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The principles and practices of lean manufacturing are widely used in industries across the globe to continuously improve processes, drive efficiencies and reduce costs.
Even in biopharmaceutical manufacturing where validation and regulatory requirements are high, lean can be used to improve processes, meaning more life-saving product can reach patients quickly.
Technology has been developed to support biopharmaceutical manufacturers, CMOs and CDMOs on their lean journey and at Parker we have worked closely with industry to develop a system that can improve operational efficiency, accuracy and safety.
Parker’s SciLog® FD System automates, standardizes and encloses final bulk filtration and dispense operations. It can support companies in addressing the eight wastes of lean: Transportation, inventory, motion, waiting, overprocessing, overproduction, defects, and safety.
As an automated, standardized and enclosed single-use system, it has many advantages over manual operations. It can increase efficiency, reduce process variation, protect the product and operator, and reduce risk.
Here is how the SciLog® FD System can help manufacturers tackle the eight wastes, and support them in implementing lean production strategies.
Transportation
As the process takes place in a single, enclosed system, the movement of products and materials is reduced. The SciLog® FD System can combine two unit operations: the sterile filtration of bulk drug product and its dispense into bottles or bags. As both of these steps can be performed on one system, transport of material is reduced. Once dispensed into bags or bottles, the drug product can be easily transported for freezing or cold storage.
Inventory
The use of the SciLog® FD System simplifies the supply chain, with the hardware and consumables, including single-use manifolds, designed together and available from a single source – Parker.
Motion
Using an automated system means that the motions associated with a manual operator – for instance operating pumps and valves – are removed from the process. All of the valves are controlled automatically, with intelligent feedback from the SciLog® single-use sensors which are part of the system.
Moving materials in a laminar air flow using aseptic technique can be challenging and has a high training requirement. Reducing the amount of movement of product through the use of a closed system reduces the risk of contaminated product. The SciLog® FD System allows recipe-driven processing, sampling and integrity testing — all taking place on the one enclosed automated system limiting unnecessary motion and associated risk.
Waiting
As the SciLog® FD System is automated, it cuts down on an operator’s waiting time in between different stages of the process. This means that staff can be utilized more efficiently. For example, a recipe can be programmed to carry out an automated filter integrity test and, while this takes place, the operator can perform other activities such as checks or paperwork completion.
Overprocessing
Time-consuming, and potentially inconstant tasks that would have been carried out manually are now automated. For instance, the SciLog® FD System generates automated batch records - an alternative to the operator having to complete forms manually (and reducing the risk of transcript error). There is also an integrated label printer with labels suited to cryogenic storage.
Overproduction
Manual fill can be inaccurate - and human error can lead to more product being transferred to a bottle than is required. Clearly this can have a significant impact on production and, given the high value of the product, can be financially damaging too. By automating the bulk fill process, costly inaccuracies can be avoided. In the SciLog® FD System, load cells located under receiving containers ensure direct measurement for high dispense accuracy.
Defects
An open process which relies on manual handling can result in contamination of a product and batch loss. Enclosing the process means that the product is protected and the risk of any contamination is greatly reduced. In addition, standardization and automation eliminate process variability and enables batch repeatability. Standardized, reliable programming ensures repeatability and control in the process.
As calibrated SciPres® single-use pressure sensors are included in the SciLog® FD System, operators can ensure that validated pressure limits are not exceeded, protecting the manifold and controlling the differential pressure over the filter.
Safety
Utilizing a fully enclosed process means the product is protected from contamination by the operator, but crucially also that the operator is protected from potentially highly potent molecules.
There are also additional advantages to using Parker’s SciLog® FD System which supports the application of lean in biopharmaceutical manufacturing. Standardization means that training is made simpler and easier, and by using a single-use system, change over times can be significantly reduced. The installation of manifolds in the system is quick and easy, again reducing labour costs and time spent on manual tasks.
To learn more about how the SciLog® FD System can help you tackle the eight wastes of lean, please visit our webpage.
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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One the biggest challenges for original equipment manufacturers (OEMs) in automotive manufacturing is ensuring reliable operation and long-term performance of equipment. Liquid and particulate contaminants, pressure build-up, temperature fluctuations and harsh environmental conditions can have devastating effects on sensitive components resulting in costly maintenance, downtime and part failure. What is the best line of defense? Are there new technologies available that provide an effective solution? Let's explore some options.
