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The increased value being placed on responsible corporate citizenship and green initiatives has prompted cement manufacturing companies to look closely at how they will comply with the proposed National Emission Standards for Hazardous Air Pollutants (NESHAP) Particulate Matter (PM) limits. The effect of these potential new limits in the United States has had a ripple effect on the design, production and adoption of filtration technologies and best practices around the world.
This blog examines solutions to baghouse particulate removal efficiency to meet the proposed NESHAP PM limits and presents the results of two studies conducted on the effects of taped seams vs. standard felled seam construction on emissions reduction.
For complete study details including data and methodology, download the full white paper.
Is there a magic solution?
Even before the details of these new regulations were settled, many cement manufacturers were already in search of a special solution — a magic filter bag that would make even the most stringent emissions challenges a thing of the past. As much as a singular solution that meets this need is desired, no such option exists.
A filter bag is only one of the many components in a dust collector. The key to effective particulate removal efficiency depends on the successful operation of all parts of the system.
These companies must consider a host of components, operating conditions and other variables such as age and maintenance history in order to ensure their dust collection system will offer optimum performance and meet the emissions levels defined in the NESHAP.
Meeting the new standards
It is well known that polytetrafluoroethylene (ePTFE) filters are exceptionally efficient in capturing particulate on the collection surface of a filter bag without having to rely on a dust-cake or control layer. A properly designed and maintained dust collector installed with these filters can meet the emissions levels required by the new NESHAP rule.
The challenge
Meeting the limits is achievable, but the question that continues to elude companies is: For how long? There is a lack of historical data available for continuous outlet emissions that shows the point in a filter’s life when emissions begin increasing.
Why do emissions occur?
Design, operation, age and process conditions are the variables that contribute to filter life. Where these can present dynamic conditions individually, their combination makes for an endlessly complex matrix of possibilities. To this end, the performance of a system with the same specifications can operate differently in every environment in which it is applied.
In order to mitigate these dynamics, companies are choosing to segment the challenges they face in order to contain the variables.
For example, understanding that increased emissions will result as ePTFE membranes age and develop fractures and fissures along flex lines, gives the plant operations managers and engineers something to evaluate and preempt through scheduled maintenance.
Can dust penetration occur at the needle holes on filter bag seams?
One hypothesis based on a previously published study, suggests that dust penetration/leakage can occur through the stitching on filter bag seams and taping them can have a positive impact on the reduction of particulate emissions.
Separate testing, commissioned by Parker Hannifin, that adhered to the US EPA’s Environmental Testing Verification (ETV) testing protocol yielded different results.
Why the discrepancy?
The independent testing commissioned by Parker put the filtration through the rigors that more closely resemble normal baghouse operation, in a laboratory setting. This testing offers a more accurate portrayal of durable filter life than the previously published study that only simulated the early seasoning phase. ETV protocol does not draw conclusions from results taken during the seasoning phase.
Results
ETS, Inc, an independent laboratory, was commissioned by Parker to perform the testing. The tests were performed per the US EPA’s ETV program and in accordance with the ASTM Test Method D830-02 utilizing Parker 22 oz. woven fiberglass media with ePTFE membrane. The results showed:
Conclusion
The truth is that there is no magic filter bag to be discovered, but there are practical lessons to be learned: Particulate removal efficiency is a function of the effective operation of all parts of the system. Properly installed and maintained ePTFE membrane filters are an effective solution for meeting the NESHAP emission limits.
This article was contributed by the Filtration technology team.
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Foundry Eliminates Shutdowns and Extends Baghouse Filter Life
Filter qualification typically involves demonstrating bacterial retention of a filter under process simulated conditions.
A crucial first step in this is in the hands of the filter vendor, who is responsible for producing a ‘fit for purpose’ filter such as those in Parker's PROPOR membrane filter range. Supporting data which demonstrates filter performance under standardized test conditions should then be presented in a validation guide.
Improving Sterilising Filtration in the
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A destructive test – bacterial retention performed during validation – should be carried out and this is typically undertaken by the filter manufacturer.
In addition, a non-destructive filter integrity test should be performed by both the end user and the manufacturer. This will be in the form of either a bubble point test or a diffusion test and will link to the work carried out in the destructive test.
Process qualification
Process qualification must be carried out to prove the filter works in the customer process and with the fluid stream.
