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Many metalworking facilities feature large, open workspaces. While ideal for large scale production, this setting presents challenges for air quality and in assuring clean air in the work environment. Weld smoke, fumes, oil and coolant mists are harmful to workers. In any manufacturing setting where welding is done, precaution must be taken to limit worker exposure to these harmful contaminants to assure a safe plant environment.
Let's take a look at how one metal fabrication company solved this issue with the help of Parker.
Learn how Parker designed the Cherubini Metal Works solution, download the full case study.
The challenge
Cherubini Metal Works, a fabricator of large structural steel assemblies for bridges and buildings in Nova Scotia, supplies hundreds of thousands of tons of cut, shaped, welded and pre-assembled steel into a variety of standard and custom designs. Their newest fabrication facility in Eastern Passage, Nova Scotia measuring 56,000 square feet, often has 15 to 20 welders operating at the same time in their large open workspace. The resulting weld smoke and fumes presented a challenge to the safe and productive environment the company valued.
Typically, source capture systems are used to collect weld fume contaminants. Source capture systems include fume collection hoods, ducting, air cleaning components and fans. However, in a large, open facility like Cherubini, where overhead cranes and large fabricated structural pieces were taking up substantial space, a source capture system was impractical. Cherubini's management team also determined that, due to the low outside temperatures in the winter that could range from -4° to -22°F (-20 to -30°C), they needed to re-circulate filtered air in order to avoid the high heating costs associated with warming air drawn from the outside.
Cherubini's management team consulted with Parker, a leader in the clean air system design, on how to proceed. Typically, there are two ambient air collection options for welding fumes:
Re-circulating air through the Cherubini facility, as opposed to exhausting it outside, was viewed favorably as it would provide a healthy work environment while saving the company substantial energy costs. Based on Parker’s recommendation, Cherubini chose to install 10 SmogHog SG-4S mist/fume collection units with automated in-place cleaning.
SmogHogs, using electrostatic precipitators (ESP) technology, are highly efficient, heavy-duty air cleaning devices that remove smoke, fumes, dust and coolant mist from the air stream. In open-air applications, like the Cherubini facility, multiple units are installed in a pattern that circulates the air from unit to unit in a circular- racetrack- configuration.
ESP works by electronically charging both visible and microscopic contaminants and capturing them like a magnet in collection cells. Operating continuously, ESP units will then circulate clean air back into the plant.
Results
Cherubini’s SmogHog systems re-circulate clean air throughout the facility, they also reduce exhaust make-up requirements by up to 80%. The air is recycled into the workspace, saving the company thousands of dollars a year in heating costs during the cold winter months. Maintenance is minimal. In Cherubini’s case, the 10 SmogHog SG-4S units are cleaned via an automatic wash system, depending on weld work volume.
“I continue to purchase SmogHog electrostatic precipitators because they are effective...and meet all local air quality and occupational health and safety requirements. And, because building heat is too expensive to waste.”
— Renato Gasperetto, vice president of Cherubini Metal Works Ltd.
Attending the 2020 AHR Expo?
The AHR Expo is the world’s largest HVACR event, attracting the most comprehensive gathering of industry professionals from around the globe each year.
Visit Parker at the AHR Expo in Orlando, booth 2525, FL February 3 - 5 and learn about our climate control and filtration solutions for improved air quality wherever you work.
Article contributed by the Filtration Team.
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Is your manufacturing plant's compressed air purity validated? Perhaps the methods you are employing to check the purity or quality of the air in your facility are only indicative? Is there a difference?
The answer to this last question is, yes. There is a difference, and it matters in how companies present their capabilities and quality.
Here, we will discuss the standard that defines the sampling methodology and equipment that must be employed in order to present compressed air purity (quality) as validated. We will also learn the relevance of practices that are indicative of the compressed air quality and differentiate them from those that present complete validation.
Validation - ISO compressed air purity standards
The ISO 8573 Series has been the international standard for compressed air purity (quality) since 1991. It is used to define the quality of compressed air used for a variety of applications across manufacturing industries worldwide. The standard is segmented into nine distinct parts.
Beginning with ISO 8573-1, users are provided a method of classification with specific contamination types and limits defined. This method is employed by compressed air users to select the treatment equipment that they will need in order to produce certain air quality. In kind, ISO 8573-1 is used by compressed air treatment equipment manufacturers to define the quality of compressed air delivered by their products and systems.