Components that are especially vulnerable include:
Many OEMs use membrane vents. Membrane vents are designed to equalize pressure and reduce condensation while preventing ingress of liquid and other contaminants to keep automotive components and devices operating properly.
When selecting membrane vents, it is important to review the following performance testing data:
Another important factor to consider when selecting membrane vents is the reputation of the manufacturer and the quality of customer service they provide. Additional attributes to look for include:
New technology
Vents made from expanded polytetrafluoroethylene (ePTFE), such as aspire® membrane laminates, are particularly effective for automotive applications. aspire membrane vents combine high water entry pressure with high air permeability to exceed automotive manufacturing requirements. The membranes are laminated to polymer meshes to provide the physical stability required for integration into automotive components and throughout operation. Proprietary oleophobic chemistry provides the level of ingress protection necessary to ensure long-term performance of automotive equipment.
aspire® performance data
Conclusion
Choosing the best membrane vent solution for automotive applications takes careful evaluation. Considering services and support the manufacturer provides, performance data and the effectiveness of the technology are key factors to ensure reliable, long-term operation of automotive components.
Article contributed by Sarah Propp, engineering manager, Parker Performance Materials.
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Computer Numerical Control (CNC) machining is a process where computer-aided design (CAD) and computer-aided manufacturing (CAM) programs are used to control the steps and functions of machine tool centers, allowing repetitive production processes to be programmed and automated. CNC machining and milling centers, as well as CNC lathes, are precision cutting machinery commonly used in industrial manufacturing applications such as metalworking. These centers have several axes, in which tools and workpieces move. Workpiece and tool changers supplement the systems so that complex geometries can be produced on one machine tool.
Today’s high-speed processing requires the introduction of cooling lubricants. These are used to cool the cutting edges on the direct contact surface to the workpiece during the cutting procedure, to lubricate the contact surface and remove any arising chippings through “purging”. Through the rotation and energy input, the cooling lubricant forms an aerosol mist, which is extremely hazardous to health if inhaled.
Let's explore how one metalworking manufacturer solved the problem of CNC machining emulsion mist and improved air quality in its production facility.
Problem:
Mauersberger und Fritzsche is an SME with a long tradition in gear manufacturing for drive technology and in the production of high-quality structural steel cupped shears. The company has CNC machining and milling centers from renowned manufacturers, such as Monforts, Doosan, Yang and Mori Seiki, in which workpieces are cooled, purged and lubricated with water-soluble cooling lubricants (emulsions). To improve air quality and safety, the corporate management team turned to Parker Industrial Gas Filtration Generation Division to design a solution to remove the hazardous emulsion mist.
Solution:
The company’s machinery comprises approximately 10 machine tools. For this reason, the advantages and disadvantages of single-station extraction units were weighed against a central extraction system.
The advantages of a central extraction system prevailed in this project. On balance, the investment costs are lower despite higher costs for piping and assembly, while maintenance is concentrated on a central point. In addition, a summer/winter set-up as hall ventilation can be easily realized with this concept. This allows exhaust air operation in the summer and a recirculated air operation in the winter to save heating costs.
In general, it is not possible to give one blanket answer to the question about single-station extraction units or central extraction systems. This must be decided on the facts of the relevant plant. However, as a general rule, the overall or life cycle costs of a central system with a ventilation system performance from 6,000m³/h tend to be lower. In this case, Parker recommended a SmogHog ESP two-staged electrostatic filter which reliably filters out harmful substances and emulsion mist, such as aerosols, and offers the client an approximately 15% reserve for production expansions.
The client was initially skeptical about an electrostatic filter solution. However, thousands of installed SmogHog electrostatic filter systems have proven successful for decades. Even oil and emulsion mists can be filtered with outstanding results if you have 50 years of knowledge like Parker. Knowledge, which can also be seen, for example, in the piping used for raw (polluted) gas, as this should be made of longitudinally welded steel and be oil-tight on the flange connections. “Cheaper” folded spiral-seam pipes are reputed to save costs but, according to Parker's experience, they carry a risk of a production hall becoming a “stalactite cave”. By visiting a comparable reference system near the client’s company, Parker was able to convincingly prove this knowledge, dissipate the reservations and win the trust of the user. This and independent measurements by the Institut für Luftund Kältetechnik convinced the client to award the contract to Parker.