You can access guidance on process qualification in PDA Technical Report 26 and in ISO 13408-2:2018.
To carry out effective process qualification, it is best to start at a small scale, develop the process and then test it. Testing should then be carried out at the largest scale possible – so with the largest batch size, at the highest pressure and across the longest process time. If the feed stream is variable, then this should be taken into account. However, typically at this stage the feed stream is fairly well defined: the volume may change but the constituents of the feed stream will be the same.
Conclusion
In order to carry out effective filter qualification, you need to show that the combination of a defined, consistent filter membrane, used to filter a particular and controlled feed stream, under defined conditions of temperature, time and pressure, will retain bacteria.
To learn more about filtration in the biopharmaceutical industry, sign up for our webinar
Learn more about Parker's PROPOR range of biopharmaceutical membrane filters
This post was contributed by Paul Hymus, product manager (filtration), Parker Bioscience Filtration, United Kingdom
Parker Bioscience Filtration specializes in automating and controlling single-use 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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When it comes to supplying dry, inert nitrogen for manufacturing applications, there’s a lot more to PSA technology (pressure swing adsorption) nitrogen generators than vessels filled with CMS (carbon molecular sieve).
The correct quality gas is delivered to the application or process.
In the unlikely event of the nitrogen gas not meeting the specification requirements, the outlet to the application is shut off and the off-specification gas is vented to atmosphere at approximately 2/3rds of the generator flow capacity. The nitrogen generator automatically corrects the situation without the need for intervention. The customer is assured full compliance with specified gas purity being met under all circumstances, no product recalls or spoilage, as well as labour, time and cost savings that would be required for manual intervention. The image to the left shows an outlet valve block with off-gas by-pass valve at the front.
The NITROSource nitrogen gas generator incorporates two energy-saving features:
This procedure ensures that the CMS is filled in the columns at maximum packing density. Advantages include:
This blog was contributed by Phil Green, application and training manager, Parker Gas Separation and Filtration Division, EMEA.
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Foundries rely on the uninterrupted operation of their dust collection systems to assure a safe and productive work environment and proper operation of equipment. When dust collection systems present maintenance issues, foundries can realize tens of thousands of dollars in inefficiencies. If the issues are unrecognized or ignored, the costs will multiply very quickly and can result in lengthy shutdowns.
This was the scenario that a large Midwestern foundry sought to avoid after enduring multiple shutdowns in a year’s time to perform filter maintenance on their Carborundum baghouse.
The problem
The foundry was having significant problems with their filters being blinded by the fine particles in the gas stream. They were operating a pulse jet baghouse with seven compartments, at 250,000 ACFM. The filters that they had in operation used conventional polyester felt technology. The system had been designed at a 4.1/1 air-to-cloth ratio.
The fine particles in the dust stream were of a volume that simply overcame the filter media. This pushed the differential pressure across the baghouse to over 8 inches. The system was rendered unrecoverable and inoperable.
Maintenance was conducted using the same filtration technology, and the blinding effect repeated itself. The filters were only able to stay in operation for six months before the end of their useful life. As a result, the filters and labor cost the foundry in excess of two hundred thousand dollars over a year’s time.
The solution
In the search for a solution, the foundry turned to Parker Hannifin. Parker recommended implementing spun-bound polyester BHA® PulsePleat® filter elements (PFE) in place of the polyester felt bag and cage design that had been in use. These filter elements feature a combination of pleated high-efficiency filtration media and an inner support core that forms a one-piece element that fits directly into an existing baghouse tubesheet. The BHA®PulsePleat® filter media would offer a much better air-to-cloth ratio of 2.1/1. In addition, the pleated design of the media would not be as susceptible to the blinding effect caused by the fine particles in the gas stream.
Results
The foundry implemented the PFEs in two phases, addressing the most problematic compartments first. After seeing positive results, it moved forward and converted the rest of the collector to pleated filters. The return on the total conversion expense of $285K was realized after sixteen months of efficient operation with no maintenance required.
After twenty-one months of operation, the differential pressure was operating in the 3-5 inch range. The filters had proved capable of handling the fine particle load without blinding. Even after a weeklong accidental shutdown of the cleaning system, the filters were able to have the particle loading and maintain a low differential and efficient operation. At this point, the foundry had realized a filter life three times greater with the pleated filtration in comparison to the polyester felt.
