Mark Jeske, Contributing Writer09.16.15
The medical Industry certainly is no stranger to innovative technologies that push the limits of what was once deemed impossible. Each year, new technologies are brought to the market that save not only dollars, but—more importantly—lives as well. What the medical device industry may not be as adept with is taking an age-old manufacturing process, re-inventing it, and revolutionizing an entire field.
Die-cutting parts in a clean-room production environment is a new concept. Many production facilities still use scalpels or meshing machines, which do not result in the highest-quality outputs. True clean-room die cutting is safe, cleanable, sterile die for cutting many medical- and food-grade products within a true pneumatic clean-room press.
Medical die cutting is used to cut many valuable biologics such as skin grafts, heart valves, collagen, and bone grafts. It also can be used to cut medical-grade foam, bandages and plastics. Each system includes a press and a series of high-quality dies.
Benefits of Medical Die Cutting
Die cutting can enhance quality of parts and production by providing better precision, minimizing waste, creating consistency and safety. Die cutting also dramatically increases productivity by allowing for a quick setup, simple cleaning and the ability to cut multiple parts at one time in a matter of seconds. In instances that currently use a scalpel, die cutting provides clean cuts, efficiencies and safety.
The ability to cut multiple parts at one time will dramatically increase production abilities. A press that has a large cutting area and sufficient tonnage will achieve repeatable cut parts of exact size and shape. A pneumatic cylinder is successful at providing up to 40 tons of consistent cutting pressure. An additional platen and sub plate is necessary to handle the load while achieving minimal deflection. An extremely parallel cutting platen and sub plate (+/- 0.001 inches) across the entire cutting area with near zero deflection will add to consistent cut parts. Parallelism and minimal deflection are very key elements in die cutting, which allow die cutting anywhere cross the entire platen.
Sterilization
Sterilization is a key concept to medical die cutting. Valuable material needs to be cut under ISO 13485 regulations. An easy-to-clean die-cutting press for a clean-room environment needs to be built out of medically safe materials. The die cutting machine cannot rust or leave particulates, must be able to be cleaned with harsh cleaning agents, and must have smooth surfaces, rounded corners, and no collection areas. A fully pneumatic press will ensure no fluid contamination from the machine, like that of hydraulic presses. All press enclosures should be water resistant to work in a wet or dry cutting environment.
Dies also must be manufactured with the highest quality materials. Medical dies tend to come in three different levels: basic, moderate and premium. The basic level of medical dies typically is used for cutting cloths, plastics, masks and meshes. This die can be used numerous times and does not need to be cleaned between uses. This die also does not require sterilization and should not be used on wet products. Basic dies are made of a U.S. Food and Drug Administration (FDA)-approved base or specially coated wood.
Moderate dies are considered FDA approved for cutting non-wet materials, or for single-day use for wet materials. This die may need to be cleaned between uses and can be sterilized before first use. This tool is the only one that can be heat convection sterilized effectively. These dies are constructed out of an FDA approved base, which cannot be lasered or waterjet as they both contain contaminants. Moderate dies must be made with stainless steel rule specially manufactured particularly for this purpose and further processed before knifing, if it will get wet or cleaning in an autoclave.
Premium-level dies typically are used for biomaterials, skin grafts, bone grafts, tendons, heart valves or medical meshing. These dies will be used repeatedly and will need to be sterilized between each use. There is a 100 percent guarantee of zero contamination from construction to storage use. Premium-level dies are made for wet products and can be stored in a sterile liquid and cleaned with a mild acid. These dies are made only from specially formulated stainless steel with multi-level processing of stainless to prevent it from rusting. Special deburring makes dies free of any particulates that may break off of die and lodge into the material being cut. Certain coatings may be applied for the same reason of keeping any particulates from the die entering the material for instance of cutting bone grafts.
Many medical industries can be served by this innovative practice. Pharmaceutical companies, life-science, regenerative medicine, surgical, manufacturers of bandages, skin banks, and collagen are a few examples of the groups that can benefit from medical die cutting. Any industry that has a need for repeatable cuts in a sterile or non-sterile environment should look into medical die cutting.