The client is very satisfied with the performance and maintenance intervals of the system, especially as they clean the filter elements on-site and reuse the filter inserts.
Watch this video to learn more about Smoghog:
This article was contributed by the Filtration Team.
Thanks to Dr. Truschka and the company for approving this article and the pictures. Authors: Carlo Saling, Norbert Jedrzejak and Jörn Jacobs
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Do you need to detect ferrous wear particles in machinery? Are you working remotely, onboard a vessel, or onsite in a less than ideal environment? Ferrous wear meters allow users to measure ferrous wear debris in oil samples for condition monitoring in both marine engines and lubricated machinery.
Detecting metal particles
The Parker Ferrous Wear Meter (FWM) is a simple, easy-to-use instrument that provides accurate, reliable detection of metal particles in oil samples taken from a variety of types of machinery, including used cylinder scrape down oil, gearboxes and bearings. Monitoring of ferrous wear levels with your oil samples on an ongoing basis allows any deterioration in machine condition to be quickly spotted and corrective action taken, saving you downtime and money, and preventing more serious damage occurring. This versatile unit is ideal for testing and analysing oil samples on-site, on-board or in remote locations where full laboratory analysis is not possible.
Features include:
The FWM is constructed using a sophisticated magnetometer adapted for field applications. A 5-millilitre test tube, filled with the sample, is placed directly in the hole in the instrument and its metallic content, in PPM, is displayed on the screen in less than 2 seconds.
By taking ferrous wear measurements over time, any increase in wear levels can be monitored and appropriate actions taken to mitigate any damage. Machinery degradation can be observed as it happens and machines serviced as and when they need to be, rather than on a time or hours of operation basis, saving costs and manpower.
Performing a ferrous wear test
Each ferrous wear meter is supplied with three check standards to verify the product on a regular basis. In this example,
the 972 - 922 PPM ferrous content sample is being used.
Step 1
As per the on-screen instructions, insert the sample into the FWM for approximately one second, then remove. The result will be displayed on the screen for comparison against the check standard.
Step 2
Step 3
Insert the oil sample into the ferrous wear meter for approximately 1 second. Then remove.
Step 4
The results will display shortly after removal.
Watch this step by step video for complete instructions:
To learn more about the Parker Ferrous Wear Meter, download our datasheet.
Please visit our Hydraulic and Industrial Process Filtration Division EMEA for additional information.
This post was contributed by the Hydraulic Filtration Team.
Find more related articles here:
Optimising Feed Rate in the Fight Against Cold Corrosion
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Meeting New Sulphur Limits for Marine Fuel Oil
Bunker Quality: Why Changes to ISO 8217 Increase the Need for Condition Monitoring
Do you need to detect ferrous wear particles in machinery? Are you working remotely, onboard a vessel, or onsite in a less than ideal environment? Ferrous wear meters allow users to measure ferrous wear debris in oil samples for condition monitoring in both marine engines and lubricated machinery.
Detecting metal particles
The Parker Ferrous Wear Meter (FWM) is a simple, easy-to-use instrument that provides accurate, reliable detection of metal particles in oil samples taken from a variety of types of machinery, including used cylinder scrape down oil, gearboxes and bearings. Monitoring of ferrous wear levels with your oil samples on an ongoing basis allows any deterioration in machine condition to be quickly spotted and corrective action taken, saving you downtime and money, and preventing more serious damage occurring. This versatile unit is ideal for testing and analysing oil samples on-site, on-board or in remote locations where full laboratory analysis is not possible.
Features include:
The FWM is constructed using a sophisticated magnetometer adapted for field applications. A 5-millilitre test tube, filled with the sample, is placed directly in the hole in the instrument and its metallic content, in PPM, is displayed on the screen in less than 2 seconds.
By taking ferrous wear measurements over time, any increase in wear levels can be monitored and appropriate actions taken to mitigate any damage. Machinery degradation can be observed as it happens and machines serviced as and when they need to be, rather than on a time or hours of operation basis, saving costs and manpower.
