In the past year and a half, several major producers of high-tech, multi-layer flexible packaging membranes used to block food packaging have produced qualified co-extruded films for medical packaging. Most producers of food packaging films have already started small-scale production of medical packaging films. Over the years, they have been trying to enter the pharmaceutical packaging market with their low-cost production, economies of scale, and experience in multilayer films. Now they are becoming an important part of this high-priced professional market.
It is understood that the annual growth rate of medical packaging films is 2% to 4%, which is about the same as the growth rate of food packaging, but faster than the overall economic growth rate. The requirements for medical packaging are very different from those for food packaging. Food flexible packaging must have good oxygen barrier properties so that it can protect processed meat products and cheeses in packaging. The extruded film used in medical packaging (mostly in the form of films and packaging bags for sterilizable medical equipment and hospital supplies) must be able to block bacteria, resist puncture, and be used in sterile environments.
The food packaging film manufacturers bring expertise in multilayer film construction. Coextruded films can reduce costs in several ways. It can replace expensive materials and use resins more economically. Because it does not require a coating or lamination, it also reduces the number of production steps. The multilayer medical film may have a PE-bonded layer-nylon-bonded layer-PE-bonded layer-nylon-bonded layer-PE structure, or a PE-bonded layer-PP-bonded layer-PE-bonded layer-PP- Bonding layer - PE. Their thickness is between 2 and 16 mil (1 mil = one-thousandth of an inch), and most of the thickness is 6 ~ 9 mil. In such a co-extruded composite film, the only role of nylon is to increase puncture resistance. . EVOH does not need to be used in medical packaging films because it does not need to have oxygen barrier function.
Make the film anti-disinfectant
The two most commonly used sterilization methods are ethylene oxide gas sterilization and radiation sterilization. A packaged breather (usually medical paper or DuPont's Tyvek (high-density polyethylene synthetic paper) nonwoven) passes ethylene oxide gas. (High-temperature autoclaving, steam sterilization, or peroxyhydroperoxy sterilization are also commonly used in hospitals, but these methods are not suitable for most packaging.)
At present, the thermoformed film used for the bottom of medical equipment packaging is a typical three-layer coextrusion film of EVA-ionomer-EVA or EVA-ionomer-PE. Ionomers are tough and transparent but they are expensive. If a thicker bag film is required, a six-layer composite film is produced by folding the three-layer EVA/Ionomer blown film in half.
Wipak of Finland pioneered the production of medical films in clean rooms. It is currently transferring its experience in this area to its branch offices in the United States, which are moving from food packaging films to medical packaging films.
The top cover is usually a paper/plastic/metal foil composite produced by extrusion coating and lamination. This configuration provides special opening characteristics. For example, ambulances and emergency room syringes must be quickly removed from the package, while other tops must be opened slowly.
The sterilizable package is a transparent bag that can be opened at one end and is typically also a three-layer structure of EVA and ionomer (ionic polymer). Ionomers offer easy tear properties. If used in a gas-disinfecting environment, most bags will have a breathable portion or a top strip made of Tyvek (high density polyethylene synthetic paper) or paper. There is no need to tear the line in the top bag, so you can also use a single layer of LLDPE or multilayer parafilm.
In the past two or three years, nylon has gradually replaced ionomer (ionic polymers) in order to reduce costs. The number of layers of the composite film also increases because nylon needs to have a connecting layer and the PE sealing layer adhere together. Three years ago, Rexam Healthcare Flexibles of Mundelein, Ill., installed the first five-layer blown film production line. In addition, it installed a new experimental production line for coextruded composite films based on nylon materials. The company first introduced 5-layer nylon-based composite film in 2001. This film can provide users with a smaller thickness, for example, from a 12 mil thickness of a three-layer ionomer base film to a 10 mil thickness of a 5-layer nylon base film.
Created a new record for the number of layers
In the past 18 months, the number of layers of this film has continuously increased. Several companies have introduced qualified 8-, 9-, and 11-layer medical packaging films. Such multi-layer films still account for only a small portion of the market, but they have reduced the packaging costs of some medical commodities such as gloves, which are generally more expensive to package than the product itself. The increasing number of layers of coextruded medical composite films is a trend at home and abroad. Macro Engineering has just sold three 7- and 9-layer medical composite film production lines to China and Brazil.
