensing. Stages such as sampling and product recovery are automated, while in-line pre and post-use filter integrity testing is built into the system.
How does the SciLog® FD improve efficiency in bulk final filtration and bulk dispense?
Additional advantages Reliability
Gain a greater understanding of the SciLog® Filter and Dispense FD at the SciLog® suite at Parker Bioscience Filtration’s site at Birtley, UK.
You can undertake interactive demonstrations with the SciLog® FD system and run trials to determine how the equipment can be used to optimize your processes. This can also be carried out virtually through a video link.
Contact us to book into the SciLog® suite.
Learn more about the SciLog® FD system.
This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK
Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively ensuring the quality of the final product.
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In today’s foundries, facilities engineers and maintenance personnel are challenged with effectively balancing increases in throughput with reductions in costs. Maintaining the optimum performance of baghouses is a critical area of focus as they can have a significant impact — either positive or negative — on the output of a foundry.
A foundry located in the U.S. was experiencing high differential pressure and short filter bag life in their baghouses, resulting in costly maintenance and problems with reduced furnace airflow. Specifically, the 3-compartment Bahnson Hawley/Norblo shaker baghouse did not provide adequate airflow to the four induction furnaces, a scrap pre-heater system, and a mag inoculation station it vented. The filters were blinding with fine particulate, and the resulting high-pressure drop across the collector reduced the original design airflow of 40,000 CFM to 28,000 CFM.
The foundry knew they needed expert advice on how to solve these issues before it was too late. They turned to Parker because of the company’s deep experience in air filtration design and equipment. Parker’s specialists determined that a system like the one installed at the foundry required a design air volume of 55,000–60,000 CFM — well beyond the capabilities of the old shaker-style baghouse.
Parker’s engineering team designed a pulse-jet cleaning conversion for the existing housing incorporating the high efficiency of BHA®PulsePleat® filter elements. In the design, the existing housing had the maintenance-intensive shaker mechanisms and thimble tubesheet removed and retrofitted with a flat tubesheet for installing the top-loading BHA®PulsePleat® filters from inside a walk-in clean air plenum. The design called for only 336 BHA®PulsePleat® filter elements to meet the calculated design air volume at a 4:1 air-to-cloth ratio.
BHA® PulsePleat® filter elements can revitalize your dust collection system, by solving the most common baghouse problems: lack of capacity, short filter life, and low efficiency. PulsePleats can increase the filtration surface area in your present baghouse system facilitating higher throughputs, longer life, and higher efficiencies. Benefits include:
The foundry decided to move forward with Parker Hannifin’s recommendation. The system was installed to the design specifications and the improvements quickly proved worthy of the investment. Some of the key findings included:
Effective business management starts with identifying inefficiencies and implementing real-world solutions that provide maximum benefits through increased production and reduced operational costs. By installing Parker’s innovative BHA® PulsePleat® technology, this foundry reduced furnace airflow problems, extended bag filter life and reduced high maintenance costs.
This blog was contributed by the Industrial Gas Filtration and Generation Team.
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As production facilities managers can attest, global wine production and consumption continue to flourish. Record production levels of 293 million hectolitre were reached during 2018. Europe continues to dominate wine production with Italy, France and Spain accounting for approximately 51 percent of global production. This puts additional stress on operations for plant managers.
Precise process cooling is one of the most critical requirements in modern winemaking. The application of cooling during several production steps facilitates high volume production whilst maintaining the unique flavour profile of the final product. Temperature control is also an important factor in wine preservation where consistent quality is required to allow distribution of the product to the global market. Hyperchill and Hyperchill Plus chillers offer a robust and cost-effective solution ideally suited to the exacting cooling demands of the wine industry.
Winemaking has been around for thousands of years. Many traditional and modern techniques are employed to produce the vast array of wine products found in the market place. There are different approaches required to produce red, white and sparkling wines.