Performing a ferrous wear test
Each ferrous wear meter is supplied with three check standards to verify the product on a regular basis. In this example,
the 972 - 922 PPM ferrous content sample is being used.
Step 1
As per the on-screen instructions, insert the sample into the FWM for approximately one second, then remove. The result will be displayed on the screen for comparison against the check standard.
Step 2
Step 3
Insert the oil sample into the ferrous wear meter for approximately 1 second. Then remove.
Step 4
The results will display shortly after removal.
Watch this step by step video for complete instructions:
To learn more about the Parker Ferrous Wear Meter, download our datasheet.
Please visit our Hydraulic and Industrial Process Filtration Division EMEA for additional information.
This post was contributed by the Hydraulic Filtration Team.
Find more related articles here:
Optimising Feed Rate in the Fight Against Cold Corrosion
The Importance of Condition Monitoring to Your Business
Meeting New Sulphur Limits for Marine Fuel Oil
Bunker Quality: Why Changes to ISO 8217 Increase the Need for Condition Monitoring
Carbon dioxide (CO2), a colorless, odorless, noncombustible gas, is widely used in the food and beverage industry during the bottling process as a carbonation agent for soft drinks, beer and sparkling water. CO2 is at risk of contamination from leaks, insufficient processing, transportation, storage and handling, all of which can take place multiple times before reaching its point of use in the production plant. Contamination is a real problem for manufacturers as it can result in off-flavors and odors, spoilage, changes in appearance, product recalls and damaged reputation. That's why many beverage producers are taking measures — such as installing a Parker PCO2 Quality Incident Protection System — to ensure CO2 purity and avoid the serious impact of quality incidents on their businesses.
To help you learn more about the Parker PCO2 system, we've compiled a list of our top frequently asked questions.
Top FAQs on the PCO2 Quality Incident Protection System 1. What is PCO2?
The PCO2 is a static adsorption bed constructed from specially selected adsorbents that are designed to remove trace contamination from CO2 to guarantee gas quality so it remains within industry and company guidelines. The system prevents detrimental consequences to the finished end beverage, the producer's reputation, and their bottom-line.
The PCO2 designed as a quality incident protection device, meaning that it will treat out-of-specification CO2 to return it back to specification (within the limits of the specification). The PCO2 is not designed to constantly purify poor quality CO2 (not allowing the beverage producer to lower the incoming CO2 specification).
CO2 is produced from a wide variety of processes with differing contaminants. Some of these remain in the gas after treatment at the gas recovery plant. There have been some publicised incidents where poor quality gas passed all the way through the supply chain and into the beverage. To prevent a repeat occurrence of these quality incidents, bottlers are implementing in-line, on-site protection, in addition to tightening controls at the CO2 suppliers.
This is where a delivery of out-of-specification CO2 has been made to the plant or where CO2 has been contaminated on-site during the production process and fails to meet recommended standards.
ISBT (International Society of Beverage Technologists) & EIGA (European Industrial Gas Association) both have International recommended standards. In these standards, potential contaminants are named with a critical PPM limit of acceptance.
The PCO2 purifier will treat CO2 with up to 10 times the ISBT / EIGA levels of the named contaminants for a specified quantity of processed CO2 gas.
Many plants will find this very hard to observe if they do not have a CO2 analyser or gas inspection process on site. Most plants take the quality assurance (QA) certificate from the gas supplier as their goods inwards inspection. To improve monitoring of gas quality, many plants are purchasing online CO2 analysers in addition to purifiers.
In most cases, the gas will be clean and have very low levels of monitored contaminants. Under these conditions, there will be very little difference between inlet and outlet concentrations. In the event of a contamination spike, the purifier will remove it.
Yes, always.
All producers and bottlers of beverage products, including:
The three-layered adsorbent bed adsorbs contamination as it flows through. The three materials preferentially adsorb differing contaminants thus providing effective protection against a wide spectrum of potential contaminants.
No, although some companies may claim to be able to recover adsorbents and regenerate them, we are trying to remove contaminants to parts per billion levels and any trace residues may inhibit future performance. Additionally, many industrial processes for regenerating adsorbents ay actually add contamination to the PCO2 cartridges.