Winpak, based in Winnipeg, Canada, first introduced qualified medical packaging film in North America, which is a 11-layer composite film of nylon-based structure used to make sterilization bags. This may also be the most layered medical packaging co-extruded film in the world. Winpak did not disclose the structure of this film, but this film, which was manufactured on a cast film line with 11 extrusion heads, was initially used as a barrier film in a thermoformed food package.
Recently, Winpak produced multi-layer blown film for medical packaging on its production line with eight and nine extrusion heads at its plant in Senoia.
“We have created some interesting new options,†said David Johns, head of packaging at Winpak. Winpak's goal is to expand the company's medical business, and this goal is achieved through the use of technology in co-extruded barrier films in food packaging to reduce the cost of medical packaging films. "We have worked hard for three years behind the scenes to make several applications successful, and now we are evaluating several other things, mainly using new materials like metallocene to save costs. We found that the medical market is happy to see new things. It will be as competitive as other packaging markets." David estimates.
In Finland, Winpak has a sister company called Wipak, one of the world's leading producers of high-tech packaging films. Heikki Weijo, director of medical packaging management at Wihuri Oy Wipak in Nastola, Finland, said that Wipak's expertise in medical film has helped it gain recognition from North American regulatory agencies for its new thin-film construction. In 1997, Wipak installed a special cast film line where the cleanliness of the production line reached 100,000 in European standards (with no more than 100,000 particles per cubic foot), which is the first in the world to reach Such a high cleanliness standard medical packaging film production line, Weijo said.
“Over the past seven years, multi-layer composite membranes have been our starting point,†said Chris Osborn, Marketing Manager at Perfecseal. “You can now see that users’ attitudes towards multi-layer composite membranes are changing dramatically. The business of discovering multi-layer co-extruded films has continued to increase. Thin-split-layer films can make more efficient use of expensive high-performance polymers.†By merging the strength of medical film production previously dispersed in several food film factories, Perfecseal built its first factory specializing in medical film production in New London this year. In this new plant, Perfecseal can produce very good composite membranes with more than five layers, Osborn said.
Compared with traditional laminated medical films, co-extruded coated films have lower cost and higher strength. Rexam also switched from cohesive lamination to co-extrusion coating to produce Core-Peel tear-off films.
Blown film vs cast film
Most medical packaging films in North America are blown films because of the directionality and better tear resistance of the blown film itself. However, some blown film lines originally designed for food packaging are facing the challenge of producing medical films. High yield, water cooling, lower extrusion foam, etc. may require different nylon formulations for medical packaging because amorphous films usually have more memory and shrinkage, for sharp or fragile medical equipment, This may be a disadvantage.
In Europe, extruded film has more cast film because of its good specification control performance. The cast film can also better control the shape, and therefore can obtain a more irregular shape while having a softer feel than the blown film. "In the U.S., which method dominates is not yet certain," said the technical director of a large U.S. healthcare product company that produces co-extruded medical films. Steve Post, Flow Film Business Unit Manager, Davis Standard Film and Coating Systems, Inc., Somerville, New Jersey, added: “Multilayer cast medical film is not produced using conventional equipment. To make a flat film, it is often necessary to use Humidifying water tank and annealing roll.
React to competition
The existing medical film manufacturing companies are inherently difficult to cope with high-tech competition from food packaging manufacturers. Investing in new technologies is not an easy task for traditional medical film manufacturing companies, and they lack the incentive to do so. Once a medical packaging film is approved by the user, the manufacturer will not make any changes or upgrades to the extrusion line without the consent of the customer. As a result, the packaging film for the durable medical product is used. Old equipment and technology production.
On the other hand, food packaging equipment is constantly being updated. The co-extruded food packaging film line also uses more advanced equipment to inspect and control film thickness and barrier properties. In Perfecseal's new thin film factory in Wisconsin, the gauges used to measure thickness on the coextruded and blown film production lines are automatically monitored and controlled. In contrast, most medical film manufacturers rely on gravity feed devices and off-line sampling to control the number and thickness of layers. “The medical film manufacturing market was not actively using online measurement technology before,†said a product manager at EGS Metrology in Billerica, Mass. The company produces a FSIR (Full Spectrum External Line) system for separation membrane detection, which is said to be used for all multilayer food films.