Under the current operating conditions, the foundry is not planning to perform filter replacement maintenance for another twelve months. In this case, they will have seen a five times improvement in filter life by employing the BHA®PulsePleat® technology.
By employing the BHA®PulsePleat® technology, this foundry eliminated frequent unplanned shutdowns, increased ROI and extended the life of the filters in its pulse jet baghouse.
To learn more about BHA dust collection products, watch this video:
This article was contributed by the Filtration technology team.
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BHA® Pleated Filter Elements Improve Dust Collection for the Foundry Industry
In industrial manufacturing, the need for frequent, costly maintenance is often the stimulus that compels equipment operators to search for a better solution. Time is valuable, and hours spent on maintenance activities could be put towards other responsibilities.
This was the case when a cement company searched for a solution for the short life expectancy of the filters used in its Fuller pulse jet dust collector connected to and OSEPA high-efficiency separator.
The problem
The company was realizing a useful life of its process dust collection filters of only two years, due to a combination of issues: Velocity of the dust in their systems was rendering the membrane material on their filter bags useless. This was allowing for bleed through to the depth of the polyester filter bag, causing an increase of operating differential pressure to over 8 inches (203mm). The high operating differential pressure led to an increase in measured emissions from the system.
The original system was designed to handle an air flow of 61,000 cubic feet per minute. This called for 975 installed filters. Each filter was made of 16-ounce (500 grams) polyester PTFE laminated felt. The dimensions of each filter were 6.25 inches (158.75mm) by 144 inches (3,658 mm). This resulted in a total filtration area of 19,134 square feet (1,779 square meters.) The air to media ratio was 3.1:1.
The solution
The search ended when the company replaced the existing conventional bags and cages with Parker OSEPA BHA® PulsePleat® filter elements (PFE). PFEs offered the opportunity to increase total filtration area while reducing the physical space required. The same number of elements were installed but they were reduced in length from 144 inches to 57 inches. The spun-bound polyester media, set in a pleat, with molded urethane end-caps required no tube sheet or collector modifications. Due to the pleat design, the total filtration area was increased by 75 percent to 33,590 cubic feet. This reduced the air to media ratio to 1.8:1.
Results
After several months of operation, the cement company realized a number of savings and benefits, including:
By installing PFEs, the cement company avoided the high costs of modifying their existing equipment or adding a new dust collector. The company has realized full production capability with lower emissions, lower differential pressure, reduced energy costs and less compressed air consumption as well as longer filter life.
To learn more about BHA dust collection products, watch this video:
This blog was contributed by the Filtration Technology team, Parker Industrial Gas Filtration and Generation Division
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Business growth creates new challenges. This is the case for plant engineers and maintenance managers responsible for the efficient operation of the most common form of dust collection equipment — pulse-jet baghouses — used in foundries across the globe. Many baghouses were designed and built to accommodate a certain amount of air flow that was sufficient for past demands. As foundries have increased production, these flow requirements have amplified and the original design of the baghouses are no longer suitable. Their obsolescence is perpetuated by raised scrutiny on emissions and the focus on the business community’s responsiveness as good corporate neighbors and stewards to a sustainable environment.
In this blog, we will explore pleated filter element (PFE) technology and examine how two foundries successfully upgraded their pulse-jet dust collectors by installing PFEs, resulting in:
The Environmental Protection Agency (EPA) and Occupational Safety & Health Administration (OSHA) regulations have become increasingly more stringent, requiring foundries to upgrade their current operational ventilation systems to comply with regulatory standards. Foundries have evaluated their furnaces, shakeout, pouring and cooling lines, sand handling systems, finishing areas and many other parts of their operations reliant on pulse-jet dust collectors for proper ventilation. Their evaluations have found a multitude of problems, including:
As a result, foundries are looking for ways to upgrade their dust collection. The most economical and preferred option is to modify existing baghouses rather than installing completely new systems, which would require significant capital investment. PFEs provide an effective solution to this challenge.
Pleated filter elements, such as those manufactured by Parker Hannifin, are filters that use either a molded polyurethane or metal top and bottom that are used as direct replacement for standard felted filter bag and cage assemblies in pulse-jet baghouses, as well as in new equipment. Spun-bonded polyester fabric is the most common media used in PFEs because of its tight pore structure and rigid physical properties that allow it to hold a self-supported pleat —providing as much as 200 to 300% more filtration area at 99.992% efficiency than a filter bag in the same tubesheet hole.
