Thursday, January 28, 2010

Diecutting Food

Written by Mark Batson Baril

SO - YOU WANT TO DIE CUT WHAT? It never stops amazing me how many different products are cut with dies and specialty cutting processes. Most recently I have been reminded that there are many companies out there that need to cut food as part of their production. Sometimes it's just slitting, slicing or chopping and sometimes a manufacturer will want to produce a product in a shape that cannot be extruded or made in a mold. In this case, we as die cutters, die makers, and specialty cutters are called upon to step up to the oven and take a shot at the unusual. Years ago I built some tooling that was to be used for cutting brownies into that typical rectangular shape brownies come in. Instead of slitting the shapes in two directions after the sheet of goods was baked, the manufacturer wanted to cut the entire sheet of cooked goods in one shot as it passed down the line. They wanted a very uniform size and wanted to trim the baked edges off so everyone got exactly the same thing. As it happened, we made no effort to look into any type of government regulations or standard industry practices that would help us figure out what materials to use. We had a couple of meetings, used a bit of common sense, and came up with a very basic steel rule die that used solid stainless steel blades and a plastic base that was approved for medical applications by a US government agency (good enough for medical it must be good enough for food, right?). Ejection was handled with a center hole in each cavity that allowed a stainless stripper plate to be activated from the back of the tool. Everything was washable, would resist rusting, corroding, and no part of the tool could flake away and become part of the food. We built a great tool and everything worked well. In retrospect, we probably should have made the tool with no base and welded everything together so it would have been easier to wash, or better yet we should have passed the whole project onto someone that really knew the business. Still the question remains with me today, did we build tooling that met the standards?

All around the world governments have set-up standards that food manufacturers must adhere to. Deep down, I think this is what we all worry about when we get into making tools, or processing foods, and rightly so. In the US we have the FDA (Food and Drug Administration) that tells us how to produce things when it comes to foods - they police it too… In Europe there are as many regulators as there are countries and yet with the growing closeness of European countries an entity called The European Commission is taking more control of these matters. In China, the Ministry of Health plays a big part in who does what and how. From Ministries of Health to Food Inspection Agencies around the world, everyone has got to follow some sort of rule when they process foods. There are even cooperative agreements set-up between countries/agencies to help manage the production of food that will be imported/exported between them. All in all it can become a very complex task to take on compliance with these government regulations.

"I'm just a diemaker" you say! Well we've got to start somewhere and I'll tell you that it's quite a relief to find that a government agency (the FDA is easiest for me to access and has a pretty decent web site) uses at least a little common sense when it comes to the equipment used for cutting food. Here are some excerpts from:
The FDA Code of Federal Regulations- Title 21, Volume 2 - TITLE 21 -- Food And Drugs - Chapter I -- Food And Drug Administration, Department Of Health And Human Services - Part 110--Current Good Manufacturing Practice In Manufacturing, Packing, Or Holding Human Food.

Sec. 110.20 Plant and grounds.
(a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall be maintained in a sanitary condition and shall be kept in repair sufficient to prevent food from becoming adulterated within the meaning of the act. Cleaning and sanitizing of utensils and equipment shall be conducted in a manner that protects against contamination of food, food-contact surfaces, or food-packaging materials.

Sec. 110.40 Equipment and utensils - (This Includes the Dies and Presses)
(a) All plant equipment and utensils shall be so designed and of such material and workmanship as to be adequately cleanable, and shall be properly maintained. The design, construction, and use of equipment and utensils shall preclude the adulteration of food with lubricants, fuel, metal fragments, contaminated water, or any other contaminants. All equipment should be so installed and maintained as to facilitate the cleaning of the equipment and of all adjacent spaces. Food-contact surfaces shall be corrosion-resistant when in contact with food. They shall be made of nontoxic materials and designed to withstand the environment of their intended use and the action of food, and, if applicable, cleaning compounds and sanitizing agents. Food-contact surfaces shall be maintained to protect food from being contaminated by any source, including unlawful indirect food additives.
(b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accumulation of food particles, dirt, and organic matter and thus minimize the opportunity for growth of microorganisms.