It is understood that the annual growth rate of medical packaging films is 2% to 4%, which is about the same as the growth rate of food packaging, but faster than the overall economic growth rate. The requirements for medical packaging are very different from those for food packaging. Food flexible packaging must have good oxygen barrier properties so that it can protect processed meat products and cheeses in packaging. The extruded film used in medical packaging (mostly in the form of films and packaging bags for sterilizable medical equipment and hospital supplies) must be able to block bacteria, resist puncture, and be used in sterile environments.
The food packaging film manufacturers bring expertise in multilayer film construction. Coextruded films can reduce costs in several ways. It can replace expensive materials and use resins more economically. Because it does not require a coating or lamination, it also reduces the number of production steps. The multilayer medical film may have a PE-bonded layer-nylon-bonded layer-PE-bonded layer-nylon-bonded layer-PE structure, or a PE-bonded layer-PP-bonded layer-PE-bonded layer-PP- Bonding layer - PE. Their thickness is between 2 and 16 mil (1 mil = one-thousandth of an inch), and most of the thickness is 6 ~ 9 mil. In such a co-extruded composite film, the only role of nylon is to increase puncture resistance. . EVOH does not need to be used in medical packaging films because it does not need to have oxygen barrier function.
Make the film anti-disinfectant
The two most commonly used sterilization methods are ethylene oxide gas sterilization and radiation sterilization. A packaged breather (usually medical paper or DuPont's Tyvek (high-density polyethylene synthetic paper) nonwoven) passes ethylene oxide gas. (High-temperature autoclaving, steam sterilization, or peroxyhydroperoxy sterilization are also commonly used in hospitals, but these methods are not suitable for most packaging.)
At present, the thermoformed film used for the bottom of medical equipment packaging is a typical three-layer coextrusion film of EVA-ionomer-EVA or EVA-ionomer-PE. Ionomers are tough and transparent but they are expensive. If a thicker bag film is required, a six-layer composite film is produced by folding the three-layer EVA/Ionomer blown film in half.
Wipak of Finland pioneered the production of medical films in clean rooms. It is currently transferring its experience in this area to its branch offices in the United States, which are moving from food packaging films to medical packaging films.
The top cover is usually a paper/plastic/metal foil composite produced by extrusion coating and lamination. This configuration provides special opening characteristics. For example, ambulances and emergency room syringes must be quickly removed from the package, while other tops must be opened slowly.
The sterilizable package is a transparent bag that can be opened at one end and is typically also a three-layer structure of EVA and ionomer (ionic polymer). Ionomers offer easy tear properties. If used in a gas-disinfecting environment, most bags will have a breathable portion or a top strip made of Tyvek (high density polyethylene synthetic paper) or paper. There is no need to tear the line in the top bag, so you can also use a single layer of LLDPE or multilayer parafilm.
In the past two or three years, nylon has gradually replaced ionomer (ionic polymers) in order to reduce costs. The number of layers of the composite film also increases because nylon needs to have a connecting layer and the PE sealing layer adhere together. Three years ago, Rexam Healthcare Flexibles of Mundelein, Ill., installed the first five-layer blown film production line. In addition, it installed a new experimental production line for coextruded composite films based on nylon materials. The company first introduced 5-layer nylon-based composite film in 2001. This film can provide users with a smaller thickness, for example, from a 12 mil thickness of a three-layer ionomer base film to a 10 mil thickness of a 5-layer nylon base film.
Created a new record for the number of layers
In the past 18 months, the number of layers of this film has continuously increased. Several companies have introduced qualified 8-, 9-, and 11-layer medical packaging films. Such multi-layer films still account for only a small portion of the market, but they have reduced the packaging costs of some medical commodities such as gloves, which are generally more expensive to package than the product itself. The increasing number of layers of coextruded medical composite films is a trend at home and abroad. Macro Engineering has just sold three 7- and 9-layer medical composite film production lines to China and Brazil.