In general, wine production can be split into 5 steps:
The diagram below details the wine processing stages and where chilling may be applied:
Temperature control through precision chillers may be employed in the following wine processes:
Cold maceration techniques are often employed in the production of red wines. The process is applied prior to alcoholic fermentation and can improve the extraction of taste and colour compounds from the grape skins, seeds and stems into the wine must. Wines manufactured in this way are considered to have more fruit flavours and colour intensity, in addition to reduced tartness.
Cold maceration can be achieved using several methods. Precision chillers, in conjunction with tubular heat exchangers or jacketed vats, are often able to deliver the required cooling capacity. Cold maceration usually occurs between 4-15°C for a period of two to seven days.
Temperature control of the wine must during the fermentation process is essential in the production of high-quality wines. Alcoholic fermentation is an exothermic chemical reaction in which yeast is used to transform the natural sugars into alcohol.
Optimal fermentation temperatures range between 18-20°C for white wines and 25°C for red wines. If excess heat is not removed from the process fermentation can stop, this can result in a poor taste profile with high sugar content. Additional additives such as Sulphur Dioxide are then required to prevent spoiling during storage.
Precision chillers are generally used to supply the cooling fluid to helical coils or jacket heat exchangers in the fermentation vessel. The diagram below depicts a typical set-up:
At low temperatures, a natural component called potassium bitartrate can crystallise out of the wine and leave sediment in the bottle. The crystals are considered an undesirable component in high-quality products.
Cold stabilisation is often practised prior to bottling to remove excess potassium bitartrate. The wine is chilled close to freezing point and held at this temperature for up to 48 hours. The low temperatures cause the potassium bitartrate to precipitate out of the solution where it can be filtered off before bottling.
The diagram below shows a typical set up for tartrate precipitation:
Hyperchill and Hyperchill Plus chillers deliver safe and reliable operation under varied working conditions that can meet the challenges found in the wine industry.
Key features and benefits for the industry are as follows:
This post was contributed by James Brown, compressed air and gas treatment/analytical gas sales manager and Filippo Turra, product manager, Parker Gas Separation and Filtration Division EMEA
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Sourcing fresh water for onboard use is an important consideration for the blue water cruiser. Blue water cruisers are boats designed to handle and be out in rough seas off the coast. These boats are designed for long passages across open water. Potable water can either be stored in tanks on the vessel, or it can be provided on-demand through the use of an onboard watermaker. A watermaker turns salt water into fresh water by removing salt and other contaminants. These new on-demand water purification systems can be installed on almost any vessel.
Simple operation
Parker's latest generation of its Aqua Whisper Pro series of fully manual watermakers brings efficiency and noiseless operation to your yacht and leisure craft. The Aqua Whisper Pro is suited for charter, offshore fishing, and ocean cruising. It’s traditional manual functions and touch-pad control panel allow simple operation and digital and analog instrumentation for redundancy.
The Sea Recovery Aqua Whisper Pro is an extremely quiet, compact watermaker for leisure marine applications, designed with the blue water cruiser in mind.
Another key feature is unobstructed access to the main components for ease of maintenance.
“The modular version offers customers a water maker package that allows for customized installation of the components.”
— Paul Kamel, engineering manager for Parker Bioscience and Water Filtration
The Aqua Whisper Pro utilizes precision engineered components and features a modern push-button controller interface with a digital display. Driven by AC or DC motors, this configuration enables boat owners to fit their watermaker into tight spaces. Integral to every SRC Aqua Whisper Pro unit is an open frame, resulting in less installation time.
Noise reduction
The watermaker utilizes a stainless steel pump specifically designed for seawater reverse osmosis applications. The unique design of this high-pressure pump reduces the noise level to a negligent hum.
Blue water cruising
The Aqua Whisper Pro produces between 450 to 1800 GPD of water, making it perfectly suited for mid to large-sized yachts and fishing boats.
