SCI – Essential Services

Static Clean remains open for business during the coronavirus as an essential part of the Medical Device Industry. Static Clean manufactures Particle Trap® products that help the medical device community to deliver a cleaner and safer finished product. These devices include catheters, skin grafts, artificial heart, diagnostic test apparatus and many other interventional devices. Recently a key supplier of valves and components for ventilators reached out to our company for the Particle Trap® Cube, which is an ionizing, cleaning vacuum system that neutralizes static electricity, dislodges particles and source captures them in multiple stage filtration systems. These systems insure that dislodged particles are contained and not let back into the clean room. There is a tremendous focus in the medical device community on delivering the best possible solutions to hospitals and clinics and Static Clean is proud to do its part in helping those efforts.

Static Clean & Fraser Anti-Static Techniques of England announce Strategic Alliance / Partnership

Jim Patterson, President of Static Clean & Bob Fraser, Managing Director of Fraser Anti-Static shook hands on a deal that gives each company broader coverage and depth of products in static neutralization, static generating and particulate control in their respective markets.

Both companies have a long history of manufacturing its own products for the static industry. Static Clean has also been manufacturing one of the Fraser 24vdc static bars in the US for more than a year and the plan is to expand into manufacturing other Fraser products in the first quarter of 2019. The plan also includes Static Clean becoming Fraser’s major distributor in the Americas for its 24vdc ionizers. The Fraser products helps Static Clean gain a strong position in the Plastics and Converting markets.

Over the past 15 years, Static Clean has developed a unique line of static eliminating, particle source-capturing systems for the Medical Device sector. With medical device manufacturing growing in Europe and beyond, Fraser Anti-Static Techniques looks to include Static Clean products to serve these emerging market opp

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

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.

 

Walking for Hope, Not Hunger

Know the Facts

On Sunday May 1st, 2016 one of Static Cleans’ own participated in the once 20-mile, now 10-mile Walk for Hunger put on by Project Bread. She walked alongside nearly 40,000 people at the 48th Annual Walk for Hunger in Boston, MA.  As she was walking – she said her mind was racing. Sounds crazy, right? How can you walk and race at the same time?  Seems nearly impossible, doesn’t it? As you start to walk – your minds racing so naturally you want to walk faster to reach the finish line… or at least run to keep up with your thoughts. But that’s impossible to do when as you are walking along the path you read signs that include statistics of the poverty stricken community.

Some of the thoughts that went through her head: There are 9.6% of households in Massachusetts with some level of food insecurity. Of that 9.6%, 5.5% have a low food security and 4.1% have a very low food security. All households with children make up 19.2%.  This means that half  the population of households in Massachusetts that have children are not food secure. Half of them! How is that possible? How can we stop this? What can we do to help? In 2013, 10.6% of households in Massachusetts (nearly 700,000 adults and children) were food insecure. From the years of 2003 to 2013 – the food insecurity rate has gone up by 71%… and hasn’t moved since!

Community Solutions

There are numerous outreach programs available to help the food insecure community. Some of them include CNOP (Child Nutrition Outreach Program); Community Garden – where the community helps to garden land that provides crops; Farmer’s Markets are on the rise; Food Rescue – where fresh food is collected from restaurants and super markets and delivered to community organizations where it’s cooked & distributed; and Gleaning – which is where leftover crops from farmer’s fields can be used as they are not economically profitable to harvest. There are programs in place, but it’s up to us to bring awareness.

As she was walking alongside the nearly 40,000 people – one gentleman, a dad and his son stuck out in particular. How do you explain hunger to a child that barely understands what it means to be hungry because his belly is filled with food; his family is food secure. Well, this father explained that as much as our feet hurt from walking the 10 miles – the bellies of our brothers and sisters hurt, from hunger. Our feet hurt for the 10 miles and maybe the day after, but these men, women and children have hungry (or hurting) bellies every single day. It doesn’t go away.

How to Help

Support comes in many different shapes and sizes. Consider donating to the Walk for Hunger:  Every little bit helps. $25.00 provides a hot meal for fifteen people at a community supper program! (See if your company will match your donation!) Maybe you can’t provide financial support, but you can donate your time to a local shelter to help serve or prepare the food. Or maybe, just maybe you are a large corporation in the food industry that can help donate the food to a local shelter or even to next year’s Walk for Hunger! What better way to help others, support your community and get your name out there at the same time! Let’s walk for Hope… hope that things will be different in the future.

Resources: www.projectbread.org

Blanket and Wine Shows Support for Veteran’s Time

The Poppy Movement

 

  • Memorial Day was borne out of the Civil War to honor the war dead on both sides of the war.  Originally established on May 5th, the date was moved to May 30th in 1868.
  • Memorial Day was originally called Decoration Day and the first event was held at Arlington National Cemetery where 5,000 people laid flowers on 20,000 graves.
  • In 1915, inspired by the poem, “In Flanders Fields”, Moina Michael  was an American professor and humanitarian who conceived the idea of using poppies as a symbol of remembrance for those who served in World War I replied with her own poem, which goes as follows:

 

“We cherish too, the Poppy red

That grows on the fields where valor led

It seems to signal to the skies

That blood of heroes never dies”.