About the Author
Mark Jeske is the president and owner of Milwaukee, Wis.-based Steel Rule Diemasters and Medical Presses Inc. He has worked in the die cutting industry for more than 20 years and has gained extensive insight in die making for the medical, aerospace and electronics industries. Medical Presses provides clean-room-ready die-cutting systems and medical dies.
Die-cutting parts in a clean-room production environment is a new concept. Many production facilities still use scalpels or meshing machines, which do not result in the highest-quality outputs. True clean-room die cutting is safe, cleanable, sterile die for cutting many medical- and food-grade products within a true pneumatic clean-room press.
Medical die cutting is used to cut many valuable biologics such as skin grafts, heart valves, collagen, and bone grafts. It also can be used to cut medical-grade foam, bandages and plastics. Each system includes a press and a series of high-quality dies.
Benefits of Medical Die Cutting
Die cutting can enhance quality of parts and production by providing better precision, minimizing waste, creating consistency and safety. Die cutting also dramatically increases productivity by allowing for a quick setup, simple cleaning and the ability to cut multiple parts at one time in a matter of seconds. In instances that currently use a scalpel, die cutting provides clean cuts, efficiencies and safety.
The ability to cut multiple parts at one time will dramatically increase production abilities. A press that has a large cutting area and sufficient tonnage will achieve repeatable cut parts of exact size and shape. A pneumatic cylinder is successful at providing up to 40 tons of consistent cutting pressure. An additional platen and sub plate is necessary to handle the load while achieving minimal deflection. An extremely parallel cutting platen and sub plate (+/- 0.001 inches) across the entire cutting area with near zero deflection will add to consistent cut parts. Parallelism and minimal deflection are very key elements in die cutting, which allow die cutting anywhere cross the entire platen.
Sterilization
Sterilization is a key concept to medical die cutting. Valuable material needs to be cut under ISO 13485 regulations. An easy-to-clean die-cutting press for a clean-room environment needs to be built out of medically safe materials. The die cutting machine cannot rust or leave particulates, must be able to be cleaned with harsh cleaning agents, and must have smooth surfaces, rounded corners, and no collection areas. A fully pneumatic press will ensure no fluid contamination from the machine, like that of hydraulic presses. All press enclosures should be water resistant to work in a wet or dry cutting environment.
Dies also must be manufactured with the highest quality materials. Medical dies tend to come in three different levels: basic, moderate and premium. The basic level of medical dies typically is used for cutting cloths, plastics, masks and meshes. This die can be used numerous times and does not need to be cleaned between uses. This die also does not require sterilization and should not be used on wet products. Basic dies are made of a U.S. Food and Drug Administration (FDA)-approved base or specially coated wood.
Moderate dies are considered FDA approved for cutting non-wet materials, or for single-day use for wet materials. This die may need to be cleaned between uses and can be sterilized before first use. This tool is the only one that can be heat convection sterilized effectively. These dies are constructed out of an FDA approved base, which cannot be lasered or waterjet as they both contain contaminants. Moderate dies must be made with stainless steel rule specially manufactured particularly for this purpose and further processed before knifing, if it will get wet or cleaning in an autoclave.
Premium-level dies typically are used for biomaterials, skin grafts, bone grafts, tendons, heart valves or medical meshing. These dies will be used repeatedly and will need to be sterilized between each use. There is a 100 percent guarantee of zero contamination from construction to storage use. Premium-level dies are made for wet products and can be stored in a sterile liquid and cleaned with a mild acid. These dies are made only from specially formulated stainless steel with multi-level processing of stainless to prevent it from rusting. Special deburring makes dies free of any particulates that may break off of die and lodge into the material being cut. Certain coatings may be applied for the same reason of keeping any particulates from the die entering the material for instance of cutting bone grafts.
Many medical industries can be served by this innovative practice. Pharmaceutical companies, life-science, regenerative medicine, surgical, manufacturers of bandages, skin banks, and collagen are a few examples of the groups that can benefit from medical die cutting. Any industry that has a need for repeatable cuts in a sterile or non-sterile environment should look into medical die cutting.
About the Author
Mark Jeske is the president and owner of Milwaukee, Wis.-based Steel Rule Diemasters and Medical Presses Inc. He has worked in the die cutting industry for more than 20 years and has gained extensive insight in die making for the medical, aerospace and electronics industries. Medical Presses provides clean-room-ready die-cutting systems and medical dies.