Fluid Dynamics – Laminar Flow – Turbulent Flow – Transitional Flow & Particle Reduction

Posted on by Julianne Ouellet

In physics and engineering, fluid dynamics is used to describe the flow of fluids – liquids and gases. For the sake of this discussion, it includes the subset of aerodynamics, which is the study of air and other gases in motion. Many clean room consultants chagrin at the idea of using compressed air movement inside of a clean room that was developed using Laminar Flow techniques. Laminar air flow by design is intended to be slow, smooth regular paths of an air pattern traveling from entrance to exit. The air then travels back through the pre-filters, to the laminar flow filters and back into the room as part of the air change rate per hour. Laminar air low patterns are important to keeping particulate moving out of the clean room, but what if products being process inside of the clean room are already contaminated with particles that could come from people, other items that were brought into the space or that were created by the process itself.

In order to clean particulate from a device, component or packaging material, compressed air devices are necessary. The air devices are typically in the form of ionizing air guns, blowers, nozzles or air knives. These air tools cause turbulent flow, which is fluid motion that agitates the parts and creates eddies, which are violent swirling motions caused by the position and direction of turbulent flow. Eddies can transport mass, momentum and energy across different regions of the flow, with a result being clean, static-free parts. Heat transfer also happens in turbulent flow. So why is heat important? With heat, the flow resistance decreases, making it easier to clean parts. The process of laminar flow becoming turbulent is known as laminar-turbulent transition. It is also known as transitional flow.

Is there a happy medium between using compressed air and maintain an acceptable level of laminar flow? Can we agree that compressed air is a requirement and that compressed air is turbulent? Static Clean believes in the idea of “Controlled Turbulence”. The placement of Static Clean Particle Trap® Systems, in conjunction with compressed ionizing air devices means that the turbulence is localized, particles are captured and removed from the process and the products and parts are clean. By using an ionizing air gun or similar device in front of a Particle Trap®, the debris is directed into the flow of these source capture systems and delivered into the filter media and not back into the clean room to re-contaminate cleaned parts.

Particle Size, Particle Retention & Process Practicality

Posted on by Julianne Ouellet

Particle collection efficiency by a filtration device usually brings a common question. What is the ISO number that is associated with HEPA filters used in the Static Clean Particle Trap® series products? A recent request from a customer asked this exact question. Our answer in response was that the ISO rating on our HEPA Filter is ISO 40E-99.99% at MPPS. Obviously, the customer with the questions knew what to ask and was technically astute, but to a novice it may seem confusing, so first let’s establish what MPPS mean. It is the Most Penetrating Particle Size. Larger particles are unable to avoid the special filter media in a HEPA filter and they become embedded in the filter material. The smaller particles become the MPPS, which gives the HEPA their rating. For more critical filtration needs, ULPA filters are available and could have an efficiency of 99.99995% at MPPS.

For the world of static control, and filter efficiency of the Static Clean Particle Trap® Systems, we are mostly talking about HEPA filtration. But filtration only tells a part of the story. Although you can perform tests to validate HEPA filters and modern particle counters can provide information on airborne particulate, it doesn’t tell the story on how clean a medical injection molded plastic part may be or how many particles are on a catheter or the tray or package that is going to house the medical device. Yes, there are liquid particle counters that can verify all particle sizes, but real time production of high-volume parts means that, at best a visual inspection on the fly is the standard.

Most of the Medical Device Manufacturing is done in an ISO Class 7 or ISO Class 8 cleanroom, with an emphasis on ISO Class 8. Federal Standards FS 209E and ISO 14644-1 require specific particle measurements to verify the cleanliness of the clean room or clean area. When talking about an ISO Class 8 environment, it does mean that the maximum/particles/m3 allows for almost 30,000 particles in the 5 micron or smaller range. It also means two other things as well. There will be particles greater than 5 microns in an ISO 8 space and that total reliance on a cleanroom is not the complete answer. The use of additional filtration methods at key points in the manufacturing process will improve yields by reducing particles on products and in single use packaging that may finds its way to the hospital or clinic. The fact that ionization is used to control static on medical devices, optics and industrial environments is common knowledge, but, source capturing debris at critical stages in the process is less understood but becoming more accepted as the right tool at the right time.

Particle Trap® products are small, benchtop or floor level source-capture systems, that incorporate both pre-filters and HEPA-filters in series, whereby the pre-filter catch the larger particle and the HEPA, (the same used in the clean room construction), captures the smallest debris. What this means for the customer is that particles are taken out of the room at the source and by source, either where they are created or where they can do the most harm and end up inside of a finished package. Regardless of what ionizing blow off device is used in your process, you can rely on Static Clean to make things cleaner and your customer smile.