A major Midwest foundry used a three-compartment, 882-bag shaker baghouse to ventilate four induction furnaces, a scrap preheater system, and a magnesium inoculation station. The foundry struggled with the following problems in its dust collection system:
As a solution, the company converted the original shaker system to an engineered pulse-jet style cleaning system using BHA® PFEs manufactured by Parker Hannifin's Industrial Gas Filtration and Generation Division. The baghouse was retrofitted with a new tubesheet and a walk-in clean air plenum, to allow for a top-load design filter element. The baghouse has been operating consistently since the retrofit.
Since the retrofit, the baghouse has been operating consistently and the following results have been reported:
Finishing area
A large foundry that manufactures castings for the automotive industry had a top-load design pulse-jet baghouse that contained 650 felted filter bags and cages. The unit ventilated several shot blast cabinets, grinders, and other finishing equipment. The system was originally designed at an air-to-cloth ratio of 6.1:1. The filter bags measured 5.25 in. in diameter by 12 ft. in length, for a total cloth area of 16.5 ft2 per filter bag. The challenges the foundry was experiencing with the current design were:
The foundry engineering team determined that installing Parker BHA PFEs in the dust collector was the most cost-effective solution.
Post installation results include:
Pulse-jet dust collectors used in most foundry applications can be successfully upgraded with the installation of pleated filter elements. The case studies show that when aggressively designed to air-to-cloth ratios and demands for increased airflow capacity cause poor dust collector performance, the installation of PFEs can dramatically lower differential pressures, improve filtering efficiencies, reduce emissions and lower overall plant maintenance requirements.
This blog was contributed by the Filtration technology team, Parker Industrial Gas Filtration and Generation Division.
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Gas turbine performance is affected by the environmental challenges of a specific power plant installation. In a recent project located in the Middle East, a filtration solution to protect the turbine needed to be designed to address each of the conditions faced, including varying amounts of:
The spectrum of potential hazards that could be faced at a turbine installation means one filter cannot meet all needs. Even the different forms of dust or moisture present need to be considered within the design of the filter house.
A brutal environment for gas turbines
In the Middle East, a mixture of sandstorms, heat, mist and moisture from random fog events, make for a brutal environment for a gas turbine. It is the combination of the moisture in thick fog combined with high dust concentrations that can be particularly challenging for a gas turbine filter system.
Without the correct design and implementation of a system, the installation is at risk of sudden pressure increases, gas turbine shutdowns, difficult and time-consuming maintenance and greatly shortened filter life. Indeed, as one operator was experiencing, it is not uncommon for pre-filters to require changing every two or three days and final filters to need replacement after just six or seven months, as opposed to a normal life expectancy of over two years. The increased labour and ongoing cost to keep operations running and reduced availability of the gas turbine were having a serious impact on the operation’s bottom line.
The gas turbine installation in question was at a power plant in a coastal, desert location in the Middle East. Seasonal fog events and extremely high levels of dust were causing havoc with the system. After careful review of the installation and specific environmental conditions, however, relatively simple changes led to a dramatic improvement in performance.
When to pulse – and when not to
One of the first areas to be considered was the pulse system settings. A pulse system removes dust build-up on the filter and tends to operate in one of two ways. In the first, it can be set to run continuously without regard for the differential pressure.
Alternatively, however, it can be configured to run when the differential pressure across the filter reaches a certain level. Once this level is seen, the pulse system turns on, cleans the filters and then turns off when a low differential pressure setpoint is met.
The site’s pulse system was set to run continuously. The issue this created, however, was that the fine dust in the area was leaving the filters in a dust cloud and simply becoming re-entrained on the filter. The system was changed to operate only when differential pressure reached a pre-set trigger level. The switching levels were established based on testing with the local environmental conditions and found to be optimized with the system turning on at 1.5” wg (water gauge) and off at 1.0” wg. This meant the filters were cleaned before pressure became an issue but not before a dust cake built up on them that enabled gravity to help the dust move down the filter house. Typical set points for pulse cleaning start around 3.0” wg and stop at 2.5 or 2.0” wg.