But in order to claim compressed air purity is actually validated, users and manufacturers must go beyond IS0 8573-1 to the remaining eight standards, as shown in the above illustration. ISO 8573 parts 2 through 9 have been developed to provide the most accurate measurement of the main contaminants found in a compressed air system. In the standards, the user is presented with the equipment and methodology that must be employed to accurately test and claim validation. It offers specifics for the accurate measurement of common compressed air contamination — solid particles, water vapor and total oil — as well as contamination of specific interest to certain industries, like microbial contamination in food, beverage and pharmaceutical manufacturing applications.
Indicative testing
Indicative testing is basically purity and quality testing that is performed in a manner that is not carried out in accordance with ISO 8573 parts 2 thru 9. If the ISO standard is not followed, a company cannot claim validation on the levels of certain contaminants in their compressed air supply.
While indicative testing can not be used for validation purposes, it still can provide valuable information to compressed air users. It may satisfy that some air quality testing is conducted, required in certain industries. It remains, however, important for the users to understand the limits of the testing equipment and methodologies it employs. The chart below offers an overview of commonly available test equipment used for indicative testing of compressed air systems.
Examples of indicative testing
Performance validated compressed air treatment equipment
The cost and complexity of testing and validating compressed air purity in accordance with ISO standards can be prohibitive. Therefore, products that are third party validated are an attractive option.
Parker Hannifin Corporation, a leader in compressed air treatment, offers a complete range of products with 3rd party validated performance. These state-of-the-art components and systems are backed by an air quality guarantee.
The Parker OIL-X range of compressed air filters and Parker adsorption dryer ranges have been designed to provide compressed air purity (quality) that meets or exceeds every classification shown in all editions of ISO 8573-1. Filtration and dryer performance has also been independently 3rd party verified by Lloyds Register.
This article was contributed by Mark White, compressed air treatment applications manager, Parker Gas Separation and Filtration Division EMEA
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The Four Seasons Boston Hotel is located in a 13-story structure situated in the heart of historic Boston, Massachusetts. This prestigious hotel group dedicates itself to the highest quality of service and dining for its visitors. Parker provided the solution the Four Seasons Boston Hotel needed to improve air quality for its guests and neighbors. As part of continuing its reputation as one of Boston’s best restaurants, the hotel needed to eliminate cooking odors, smoke and grease emissions.
Challenge
Smoke and grease emissions were becoming a growing concern for guests, employees and neighbors. So while renovating, Four Seasons saw the need for a state-of-the-art kitchen emissions system that would remove hazardous pollutants and also fit its structural requirements. With its urban location, the Four Seasons Boston Hotel needed a system to clean the air exhausted into the neighborhood. Since Four Seasons serves guests 24 hours a day, the hotel restaurant required a system with minimal downtime for cleaning. Space for the unit and connecting ductwork were also issues. Four Seasons needed the unit to connect to their existing maintenance system without adding a lot of ductwork. In addition, the system had to comply with federal, state and local standards.
Solution
Parker evaluated the Four Seasons Boston Hotel and customized a SmogHog® PSG to fit all their needs. The SmogHog kitchen emissions system uses electrostatic precipitation technology to filter odors and electrically charge contaminants. The PSG then captures contaminants like a magnet onto aluminum collection plates. For maintenance, the system is programmed to shut down for one hour each day for a self-cleaning cycle, allowing Four Seasons to serve its customers day and night. Additionally, the PSG was custom-designed to fit the hotel’s unique space requirements by connecting the kitchen emissions unit to the facility’s existing energy maintenance system and the ductwork from the parking garage to the roof. It only consumed five parking spaces while eliminating expensive and space-consuming ductwork.
For more details on PSG Series Kitchen Emission Systems, check out the ebrochure.
Results
Parker's Smog-Hog PSG removed odors, smoke and grease emissions so that only clean air was released into the hotel and outdoors. With this new system, Four Seasons now emits cleaner air for its neighboring citizens and businesses. The new system also brought the hotel in compliance with local, state and federal environmental standards. The design was ideal for Four Seasons because Parker was able to work within the hotel’s unique space limitations and customize a system to fit every need.
The AHR Expo is the world’s largest HVACR event, attracting the most comprehensive gathering of industry professionals from around the globe each year.