Ms. Michael started wearing poppies as a personal tribute.

  • In 1922 the VFW  (Veteran’s of Foreign Wars) became the first veteran’s organization to sell poppies nationally.
  • In 1948, the US Post Office issued a red, 3 cent stamp with the likeness of Ms. Michael for establishing the National Poppy movement.
  • Since 1971, it is recognized as a National Holiday that is celebrated on the last Monday in May.
  • In 2000, the National Moment of Remembrance resolution was passed.  It was a voluntary, informal moment, where at 3:00 we observe a moment of silence or listen to TAPS.

Info gathered from works by Joshua Claybourn 2014 entitled, Memorial Day.

Land of the Free Because of the Brave…

Two weeks ago, I attended “Night of Blues” fundraiser for Vietnam Veterans and was the winning bidder on a beautiful patriotic, handmade blanket.  I am proud to own such a treasure as a reminder of the liberty our country offers and the sacrifice that our heroes have given to keep us free.  I was in a wine store last week and I came across a bottle of wine that was called “Purple Heart”.  Below you can see the images of both the wine and the blanket.  If you are sitting on a blanket, enjoying a good glass of wine anytime soon, please remember those who made it possible for us to enjoy such freedoms.

Moina Belle Michael (August 15, 1869-May 10, 1944) who was mentioned in the blog was an American professor and humanitarian who conceived the idea of using poppies as a symbol of remembrance for those who served in World War I.

Spring Has Sprung And We Are On The Move

Stepping Out of Our Comfort Zone

Like the flowers bloom, we have sprung into new growth, too.  Static Clean International no longer resides at 15 Adams Street Burlington, MA 01803 alongside Filter Sales & Service. We are now in a new location: 267 Boston Road Suite #8 North Billerica, MA 01862. We have grown out of our space in Burlington, but … we still work very closely with Filter Sales & Service on cleanrooms and HEPA filtration. It is an integral part of our business to provide clean space and a controlled environment to our customers, mainly medical companies.

There was a lot of work and preparation in getting ready for the move. Not only was the building redesigned to fit our needs – but we had a lot of packing, unpacking, organizing, heavy lifting, many trips between locations and several weekends spent working to get the new digs up to our specifications.  One of our favorite rooms is our new conference room.  Furnished with a new Vizio flat screen television this will allow us to show our products better in a presentation as well as our vendors showcasing theirs to us. We also have a wide array of products on display. Our MCS-AS (automated medical cleaning station), Hepa Clean 3000 and Particle Trap® are now set up so that customers can bring their parts in and test out our equipment.

Slow Growth Bears the Best Fruit…

Static Clean has been steadily growing, so it was time to find our own space that includes a new 6,000 square foot manufacturing department. We now have more space for the production and development of new products. So stay tuned! As the business has grown, so has the employed staff. We needed a space that was large enough for our expanded production and to create more office space.

Chris Middleton, Manufacturing Supervisor, when asked how he felt about the move said, there is “more space, more room for growth and more efficient work space”.

Matthew Crothers, Customer Service Rep said, “This move for Static Clean brings us up to the next level of being a competitor in the field of static control and contamination control. We have a strong team that is working towards a cohesive goal of becoming a major player in this industry. Moving to this new building provides us with the space and ability for even more product development and efficiency. It is a step in the right direction”.

Jim Patterson, President said, “It is a big move for our company but with the anticipated growth we knew we had to move to a larger facility.”

The general consensus of the Static Clean team is that this move will provide us with the tools we need to bring this business to the next level.

John Maxwell once said, “If we’re growing, we’re always going to be out of our comfort zone”..and we sure are growing. With the start of spring (minus the freak 6 inches of snow that New England got on the first day of spring), we have sprung into a new move. Our new facility is large enough that there is room for even more growth. A freak 6 inches of snow on the first day of spring is out of the realm of normal weather patterns this time of year (well, maybe not for New England), so you might need to wear warmer clothes to adapt to the changes. Just like the weather patterns change and you may need to step outside with snow boots in a month where the grass is supposed to be green, we need to continue learning and gaining knowledge so that as we do grow we remain #staticeliminator experts. “Life isn’t about waiting for the storm to pass… It’s about learning to dance in the rain”… or snow! (Anonymous, more recently attributed to Vivian Greene).

 

Static Innovates for High Reliability

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.

The Real Heart of the Month

The Heart of the Matter

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!

Resources:

Goredforwomen.org

Wikipedia

Organdonor.gov

Is It Getting Better?

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/