Where do the particles go?

Posted on by Julianne Ouellet

Did you ever rub a balloon on your hair and stick it to the ceiling? The balloon sticks because you’ve created static electricity on the surface of the balloon. This energy is non-moving static charge. Every material is made up of atoms and they are the basic building blocks of ordinary matter and they can join to form molecules, which is a basic ingredient of most of the objects around us. An atom can hold a positive charge that is called a proton or a negative charge that is called an electron. Atoms with the same charge or polarity repel each other, while those with the opposite charge are attracted to each other. Just like the balloon scenario, static is created by the contact and separation of two materials. The same is true of when you walk across a carpet and touch the metal door knob and get a shock. We call these electrostatic forces, tribo-charging, which renders a plastic material in a state where it can attract dust and other particulates.

Let’s face it, we are using more plastic in our every day lives, from cars to single use medical devices that may end up inside of the human body. Plastic, being highly insulative, can store huge amounts of static electricity. If we just look at the medical device sector, one of the biggest reasons for rejects, rework and potential device failure, is from foreign particles that end up in the finished device. These particles could be in the form of airborne contaminants, plastic flash, skin flake, human hair and other debris that is found in the manufacturing process. Static eliminators in the form of ionizing air guns, nozzles and ionizing blowers are used to negate the ill effects of electrostatic forces that pull particles right out of the air and hold them to a device or components. The use of ionized air is absolutely a good practice, but the problem is “where do the particle go”? Typically, they hang around and end up on the work surface to be a source of re-contamination or the particles end up downstream on already cleaned products.

Enter the Particle Trap® 6000. The Particle Trap® 6000 (PT6000) is the solution to getting rid of particles in the assembly and packaging areas of the medical device manufacturing process. The PT6000 is a source capturing system with a HEPA filter on the exhaust. You can still use the conventional ionizing air blow-off devices, but when working in front of the opening of the PT6000, dislodged particles now are delivered through a pre-filter and then through the HEPA filter, ensuring only clean air is let back into the room. The PT6000 is used not only to clean medical components, but it is especially helpful when used at the packaging level, just prior to the heat sealing of a lid stock to the thermoformed tray. The same would be true for pouching of products such as a catheter on a die cut card being slid into a long plastic bag and then sealed at the end. Normally, most medical device manufacturers do a 100% inspection for foreign matter/particles inside of the seal trays. If a particle is discovered, the lid is ripped off, the product taken out, recleaned and then repackaged. This reject rate is also called the tear down rate, which translates into poor yields, time and money along with customer dissatisfaction, when a product gets through that is not totally cleaned.

Who would benefit from the Particle Trap® 6000? The Particle Trap® 6000 and its sister products, the PT Mini, Particle Trap® CUBE and Medical Cleaning Systems. While the medical device sector has endorsed these products, they also have application in the optics, food and electronics industries for the same reason why all companies are looking to lower their tear down rates, which translates to higher profits. If you want to learn more about how Particle Trap® products can help improve your process, please contact our technical sales team for more information.

Medical Cleaning Station Testing - Static Clean International, Inc.

Introducing our NEW “Clean & Pack,” Don’t Look Back!

Posted on by Julianne Ouellet

Let’s face it, the Medical Device Manufacturers have come under scrutiny, not only from their customers, but also from the FDA in an effort to create a manufacturing environment that has less particulate which can impact quality.  Static Clean International manufactures static control and particle source-capturing products that aid in this effort by reducing particles at critical points in the process.  Three of the most critical areas in the process are at the molding, assembly, and packaging stages of these medical devices. Packaging is the primary source of foreign particles in the process.  Remember, these packages are going to house a medical device that eventually ends up at a hospital or a clinic for use on patients where “clean” is critical.

Medical Clean Room Test Environment

Customers ask us how well our Medical Cleaning Systems work and to what level our “Clean and Pack” system helps to reduce contaminants.  In an effort to guarantee success, Static Clean International recently installed a brand new ISO Class 7 Clean Room that is fully equipped with products that are designed to reduce particles, lower rejects and improve yields.   Customers are invited to visit our facility, bring their trays or devices into our clean room, and learn first-hand the value that Static Clean and its products bring to the Medical Industry.

 

All That Glitters Is Not Gold

Posted on by Jim Patterson

Meaning

“All That Glitters Is Not Gold” —  Not everything that is shiny and superficially attractive is valuable.

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Cleaner Means Safer..