Visit Parker at the AHR Expo in Orlando, booth 2525, FL February 3 - 5 and learn about our climate control and filtration solutions.
For additional information on SmogHog Kitchen Emission Control Systems, please visit our website.
This article was contributed by the Filtration Team.
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The Sandia Resort and Casino opened to great anticipation. The Indian gaming operation’s new property in Albuquerque, New Mexico featured multiple dining options, a huge casino and over 200 sleeping rooms. A truly gorgeous destination, the resort promised a luxurious and relaxing getaway to its guests.
But shortly after it opened, the Resort faced a challenge that could seriously impact its image and reputation. When reports of kitchen fumes and smoke in guest rooms came to the attention of management, they grew very concerned and immediately investigated the cause and a solution.
The Sandia Resort and Casino operated their kitchens on a nearly 24/7 basis in order to serve their thriving business. While the kitchens were equipped with exhaust fans and grease catchers, reports of kitchen fumes and smoke began pouring in from guests. There was also criticism that the fans detracted from the resort's appearance, as they were in plain sight of the guests. In order to address the problem, the Resort contacted Parker. They asked Parker to review their needs and design a custom solution. They advised Parker that they wanted a robust system, using the most advanced technology to remove the pollutants from the air. In addition, it was important that the system blend in with the resort’s structure and aesthetics. They knew this would be a challenge, given the high altitude and limited space on the roof. They also knew the system had to be compliant with local, state and federal standards. The Resort management felt assured that Parker, with its deep expertise and technology, would be able to provide them with a solution.
The solution
The hotel management and the Pueblo of Sandia Tribal Council contacted Parker because of the manufacturer’s strong reputation and successful work with other restaurants experiencing similar problems. After a thorough review of the existing emissions collection systems as well as the desired improvements to be made, Parker introduced the hotel team and Tribal Council to SmogHog® PSG fume collectors. They recommended that the hotel install eleven custom-designed SmogHog systems to address their needs. Parker worked with the onsite facilities staff to optimize the designs for each kitchen.
How SmogHog works
The SmogHog kitchen emission system uses electrostatic precipitation technology (ESP) to filter odors and electrically charge contaminants, which are then captured onto aluminum collection plates.
SmogHogs are self-cleaning, eliminating the need for costly filter replacements. The self-cleaning cycle was scheduled at a convenient time to prevent interruptions to guest services. In addition, SmogHog uses existing hot water supplies, presenting the savings associated with having to source and pay for additional resources.
System design
Parker designed the SmogHog to fit into space and aesthetic requirements. The units were configured to fit the roof’s unique design and weight limit, as well as accessibility. They were also painted to adhere to the color scheme of the facade. All of this was done within the requirements of the structural code.
Results
Parker was successful in meeting the Sandia Resort and Casino’s needs with SmogHog technology:
“SmogHog is an excellent product ... While our original exhaust fans were working to some extent, they weren’t nearly as effective as the SmogHogs. These new units allow our HVAC team to concentrate on other areas, as wash cycles and operations are all computerized. The HVAC staff only needs to perform routine maintenance and exchange cleaning solution once a month. These units have shown to be low maintenance and have already provided savings in labor costs compared to the old exhaust fans. The additional savings have been in these units not requiring monthly filter changes".
— Mark Cuzzola, facilities manager, Sandia Resort and Casino
“The Council wanted results, and to date, they have been exceptional. Since installing the SmogHogs, there have been zero complaints from guests ... The systems clean all the exhaust, and only fresh clean air is exhausted ... Not only was the Parker Hannifin team very attentive and great to work with, they helped us come up with a tailored solution that does exactly what we need it to.”
— Paul Collins, superintendent of facilities, Sandia Resort and Casino
The AHR Expo is the world’s largest HVACR event, attracting the most comprehensive gathering of industry professionals from around the globe each year.
Visit Parker at the AHR Expo in Orlando, booth 2525, FL February 3 - 5 and learn about our climate control and filtration solutions.
Article contributed by the Filtration team.
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The oil used to lubricate the cylinders of large 2-stroke marine diesel engines has to contend with high temperatures and acidic products formed during the combustion of sulphur-rich bunker oils.
Cylinder oil is used on a continuous loss basis. In recent times ship operators have taken to running engines at reduced speeds (so-called slow steaming) as a means of improving fuel consumption.