Sec. 110.80 Processes and controls.
(10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and inspecting, mashing, dewatering, cooling, shredding, extruding, drying, whipping, defatting, and forming shall be performed so as to protect food against contamination. Compliance with this requirement may be accomplished by providing adequate physical protection of food from contaminants that may drip, drain, or be drawn into the food. Protection may be provided by adequate cleaning and sanitizing of all food-contact surfaces, and by using time and temperature controls at and between each manufacturing step.

Wow - Did you actually read all that? Those are three minor sections of a seventeen page document that outlines the basics you need to know to cut food or to build tooling that will cut food in the US. You'll have to go to another document for some of the definitions of some of those sections. All in all though I must say that most of it is common sense and quite achievable within most diemaking shops and with many die cutting machines. If you are not in the US you may find that the rules to follow are more stringent or less stringent. Putting it all together as one neat, consistently reproducible manufacturing process is the trick. There are consultants as well as people from within your various government agencies that can help in setting up and maintaining a proper process.

So to answer the question of whether or not we built tooling that met the standards - I would say yes we did. (That's a load off my mind!) In fact, if the company that was using the tooling was following the rules, they would have had a person in charge of making sure we were in compliance and if there had been a problem, we would have heard about it. And if they were somehow out of line with this way of thinking, I'm sure the Food Police would have caught up with the whole bunch of us.

Of course none of this covers the very related area of diecutting items that will come into direct contact with foods. Labels, packaging, tags, etc….. all fall into this category and although the manufacturing of these will carry somewhat the same rules and regulations that actual food cutting does, the big added factor to watch out for is the type of material that you are incorporating. Papers, plastics, inks, coatings, glues, etc….. are all controlled under many government agencies.

Good luck and I hope this gets anyone interested in die cutting food, or making tools for the same, started in the right direction and further away from that anxious feeling that comes with dealing with government regulations.

Please contact Cut Smart if you would like more information on this subject.

Wednesday, January 20, 2010

The Natural Hierarchy of Industrial Information

What, When, and Why to Share Your Knowledge
Mark B. Baril – Cut Smart Engineering & Manufacturing, Inc./ IADD TECHTEAM

Have you ever wondered what the inventor of the wheel did to protect the idea when he or she came up with the first prototype? I picture a heavy load of stones rolling down a path, the entire load, including wheel(s), completely covered with animal skins so nobody could see how this difficult task was being performed so easily. He moved the loads at night to try and keep the idea to himself for as long as possible but after some time passed, he took the wheel idea and shared it with his closest group of friends so they could have an easier life as well. Some of them paid him in food for the idea, while others simply became part of his group of idea makers. Because the idea was shared within this close and trusted group, the axle was invented by another person inspired by the original invention within the same group of people. Cloaked in secrecy, he and his friends could now go further and faster than anyone else in the village and they prospered because of it. This sharing, stacking, and building of ideas upon one another is the basis for technological and social advancement whether it be for a wheel, a new teaching technique, or an advanced material. It is one of the most exciting and complicated activities we can focus on in our businesses.

GE (General Electric, a USA based mega-corporation) uses the tagline “Imagination at Work.” BMW (the German Luxury car maker) says in their advertising “At BMW ideas are everything.” Having great ideas is sexy and not only are these companies working to capitalize on it in their marketing strategies, they are working hard internally at finding these new ideas and innovations. Google (the World’s leading internet search engine), seeing such enormous value in this concept, has built an intranet site specifically to bring in new ideas from all employees. Each employee, no matter their position within the company’s hierarchy, or their level of expertise, is encouraged to spend time each day in the R&D function of assembling their ideas and thoughts for improvement. They then place the ideas onto the Google internal site. All employees are then able to enter into discussions and debates around the ideas and a buzz of activity starts to surround the ideas with the best legs. The person in charge of moving new ideas forward is then able to categorize, review, and bring to group brainstorming sessions these new ideas. By bringing everyone into an interactive process of thinking out-loud, more ideas are born creating an ever growing system of new ideas.

