What’s in a name? Customer have always considered the name, “Static Clean” to be synonymous with producing products that clean sheets and webs in the Converting Industries. For many years, our company has been manufacturing WebVAC Systems that achieve the cleaning criteria that many customers expect. How clean is clean? The cleaning level or efficiencies that are reached with the Static Clean- WebVAC and similar systems is a 95% success rate in the 25-30 micron range.
Raising the Bar
With multi-laminations, higher cleanliness standards of materials used in notebook, laptop, television screens, finer lines of resolution in printed circuit boards, and the growing medical device packaging market, the bar has been raised. Demands have been placed on suppliers to deliver sheeted or web based paper and plastic materials that contain less debris, or what is now called Foreign Matter (FM).
A Higher Standard of Clean
In an effort toward continuous improvement, Static Clean has partnered with Polymag Tek. What’s in a name? Polymag Tek’s original business model was to provide materials and equipment to clean magnetic tape. Does everyone remember magnetic tape? Back around 1928, magnetic tape was invented in Germany to record sound. In the 1950s and 1960s, magnetic tape was widely used by IBM in the storage of computer data, particularly for backups. In the 1990s, the pressure was on to store even more data on mag tape and it meant making sure that the surface of the tape was totally clean. How clean is clean now?
Polymag Tek’s Contact Cleaning rolls and equipment achieved cleaning levels down into 10 microns and below beginning in 1994. For a greater understanding of the technology, please visit their website by the following link to their “Dirt Report”
For information on their full line of hand rollers, web and sheet cleaners, as well as process roll cleaners including the water wash systems, please visit their website at www.polymagtek.com.
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.
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.
Who doesn’t like FM when it comes to listening to the radio? In the world of music, FM stands for Frequency Modulation, a method of broadcasting electrical signals. In a short blog, it is difficult to fully explain FM, but there are online tutorials and videos that explain how Frequency Modulation works in relationship to the amplitude and phase remaining constant, while the frequency is changed because of the signal input.
In the world of Medical and Pharma Packaging and Processing, FM has a totally different meaning. Foreign Matter (FM) is the cause of contamination, poor yields, rejects, rework and the total recall of products once in the field. The FM can be particles in the form of lint, clothing, skin flakes, hair, and dust. Another form of foreign matter particles are bits of plastic chips and slivers of angel hair which come from the plastic forming process, especially thermoforming.
The Life Sciences Industry as a whole spends huge sums of money to construct clean rooms that, by design, are supposed to keep foreign matter out of these processes. This assumes that the room is always operating at full efficiency, that humidity and temperature are being controlled, and that everything and everyone that enter the clean rooms are particle-free. That, of course, is not reality, especially if the clean room is not up to semiconductor level protocols, with strict adherence.
The Missing Equation
The missing part of this equation is ionization, whether passive or active, room type of systems or local ionization with source capturing abilities. Static electricity by nature not only attracts particles, but holds them securely to any plastic substrate. Plastics have been the widely used in the manufacturing of medical devices and their packaging is almost always some form of plastic that includes bags, pouches and molded trays. When you rub a balloon, you can pin it to the ceiling with static electricity. When a plastic part of a package generates static by handling, it has the ability to violate the process of keeping the environment Foreign Matter (FM) free.
That reminds me of the bridge in a Steely Dan hit and the line in the song goes like this, “FM –no static at all”.
If you want to reduce foreign matter (FM) and the root cause, “static”, Static Clean can get you to no static at all. Contact our tech sales team today and find out how we can assist you meet your goals.
The term “As the Crow Flies” has been found in print since as early as 1758. The term came from British coastal vessels that customarily carried a cage of crows. Crows detest large expanses of water and when released from a ship, they headed straight for dry land. This was very useful for sailors at sea who weren’t sure which direction they would find land. It was their form of radar long before radar was even invented as a standard navigational tool. The lookout perch on ships became known as the crow’s nest and a sailor would sit in the perch and note the direction the crow flew. Basically the crow instinctively knew the shortest distance between two points.