Unfortunately, slow steaming is accompanied by a drop in engine temperature which allows acid to build up on the cylinder liners thereby promoting their “cold corrosion”. The iron compounds formed by this process are then flushed from the engine by the cylinder oil. This leads to excessive liner wear, requiring expensive replacement. The iron found in used cylinder oil samples typically exists in various forms, each one having its own particular properties. For example, metallic iron particles worn off the cylinder liner by cat fines exhibit strong ferromagnetism and may be detected. There are cold corrosion test kits to aid in this condition monitoring process.
Performing cold corrosion test
Step 1
First, fill both sample vials to the five-millilitre graduation line with Reagent One.
Step 2
Prepare your cylinder scrape down oil sample with some gentle agitation for approximately 30 seconds. Using the syringe, add 0.2-millilitres of the sample to each of the cuvettes.
Step 3
Step 4
Leave for four and a half minutes for the layers to settle out.
Step 5
Insert the color wheel into the
Place the cuvette containing Reagent Two into the centermost slot and the cuvette with Reagent Three into the anterior-most slot.
Step 6
Step 7
Read the concentration figure in PPM directly from the wheel.
Watch the video to follow along with the steps:
Please visit parker.com/kittiwake for more information.
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ISO (International Standards Organization) is the world’s largest developer and publisher of international standards. There are three ISO standards that relate to compressed air quality and testing — ISO8573 Series, ISO12500 Series, and ISO7183 Series. The most commonly used standard is the ISO8573 Series, in particular, ISO8573-1:2010.
ISO8573 is the group of international standards relating to the quality (or purity) of compressed air. There are nine parts to the standard. ISO8573-1 (part 1) is the most commonly used and relates to quality classifications for compressed air. Parts 2 - 9 specify methods of testing for a range of contaminants.
Here, we will discuss six essential factors to consider when using the ISO8573 Series Part 1 to maximize the effectiveness and efficiency of air treatment in your industrial manufacturing facility.
1. Understanding the air purity classification tables
ISO8573-1 contains air purity classification tables that will provide you with guidance that specifies the minimum air purity required at each usage point, based on the types of contaminants you may seek to remove: solid particulate, water and total oil. See figure 1. From this table you can:
Figure 1 - Combined ISO8573-1 Table
In the ISO8573-1 table, compressed air contaminants are grouped as solid particulate, water and total oil. There are various degrees of each of these contaminants itemized to help in the selection of an appropriate combination of levels, based on your usage. These combinations are referred to as purity classes. When using ISO8573-1 to define the air purity required, it should be written in the following way:
Below is an example of an air purity specification:
ISO8573-1:2010 Class 1:2:1
Based on figure 1, this air purity specification would specify Class 1 particulate levels not to exceed 20,000 particles in the 0.1 to 0.5 micron size range, with additional levels at other particle sizes; Class 2 water levels identifying a pressure dewpoint (PDP) of -40 degrees Celsius, and Class 3 oil of no more than 0.01 mg of total oil.
3. Facts and myths of ISO8573-1 Class 0
In 2010, ISO8573-1 was updated with the inclusion of Class 0 to the three contaminants. See figure 2. Class 0 was introduced as a “customizable” specification that users and equipment manufacturers could use to identify a specific air quality that would be more stringent than Class 1. This has led to certain misrepresentations or myths. These include:
The following are the important facts to remember:
Figure 2. 2010 Classification Table (combined)
4. Which ISO8573-1 revision should I use?
Of the three revisions — 1991, 2001, and 2010 — 2010 should be used when specifying a new system or upgrading a new system. However, if a previous revision has been used to specific purity levels, it is acceptable to continue using it, noting that changes in contamination levels require different purity equipment.
Parker, for example, offers a range of purification equipment that allows the user to specify the quality of compressed air for every application, from general-purpose ring main protection, through to critical clean dry air (CDA) point of use systems. Parker has comprehensive ranges of purification equipment available to exactly match system requirements, ensuring both capital and operational costs are kept to a minimum. Figure 3 provides an overview of Parker purification equipment required to meet or exceed the ISO8573-1:2010 classifications.
Figure 3. Overview of Parker purification equipment that meets or exceeds ISO8573-1:2010 classifications
Identify the quality of compressed air required for your system. Note that each point in the system may require a different quality, depending on the application. Refer your supplier to the quality classifications shown in ISO8573-1.