I would like to focus on one very strong basic feeling or concept in this paper. It’s the same, very simple, concept your parents probably taught you at a very young age, with a small twist at the end. That concept is; Sharing is good - as long as everyone involved is aware of what is being shared.
One of the first things I tell potential clients is that I am really good at keeping my mouth shut. In the business I’m in I have to be…. I recently went through the process of signing a NDA (Non-Disclosure Agreement) with a potential client. This was a medical device manufacturer and they knew my company already had clients in this market. They wanted some protection against me possibly taking their ideas and sharing them with the competition. This was fair enough, and I have done this enough times in the past that I have a file full of NDA’s. They are an important part of many new relationships and should be treated with respect. Off we went into sharing information, most of it not very new to anyone involved, some of it reminding us of ideas we hadn’t thought of for quite some time, and a few hints of fresh tracks here and there. This talking process led to a meeting at their facility and a full-blown tour of what they do and how they do it. It was informative and enlightening, yet, besides a few details on quantities of parts and forecasts for usage, etc… there hadn’t been a great deal of new idea sharing in either direction. Going into the tour, the one particular process I was curious to learn about was a special material that this company is world renowned for being able to make. I had assumed that the NDA was mostly there to protect this sensitive area of their shop. As we hovered around that production area door with the large “Restricted Area” signs, and saw the finished goods warehouse, and discussed the complexity of building the material, I asked if I could be brought in to see how it is manufactured. The two people giving the tour both shook their heads “no way.” The head of R&D who has been there for many years said nothing more, but the junior engineer seemed to feel that an explanation was in order. He said, “you know, I have been working here for seven months now and they won’t even let me in to see that operation.” It was a valuable moment for me. Here is a company that is a World leader in a very specific niche market and not only were they experts in building what they build, but they were experts at controlling the information that makes that product and their business possible. They know exactly what they have and exactly who they can and will share it with. We continued with the tour and did end up sharing some information that proved to be valuable to both companies.

Knowing What Kind Of Information You Have Is Essential To Knowing What You Can Share

When have you shared too much? Everyone has had that feeling of wanting to pull back information that just spilled out of their mouths. Maybe you talked about something you have talked about with many people, but this person was not the person to tell. Maybe part of your new idea came out and it shouldn’t have. There’s not much you can do once it’s out and it’s not a great feeling when it happens. Reducing this to as close to zero occurrences as possible is an important goal. When have you not shared enough? Most information people have at their disposal is not only known by them but is known by many or most in their industry. When you don’t share this kind of information you make it more difficult to sell what you know and you make it harder for others to want to share with you. That mutual giving is one of the basic concepts in good sharing.

Let’s define this TYPE OF INFORMATION IDEA a bit better.
Information and ideas break down, in their simplest form, into one of four sequential categories or stages. Each stage goes through a time cycle that can be very short, as in minutes, or very long, as in many years. All four stages are forever linked and are interdependent much of the time. All new ideas/concepts start at Stage 1 and most ideas will reach Stage 4 at some point. In some cases, ideas may never make it to Stage 4. They are truly best in the business ideas and may remain at Stage 3 for thousands of years. Let me explain…..

 Top Secret

• A brand new idea, technique, product or method.
• Valuable to inventor.
• Top Secret, Confidential, Proprietary.
• Used & known by very few people / companies. (perhaps just one)

 Some examples may include; That new technique I can’t talk about in this type of situation! Perhaps your gravy train idea for die cutting that nobody else has figured out how to do yet. It could be an idea, a technique, or an invention, but the one thing it surely is, is new.

This is my favorite Stage to be involved with! It is where things are moving fast, are invigorating, and very exciting. It is also the most important Stage to know you are dealing with from a confidentiality standpoint. Both the sharer and the sharee must feel comfortable talking about these ideas and must know what is expected of them in dealing with this type of information. These concepts are what puts you ahead of the competition, allows you to bring something special to the table with your clients, and stimulates a culture of innovation in your organization. It’s very difficult to share this type of idea with someone you don’t know.