Handling the moisture from the fog
The next area to be considered were the coalescers, which were experiencing serious issues. Coalescers are used to remove moisture from the air flow prior to it reaching the filter. If there is a lot of moisture in the air flow when it reaches the filtration stages, small moisture droplets combine with the dust and sand to create blockages and sudden increases in differential pressure. The size of these droplets means they can also work their way into the matrix of the filter media and get stuck. Coalescers usually work to prevent this from happening by combining small moisture droplets to form bigger, heavier ones — many of which will then naturally fall out of the airflow.
The site in question had traditional coalescers installed, known as mat coalescers, which employ media similar to that used in dust filtration. The issue with these, however, was that the high volumes of dust were quickly clogging them and, with no path for the inlet air flow, they were being forced out of place. Once the air was able to completely bypass the coalescers, the moist air and dust were continuing to the filter and creating blockages. Placing the coalescing technology with a modern, fully washable, 100% synthetic mesh resolved this issue and, even after 12 months of operation, the coalescers remain firmly in place and doing the task for which they are installed.
Unlike the traditional mat equivalents, the new synthetic media coalescers had been specifically designed to allow the sand and dust to pass through. The new units work by using a two-stage coalescence configuration. The first stage is a moisture separator with coalescing efficiency down to 50 microns. The second stage, a clearcurrent TS1000 coalescer, has 99 percent coalescing efficiency for droplets down to 10 microns but which has limited dust removal capability. It is this deliberate limitation of dust removal capability which avoids blockages and significantly reduces the maintenance overheads where high levels of both dust and moisture are present. The dry dust is then easily handled by the filtration system, to prevent it from damaging the turbine.
Two simple changes equal huge improvements in performance
Following these two changes on site, pulse system settings and coalescer technology employed, the site has experienced no shutdowns because of problems with the filter system or sudden differential pressure increases. The self-cleaning filter life is exceeding the customer requirement of two years and maintenance intervals have been extended. This has reduced operating costs, limited manual labour interventions required, and increased production availability — significantly improving operating profits.
In regions where extreme conditions as found, such as in the Middle East, operators are advised to:
Success is not about paper specifications
Measurement of the success of a filtration solution cannot be measured by specification comparisons or laboratory testing, as these do not portray the real-world conditions of each installation. Instead, success criteria need to be based on critical factors such as the reduction in turbine downtime and outages for filter replacements.
The example given above shows that, with the correct experience and expertise, significant improvements to turbine performance can be gained with even relatively small solutions and adjustments. System design and settings need to be geared towards the real-world environment in which the solution is installed. Working with filtration experts, other turbine operators can benefit from evaluating total solution management of their inlet systems.
View the presentation given at Middle East Rotating Machinery Technology and Innovation Conference & Showcase (ROTIC) 2018
About Parker Gas Turbine Filtration
With more than 50 years of experience delivering innovative solutions for gas turbine inlet filtration and monitoring fleet-wide performance data, our industry and applications experts will select the appropriate filter for your site designed to meet your specific operating goals.
Parker Gas Turbine Filtration supplies a full range of inlet systems and filters engineered to meet your operating goals, including:
Through our Parker brands, altair® and clearcurrent®, we are the choice for advanced filtration for new units and replacement filters. Our inlet system designs include self-cleaning (pulse) and static inlet systems for all gas turbine OEMs. We supply a full range of filter types at all efficiency levels. The predictable and reliable performance of our air filters significantly reduces compressor contamination and the need for unplanned maintenance for gas turbines in power plant applications.
This article contributed by David Trisante and Dan Burch.
David Trisante is sales director at Parker Hannifin Gas Turbine Filtration division. Trisante earned his engineering degree in the prestigious Universitat Politecnica de Catalunya (Spain) and the Aalborg Univeritet i Esbjerg (Denmark). He holds more than 20 years’ experience in purification and air pollution control markets as well as in a variety of filtration equipment ranging from dust collectors, electrostatic precipitators or gas turbine air intake systems.
Dan Burch is pricing manager, Gas Turbine Filtration (GTF) Division, Parker Hannifin. He’s covered all aspects of the company’s filtration offerings, with a particular focus on developing marketing and pricing strategies for gas turbine inlet filtration products. He has 15 years of experience in marketing and journalism roles. Dan has a B.A. in journalism from Indiana University and an MBA in marketing from the University of Missouri-Kansas City (UMKC).
This article originally published in Power Engineering in January 2019
The case study and paper were presented as part of the Middle East Rotary Machinery Technology 2018 conference.