6. Cost-effective system design
To maximize the return on investment in purification equipment, it is recommended that compressed air is treated for plant distribution in the compressor room to meet the broad needs of the facility. Point of use purification should also be employed with specific attention to the air quality required at each application. This approach assures the air is not over-treated and provides a cost-effective solution to high quality compressed air. Figure 4 shows an example of general purpose air with oil-free air for critical applications.
Figure 4. General Purpose Air with Oil-Free Air for Critical Applications
This article was contributed by Mark White, compressed air treatment applications manager, Parker Gas Separation and Filtration Division EMEA
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Efficient operation of baghouses is an expected and necessary element of foundry productivity. These manufacturing facilities and systems assure clean and safe work environments, allowing people and equipment to operate without interruption. When the media, often filter bags, employed in the baghouses plugs with collected solid matter, immediate maintenance is an absolute priority. The proper function of baghouse filtration is integral to efficient foundry operations.
This was the case at a large foundry located in the United States where restricted air flow to mold cooling and sand handling equipment had reached a critical point.
The problem
The foundry employed a 450-bag Carborundum pulse-jet baghouse. The system had been designed with an air-to-cloth ratio of 9.3:1, aggressive by any standards. The processing at the foundry exposed the filter media to very fine particulate. Specifically, the particulate came from the sand handling system. This particulate, along with high moisture and hydrocarbon carryover from the mold cooling line, formed a substantial and difficult dustcake on the filter media in the baghouse. After only six months of service, blinded filter bags caused differential pressure to exceed 8” w.c., greatly reducing airflow venting of the applications. As a result, time-consuming and costly filter bag and cage change outs were required.
The foundry determined that they needed the help of experts in the area of filtration, specifically with baghouse efficiency and performance. They turned to Parker Hannifin, a leader in the design and manufacture of filtration systems. Parker recommended replacing filter bags and cages with BHA® PulsePleat® Filter Elements — a versatile and cost-effective solution. They designed the system in order to increase the total filtration area of the dust collector by over 220%. This was done with no physical modification of the dust collector.
Benefits of BHA® PulsePleat® filters elements
Performance
The new system, featuring an increased filter surface area of the pleated elements, helped lower average differential pressure to 3.5” w.c. — a greater than 40% reduction from the peak of 8” w.c.
Fan amps went up by 157%, increasing air volume through the dust collection system and providing the ventilation needed by the process applications for optimum performance.
Installation and maintenanceThe one-piece bottom-load design of BHA® PulsePleat® filters elements reduced filter installation time by 70%.
The increased filter surface area contributed to a dramatic reduction of unplanned maintenance time and expense.
By installing BHA PulsePleat filter elements, the foundry returned to efficient production and avoided the high costs of unplanned maintenance and baghouse redesign or replacement.
To learn more about BHA PulsePleat filter elements, watch this video:
Article contributed by the Industrial Air Filtration Team.
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Although bulk filtration of a product prior to shipping was one of the first bioprocessing steps to benefit from single-use technology, it has been one of the last to benefit from single-use automation.
Indeed, for many biopharmaceutical manufacturers, the process has changed very little from the days before single-use technology was adopted: the main differences have been the replacement of the stainless steel tank with a bag and the steam cross with aseptic connectors.
Parker Bioscience Filtration was approached by a customer to develop a solution that would address concerns around the bulk filtration unit operation.
To learn more, download the full white paper: Implementation of Single-Use in Drug Substance Filling Before Transportation
Protection - As the customer was filling high potency active pharmaceutical ingredients (HPAPIs), it needed to eliminate open processing to protect the operator and the product.
Standardization and simplification - The customer needed to standardize the filling platform in order to create a standard operating procedure (SOP); this would simplify training and eliminate process variation.
Hygiene -The customer wanted to reduce the number of people involved directly in the filling.
How Parker helped
Working closely with the customer, Parker Bioscience Filtration developed the Generation One SciLog® Filter and Dispense System. This enabled fully enclosed automated bulk filling of the HPAPI into bottles in preparation for transportation to a filling site.
Parker was able to identify several benefits of automated closed filling:
No more false positives - The elimination of false positives meant that the customer would not be exposed to the costs (and lost time) of the quarantine and investigation process related to a false positive. Nor would it be exposed to the risk of a batch being rejected.