New lower energy consumption watermaker
The low-hassle PRO (Parker Reverse Osmosis) Mini System is engineered to fit anywhere. Measuring at about 2 - 3 cubic feet, sail, center console, small power boaters and catamarans have the opportunity and the convenience of a Sea Recovery Watermaker without space restrictions. Featuring a simple interface, the PRO Mini can be monitored via the control panel or remote (optional). The perfect seaworthy companion for the solo cruise, the PRO Mini can produce up to 7,15, 23, or 31 gallons of fresh water per hour and 170, 350, 550, or 750 gallons per day.
Features include:
Conclusion
Whether you use it to drink, for cooking, to shower, for washing clothes or dishes, or to wash down your yacht, a Parker reverse osmosis (R.O.) watermaker system offers more than enough potable water for any crew, big or small. Having a Parker watermaker on board provides unlimited possibilities for saving money, and increasing leisure time.
To learn more about Parker Watermakers, view our selector app.
This article was contributed by Paul Kamel, engineering manager, Parker Bioscience and Water Filtration
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The food and beverage industry is the largest manufacturing sector to use chilled water systems. Applications within the industry are very diverse due to the wide range of product types and how they are produced. Applied to most food applications through to packaging, cooling is a way of speeding up the throughput of produce, as it reduces the time after cooking or baking.
The soft drinks industry requires cooling during the process of fizzy drink manufacturing. The fizz is provided by carbon dioxide, which is injected prior to packaging into bottles or cans. If the product is not chilled, the carbon dioxide will boil off, and frothing occurs; chilling the product is key to maintaining product integrity.
Precision cooling is a key factor in meeting some industry standards and ensuring consistently safe production methods are used. In addition to the regulatory requirements, precision cooling is also used to speed up the process, so that manufacturers can reduce lead-times and save money.
Chillers are prevalent in most types of food production. Broadly speaking, if a food is heated for cooking or baking, then it is likely to require cooling down prior to finishing and packaging. In some instances, it is necessary to cool specific ingredients during the process. In a bakery, the dough is typically mixed with cooled water, as this controls the yeast rising and allows consistency.
Some key methods of cooling product applied during production are:
Some typical illustrations below:
At the end of production, almost all food and drink needs to be packaged. Most companies install machines specifically designed to pack the produce using an automated system. Some of these machines are manufactured by global OEM companies and others are bespoke systems, designed and installed by specialists in the field.
Irrespective of their origins, most of these machines adopt the same principle whereby they hermetically seal the food within a container to preserve shelf life.
The sealing process uses a heated tool to apply the seal and chilled water to set and free the package from the tool. These machines can sometimes be supplied from a central cooling system, or more commonly, will have a dedicated process chiller located at the point of use.
Centralised cooling systems have some benefits but also limitations. If well designed, they can be more efficient than small, single, point of use chillers, and combining multiple chillers in a modular system provides a robust solution. Hyperchill units are designed to be installed into a combined modular system, with the ability to add further chillers to increase capacity to customers’ needs.
Individual point-of-use chillers are generally used where numerous applications within a food or drinks factory have different operating criteria for water temperature and pressure. Parker Hyperchill and Hyperchill Plus units are designed to be fully configurable to meet the specification of these applications.
Potable water is widely used both as a food ingredient and in food preparation. A town’s mains water supply is inconsistent, with temperature values increasing in summer and decreasing through winter.
The solution is to combine a chiller with an external heat exchanger and tank, packaged with a control system to deliver a metered volume of water at the specified water temperature.
The system package size is based on batch size, cycle time and water temperature. The chiller water circuit and process potable water circuit must be independent, as food standard regulations do not allow potable water to be directly cooled by a chiller, due to the risk of refrigerant contamination. Hyperchill and Hyperchill Plus are ideally suited to potable water packaged systems.
Why Parker?
Parker Hyperchill and Hyperchill Plus chillers offer the ideal solution for food and beverage cooling processes that require high performance, energy efficiency, reliability, continuity of operation, and reduced maintenance costs. Each Hyperchill and Hyperchill Plus unit is extensively tested to guarantee efficient operation and reliability under all working conditions.