The purifier treats vapour phase CO2, so it has to be installed downstream of the vaporiser (evaporator), with a maximum approach temperature of 40°C. Some plants have installed the purifiers close to the carbonator, while others have chosen a central point close to the evaporator for complete site treatment. The Parker PCO2 is suitable for either option. The PCO2 is also suitable for external installation.
This blog was contributed by Danny Silk, product manager, specialist filtration, Parker Gas Separation and Filtration Division, EMEA.
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Carbon dioxide (CO2), a colorless, odorless, noncombustible gas, is widely used in the food and beverage industry during the bottling process as a carbonation agent for soft drinks, beer and sparkling water. CO2 is at risk of contamination from leaks, insufficient processing, transportation, storage and handling, all of which can take place multiple times before reaching its point of use in the production plant. Contamination is a real problem for manufacturers as it can result in off-flavors and odors, spoilage, changes in appearance, product recalls and damaged reputation. That's why many beverage producers are taking measures — such as installing a Parker PCO2 Quality Incident Protection System — to ensure CO2 purity and avoid the serious impact of quality incidents on their businesses.
To help you learn more about the Parker PCO2 system, we've compiled a list of our top frequently asked questions.
Top FAQs on the PCO2 Quality Incident Protection System 1. What is PCO2?
The PCO2 is a static adsorption bed constructed from specially selected adsorbents that are designed to remove trace contamination from CO2 to guarantee gas quality so it remains within industry and company guidelines. The system prevents detrimental consequences to the finished end beverage, the producer's reputation, and their bottom-line.
The PCO2 designed as a quality incident protection device, meaning that it will treat out-of-specification CO2 to return it back to specification (within the limits of the specification). The PCO2 is not designed to constantly purify poor quality CO2 (not allowing the beverage producer to lower the incoming CO2 specification).
CO2 is produced from a wide variety of processes with differing contaminants. Some of these remain in the gas after treatment at the gas recovery plant. There have been some publicised incidents where poor quality gas passed all the way through the supply chain and into the beverage. To prevent a repeat occurrence of these quality incidents, bottlers are implementing in-line, on-site protection, in addition to tightening controls at the CO2 suppliers.
This is where a delivery of out-of-specification CO2 has been made to the plant or where CO2 has been contaminated on-site during the production process and fails to meet recommended standards.
ISBT (International Society of Beverage Technologists) & EIGA (European Industrial Gas Association) both have International recommended standards. In these standards, potential contaminants are named with a critical PPM limit of acceptance.
The PCO2 purifier will treat CO2 with up to 10 times the ISBT / EIGA levels of the named contaminants for a specified quantity of processed CO2 gas.
Many plants will find this very hard to observe if they do not have a CO2 analyser or gas inspection process on site. Most plants take the quality assurance (QA) certificate from the gas supplier as their goods inwards inspection. To improve monitoring of gas quality, many plants are purchasing online CO2 analysers in addition to purifiers.
In most cases, the gas will be clean and have very low levels of monitored contaminants. Under these conditions, there will be very little difference between inlet and outlet concentrations. In the event of a contamination spike, the purifier will remove it.
Yes, always.
All producers and bottlers of beverage products, including:
The three-layered adsorbent bed adsorbs contamination as it flows through. The three materials preferentially adsorb differing contaminants thus providing effective protection against a wide spectrum of potential contaminants.
No, although some companies may claim to be able to recover adsorbents and regenerate them, we are trying to remove contaminants to parts per billion levels and any trace residues may inhibit future performance. Additionally, many industrial processes for regenerating adsorbents ay actually add contamination to the PCO2 cartridges.
The purifier treats vapour phase CO2, so it has to be installed downstream of the vaporiser (evaporator), with a maximum approach temperature of 40°C. Some plants have installed the purifiers close to the carbonator, while others have chosen a central point close to the evaporator for complete site treatment. The Parker PCO2 is suitable for either option. The PCO2 is also suitable for external installation.
This blog was contributed by Danny Silk, product manager, specialist filtration, Parker Gas Separation and Filtration Division, EMEA.