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The consequences of failure during downstream processing are severe. Following the Affinity Chromotography stage, the value of the product increases significantly at every step. A failure at the final bulk filling stage, therefore, could lead to the waste of millions of dollars’ worth of drug product.
It’s vital, therefore, to safeguard the bulk filling process. But traditional methods of conducting bulk fill operations have several disadvantages including:
1. Manual handling
This introduces the possibility of human error to the bulk filling process. It is also labour intensive, meaning that process operators need to divert their resources into this task.
2. Operator training
When bulk filling is carried out manually, investment must be made in operator training. This can be costly, both financially and in terms of the time dedicated to it by personnel.
3. Supply chain complexity
By using a range of components from several different suppliers in the bulk filling process, there is more potential for variation – and more time must be spent on sourcing and ordering suitable components.
4. Laminar air flow (LAF) maintenance and validation
In traditional bulk fill operations, laminar air flow must be maintained and validated to protect the products from contamination. This requires time and resources.
5. Shipping issues
At the shipping stage, poor handling of bottles – and the use of unsuitable containers – can lead to damage to products before they even arrive at their destination.
6. Non-standard operations and process variability
Traditional methods of bulk filling introduce variability into the process. If bulk filling operations aren’t standardized, they can be subject to a number of factors which can impact the final product. Factors such as different flow rates applied by different operators come into play.
The solution
Automating and enclosing bulk fill operations can address the challenges detailed above and increase safety for operators. Parker Bioscience Filtration has developed the SciLog® SciPure FD system as an automated and integrated single-use system for final bulk filtration, filter integrity testing and dispensing into final bulk product containers.
Here are some of the benefits:
Automation
This reduces the risk of human error from manual handling and allows operators’ resources to be spent on other tasks.
Standardization
Standardizing operations means that training can be simplified and variations in the process can be eliminated.
Enclosure
Enclosing the process allows operators to process highly potent molecules and protects both the operators and the process. And, as the flow path is completely enclosed, both filtration and dispensing can be performed in areas of lower classification, eliminating the requirement for vertical laminar flow cabinets.
The SciLog® SciPure FD system
The SciLog® SciPure FD system benefits from innovative component selection based around material science studies, improved filling accuracy (+/-1%), and greater flexibility in the scale of filling (from 50ml samples to 20L).
The system features include a barcode reader for manifold tracking, reverse flow and purge options to maximize product recovery and fully programmable alarms and interlocks to product and process.
A validated shipping solution
To reduce the risk of damage to the product when shipping, Parker Bioscience Filtration has designed a fully validated shipping solution to complement and extend the capabilities of the SciLog® SciPure FD System. Parker Bioscience Filtration has created a unique bottle design that offers manufacturers the confidence that bulk drug products will arrive at their final destinations without contamination.
Parker Bioscience Filtration drew on its extensive material science knowledge during the development of the bottle and material selection was based on an FMEA study. The bottle integrity has been validated down to -89˚C.
Parker Bioscience has also developed an anti-foaming device that eliminates foam and enables a higher filling speed.
Conclusion
The development of the SciLog® SciPure FD System is an example of the change in the vendor/end user relationship: by using a vendor such as Parker Bioscience Filtration, which can provide a complete solution, end users can increase their productivity and gain greater control and protection over their processes.
This post was contributed by Graeme Proctor, product manager (single-use technologies), Parker Bioscience Filtration, United Kingdom
Parker Bioscience Filtration specializes in automating and controlling single-use 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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Mycoplasma contamination events, although rare, can have an enormous and immediate negative impact on biomanufacturers leading to reduced productivity and delays in products reaching patients.
Parker Bioscience Filtration will be examining how to implement a holistic approach to the prevention of Mycoplasma contamination in an upcoming webinar entitled: The Prevention and Control of Mycoplasma Contamination in Bioprocessing which will take place on January 15, 2019, at 3 p.m. London time/10 a.m. New York time.
Here presenters Guy Matthews, global market development manager, and Dr. Carolyn Heslop, technical support group team leader, answer common questions on the threat posed by Mycoplasma contamination and how this can be tackled by biopharmaceutical manufacturers.
What are the potential consequences of Mycoplasma contamination?
“Short-term consequences for a biopharmaceutical manufacturer can include unplanned downtime and lost batches. This can result in the supply of pharmaceutical products to patients being affected. In the long term, there may be financial consequences through a loss of confidence in the manufacturer and a resulting decline in the company’s stock value.”