Just Released

• A just released to the public idea, technique, product or method.
• Very valuable to those selling it and using it.
• Cutting Edge Technology, a valuable sales tool.
• Used & known by only the most informed people.

 Some examples may include; fuel cells, automatic benders, high speed blanking innovations, galvo laser cutting systems, hybrid cars, and the internet. (yes, you are familiar with these ideas, but millions of people are not)

Stage 2 information has just been released to the public. The timeline and sharing in this stage can be interesting to deal with because what some people have known about for only a little while, others that are more on top of new products and ideas may have known about for much longer. Also presenting a challenge are people needing services from outside their industry that involve your industry to help them. They may consider what you bring to the table Stage 1 ideas, when in reality they are not. Your competition knows this but your client may not. Knowing what to share and when is a key to keeping customers, and from your competition’s standpoint – landing new customers. It’s difficult to share this type of idea with someone you don’t know, but much easier than sharing a Stage 1 idea.

Common Knowledge

•Common Knowledge idea, technique, product or method.
• Valuable to everyone using and selling it.
• Level playing field technology, as everyone has it or knows it exists. If you don’t have it you may be falling behind. It’s mainstream.
• Used by most people and/or companies.

Some examples may include; language, cell phones, laser dieboard cutters, counterplates, cars, bicycles, computers, dancing, use of tools, electricity.
Most of us work in this area everyday in nearly everything we do. From sending an e-mail to washing your car – you are in Stage 3. The same situation exists as it does in Stage 2 ideas in regards to other industries or cultures coming to your industry or your culture. The ideas and ways of doing things that you take for granted are new to them. That creates an ideal mixing point for new ideas to be born. It’s easy to share this type of idea with someone you don’t know.


•Obsolete idea, technique, product or method.
• No longer being used or sold by most people.
• Old technology, in some cases forgotten by most in the industry.
• Antique status. Old timers may find comfort and knowledge in knowing the roots of the idea but new comers have a faster and better way.
Some examples may include; the horse and buggy, leather boots for skiing, letter presses, nicking dies with a screw driver and hammer, maybe even film for cameras is heading this way?
Can you think of any more examples here? I’m betting you can as we are surrounded by new inventions that have made what we used to do seem slow and outdated. The beauty of knowing about and remembering these outdated concepts becomes evident when we can take that old idea and combine it with another idea to build a brand new concept. It’s very easy to share this type of idea with someone you don’t know.


So Again – What Is My Point?

Sharing is good as long as everyone involved is aware of what is being shared and knowing what kind of information you have is essential to knowing what y can share especially when you as the sharer intend to share Stage 1 information. What kind of information do you have in your business? Who are you going to share it with and who are you going to keep it from? In order to move up in the information food chain you must be willing to share Stage 2, 3, and 4 information openly. Openly doesn’t mean carelessly but it does mean that you are at least open to the idea of sharing most of the time with later than Stage 1 ideas. In order to build trust within your circle of peers you must be willing to give. The openness created by stating what you are sharing and then sharing it, without reservation, is a stimulating, relationship building, trust building, and sometimes a trying exercise for all of us especially when we are sharing with potential rivals. The problem with not sharing Stage 2, 3, and 4 information, is that if you don’t someone else will and when they do you will have sacrificed an opportunity. That lost opportunity was to learn something new from them. You will have driven away a potential new idea someone else may have shared with you. The sharing of information opportunity you may have received from that person is gone and you have handed that opportunity to someone else. Knowing where to draw the line is the key to sharing well and moving up your circle of peers to as close to Stage 1 information as possible. It makes you stronger as a person, and as a company. By not sharing non-confidential information we isolate ourselves and make it harder for our organizations to grow and prosper.
Let’s Put It All Together

Between each idea stage there is a mixing point. That mixing point is what intimidates us when sharing because we may be sharing our higher stage information with someone that doesn’t know it yet. We may help the competition. We may help a customer do it themselves. There are all sorts of reasons to not share but unless you are working with Stage 1 or very early stage 2 information, that person is going to find out from somebody else. By not sharing, that relationship opportunity will be lost and you will lose in the long run as you will not be exposed to the potential benefits that the mixing point inherently provides – New Ideas….

