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, I mean 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.
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 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 worksurface 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 visit the Static Clean Website, www.staticclean.com or call us direct for expert technical advice.
U.S. Jobs Returning Home
There has been quite a bit of talk in the Media lately about Inshoring, and the candidates in the Presidential Debates are certainly quick to mention that this trend is increasing. The basic principle is that more and more companies that had moved their business operations offshore to places like China and Mexico, for lower labor or more favorable economic conditions, are now coming back to the United States.
Historically the two terms, inshore and offshore, are related to the Fishing Industry. The manufacturing industry has been greatly affected by the trend of offshoring both it’s operations and it’s workforce. We can look to the Fishing Industry to better understand what happened to our jobs in the manufacturing sector.
Time to Reel it in
For the fishing industry, there are six criteria that help to differentiate between the two terms and in a creative way, we will marry the two to present why we are seeing the resurgence of US jobs returning back home.
- Inshore fishing typically requires a small boat that remains within a few miles of shore and in times of trouble, such as engine failure, they can make it back to land in a timely manner. There are controls in place and with the use of quick reactions, trouble is averted. For offshore, the boats tend to be bigger and operate much further away in waters that are thousands of feet deep. When problems occur, it is much harder to fix the issue and it is often managed many miles away from home. The smaller boats can represent the smaller businesses in the USA that cannot take advantage of Offshoring because of their scale and the cost of operating too far from home base. On the other hand, many larger corporations were able to take advantage of the low labor rates in places like China, but still have to deal with issues such as culture and management from afar. Many times it meant extensive travel by the U.S. management team to reach their overseas factories to review any issues firsthand.
- Weather is a constant concern of the fishing industry. Inshore fishing provides consistent fishing year-round, even with significant seasonal changes, while Offshore is trickier. Weather and time of the year often dictates the type and quantity of fish. The smaller manufacturing entities in the States tend to offer higher quality and better service. The Offshore factories are huge in size and often the bigger the factory, the bigger the problems. Use the latest Samsung battery fiasco as a good example of what happens when large scale manufacturing has a problem.
- The expense of Fuel and Suppliers can make or break a profitable season. To use a fishing example, it requires more ice to keep the fish fresh so that it arrives on shore as a quality product. Environmentalists are using carbon tracking as a selling point to lowering the carbon emissions. There are software programs that give you the tools to meet your reporting and carbon management needs. There is a cost with bringing in goods from afar, but there is also a price associated with the Carbon Footprint that is created by long delivery times, especially by shipping containers. There is a growing trend to save money and our environment by shortening the carbon footprint. There is also consideration for the time involved in getting goods from the factory to the customer.
- The type of Tackle used by the different fishing industries varies as well. The Inshore tackle tends to be light, and the offshore requires bigger equipment with heavier tackle and bait. The Offshore companies are large in scale and tend to carry heavier inventories because they bring higher quantities of goods into the USA in the largest possible sea containers.
- Electronics used on fishing boats are vastly different when considering fishing locations. Close to shore (Inshore) boats still have to use tracking devices, but a ship to shore radio is a simple tool. If you are fishing offshore though, you will need radar, sonar, XM satellite radio and weather updates, etc. When a company is operating Offshore, the monitoring and tracking of daily activities and production is a key factor in whether. Employee monitoring to track performance, protect trade secrets and to address other security concerns are a requirement. Some call it an attack on privacy, but for Offshore factories it is of vital importance, whereas in the States it happens, but on a much smaller scale and in truth in many instances the co-workers make sure that everyone is pulling their fair share of the workload.
- The variety in size of the fish is dictated by their fishing grounds. Closer to shore you find today, the catch is smaller and the quantities are also lower than in years past. High volume consumer electronics are almost always made offshore today, but high tech military electronics contracts are still awarded to local companies. This in large part is due to the security concerns. There is a strong sense that the Printed Circuit Board (PCB) industry is about to see a re-emergence and a resurgence in the USA, that is most anticipated because of the cars of the future that will be driver-less. You will be able to read a book or newspaper on your way to work, while the electronics in the automobile will function as a human. It will require many PCB’s to address the varied functions of a vehicle where no human intervention is necessary. The auto industry who has lost ground to overseas manufacturers, even though many have US factories, are excited about the future potential. The biggest impact if this happens is for the local companies who make PCB’s, wiring harnesses, mold plastic parts, decorate and laminate, and provide interiors and lights etc. It is about bringing the jobs home and instead of reaping the harvest of the smaller fish, we will finally see an explosion in having a crack at the large fish.
American Made Matters
The idea for the fishing analogy came from the website Home Run Fishing Charters and Lodges, a Louisiana based business. One of the company’s captains is Captain John Pisa, who learned to fish by his father, a famous bar owner in Baton Rouge, LA. It is great to see the continuation of small business in America as we celebrate “National Manufacturing Day”. Static Clean International has continued as a 3rd Generation Manufacturing Entity. From humble beginnings in 1970, our company has not only survived, but thrived as a manufacturer and the future looks bright not only to the new generation of family members and the team that has steadied the course, but by the promises of Inshore actually taking hold.