— Guy Matthews
Why does Mycoplasma contamination pose such a risk in biopharmaceutical manufacturing processes?
“As Mycoplasma can infect mammalian cell cultures through adhesion and subsequent fusion to cell membranes, this allows them to exploit the conditions and synthesized molecules provided by the host cell. This means that detection and quarantine procedures must also be implemented around cell lines. Mycoplasma can vary in size and shape from 0.2 microns upwards, have no peptidoglycan cell wall and exhibit pleomorphism (the ability to alter size and shape in relation to environmental conditions). This means that they are capable of penetrating sterilizing grade filtration systems.”
— Dr. Carolyn Heslop
What steps should biopharmaceutical manufacturers consider in combatting this threat?
“Start with the basics: employing the standards of Good Laboratory Practice. Considering factors such as the storage and packaging of media, and understanding the nature of the supply chain are all important factors in mitigating the risk of Mycoplasma contamination. Identifying where contamination is likely to originate from and mitigating the risk at the source can prevent problems further on in the process. Gamma irradiation or heat inactivation to eliminate Mycoplasma present on gamma or heat-stable incoming raw materials can be used to guard against contamination. However, not all media components can be heated or subjected to irradiation. Therefore, filtration has a vital role to play in combating contamination during the biopharmaceutical process. Biopharmaceutical manufacturers should consult with their filter suppliers on issues such as filter sizing to ensure that their filtration systems are optimized appropriately."
— Guy Matthews
What kind of filtration system is needed?
“In order to effectively control Mycoplasma, the use of a Mycoplasma retentive 0.1 micron filter – such as Parker's PROPOR MR – is recommended. However, as the filter is twice as tight as a standard 0.2 micron sterilizing grade filter, pressure levels in the process can be a major concern. Filters may not function effectively if the flow is too rapid – for instance when pressure peaks occur.”
— Dr Carolyn Heslop
Is there a solution to this challenge?
“Biopharmaceutical manufacturers could consider implementing an automated single-use system. This ensures that critical process parameters such as pressure levels can be constantly monitored, ensuring the process stays within the validated process limits. An automated single-use system will also remove the possibility of human error – and give manufacturers more control over the process.”
— Guy Matthews
Sign up for our webinar and learn how to mitigate the risk of Mycoplasma contamination
For more information on the advantages of single-use technology in mitigating the risk of Mycoplasma contamination and how to implement a holistic approach to the prevention of Mycoplasma contamination, register for Parker Bioscience Filtration’s forthcoming webinar: The Prevention and Control of Mycoplasma Contamination in Bioprocessing. The webinar will take place on January 15, 2019, at 3 p.m. London time/10 a.m. New York time.
This post was contributed by Guy Matthews, global market development manager, and Dr Carolyn Heslop, technical support group team leader, at Parker Bioscience Filtration, United Kingdom.
Parker Bioscience Filtration specializes in automating and controlling single-use processes. By integrating sensory and automation technology into a process, a biopharmaceutical manufacturer can control the fluid more effectively, ensuring the quality of the final product.
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What's Stopping you from Automating your Single-Use Process
Many companies, including those in the food and beverage, pharmaceutical, cosmetics, manufacturing and electronics industries, recognize the negative effects on quality created by oil contact with their product during production. Product rejections and consumer safety concerns associated with oil contamination can have broad negative financial and commercial impacts on a company. However, an often overlooked source of oil in compressed air — ambient air — is frequently misunderstood, underestimated or ignored.
In this blog, we’ll examine the effect that ambient oil vapour levels can have on downstream compressed air quality and what to consider when looking for technically oil-free compressed air to ISO8573-1 Class 0 or Class 1 for total oil.
For details on oil vapour testing levels in ambient air, test methods, compliance and other gaseous contaminants of concern, download the full white paper “Oil Vapour in Ambient Air”.
What is ambient air?
Ambient air is the air we breathe and it’s all around us. It’s also the air that is drawn in by air compressors. Ambient air is made up of approximately 78% nitrogen and 21% oxygen. The remaining 1% contains a mix of argon, carbon, helium and hydrogen as well as a variety of contaminants — oil vapour being one of them. Ambient air is an often overlooked source of contamination that can have a big impact on a compressed air system.