The intersection of very new ideas and recently new ideas is where the best action is to be found.

The reality of these mixing points may look more like this model, multiplied out to cover the Earth, where many industries and many ideas all mix together at various times within the lifecycle of each stage creating an infinite number of possibilities for innovation.

There Are Several Factors That Have Developed And Continue To Develop Quickly That Make This Base Concept Of Sharing An Urgent One To Understand, Set Policy For, And Embrace.

The first is that the days of people staying in one job for their entire working life are gone. People change jobs frequently and are willing to uproot for many different reasons. This change in business reality has led to information and ideas moving with them. In many cases this is good for the company receiving the new employee and bad for the company loosing the employee. Confidential information, Stage 1 ideas, can walk right out the door with them. Some companies deal with this with non-compete agreements or other legal documents that cover information secrecy for a term that seems safe and fair, while other shops protect information so tightly that new internal ideas cannot form as easily as they would if the culture was more open. Whatever the case may be there must be an understanding of the root idea of sharing and what it can lead to both with internal and external information. Risks must be accessed and a plan must be in place to move forward.

The second is that technology has made it incredibly easy for us to share our information. The pace of new ideas forming has never been greater in all of human history. Concepts that used to take months or years to filter out into the public domain can be made understandable and available nearly instantly. CAD and graphics programs have become easier to use and more available to the masses for easy explanations and the advent of the world wide web of information access via the internet has pushed the exchange of this information right into the fast lane. If we understand what we have and want to share, this speed-up can work greatly to our advantage but if we are unsure of, or have no clue as to, what we have and want to share, then this speed-up can work against us.

The third relates to competition and exchanges both on a local and international level. Sharing with the local competition, if you are a local area service provider, is seen by some as self-defeating. I would say, for all the reasons outlined in this paper so far, that this can be true if you don’t know what you are sharing. If you do know what you are willing to share and are not will to share, then again for all the reasons outlined so far in this paper, you are making a wrong move by not sharing, even with the local competition. Taken to the next level of international competition that word “self-defeating” can rise to the term “treason” via feelings of patriotism and cultural superiority. How often do we complain about anyone caught sharing ideas or helping a start-up shop in a competitive country? It doesn’t matter if it’s an idea or concept being shared from Europe to China or an idea moving from India to the USA, the people in both giving information countries feel as though they are losing something that will eventually hurt them because they are helping the competition. They are taking jobs away. In reality, if they are sharing open information in an organized manner, they can gain more in the exchange than they give. They will build those relationships that provide fast, up-to-date, and fresh ideas that will help them survive both the local and international competition. If the new ideas in the industry have the current or future potential of emanating from outside your sphere of peers, whether that is local or international potential, then you will need to move your focus on sharing to a wider circle of peers. That may include the competition both near and far. It may also include the guy sitting in the office right next to yours!

So I admit it, I’m addicted to sharing. I love the giving part and I love the getting part as well. Most of all though I’m addicted to the mixing part caught between my ideas and someone else’s. That’s where the action is! I highly recommend putting the sharing information process way up on your list of things to do as often as possible. Whether it be with your best customer, your most loyal co-worker, your best supplier, or your biggest rival, the rewards can be terrific.