Winpak, based in Winnipeg, Canada, first introduced qualified medical packaging film in North America, which is a 11-layer composite film of nylon-based structure used to make sterilization bags. This may also be the most layered medical packaging co-extruded film in the world. Winpak did not disclose the structure of this film, but this film, which was manufactured on a cast film line with 11 extrusion heads, was initially used as a barrier film in a thermoformed food package.
Recently, Winpak produced multi-layer blown film for medical packaging on its production line with eight and nine extrusion heads at its plant in Senoia.
“We have created some interesting new options,†said David Johns, head of packaging at Winpak. Winpak's goal is to expand the company's medical business, and this goal is achieved through the use of technology in co-extruded barrier films in food packaging to reduce the cost of medical packaging films. "We have worked hard for three years behind the scenes to make several applications successful, and now we are evaluating several other things, mainly using new materials like metallocene to save costs. We found that the medical market is happy to see new things. It will be as competitive as other packaging markets." David estimates.
In Finland, Winpak has a sister company called Wipak, one of the world's leading producers of high-tech packaging films. Heikki Weijo, director of medical packaging management at Wihuri Oy Wipak in Nastola, Finland, said that Wipak's expertise in medical film has helped it gain recognition from North American regulatory agencies for its new thin-film construction. In 1997, Wipak installed a special cast film line where the cleanliness of the production line reached 100,000 in European standards (with no more than 100,000 particles per cubic foot), which is the first in the world to reach Such a high cleanliness standard medical packaging film production line, Weijo said.
“Over the past seven years, multi-layer composite membranes have been our starting point,†said Chris Osborn, Marketing Manager at Perfecseal. “You can now see that users’ attitudes towards multi-layer composite membranes are changing dramatically. The business of discovering multi-layer co-extruded films has continued to increase. Thin-split-layer films can make more efficient use of expensive high-performance polymers.†By merging the strength of medical film production previously dispersed in several food film factories, Perfecseal built its first factory specializing in medical film production in New London this year. In this new plant, Perfecseal can produce very good composite membranes with more than five layers, Osborn said.
Compared with traditional laminated medical films, co-extruded coated films have lower cost and higher strength. Rexam also switched from cohesive lamination to co-extrusion coating to produce Core-Peel tear-off films.
Blown film vs cast film
Most medical packaging films in North America are blown films because of the directionality and better tear resistance of the blown film itself. However, some blown film lines originally designed for food packaging are facing the challenge of producing medical films. High yield, water cooling, lower extrusion foam, etc. may require different nylon formulations for medical packaging because amorphous films usually have more memory and shrinkage, for sharp or fragile medical equipment, This may be a disadvantage.
In Europe, extruded film has more cast film because of its good specification control performance. The cast film can also better control the shape, and therefore can obtain a more irregular shape while having a softer feel than the blown film. "In the U.S., which method dominates is not yet certain," said the technical director of a large U.S. healthcare product company that produces co-extruded medical films. Steve Post, Flow Film Business Unit Manager, Davis Standard Film and Coating Systems, Inc., Somerville, New Jersey, added: “Multilayer cast medical film is not produced using conventional equipment. To make a flat film, it is often necessary to use Humidifying water tank and annealing roll.
React to competition
The existing medical film manufacturing companies are inherently difficult to cope with high-tech competition from food packaging manufacturers. Investing in new technologies is not an easy task for traditional medical film manufacturing companies, and they lack the incentive to do so. Once a medical packaging film is approved by the user, the manufacturer will not make any changes or upgrades to the extrusion line without the consent of the customer. As a result, the packaging film for the durable medical product is used. Old equipment and technology production.
On the other hand, food packaging equipment is constantly being updated. The co-extruded food packaging film line also uses more advanced equipment to inspect and control film thickness and barrier properties. In Perfecseal's new thin film factory in Wisconsin, the gauges used to measure thickness on the coextruded and blown film production lines are automatically monitored and controlled. In contrast, most medical film manufacturers rely on gravity feed devices and off-line sampling to control the number and thickness of layers. “The medical film manufacturing market was not actively using online measurement technology before,†said a product manager at EGS Metrology in Billerica, Mass. The company produces a FSIR (Full Spectrum External Line) system for separation membrane detection, which is said to be used for all multilayer food films.
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