Clean Room Laminar Air Flow principles are based on the desired plan of air taking the most direct path from entrance to exit and extracting unwanted particles in that airflow to keep the clean room at a stated level of cleanliness. It has been long known that static electricity can influence the oceans of the world. Warm water meeting cold water, and each having different densities can create the tides that can even shape our shorelines.
You may ask, “What can influence the air patterns in clean rooms”? One of the biggest problems is the forces of static electricity which causes particle pull. Instead of the air taking that beeline or direct path, electro-statically charged plastics pull particles right out of the air flow and they become attracted to the plastic. If you are in the medical device manufacturing or packaging, these unwanted particles become the cause of poor yield, downtime, rework and lost revenue. The use of ionization in the air flow assists in delivering ions that reduce static levels on plastic materials. The ionization also helps to keep particles in the air flow for removal from the clean environment.
There are several key ionization tools that have been designed for use in laminar flow rooms and work stations. Static Clean offers the DC-ESR bar that mounts easily below a Fan Filter Unit and with its small profile does not obstruct the air pattern.
Most Clean Room experts and consultants cringe at the thought of having turbulence inside of a clean room or clean space even though it is a necessary evil. Compressed air driven ionizing guns and nozzles are indeed a requirement to get rid of particles in the process, on the product itself and worse yet inside of the package. Particles typically show up after heat sealing the lid in place. How do you make a process cleaner and reduce waste without the use of ionizers that use compressed, Clean Dry Air (CDA) or Nitrogen (N2)? The simple answer is that you go with whatever blow-off device is required, but control the turbulence.
What does turbulence have to do with a Clean-room, you might ask? Unlike laminar air flow, turbulent air flow is not channeled in smooth parallel paths but distorted or agitated. Typically this dilutes the contamination but it can also distribute it across the whole clean-room. Wikipedia’s definition of a clean room is this; A cleanroom or clean room is an environment, typically used in manufacturing or scientific research, with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.
The basic problem associated with the use of turbulent air tools is “where do the particles go”? The answer is quite simple; source capture the debris where it is being created. With the right containment equipment in place, the dislodged particles can be drawn into a filter media that greatly reduces the risk of re-contaminating the products just cleaned or dumping the particles on the nearby manufacturing cell. The hotspots where particles are created may be at the molding machines, ultrasonic welding stations, de-burring, assembly, packaging or other points of friction where static is generated.
The best solution for companies dealing with these problems, especially the applications that involve medical packagers is to incorporate an ionizer into the source capturing equipment or use ionizing in conjunction with a means to capture the debris. Static Clean can offer both solutions. If you are using an ionizing air gun to remove particles, it only makes sense to use the Particle Trap® to capture those particles. If the same problems apply and the desire is to take human error out of the equation, the answer is to use a Medical or Parts Cleaning Station that we offer in both manual and automated models. View the details about the Particle Trap® 6000 and our Medical Cleaning Stations-MCS-AS.
Being a big music enthusiast, running jam sessions in the barn behind our house and working in the static business always has me thinking of cool names to call our jam band. The band is made up of four people from our company, Static Clean International and other invited guests. Then it hit me, we will call our band “Guns and Nozzles”.
In our lineup of static control products, some of the key tools to deal with static electricity and particle contamination problems are ionizing air guns and ionizing air nozzles.
Simply stated, they use compressed air or nitrogen to blow off debris and the ionizing components inside of the units make sure that the particles are not reattached back onto the newly cleaned substrate. The latest edition to the ionizing air tools is the Zapp Plus, which features a controller, a sensor eye, a goose-neck for flexibility, a built-in piezoelectric transformer and a fault detector to warn of power supply problems.
Without deviation progress is not possible-Frank Zappa
The Zapp Plus has gained wide acceptance for use with our Particle Trap® 6000, a source capture systems that collects the particles once removed from optics, medical devices, thermoformed trays and any product that requires cleanliness. The Particle Trap® 6000 was developed with a guy named Frank and as corny as it sounds, we’ve thought about calling the product the Frank Zappa. Of course that was never really going to happen, but who can argue with genius of the real Frank Zappa and the Mothers of Invention.