Mark Batson Baril of Cut Smart Engineering & Manufacturing, Inc. grew up as a steel rule die maker and has been involved in die making and die cutting since 1976. His company provides vital component engineering & manufacturing for complex specialty products, medical devices, filtration, life sciences, and aerospace products. Mark is a member of the IADD TECHTEAM. &

Thursday, January 14, 2010

Medical Device Tooling For Diecutting

Written By Mark Batson Baril

More than once in the last month, the question has been put forth as to how to produce a good steel rule type die that will be used to cut a disposable medical device. There are many different types of medical devices. The ones we are talking about here may be produced in clean room conditions but are more likely required to be produced in clean areas that have very little contamination allowed. These medical devices may be used internally and almost always come in contact with the body. The parts may be sterilized after they are produced but they are expected to pick up as few extra particles as possible during all phases of production. In some cases the tooling is used in production of bio medical devices/products where it is important to the product to be exposed to as little extra material as possible during processing.

The make-up of the tooling seems quite simple until you start to research the methods and materials needed to produce a die that will fit the following set of conditions:

-Will not rust even if exposed to alcohol, water, and other nasty chemicals (we consider water to be nasty because it causes rust)

-Will not flake or shed material, including steel, wood, rubber, plastic, etc…

-Will enable cleaning of the tool to remove glues, hydrogels, foam residues, etc…

-Will be accurate, reproducible, long lasting, fast to produce, and of course inexpensive

-Will not crack or loosen during production runs.

Considering all of the above - the tool should be made of some type of plastic base with stainless steel rule/punches and a non-shedding ejection material. Here's what we found in each case:

Base Materials:
Acrylic is the clear plastic base material of choice for many diemakers. The main reasons are that it is clear, readily available, and it cuts very well on a laser. The main drawbacks for medical are that it is not FDA*(US Food and Drug Administration) approved and it cracks easily under the stress of diecutting. This material is not a great choice for medical dies.

Polycarbonate (common trade name is Lexan) is another common choice. It is clear, easily found, and resists cracking very well. It is 30 times as strong as Acrylic. It's two main drawbacks for medical dies are that it cannot be cut on the laser (thin polycarbonate can be cut on the laser, while ½" to ¾" prove to be almost impossible) and it is not FDA approved. If your tools must be clear (see through) this is probably you best choice.

High Density Polyethylene, Low Density Polyethylene, ABS, PVC and PETG are also commonly available base materials that are tempting to use. None of them cut well on the laser and none of them are approved for use by the FDA. We see no advantage to considering any of them unless you need to think about electrical properties and static.

UHMW-PE (Ultra High Molecular Weight Polyethylene), Nylon, and Delrin are all readily available, and are FDA approved. None of them cut well on the laser but we highly recommend all of them for use in die bases. They are very impact resistant, chemical resistant, machine well, and come in White which really looks great when you are making a medical die. This is your best choice.

The problem with this best choice for base materials is that the laser is not a great way to work the material to the shape you want. The material can be jigged well and can be machined well which leaves us with quite a few production options. Most die shops will have a jig saw at their disposal and can produce their tool as it was done before lasers. Most also have some type of drill press or milling machine that will allow for simple shapes like holes to be cut to receive punches, washer sets, and specialty punches. All of us have at our reach the ability to outsource a specialty base like this to a machine shop equipped with CNC machining capabilities. The base can be machined in two pieces or more, in order to build just about any shape imagined. Offsets can be built in to receive rule or punches and the tool is built without bridges. Every project will be different, but there are very few limits that can be placed on a die when we combine the methods that are available to accurately machine plastics. Keep in mind one of the advantages of the old methods of producing steel rule dies (non-laser) is that the kerf is very consistent from top to bottom. There are typically no voids or pockets left to collect any of the fluids that the tooling may see for medical production clean-up and the top and bottom only grabbing we see from a laser kerf is replaced by a tight non-moving match of rule to base.

When it comes right down to it, if you can use a tool that has no base material, you will be best off. Forged tooling type dies are a great choice in this area.

Blade Material/Punches:
All the rules that we commonly use for steel rule dies will rust. They have coatings (usually oils) that stop them from rusting in the box, but once they're in the die and the oil wears off, they are going to rust, especially if you wash them with water. We have one customer who washes their tooling by putting it in a bucket of water (FDA Approved of course) and then scrubs it down. The other thing that we need to avoid in the medical field is delivering a tool that has oil on it to start with.

