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 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.
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.
Is it February already? Where did January go? With Valentine’s Day just around the corner, it got me to thinking about roses, chocolate, love, the color red, hearts, giving your heart to the one you love, American Heart Month, heart disease and organ donation, specifically hearts.
While the first few things I mentioned are rather cliché and Valentine’s day which is sometimes referred to as the “Hallmark Holiday”, people tend to forget the more important things about the month of February; The Real Heart of the Month. Did you know that The American Heart Association has declared February 5th, 2016 as National Wear Red Day? A day that is now dedicated to help raise awareness for heart disease and stroke in women. This year marks the 13th anniversary of National Wear Red Day and huge strides towards awareness on heart disease have been made, here are some successes:
Nearly 90% of women have made at least one healthy behavior change.
More than one-third of women have lost weight.
More than 50% of women have increased their exercise.
6 out of 10 women have changed their diets.
More than 40% of women have checked their cholesterol levels.
One third of women has talked with their doctors about developing heart health plans.
Today, nearly 300 fewer women die from heart disease and stroke each day.
Death in women has decreased by more than 30 percent over the past 10 years.
Don’t Miss a Beat!
Despite the progress there is still more work to be done, one in three deaths among women each year is caused either by heart disease or stroke. Approximately every minute one of these women dies in our country alone, more than 500,000 a year. It is the #1 killer in women, yet only 1 in 5 women believe that this is a great health risk for them. Perhaps our lack of awareness is due to the media and how many heart problems portrayed on television, commercials, and infomercials involve a man as opposed to a woman. With proper education – many of these deaths, for men and women, are preventable. That is why the entire month of February is now dedicated to raising awareness of cardiovascular health, American Heart Month. Uncontrolled high blood pressure is the leading cause of heart disease. There are pills that will help regulate your blood pressure, but it’s very important to live an active and healthy lifestyle as well. Educate yourself, learn the warning signs, visit www.heart.org or www.goredforwomen.org to learn more about how you can educate yourself – you might save your life or the lives of your loved ones. Be a sweetheart & explore the real heart of the month.
In the spirit of love – consider organ donation. Did you know that “121,514 people are waiting for an organ? 22 people will die each day waiting for an organ. One organ donor can save up to eight lives”.
Static Clean understands the importance of American Heart Month. We have donated to the cause and will continue to provide static and contamination control products to hospitals and medical companies that need to use clean, contamination-free equipment on you and your loved ones. We also have a number of people within the company that are organ donors. From all of us here at Static Clean to you and your loved ones – have a blessed, loved & aware month!
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.
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”.
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.