How is ambient air contaminated?
Ambient air quality is directly impacted by air pollution caused by industrial processes such as burning fossil fuels and emissions from vehicle exhaust, oil and gas fields, paints, and solvents.
Oil vapour in ambient air is made up of a combination of hydrocarbons and volatile organic compounds (VOC). Ambient air typically contains between 0.05mg/m3 and 0.5mg/m3 of oil vapor, however, levels can be higher in dense, urban or industrial environments or next to car parks and busy roadways.
These levels may seem negligible, but when it comes to compressed air contamination, we must consider the effect that compressing the air has on the ambient contamination, the amount flowing into the compressed air system, and the time the compressor is operating.
Compressing air – compounding the problem?
The process of compression, as well as flow rate and time, build the level of oil in the compressed air that travels through a production system — air that eventually finds its way to production equipment, instrumentation, products and packaging materials.
Compression, or pressurizing the compressed air, can significantly increase the volume of oil. The greater the operating pressure, the higher the potential level of oil in the compressed air. This is compounded by the flow rate and time of operation. Compressors are often designed to operate continuously. This means that the concentration of oil continues to multiply in the confined space of the compressed air system. In turn, it will only exit the system at points where the air is released. These exit points are often in areas where the contaminated air comes in contact with product, production equipment or instrumentation. So, what may seem like negligible levels of hydrocarbons and VOC in ambient air, can become a great concern when the same is drawn in and compressed for use in manufacturing.
Effect on quality
Once inside the compressed air system, oil vapour will cool and condense, mixing with water in the air. This contamination causes numerous problems to the compressed air storage and distribution system, production equipment and final product leading to:
Due to the financial and commercial impact of contaminated product, many companies specify the use of an oil-free compressor, in the mistaken belief that this will deliver oil-free compressed air to critical applications.
Oil-free compressed air systems are typically installed without downstream purification equipment intended to remove oil, as they are deemed unnecessary accompaniments. While it is true that oil-free compressed air systems will not contribute contamination in the manner that oil lubricated systems will, oil vapour from ambient air remains untreated.
Considerations for technically oil-free airTechnically oil-free air, in accordance with ISO8573-1 (international standard for compressed air purity) Class 0 or Class 1 for Total Oil, can only be guaranteed through the proper application of downstream purification equipment. This equipment may include water separators and coalescing filters to remove liquid water and oil, aerosols of water and oil, and solid particulate as well as adsorption filters to treat oil vapour. Compressed air users seeking an oil-free source of air would be wise to consider these precautionary purification steps, whether they are used with oil-lubricated or oil-free compressed air systems.
In order to establish compliance with ISO8573-1 Class 0 or Class 1, the international standards categorizing oil level in compressed air, users must perform tests to assess both oil aerosol and oil vapor presence in their systems. The levels of each phase will combine to establish total oil in the compressed air system.
To conduct the tests, samples of each phase must be drawn through a solvent extraction process and analyzed using gas chromatography (GC) or Fourier transform infrared (FT-IR) technology. The combination of the two methods will provide an accurate reading down to 0.003mg/m3.
While there are other methods for testing oil levels, like Photo Ionisation Detector (PID), these will leave certain compounds undetected. To this end, they should be used for estimation purposes only. GC and FT-IR will provide results that can be related to ISO standards with reliable and complete accuracy.
Advanced solutions
Parker has recently introduced a new compressed air purification system. The OFAS Oil Free Air System is a fully integrated heatless compressed air dryer and filtration package suitable for use with any compressor type and can be installed in the compressor room or at the point of use. Fitted with a third adsorbent column for oil vapour removal, the OFAS has been third-party validated by Lloyds register to provide ISO 8573-1 Class 0, with respect to total oil from both oil-lubricated and oil free compressors, ensuring the highest quality air at the point of use for critical applications.
Conclusion
Compressed air is vital to any production process. Whether it comes into direct contact with the product or is used to automate a process, a clean, dry reliable compressed air supply is essential. If the compressed air contains oil, the consequences can be high both financially and in terms of brand damage.
For details on oil vapour testing levels in ambient air, test methods, compliance and other gaseous contaminants of concern, download the full white paper "Oil Vapour in Ambient Air".
This blog was contributed by Mark White, compressed air treatment applications manager, Parker Gas Separation and Filtration Division, EMEA.
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