So there are a couple of choices to make. One is to produce the tool using a rust resistant steel, the other is to plate or cover the regular tool steel with a rust resistant coating.

Stainless Steel is the best thing to use for both rule and any type of punch. It is expensive, hard to find anyone who wants to work with, takes a long time to get through the machining process, and is hard to bend and work with once it is heat treated. 400 series stainless can be machined well, is heat treatable so it can be brought to the hardness needed for big volume diecutting, and it is still rust resistant. We accomplish everything we need except quick turn-around times for tooling and it is not cheap to make. 300 series is more common for diemakers to use in that it does not have to be heat treated, and is bendable. It is not as hard as a 400 series but it will withstand many impressions in many materials and is actually more rust resistant than the 400 series. 303 and 304 are more common than 316 and are use commonly for cutting medical products. The 316 series steel designation shows up as "the best" steel to use for medical devices and this is true for implanted devices that will be in the body for more than 30 days. For standard cutting the 303 and 304 work well.

Coatings are a great way to go if you have the right coating. The one major drawback that all coatings can have is possible flaking or wearing off. Especially in the medical field where non-contamination is key, the concerns with coating steel used for cutting is real. However, if you can create the correct coating the results can be no worse than the normal wearing off of steel you get from the typical steel rule, punch, or even stainless steel rule. We have found that Electroless Nickel Coating with an after coating heat treating, works well. This process adds .0002 (.00508mm) of rust resistant material that wears at close to the same rate as the steel it is covering. Relative to having the parts made in stainless it can be much less expensive, and it is a fairly common and fast process to get through. Make sure you deal with a company that can not only specify what they are doing for you, but can also provide a certificate that says that's what they did. Coating shops are a dime a dozen. Good ones are worth their weight in …. Electroless Nickel.

Ejection Materials:
Typical materials we use in the steel rule die industry for ejection will naturally wear and start to shed material after a certain number of impressions. That number will vary with every project and every press being used. Some of the tricks used for ejection for medical include the following:

-Don't use it! Yes, creating holes in the tool or some other way of ejecting the part is the best way to avoid contamination.

-Use Waterjet cutting to produce the rubber shape. This eliminates that first round of debris you may have from pressing the rubber into the tool or using another type of cutter to cut the rubber.

-Use a top coating or some type of sheet plastic material. This layer stays on top of the rubber and not only helps the top surface of the rubber last longer but also stops any debris from touching the product. I have seen regular old fiberglass reinforced packing tape work well for this.

-Use springs or even flat top ejection plates were you can within the tool. Make these out of stainless or have them coated.

-Consult with your rubber supplier on their best type of material that will give you the push you need and the lack of shedding that your customer requires.

Putting it All Together:

The one last key ingredient to make part of your system of making your medical dies work well is to train the final user to replace their tools on a regular basis. Base materials will wear and get contaminated. Steel used for cutting will wear, flake, and stop cutting well. Ejection will eventually stop ejecting and start to break down. Finding that breaking point in the tools productive life is probably best left to the operator. Telling the operator that a breaking point exists is up to the tool maker.

Tools for the medical industry can be tough to manufacture. I have met many die makers that tend to turn down this type of work. I have also met a few that like this type of work because it tends to pay very well and can be rewarding from a technical standpoint. I have found that it is very possible to meet all the parameters found in the first part of this article except - fast and inexpensive. I Hope this passes on a few tricks of the trade and helps you to develop new ideas on producing or buying better tools.

* The FDA recognizes certain materials as being OK to use for contact with food products during production. Although there probably is a special designation for base materials for cutting tools that the FDA sees as OK for producing medical devices, we have not been able to find it yet. We have always gone with the assumption that if it works for food it works for medical dies. Most medical manufacturers we have dealt with seem to run on the same assumption.

Please contact Cut Smart if you would like more information on this subject.