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The Importance of Maintaining CO2 Gas Quality in Bottling Applications | Case Study
When compared to bacterial contamination, Mycoplasma contamination isn't immediately obvious.
The outcome of any contamination event is the same — the disposal of the contaminated media and decontamination of equipment used in the process — but the methods of detection and the timelines differ enormously.
You would know if a culture was contaminated with bacteria within 24 hours: the contamination would be obvious — as would the need to immediately remove and dispose of the culture.
Mycoplasma's secret weaponMycoplasma contamination, however, presents a different scenario. A culture could have a Mycoplasma infection at as much as 10,000 Mycoplasma per mammalian cell, with no detectable effect.
Mycoplasma stays under the radar and co-exists with a cell line, with no immediately visible side effects. There is no change in the media appearance, or in the pH or DO demand. What will happen is that the Mycoplasma will compete for nutrients at a low level, resulting in potentially slower cell growth and lower yields.
As well as depleting the nutrient supply, the Mycoplasma's metabolic activity will result in the release of toxic and/or cytolytic metabolites which will have a negative effect on the cells.
The results? Production levels could be lower than expected and R&D decisions could be made based on compromised data, due to an undetected Mycoplasma infection affecting cell growth and productivity.
If you'd like to learn more about Mycoplasma contamination and how to tackle it read our white paper: Preventing Mycoplasma Contamination
How the wider supply chain is affected
A Mycoplasma contamination event can have serious consequences for patient safety as it can disrupt supply of critical drug products. It will result in unplanned downtime, leading to disruption in the supply chain causing reputational damage and financial consequences.
From an operational perspective, Mycoplasma contamination will lead to an investigation and remedial works, all followed by the cleaning in place (CIP) / sterilizing in place (SIP) of fixed assets. If a facility is using single-use systems, CIP and SIP won't be needed, however, the entire site will still need to be decontaminated.
So what options are available for testing? Direct culture on agarThis is the classic method for detecting a Mycoplasma contamination and is the regulatory test to show clearance for clinical use.
While this test is effective and sensitive, it is the most difficult and time-consuming method - it takes 28 days for results to be obtained. This method also requires live Mycoplasma cultures to be maintained to act as positive controls. However, bearing in mind how easily Mycoplasma can spread, this may not be something that is advisable to have in the same building as a cell culture lab. As a result, this test tends to be outsourced — which further extends the time taken for a result to be attained.
PCRPCR is a sensitive and analytical testing method. It is relatively quick and effective in detecting contaminations which can be difficult to spot. However, it can't distinguish between viable and non-viable organisms. In addition, to avoid giving false-positive results, the testing laboratory must implement strict measures to ensure containment to prevent cross-contamination and environmental contamination.
DNA fluorochrome stainingThis is a simple and fast method that stains DNA using a fluorescent dye which can then be viewed under a fluorescence microscope. It requires positive and negative controls and while in normal circumstances, the requirement for positive controls would count against a method, these controls are commercially available. And as the Mycoplasma have already been fixed onto slides, they present no contamination risk to the lab.
ELISA testingEnzyme-linked immunosorbent assay (ELISA) is a technique used to detect infectious agents in a sample. This form of testing can yield quick results, however, it may not be able to detect uncommon sources of contamination.
But which is the best practice?Best practice (and that required by the FDA) is a combination of the direct culture method (given its high sensitivity) and DNA Fluorochrome testing, which will detect low-level fastidious Mycoplasma contaminations.
So how can Mycoplasma be eliminated?Once identified, you must eliminate any Mycoplasma infected material, solutions or equipment. An autoclave cycle will have a 100 percent success rate. But if a cell line is unique and you cannot afford to lose it, you have no option but to try to recover the cell line.
You could turn to antibiotics — but that should be a last resort and only used if a highly valuable or unique cell line can't be thrown away. The process lasts for a number of weeks and antibiotics may also be detrimental to the cells, resulting in the loss of the culture you are trying to preserve.
Once treatment with antibiotics is complete, thorough screening is required to ensure that contamination has been eliminated and not just suppressed.
Tetracyclines, macrolides and fluoroquinolones can be used, but their use should be limited to avoid resistance.
