Greg Hrinya, Associate Editor10.11.19
Medical labels occupy a unique niche in the printing industry. Aesthetics are far less important than functionality, and regulatory requirements rule the roost.
This labeling segment also has new technology at its disposal. Smart labeling, with RFID specifically, can provide track and trace capabilities, temperature tracking, anti-counterfeiting properties and a plethora more. Medical labels must also perform well in humid or chilly conditions, especially in storage.
“Medical labels have to include crucial product info, must be clearly legible and leave room for subsequent imprint of variable data such as batch number and expiration date,” states Gene Dul, president of Schreiner MediPharm US. “Labels can include additional functionalities that support healthcare personnel in drug administration, such as detachable parts for the medical records, integrated hangers to suspend infusion bottles or multiple layers for extensive texts in several languages.”
According to Paavo Sillanpaa, business segments manager, specials, Americas, UPM Raflatac, medical labels are designed to protect, inform and secure. “Medical labels need to safeguard the integrity of the product and the safety of the patient, and they must meet or exceed strict industry regulations and safety requirements,” he says. “The material needs to comply with the local regulatory environment and have robust performance in the application itself.”
ID Images, a label converter based in Brunswick, OH, USA, sees medical labels as application driven. Various considerations might include where the substrate is being applied, how the label is being applied – machine or by hand – and environmental factors like temperatures, chemical exposure, sterilization and more.
“Any component within the label and/or packaging can be a key element,” says Tim Mlnarik, director of sales and marketing at ID Images. “Perhaps the most important element is any material or product specifications – and or drawings – and ensuring the converted label adheres to those specifications.”
For ID Images, the converting process does not change for medical labels. Flexo, digital and offset all remain viable options to print these labels. However, the environment might change, as a clean room could be required. Plus, quality inspections are crucial, as well.
Medical labels feature a wide range of substrates, and the industry is seeing a trend toward films. “Papers are the most common substrate, but we are beginning to see a shift to more films with the growth of drug products being packaged in vials and syringes,” says Agata Kowalska, product manager, pharma, at Avery Dennison. “Films can provide clarity and better performance for tight mandrel packages. Avery Dennison offers a selection of papers and films that can address a wide variety of applications.”
The next generation of medical labels features an endless array of possibilities. “The concept of smart technology is making inroads to various industries, and healthcare is no exception,” notes Jay Wittmann, product manager of intelligent labels at Avery Dennison. “Hospitals today are taking bold steps toward making use of modern solutions to better manage their resources and ensure the best service to their patients.”
Smart labeling allows hospital staff to engage in more patient-facing activities, and tracking medications and other medical supplies can reduce waste and help fight theft. There is also a significant advantage when facing inventory.
“With high-value supplies, you’re saving time taking inventory, more accurately capturing chargebacks, and reducing waste from expired products, which is a common trend,” says Wittmann. “RFID enables specimen tracking, which enhances labor productivity and error reduction. When it comes to controlled drugs, the technology can better prevent and monitor theft and abuse. Additionally, high-value medication carrying costs are reduced through better inventory management, including expiry date visibility.”
According to Wittmann, this process is already underway for some brands–specifically with RFID technology for the authentication of prefilled syringes and shipment tracking. “RFID is a great solution in the pharmaceutical and medical space because of its unique identification and tracking capability,” he says. “Manufacturers are able to verify that authentic products leave their facility and reach the consumer safely.”
Durability is also a key concern. While durability extends to various markets, such as a wine label’s ability to withstand an ice bucket, medical labels deal with life and death circumstances. “The durability of this kind of label is vital, as the label contains essential dosage or safety information that needs to remain in place and legible for the entire life of the product, even during and after sterilization,” says Sillanpaa. “The application might require the label material to perform well in labeling of tight mandrel containers, being tested and validated for low leachable characteristics, adhere and retain the adhesion in different low and high temperatures and withstand various sterilization methods, just to mention a few.”
“While all labels are important, some medical label applications can impact the health or life of a person,” notes Mlnarik. “Whether labeling for dosing of medication, lab testing/vial labeling, medication warnings, IV-line tracing, patient identification and records, etc. – an error could result in more than a packaging line going down.”
The right substrate
Choosing the right substrate for a medical label is no small task. Avery Dennison and UPM Raflatac have both invested heavily in R&D to ensure optimal quality in this space. There are a number of considerations, including small diameters and contoured surfaces.
“Numerous substrates present their own challenges for label face materials and adhesives – from glass, PET and PVC to cardboard, polypropylene and squeezable LDPE and COC,” explains UPM Raflatac’s Sillanpaa. “In many cases, label materials are classified as primary packaging materials due to indirect contact with the medicine through containers. Anything that leaches from the packaging into the drug can directly affect patient safety due to its inherent toxicity, indirectly affect patient safety due to its interaction with the product, affect the product’s general, chemical or physical characteristics (pH level, appearance, etc.), or affect the product’s efficacy or stability.”
The adhesive also plays a role, too. “Since labels have to adhere reliably to primary and secondary packaging, adhesive strength plays an important role, as well as a tailored approach, when it comes to finding the right adhesive and material for a specific application,” says Schreiner MediPharm’s Dul. “In addition, such aspects like environmental conditions and mechanical abrasion have to be considered.”