Sometimes the smallest parts are the trickiest to clean.  At Static Clean our customers often bring us size challenging parts and devices to work on. Until recently no one in our industry has been able to address these challenges. Static Clean has now developed a method using our Medical Cleaning Station and Medical Cleaning Station-AS cleaning benches to batch clean these small part products. We have a Stainless Steel sieve that is fed through the upper and lower hoods that are part of our MCS line.  We had a potential customer from New Jersey who was amazed at how well it worked. Before he arrived, he went to a Michael’s store with his daughter and bought all kinds of colorful glitter that you would use for arts and crafts.  He used the glitter to contaminate the white caps that you see in the video.  It was overkill but a very good test.  The white caps that you see here go on the top of things such as suspension bottles, eye drop bottles, contact lens cleaning bottles etc.  If they have particles, plastic bits, human hair or any foreign matter, it could be the cause of a health problem.   Our batch cleaning system worked so well that he has said he is interested in purchasing not one but two MCS Systems and commented that “it worked better than I ever anticipated”.

For more information on our MCS or MCS-AS Cleaning benches, contact our technical sales department today.

Static Innovates for High Reliability

Posted on by Jim Patterson

Shocking Technology!

Static Clean International has developed a new breed of transformer-based high-voltage line-frequency AC power supplies (e.g. TSN75A and TNS75E 7500Vac PSs) relying upon patent-pending technology for application in ionizing equipment. This new technology has been so far applied within SCI static-neutralizing equipment systems and within SCI ionizing blowers.

The longstanding conventional technology within the industry relies upon the use of sound-muffling and corona-resistant materials to pot over the underlying iron-core transformer. The high-voltage secondary winding of the iron-core transformer generates partial discharge of encapsulated air bubbles at normal operating voltages. This limits MTBF of such equipment due to eventual chemical breakdown of the organic polymers subjected to the continuous slow and insidious damage from corona.

The user HV connections (if applicable, as in some static-neutralizing systems with HV-cable user-mounted components) in the conventional power supplies also require proprietary methods and tooling to fabricate the secondary section of the transformer that are only used within the ionizing equipment industry for the most part.

Warning! High Voltage..

SCI’s new technology is a form of resistive coupling between transformer secondary winding and ionizing electrodes circuitry. It enables the use of more common transformer fabrication methods and raises the partial-discharge inception voltage (aka PDIV) to levels above normal operating voltage for the equipment. It provides some regulation (i.e. high-voltage stability) for non-ferroresonant HV transformer topologies, and it enables the quick-connect/disconnect de facto standard (threaded spring-contact) for ionizing equipment systems that contain a user-mounted HV-wire component as well as similar equipment-internal spring-contact HV connections that are desirable for assembly and reliability.

We at SCI believe that a superior cost-performance-quality trade-off can be achieved with the new transformer/resistive-coupling methods for some products, and are continuing with ongoing new product development based upon this proprietary technology and provides a high reliability solution.  New products in the field have demonstrated excellent robustness with respect to the common failure mode of HV-secondary dielectric breakdown.

Is It Getting Better?

Posted on by Jim Patterson

The Waiting Game

One of the claims by Medical Device Manufacturers, especially start-ups, is that it takes way to long to bring a new medical device to market and that the regulator process is cumbersome. While the FDA is trying to streamline the process, the FDA takes a cautious approach to new product approval, in large part due to the litigious nature in America.   The development from devices to disposables, which are less intrusive forms of treatment, are scrutinized by the FDA’s claim that the devices have to work and they have to be safe.

According to Dr. Herbert Lerner, Deputy Director of the FDA’s Division of Reproductive, Gastro-Renal and Urological Devices, the relationship between the device manufacturers and FDA is getting better as seen in the video below.  A great term when talking about medicine and treatments, it is “getting better”.  Some of the inventions that are designed to treat us, cure us, prolong life and yes,  save lives include: transfusion disposables, infusion pumps and cardiology disposables like catheters/stents and IV sets.

Progress a Long Time Coming

For the sake of discussion, let’s focus our attention on Cardiac Catheterization, which was first performed in 1711, when a long metal tube was inserted into the right and left ventricles of a living horse. We’ve come a long way today with the use of Teflon tubes, self-expanding wall stents, balloon catheters, guide wires, the medical grade plastics and the mass assembly process. Devices are molded, extruded, machined and processed for eventual assembly in a Clean Room.   It could become a finished product at the medical device manufacturing facility or at a contract manufacturer site that follows the protocols set by the original device manufacturer.