Features and benefits include:
This post was contributed by James Brown, compressed air and gas treatment/analytical gas sales manager and Filippo Turra, product manager, Parker Gas Separation and Filtration Division EMEA
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Improving indoor air quality (IAQ) has been a major focus in manufacturing, industrial, and other commercial environments for decades, given that poor IAQ can not only cause immediate deleterious effects but can also lead to long-term damage.
Then, COVID-19 entered the picture, and it became increasingly important to analyze the filtration systems in commercial HVAC units to gauge their effectiveness in reducing the spread of the virus.
Understanding the MERV rating system is important because not all filters are created equal when it comes to capturing airborne particles. See figure 1.1.
Not all particles are the same in type. Even within the two categories of aerosol – solid and liquid – and compounds, there are specific differences. Solids include coarse, fine, and ultrafine as well as nanoparticles (the same as ultrafine) and bioaerosols (airborne biological materials). Liquid particles include fogs and mists, while compound particles include smoke, smog, and environmental tobacco smoke.
MERV (Minimum Efficiency Reporting Value) rates the fraction of particles removed from the air passing through a filter under standard conditions – i.e., filter efficiency. MERV ratings range from 1 to 16. The higher the MERV number, the higher the efficiency of that rated filter. A filter capable of capturing very small particles (5 μm or smaller) will help reduce the risk of spread of infectious aerosols that can otherwise remain airborne for an indefinite period of time. See figure 1.2.
It’s also important to note that several factors affect the overall effectiveness of reducing particle concentrations, including the filter efficiency, airflow rate through the filter, the size of the particles, and the location of the filter in the HVAC system or room air cleaner.
Improving indoor air quality by installing higher-rated MERV air filters has documented physical advantages but the equipment in the work environment benefits as well. When HVAC systems are equipped with MERV 13-16 rated filters, more contaminants are removed from the air, reducing the number of particles that settle within the equipment, potentially damaging their components or degrading their performance.
The reduction of airborne particles through the installation of higher MERV-rated air filters combined with a regular HVAC maintenance schedule will ensure the air quality of the environment and the operational performance of the air handling equipment remain at an optimal level.
Parker HVAC Filtration recently introduced its Clean-Pak® extended surface synthetic bag filter – the first MERV 16 rated bag filter in the market – that can trap air particle sizes .3 to 1.0 microns.
In the past, hospital inpatient care, healthcare facilities, microelectronics manufacturing, and other commercial clients who required this level of particulate reduction had to install sub-HEPA or HEPA/ULPA air filters into their system. Clean-Pak MERV 16 bag filters are a sub-HEPA alternative.
Clean-Pak filters are designed with microfine synthetic media that is unaffected by moisture or humidity and provides maximum dust holding capacity. Other features include a rugged construction that reduces filter damage during transport and installation, sonically-welded filter pockets creating high strength and maintaining pocket integrity when in operation, and fabric ribbon separators sonically-welded inside the pockets to create aerodynamic channels for smooth air flow and low resistance.
Since the Clean-Pak synthetic bag filter is available in a variety of filter dimensions and pocket quantities, it easily replaces lower MERV rated filters while providing greater filtering results. Always check with a professional contractor or the system manufacturer when upgrading a filter since high-efficiency filters can affect the performance of an HVAC system.
This article was contributed by the HVAC Filtration Team.
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In bulk dispense operations, filtration can sometimes be treated as either a completely separate unit operation or in some systems as a bolt-on – an optional module that while performing this critical process step, hasn’t been truly optimized. This means that it may not work as efficiently or safely as it should, with consequences for product output, product safety and manufacturing capacity.
But what if bulk filtration and dispense could be optimized and delivered from one integrated system?