All equipment should be decontaminated either by SIP or autoclave cycles. Disinfectants that target Mycoplasma are also available. If it is not possible to apply these methods after suspected contamination, any equipment needs to be removed from the facility and replaced.
To avoid cross-contamination events, media and reagents should only be used for one cell line and never stored in the laminar flow hood. Any media and reagents that have been near a contaminated culture should be disposed of immediately.
Implementing a system to isolate cell lines, reagents and equipment — combined with good housekeeping procedures — should help to prevent contamination from spreading.
Prevention is always better than cure
The key is knowing the source of the cells, using media from reputable sources and following a good aseptic technique.
When looking at a mitigating risk from media and components that are heat labile, a particularly successful method is filtration using a 0.1 micron rate membrane such as Parker Bisocience Filtration's PROPOR MR.
Incorporating a highly retentive 0.1 micron PES membrane, PROPOR MR filters provide fast and effective removal of Mycoplasma from cell culture media.
If you'd like to learn more about Mycoplasma contamination and how to tackle it read our white paper: Preventing Mycoplasma Contamination
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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In a world where we measure on-time delivery, is 98 percent really acceptable? It sounds good but in the supply chain of the pharmaceutical industry, what is the impact on the 2 percent of patients who experience a delay in the supply of vital medicines?
During downstream processing, the value of a biopharmaceutical product increases at every step, as the purity of the product increases. Therefore, if there is product loss at the bulk filling stage, this could prove very costly indeed for a manufacturer and have serious consequences for patients further down the supply chain.
The only acceptable loss in terms of product and time, therefore, is zero. But how can that be achieved?
Automation and enclosure
Automating and enclosing bulk fill operations can reduce the risk of human error in the bulk filling process. There is no open manual manipulation of tube sets – a very real potential source of product loss – and by standardizing the process and simplifying training, variations in the process are eliminated.
The introduction of enclosure processing protects the product, as well as having a significant benefit for the safety of operators. As the process is enclosed, dispensing can be performed in areas of lower classification, potentially eliminating the requirement for vertical laminar flow cabinets and/or isolators to be installed, validated and maintained.
Parker Bioscience Filtration has developed The SciLog® FD System as an automated integrated single-use system for final bulk filtration. The system enables the automated flushing, integrity testing of filters and dispensing into final bulk product containers - bags or bottles.
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 protect the product and the process. All of this is delivered in a package that is cGMP ready.
Watch the video:
Tubing optimization
Tubing selection is also important: wall thickness, brittleness and the material itself must all be considered, especially when storage will be at ultra-low temperatures. TPE and silicone both have different qualities and a one size fits all approach needs to be avoided.
Ensuring bottle integrity
After dispense it is crucial that the substance being shipped remains in an optimum condition as it completes the journey from production to the filling site. A poor bottling solution can lead to product loss, even if bulk fill has been successfully completed. Common problems include the tubing from the bottle breaking under impact once frozen, the bottle cap seal leaking and variable torque on the bottle cap allowing ingress of air during thawing of the frozen bulk.
It is critical to validate each step within the shipping process and implement solutions to alleviate the risk of product loss.
At Parker Bioscience Filtration, we’ve created an end-to-end automated packaging solution that creates a platform for bulk shipping. We have validated this solution with a focus on bottle filling, bottle integrity and liquid ingression, across the full range of temperatures found in a typical supply chain.
Conclusion
Eliminating the risk of human error at the bulk dispense stage through automation can play a key part in minimizing the risk of product loss – and reaching that 100% on-time delivery figure. But it’s also vital to consider what often gets overlooked: bottle integrity and protection during shipment. Parker Bioscience Filtration, by taking a holistic approach to this often-overlooked process step, has created a solution: the SciLog® FD. This solution protects the product being filled and the operator running the process but also enables the reliable, on-time delivery of critical pharmaceutical products.
To learn more about the SciLog® FD system can protect your product, visit our webpage or contact your local Parker Representative.
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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Automating and Enclosing Bulk Fill Operations - the Way Forward?