As mentioned, the concern of the FDA is ensuring a product works and that it is safe.   Most medical devices on the disposable side are individually packaged. This means that once the product goes into the package, it is ready for shipment to a hospital, clinic or a supply shop.   A growing concern by medical device companies and the FDA is whether the product is clean, meaning that it is free of particles that could end up inside of the human body through veins or other body cavities depending on the actual device.   The precautions set forth by the nature of the product and its application is that “it has to be kept clean and free of foreign particles.

FM the Common Denominator

The common denominator for particle attraction is the static electricity that is created by simply handling the components that go into a medical device.   The plastic materials used can easily generate the electrostatic forces that pull particles out of the air, even when the work is being performed in a clean room. Room Ionization is gaining in popularity to keep the amount of static electricity at lower levels, but room systems with slow decay rates can’t solve the problem at the assembly workstation. The medical community has to assume that the devices have debris on them and to recognize the need to treat the problem at key points in the assembly process. This is especially true before the parts go into the pouches, blister packs and rigid trays that ship to end users.

Static Clean the Equalizer

In the past year, Static Clean has launched a number of important products to address foreign matter, especially the Particle Trap® line that includes the Particle Trap® Cube, which removes particles from the balloon portion of the catheter and also from any plastic parts that are assembled in the Clean Room. Static Clean welcomes the opportunity to have a partnership approach with our clients old and new, to find the right solution for your process.

As the U2 song ONE say, “Is it getting better, or do you feel the same, will it make it easier on you, now you got someone to blame.

Don’t be the blame for failures, poor yields, rejects, rework and recalls from the field. Let us help.

Image By Matt Skoufalos: http://medicaldealer.com/the-key-to-compliance-cmstjc-guidelines-combine-to-promote-patient-safety/

 

Cancer Treatment in the Form of Static Electricity

Posted on by Jim Patterson

Fighting to Win!

Last week I went to Toronto to attend a “Bell Ringing Ceremony”.  Before I received the phone call invite from my niece who has been battling a cancerous brain tumor, I hadn’t heard of this particular event.   Here is the back story.   Cancer patients are subjected to 30 straight days of Radiation and Chemotherapy on an outpatient basis.    In the hallway, outside of the treatment rooms mounted on the wall is a brass “Celebration Bell”.  At the end of the treatment period, the family and friends of the patient meet at the hospital and help their loved ones “Ring the Bell”.

Next to the bell was a plaque that had the following saying.

“Ring this bell three times well – Its sound to clearly say – My treatment is done – This course is run – And I am on my way”.

Static Treatment

Before I went into the Juravinski Cancer Center in Hamilton Ontario, I sat on a park bench near the entrance to the lobby and watched patients come and go.  Many struggled on their way into the center, but more seemed to struggle after their rigorous treatments.   It was a very sad, moving and thought provoking experience.  However, it got me to thinking about cancer treatments and whether the day will come when there are less invasive methods to treat cancer, the number one killer in the world.   Back in Boston, I did a little research and found out that static electricity, which is considered as part of Natural Medicine is in consideration and going through clinical trials, especially in Japan.  Of course!!!

The thought behind using static electricity is nothing new to the medical community.  In the Reading Eagle newspaper, dated September 2, 1951, a retired military surgeon by the name of Colonel Francis Usher suggested the use of static electricity as a possible new cancer treatment.  His premise was that it would enhance existing treatments and possibly slow the growth or kill the cancer cells.

Back to the Future

Fast forward 60 years and many articles can now be found on using static electricity in the treatment of cancer and clinical trials are underway by a number or researchers.  In a paper presented by Philip H. Gutin, MD, and Eric T. Wong, MD, they wrote about Tumor Treatment Fields (TTF) claiming that TTF treatment or an electric field has a superior safety profile, and its minor side effects do not seem to overlap with those of cytotoxic chemotherapies, targeted agents, or anti-angiogenesis drugs. Therefore, the rational combination of TTF therapy with specific pharmacological agents may enhance tumor cell death.

The definition of an electric field is attributed to Michael Faraday in the 1820s and was later formulated by James Clerk Maxwell in his electromagnetic theory in 1865.   It is a field of electric forces that surround a source charge. When a test charge is placed within an electric field, a force acts on it because it is energy. By using a battery with a couple of wires on an AC or alternating current, tests are easy to conduct.   Negative charges attract positive charges, while similar signed charges repel each other.  Basically, two electrodes are placed at a given distance from each other on the human body in proximity to a tumor or cancerous cells.  Voltage is applied and the energy travels from one electrode to the other and has an effect on the bad cells in its path.   TTF therapy is now a U.S. Food and Drug Administration (FDA)–approved treatment for patients who have exhausted surgical and radiation treatments.