Introducing the SciLog® Filter and Dispense (FD) system
Parker Bioscience Filtration has more than 50 years of experience in designing and delivering filtration solutions. And working closely with the biopharmaceutical industry, we used our expertise to create a solution that could ensure that the filtration process step prior to bulk filling was fully integrated with the filling step in one closed, automated operation. In doing so, we have enabled biopharmaceutical manufacturers to benefit from an automated single-use system which helps them to minimize product loss and maximize yield, while saving resources on manual operations.
The SciLog® FD System allows the bulk filtration and dispense of biopharmaceutical products into either bags or bottles. It was designed and fully optimized with customer concerns in mind – for example, the FD system allows for ‘on-line’ integrity testing of both filters and manifolds through the use of Parker’s Scilog SciPres® Single-Use Pressure Sensors.
An automated, enclosed single-use system, it protects both the operator and the product: operators are not exposed to active biopharmaceutical compounds and the risk of contamination is minimized.
Advantages of the SciLog® FD system for the bulk filtration process
Parker Bioscience Filtration can customize the manifolds used on the system using our own technologies and through an open architecture approach, this would allow us to design a manifold with any commercially available filter capsule included in it.
Optimize your processes
You can gain a greater understanding of The SciLog® FD system at the SciLog® suite at Parker Bioscience Filtration’s site at Birtley, UK.
You can undertake interactive demonstrations with The SciLog® FD System and run trials to determine how the equipment can be used to optimize your processes. This can also be carried out virtually through a video link.
To book into the SciLog® suite, contact us.
For detailed information on the SciLog FD system, please visit our web page.
This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK
Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively ensuring the quality of the final product.
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The amount of dust created in metalworking applications calls for plant engineers and maintenance managers to make careful selections in their mitigation measures and equipment. While dust collectors are carefully engineered to handle the load, they are often overcome as production expands. In bronze manufacturing, for example, there is a strong need to find ways to extend filter life due to the high quantities of the dust generated in zinc processing operations. Here, we will examine how one company resolved an issue with premature binding of paper filter media.
The challenge
In the processing of zinc, a sticky, highly binding dust is created. A dust collector in operation at a bronze manufacturing facility offered a reasonable 2” differential pressure when it was first installed. Soon after installation, however, the pressure drop increased to over 5” and in a three month period, surpassed the 8” mark. The plant maintenance team investigated and determined that the increase in pressure drop was caused by an acute binding effect. The paper filter media used in the dust collector was clogged with a heavy conglomeration of dust created during processing resulting in:
The solution
The manufacturer turned to Parker for a solution. Parker’s experienced filtration engineers reviewed the situation carefully and made the recommendation of replacing the paper media with BHA® Spunbond Polyester Cartridges. In addition, Parker recommended the initial, then daily application of BHA® Neutralite SR Spark Resistant Conditioning Agent.
BHA® Neutralite SR
Neutralite SR is a light-density, neutral aluminum silicate powder that extinguishes hot sparks on contact before they can damage filters. The powder consists of microscopic particles of varying shapes. When injected into a baghouse, it creates a porous dustcake layer on the outer surface of the filter bags that increases filtering efficiency, improves airflow, and absorbs moisture and hydrocarbons.
BHA® Spunbond Polyester Cartridges
Ideal for industrial applications like metalworking, spunbond polyester is a synthetic media that has similar filtration efficiencies to cellulose. It’s strong, more resistant to abrasion and moisture, and it has a better life cycle. It carries an average MERV rating of 10 and a MERV rating of 15 with nanofibers applied to the surface. With an ePTFE membrane applied to the surface of the base media, it has a MERV rating of 16+. The temperature rating is 265•F, continuous.
To test the effectiveness of the recommendation, the Parker BHA® Spunbond Cartridges and Neutralite SR treatment were installed to run a side by side comparison with the paper cartridges.
Results
Conclusion
The dust created in metalworking applications can be extensive and cause delayed or lost production and costly maintenance. Choosing high-quality filtration equipment, like BHA® Spunbond Cartridges, can prevent premature filter binding, extend the life of baghouse filters and reduce downtime and expensive maintenance.