Listening, Learning and Applying Knowledge in Product Development
Compressed air is used throughout industrial manufacturing, often for applications that cannot be replaced by electricity. The drive to reduce energy consumption and costs creates a dilemma for manufacturing facilities with regard to compressed air treatment. Manufacturers often identify the compressed air system as a place to realize savings. However, when it comes to purification equipment, such as compressed air dryers, choosing a model based on the lowest energy consumption can directly impact air quality.
Most of today’s manufacturers use an air quality specification, typically based around the ISO 8573-1 air purity classifications, as a benchmark for the selection of their compressed air treatment equipment. While this should be the primary criteria used for product selection, energy reduction is often given higher priority. These two factors can offset each other, resulting in air purity below the desired classification.
Here, we will discuss several alternative air dryer technologies and their impact on the balance between energy consumption and air quality to help users identify the technology that best suits their facility.
There are several types of adsorption — or desiccant — dryers available. These are preferred for applications with particular sensitivity to moisture, like instrumentation and where external temperatures may have an impact. While the principle used to dry the compressed air is identical, the way they regenerate the desiccant material is different.
The simplest way to regenerate the desiccant material also uses the most energy. Dry process air (purge air) is used to regenerate the off-line desiccant bed. This type of dryer, referred to as heatless, is most common. However, for higher compressed air flows, there are more energy-efficient alternatives available. Types of heatless dryers include:
While blower dryers do not use any purge air for regeneration, they do use dry process air to remove heat from the desiccant material. The amount of cooling air is typically expressed as 1~2% of the dryer’s flow. However, this is an average over the drying cycle, and during the cooling period, air consumption can be as high as 10~20%, significantly increasing overall energy consumption.
To reduce energy consumption, some blower dryers use ambient air for cooling. This practice can add up to 77°F (25°C) to the ambient air temperature, leading to inefficient cooling and directly impacting the delivered air quality (outlet dewpoint).
HOC Dryers, often installed with oil-free compressors, use the heat generated from air compression to regenerate the adsorbent material. This process does not include a cooldown of the adsorbent material, the lack of which has a negative impact on the air quality (outlet dewpoint) delivered by the dryer. During periods of low air demand, insufficient heat can be available for full regeneration, further impacting outlet dewpoint.
As the dewpoint delivered by this type of dryer can fluctuate greatly, they are typically classified as dewpoint suppression dryers and will not provide an outlet air purity consistently in accordance with the ISO8573-1 classifications.
The operation of a vacuum regeneration dryer is similar to a blower dryer. Instead of using a blower to “push” heated ambient air over the off-line desiccant bed, they use a vacuum pump to “pull” heated ambient air over the material. The desiccant material can regenerate more efficiently under vacuum, saving more energy. No process air is required for cooling (the desiccant is not impacted by heat generated by the vacuum pump,) providing significant energy savings without a negative impact on the outlet air quality (dewpoint).
An optimal solution
A successful example of vacuum regeneration technology is the WVM Series Generation 5 Vacuum Regeneration Dryers. The WVM Generation 5 is a low energy consumption adsorption dryer that does not require any process air for either the regeneration of the desiccant material or for cool down purpose after regeneration.
WVM Generation 5 dryers deliver outlet dewpoints in accordance with ISO 8573-1 Classes 1, 2 or 3 (-70, -40 or -20 respectively). They are equipped with a dew-point controlled energy management system, which ensures energy consumption is matched to the incoming water vapor loading — helping to prevent negative impact on the outlet dew-point.
Each model has a 7 inch, IP65 touchscreen HMI linked to an advanced PLC control system. IIOT (MQTT or OPC UA) connectivity, Modbus RTU via 2 wire RS485 & Modbus TCP/IP via Ethernet RJ45 are standard features, with Profinet/Profibus protocols and cloud connectivity available as options.
Additional energy savings can also be realized by replacing the electric heater, fitted as standard to WVM Generation 5 dryers, with an alternative heat source. If the manufacturing facility has steam on-site, the electric heater can be replaced with a steam heat exchanger, or a dual steam and electric configuration, which offers optimum conservation of energy and the peace of mind offered by a redundant system.
This article was contributed by Mark White, compressed air treatment applications manager, Parker Gas Separation and Filtration Division EMEA
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Learn more by reading the full article, Don't Compromise Air Quality for Energy Reduction, published in Industrial Plant & Equipment magazine