Obviously, much more needs to be done, but it certainly feels good to serve an industry that not only has a long history in solving static problems, but one that has a future in the Medical Treatment of Cancer.  In the meantime, our Particle Trap® Cube is used to solve particle contamination problems in the packaging of Medical Devices that are utilized in hospitals and clinics.

The FM Fight Goes On

Posted on by Jim Patterson

Tribo-Charging, Who Really Discovered Electricity?

The relationship between static electricity and particle attraction has been long known. The Ancient Greeks when polishing their jade and precious stones noticed that straw, chafe and other particles were attracted to the exact things they were trying to clean, the family jewels. This phenomena became known as “Tribo-charging“. Simply stated it was the contact and friction that generated an electrostatic field around the parts that attracted the debris.

The Plastic Attraction

In the Life Sciences Industry of today most companies use plastics in their process. Whether it is to replace body parts, catheters, injection systems, pumps, blood separators or their packing, plastics are here to stay. Not only are they here to stay, but plastic is being used in this process at an increasing rate. Most of these engineered plastics are for a specific need but the premise is the same, they generate huge amounts of static that causes Foreign Matter (FM) to be attracted to the products and the process.

Medical Device Manufacturers most often individually package each medical device and they are subjected to 100% inspection. When the inspector sees a speck of debris (FM), which could be in the form of plastic bits, fuzz balls from clothing, or even human hair, the package is then ripped open and put aside for repackaging. These units are tracked in what is generally called “the tear down rate”.   In almost every case, the root cause was the forces of static electricity pulling unwanted particles onto the product and the packaging materials. In addition to the packaging level there are various stages in the assembly process where FM causes rejects.   Some of those stages include Injection Molding, Coating, Ultrasonic Welding, Bonding/Gluing, Forming, and handling during the assembly processes.  These are also key functions that need to be addressed. The common denominator being that contact and separation (tribo-charging) occurs, static is generated and FM comes into play to contaminate products that could end up inside the human body or blood stream. The FM could also potentially block injection or fluid systems clogging pathways designed to deliver medicine.

 Gains are Being Made, Reducing FM

The front line of defense is a properly maintained clean room, but that doesn’t address process problems at the local level, aka the workstation or cell. How does static control reduce particles via ionization in the fight to reduce FM? Static Clean did a job last year for a major medical device company that was experiencing a very high tear down rate. They approached us to come up with a system where they could pass their products thru a blow-off, ionized, vacuum table. The results of this first system allowed them to run 50,000 parts without a single tear-down.

While not all medical device manufacturers have identical assembly lines, let’s take a look at the types of static controls are that implemented for specific reasons or points in the process.

Room Ionization: In this installation, ionizers are mounted in the ceilings and the preferred method is to locate the ionizer right under the Fan Filter Unit. (FFU) to take advantage of the clean air being delivered into the room.

Local Ionization: is another method of static control. These ionizers could be in the form of an ionizing air gun or nozzle, static bars, specific ionizing fans at the work bench or a two or three fan overhead ionizing air blower when bench space is at a premium.

The Increasingly popular approach has been to use source capturing methods in conjunction with ionizing air tools. Recent gains have been made in the development of customized medical cleaning workstations that meet clean room protocol and are tailor engineered to a specific product or package.

Cliché Slogans Designed To Keep a Conversation Alive

Posted on by Jim Patterson

Stereotyping Our Expressions

People always feel the need to say something when they greet people, so they usually say things like, “it’s a beautiful day”, “they’re calling for rain”, “it’s a bit cloudy” or some other reference to the weather. Let’s face it we all do it.   It seems that every time we watch the news or talk shows, they all say the same old clichés, but the one that seems to be getting most people’s attention and disdain is the over-used and abused, “At the end of the day”.

The Cliche Commonplace

There are more attractive ways to say the same thing, including “when all is said and done”, “the fact of the matter”, and “in the final analysis”.  A friend of mine from Carmel, Indiana was a big Pink Floyd fan who put together a compilation album of their hits and he had a clever title for the CD.  He called it “The Animals Wish You Were Here on the Dark Side of the Wall. It was his way of getting four separate albums under one creative name. If you know the group Pink Floyd, you already know the creative genius behind the band, but you will also recognize the creative liberty that my friend took in coming up with his title.

A Rose by Another Name

When it comes to being creative and trying not to be so cliché, coming up with names for newly developed products, can be as hard as trying to pick a name for a new baby.   Watch for new products from Static Clean in the coming weeks with names like Particle Trap® Mini, Tempest, and the APSC-5 Nozzle. Let’s face it, when all is said and done, at the end of the day, the fact of the matter is that in the final analysis, you can always find something new at www.staticclean.com