This blog was contributed by the Industrial Gas Filtration and Generation Division Team.
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Precision cooling is an integral part of the brewing and distilling process. The quality and integrity of the finished products are reliant on accurate temperature control and reduction during key stages of brewing operations. Key aspects of production include:
During the initial stages of brewing, grain kernels are milled to form grist. The grist is transferred to the mash tun and heated water is added. During mash conversion, natural enzymes in the grist break down the malt starch into fermentable sugars. The mash is then pumped into the lauter tun where a sweet liquor (wort) is separated from the grist.
The wort is transferred to a kettle and heated to a controlled boil temperature of approximately 60°C before hops are introduced. After the boiling phase, residual malt and hop particles are removed.
Whilst the wort is still hot it is rapidly cooled for the following reasons:
The diagram below shows key aspects of the brewing process (click to enlarge).
Most breweries pass the wort through a single or double stage plate heat exchanger to achieve cooling. The application is demanding; a significant heat load must be removed quickly form the process. A glycol water mix on the water circuit is common to provide enhanced cooling capacity. A double-walled food grade heat exchanger is generally selected to prevent contamination issues between the wort and cooling fluid.
When sizing a chiller for wart cooling, consider the following:
The provision of cooling capacity from a precision chiller is important throughout fermentation. The chiller must regulate the fermentation temperature to prevent product spoiling. In some instances, the brew is also rapidly cooled at the end of fermentation to assist yeast flocculation.
During the fermentation stage, the wort is generally transferred into stainless steel cylindroconical vessels (CCV). Brewer’s yeast is added to the sugary wort when the vessel is filled to begin fermentation. Sugars in the wort are converted to alcohol and CO2 along with other flavour adding compounds.
Fermentation is an exothermic process and can liberate significant heat. This heat must be controlled to protect the integrity of the brew. Temperature control is important for the following reasons:
When sizing a chiller for fermentation, the following points should be considered:
In certain processes, beer and lager are cooled in the latter stages of conditioning and filtering. This is often done to improve product clarity and stability. In larger breweries, the temperature is often monitored and controlled during bottle and keg filling. Excess heat from bottling machines may need to be controlled to protect the integrity of the final product.
Precision water coolers are vital in the production of high-quality consumer spirits. Several steps in the production of spirits are reliant on maintaining a consistent temperature and removing excess heat. Initial production stages for whiskey and spirits mirror those in the brewing process. Additional distillation and conditioning stages follow fermentation to produce the final product.
A typical process for producing whiskey is shown in the diagram below (click to enlarge):
Precision water coolers are often employed in the following processes during the production of whiskey and other spirits:
Non-filtered whisky with an ABV of 46% or lower can often form sediment in the bottle when stored in a cool place. The drink can also take on a cloudy appearance when water or ice are added before consumption. These cosmetic factors are considered undesirable in quality products. Natural fatty acids, esters and proteins in the whiskey form during distillation in addition to being imparted from the cask during maturation. These components flocculate and precipitate out of the whiskey when it is chilled.
Chill filtration is employed to prevent the above issues. The process involves dropping the whiskey temperature to 0 °C for malts (-4 °C for blends). Once chilled, the whiskey is passed through a series of tightly knit metallic meshes or paper filters under pressure. During this process, the precipitate and any other sediment or impurities from the cask (coals) are removed.
As with other brewing processes, food-grade heat exchanger is employed to manage the cooling.
Parker Hyperchill and Hyperchill Plus chillers deliver safe and reliable operation under varied working conditions like those typically found in the brewery and distillation industry, helping owners and operators maintain the integrity of the final product and reduce cost of ownership.
Design features on the Parker product can deliver significant benefits to the end-users in the brewing and distillation industry.