Saving time - Comparing manual filling and automated filling, data was generated on time savings based on two filling volumes and a set batch size. If these time savings were applied to a facility producing 35 batches per year, the cost reductions generation could run into €100,000s.
Reduction in clean room personnel required - As the process is fully enclosed and automated, the need for QC sampling and QA oversight was reduced - this meant fewer staff were required in the clean room.
Standardization driving simplification - Training and SOP became simpler as a result of standardization. The risk of deviation and human error was also reduced, and the supply chain and handling process was simplified.
The development of the generation two system
Although we had developed a solution for a fully enclosed and automated filling process, collaboration with the customer did not stop there. The safe arrival of the bottles at a filling site was the customer's priority - and taking into account their feedback, we developed the generation two SciLog® Filter and Dispense System.
How did Parker do it? Increasing the filling accuracy
The filling accuracy of the generation one system was +/- 10 percent - initially deemed acceptable.
However, the filling accuracy was increased to a much higher level of +/- 100 mg following feedback from the customer's QA team and our knowledge of how many bottles they needed to fill, as well as product and consumable reconciliation.
With the generation one system, based on a 20 L and a 500 ml fill, anywhere between 36 and 44 bottles were required. With the generation two system, the maximum number of bottles required is 40 and the minimum is 39.
Improving the filling processAs the generation two system allows a rapid fill to 90 percent of target volume, the process can be run at a slower rate to ensure accuracy. This balances the requirement for product quality and process efficiency.
Parker also introduced a J-tube system which diverts the flow of liquid to the side of the bottle. This was developed to prevent the foaming that would occur if liquid was dropped into a bottle vertically.
Component selection driven by process facility knowledgeIt is essential to choose materials that can support the process - and this can only be done if the full extent of the storage conditions is known. A solution may be filled following cold storage at 4°C, for instance, but may then be stored in dry ice at -78.5°C. This will have a critical impact on the choice of materials. In addition, not all products will be compatible with all of the materials used in a single-use assembly. Again, knowledge is key.
Validating the systemWhile the system was validated to perform the fully automated and contained filtration and dispense of bulk APIs, this was not the end of the validation process.
Shipping of the product to the final destination was also part of the solution Parker needed to provide for the customer and, therefore, this also needed to be validated. To do this, Parker subjected the bottles to further testing to demonstrate their post-shipping integrity — a crucial final step in validating the entire process.
Conclusion
Our work in developing the generation two SciLog® Filter and Dispense System underlined the importance of truly understanding what matters to a customer — and in this case, that went beyond the system's functionality.
To learn more download the full white paper: Implementation of Single-Use in Drug Substance Filling Before Transportation
This post was contributed by Guy Matthews, division marketing manager, 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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Whether you are running a process in a 30,000 L bioreactor in fed-batch mode, a 200 L continuous process, or have scaled-out (rather than up), you will start at small scale and look to increase the volume - scale-up - to some degree.
However, we are recognizing that some biotech companies aren't adopting single-use automated technology until the process reaches pilot scale. This can reduce the likelihood of a successful outcome or the speed of the development process, as process rework may need to be managed further along the manufacturing development process. In some cases, changes to inefficient processes may be more difficult to implement, especially if they have already been approved.
The adage "start with the end in mind" has never been more relevant. For scale-up to be successful, we recommend using the same automated single-use equipment, strategies and materials from the R&D stage through to manufacturing scale. That way, speed to market can be optimized through simplified technology transfer of optimal process. You will also avoid unexpected rework that may come about due to material compatibility or availability issues.
Start as you mean to go onSpeed to market is of critical importance, both from a return on investment point of view, but also with the benefits to patients in mind.
Having single-use automated technology in place at the R&D stage can make the move into the manufacturing stage more efficient.
The benefits include:
And, if you use single-use technology during R&D you can also benefit from:
However, there are a few common pitfalls to avoid, which include making incorrect assumptions regarding how processes will behave at larger scale.
Ensuring successful scale-up in single-use bioprocessing webinarParker Bioscience Filtration is delivering a webinar on November 12th, 2019 which will help biopharmaceutical manufacturers build a strategy for effective scale-up of filtration and single-use processes that will facilitate technology transfer, in order to avoid delays in commercialization caused by inconsistent scale-up of a single-use process between R&D and manufacturing.
It will explain how to conduct a small-scale filtration trial using an automated single-use system at laboratory scale and examine the advantages this provides.