Key features and benefits include:
This post was contributed by James Brown, compressed air and gas treatment/analytical gas sales manager and Filippo Turra, product manager, Parker Gas Separation and Filtration Division EMEA
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Cell culture media is a key component of upstream bioprocessing needed to encourage the growth and survival of cells. This is vital to achieving a viable cell density and, ultimately, the desired product titre. However, its filtration can be a challenge for biopharmaceutical manufacturers.
Cell culture media is a complex mixture and typically contains up to 60 ingredients. However, the exact composition will differ based on the media chosen for the specific application.
Media is usually supplied either as a powder, concentrate or working solution. If a powdered media is used, it must be mixed and sterilized on site prior to use.
Cell culture media can be categorized into several different formats based on its composition:
Serum
Serum is a nutritionally and protein-rich substance derived from animal blood. Serum containing media was once seen as essential for good cell growth and proliferation, however, the desire for animal component-free media due to concerns about contamination and regulation have led bioprocesses away from this media type.
Serum is also expensive and as it is a natural product, it is by nature uncharacterized and is prone to a high degree of variation.
Serum-free media
Serum-free media often contains proteins/protein hydrosolates and, while it is more characterized than serum-based media, it may still contain components derived from animal sources.
Animal-derived component-free media
Animal-derived component-free media offers an alternative to serum media. It uses non-animal derived proteins and hydrololates available from soy, yeast or other non-animal-based sources.
Protein-free media
Protein-free media allows greater chemical definition of the media's make up.
Chemically defined media
Chemically defined media aims to eliminate variation by using only fully defined components - these may be animal-derived or animal-free depending on the media.
Whichever media is used, a compromise must be found between safety, characterization and performance. Robust supplier quality assurance is needed to ensure traceability and the procurement of contamination-free media.
The media will ultimately be chosen to suit the process.
So, what is cell culture media composed of?
Depending on how characterized the media is, the concentrations of components and exact composition may vary lot-to-lot. Different medias will also have different compositions.
The ingredients in cell culture media provide a rich nurturing environment for the cells biopharmaceutical manufacturers wish to propagate. Unfortunately, that kind of environment is a place in which bacteria or other unwanted microorganisms can flourish.
The role of filtration
Filtration is commonly used to protect cell culture media from contamination. If the powdered media is prepared on site, it will be prepared in a mixing vessel. Components such as water will be filtered to remove contamination prior to entering the vessel and any air and gas or venting will be protected using gas filters.
Prior to entering the bioreactor itself, the media will be filtered to ensure its sterility - and to, therefore, protect the bioreactor. This filtration may involve prefiltration as well as sterilizing-grade filtration or Mycoplasama removal filtration, depending on the process.
0.2 micron rated validated sterilizing-grade filtration is used to achieve sterility, or if Mycoplasma contamination is of concern. 0.1 micron rated filtration validated for Mycoplasma removal should be used. Depending of the process and media, prefiltration may also be required.
The correct design of this filtration system is crucial in optimizing the process. The design must take into account:
The challenges of cell culture media filtration
A number of issues can arise in the cell culture media filtration process:
However, these issues can be mitigated by optimizing the filtration system correctly.
Parker supports biopharmaceutical manufacturers in filtration system optimization through testing, process trials and validation as well as technical support for existing systems. We have an extensive range of filters designed for cell culture media filtration including PROPOR SG, our standard 0.2 micron sterilizing grade product, PROPOR HC, our high capacity sterilizing grade product for difficult to filter or variable medias and PROPOR MR 0.1 micron filter designed for use in processes where Mycoplasma contamination is a concern.
For more information on cell culture media filtration, view our recent webinar: Optimization of Cell Culture Media Filtration in Bioprocessing
What are your biggest challenges in sterilizing filtration media? Let us know in the comments below.
This post was contributed by David Heaney, market development manager, Parker Bioscience Filtration, UK
Parker Bioscience Filtration specializes in automating and controlling bioprocesses. By integrating sensory and automation technology into a process, a manufacturer can control the fluid more effectively ensuring the quality of the final product. Visit www.parker.com/bioscience to find out more.
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