The webinar will also further explore the benefits of single-use technology in both R&D and manufacturing, and consider how to ensure successful implementation of single-use automation from laboratory scale through to large-scale production.
Register now for our webinar: Ensuring Successful Scale-Up in Bioprocessing
This post was contributed by David Heaney, market development manager (life sciences), 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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Single-use solutions have been widely adopted on a global scale within the biopharmaceutical industry due to the many advantages and process improvements they offer.
Key applications for single-use assemblies include the creation of process fluid flow paths, buffer/product storage solutions and sampling systems on varying scales.
Most of these systems will start with either a bioprocess container or a tubing option and require the ability to connect to further pieces of equipment or additional single-use systems/manifolds.
In order to achieve this connectability, some form of connection needs to be selected — but with so many different connection types available, where should biopharmaceutical manufacturers start?
There are many different options available when embarking on the selection process. Consideration must be given to whether the connection type needs to be aseptic to provide quick and easy sterile connections, (even in non-sterile environments) or non-aseptic (to provide quick and easy non-sterile connections).
How do you choose the correct option?
The choice should be guided by the process itself — and the capability of the manufacturing plant should also be taken into account.
Key factors which will determine the correct choice of connection type include:
Only when these factors have been addressed can the end-user begin to fully specify the connection type required.
Connection types The Luer connector
The Luer connector is the simplest connector. It consists of both a male and female form, and the connection is made using a twist-lock action. These connections are suited to sample lines (with syringe connectivity) and low flow narrow-bore tubing applications and can be used within a laminar airflow hood to create aseptic connections.
However, there is a downside: potential misconnections can occur when they are not mated correctly.
Quick connectorQuick connectors such as the MPC, MPX or MPU from CPC (Colder Products Company) are similar to Luer connectors in that they can be used within a laminar airflow hood to create aseptic connections. They have the added security of a push-fit feature with a secure locking mechanism.
TriclampTriclamp (sanitary style) fittings can be used as connectors. While these are effective and secure connections, care must be taken to position the required o-ring seal within the connection prior to fixing the connection using an external clamp. The sheer size of the external clamp may make this an unsuitable method for connecting narrow bore or thin-walled tubing due to the weights involved and the potential for kinking/doubling of the attached tubing. Triclamp connections can be used within a laminar airflow hood to create aseptic connections.
Connections outside of a laminar airflow hood
Should aseptic connections be required to be made outside of a laminar airflow hood, two options are available, which both allow the connection of varying tube sizes:
Gendered aseptic connectorThe first option for connecting aseptically in a non-aseptic environment would be to use a gendered aseptic connector, such as CPC AseptiQuik® gendered, which has both a male and female version. The benefit of using a gendered connection is that it can help by safeguarding which lines can be connected to certain points in the process; this helps to mitigate against human error and the accidental connection of the incorrect lines/equipment.
When designing single-use assemblies using a gendered connector approach, care must be taken to ensure that the correct male / female side is designed into each part; this in itself can also create some areas for error to creep in.
Genderless aseptic connectorShould the end-user not have any concerns over an accidental connection to the incorrect lines/equipment, or simply want to remove the error of male/female connector type which can creep in during design, there is the genderless aseptic connector, such as CPC AseptiQuik® genderless. These connectors take out the requirement for designing in the correct male/female orientation and can enable universal assemblies to be manufactured and connected with many other assembly/equipment types.
Both gendered aseptic connectors and genderless aseptic connectors operate via a mechanism that enables connection in non-sterile environments to be made possible. This is because of the use of proprietary seals which mate together before a protective seal is removed, thus keeping the process stream in its aseptic/sterile condition.
Connecting stainless steel and single-use
Should sterile connections between traditional stainless steel biopharmaceutical processing equipment and single-use assemblies be required, there is another option:
Steam-to connectorsSteam to connectors, such as CPC Steam-Thru®, work by allowing steam to pass through the section connected to the stainless steel equipment. Once steamed and connected, a valve within the connector is manipulated, creating a sterile or aseptic flow path.
Conclusion
It is apparent that there are many connections capable of creating or maintaining an aseptic/sterile environment, but without the correct process condition assessment, operator care or design considerations, biopharmaceutical manufacturers could be looking at a costly connection failure.
Download our white paper to find solutions to more single-use challenges: Single-Use Technology: The Next 5 Challenges to Conquer
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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