“The time taken for labeling before the product returns to cold storage should also be considered, as this is when adhesion will develop,” says Sillanpaa. “If the container is being sterilized after labeling, your choice of sterilization method will affect your choice of label material. Typically, the label must be heat and moisture resistant, but not all label materials are suitable for all types of sterilization.”
Avery Dennison’s adhesives provide high initial tack and excellent adhesion on a variety of substrates, as medical facestocks must be high strength and offer top print quality. “Adhesives used within the pharmaceutical industry must undergo comprehensive FDA testing to ensure they comply with toxicology requirements,” says Avery Dennison’s Kowalska. “Avery Dennison pharma adhesives reduce the risk of contamination with our industry proven low-migration adhesives. They offer excellent label stability throughout the manufacturing and sterilization process – even on small applications.”
As is to be expected, the complex nature of this labeling segment can lead to several challenges, especially for converters. “One on-going trend that is making these demands more difficult to obtain is the fact that material suppliers continue to downgauge liners and facestocks, which makes it even more challenging to convert some products, as well as providing the attributes required in certain applications,” explains ID Images’ Mlnarik.
Rising regulations
Medical labels face strict requirements and regulations. Unlike the average label that is designed to pop off the shelf, improper labeling could lead to dire consequences.
“Regulations for pharmaceutical and medical labels are very important and drive a host of labeling and packaging decisions,” explains Avery Dennison’s Kowalska. “REACH is another good example where we monitor regulations to ensure compliance of our adhesives. Since there are so many different applications for pharmaceuticals, we offer application-specific portfolios such as syringe, cold chain, blood bag, security and more.”
According to Kowalska, regulations could impact the content of the labels, traceability of the product, among others. The medical product being labeled may drive the design and size of the label, as well as substrate’s durability.
“The Falsified Medicine Directive in the European Union and the Drug Supply Chain Security Act in the US have increased the requirements and urgency for supply chain security,” says UPM Raflatac’s Sillanpaa. “An increased need to secure the pharmaceutical supply chain offers opportunities in tracking and tracing, serialization and brand protection and tamper evident label solutions.”
According to Schreiner MediPharm’s Dul, the EU Falsified Medicines Directive requires a unique ID and a tamper-proof device for each medicine pack. He says that special sealing solutions can help to ensure the integrity of the pack while clearly and irreversibly indicating first opening.
Since proper labeling is of paramount importance, inspection is also a critical step in ensuring the accuracy of the label. “Due to the high-quality demands of the pharmaceutical industry, continuous inspections and 100% camera control play a major role in medical labeling,” adds Schreiner MediPharm’s Dul.
“Mislabeled or illegible labels can pose a threat to patient safety, and therefore label converters of medical labels need to follow cGMP processes in order to make sure there is no chance of mixing, missing or contaminating the labels. They also must perform 100% quality control of the label image by scanning it to a computer and using a camera to cross check every label for potential misprint or contamination, which could make the text unreadable or get a wrong interpretation of the dosage,” adds Sillanpaa. “For example, a dirt spot could be mistaken for a decimal point, like 3.0 mL instead of 30 mL.”
At Avery Dennison, a Pharma and Complete Compliance Expert Team offers converters and pharmaceutical companies detailed information, full transparency and technical support. The goal is to ensure that labeling applications are successful and compliant.
In the future, changing healthcare regulations – in North America specifically – could lead to a rise in demand. “When dealing with universal healthcare, more standards and record keeping requirements will drive labeling needs,” concludes ID Images’ Mlnarik. “There are other regulatory issues like HIPAA.”
Schreiner MediPharm is now offering a new forensic authentication feature for pharmaceutical labels in cooperation with Applied DNA Sciences. SigNature DNA is a high-security feature based on DNA markers with which pharmaceutical manufacturers can protect products against counterfeiting, and patients against potential health risks.
DNA markers are deemed to be impossible to counterfeit and recognized as forensic authentication evidence in courts of law.
A secure supply chain is indispensable in the pharmaceutical industry. If counterfeit medicines are put into circulation, this may result in claims for damages by affected patients. Pharmaceutical manufacturers are able to counteract such illegal practices by providing their original products with forensic anti-counterfeiting features such as DNA markers. Using conventional printing techniques, Schreiner MediPharm flexibly and invisibly integrates this high-security technology from Applied DNA Sciences into existing label designs.
Robust and counterfeit-proof, DNA molecular tags are covert authentication features based on uniquely modified, encrypted DNA sequences. Various multi-level methods to verify the authentication feature along the supply chain are available to informed experts. For example, Beacon technology enables fast and reliable on-site verification by means of a decryptant liquid and UV lamp. Specialized mobile devices also may be used to authenticate the SigNature DNA molecular tags. An extensive forensic DNA analysis by a laboratory provides results that qualify as admissible evidence in courts of law.
With the SigNature DNA marker, Schreiner MediPharm has expanded its portfolio of multi-level security systems and customized solutions for supply chain integrity. “The integration of SigNature DNA, in combination with Beacon in our functional pharma labels, will set a new security standard in the pharmaceutical industry,” says Nadine Lampka, product manager Pharma-Security at Schreiner MediPharm. “DNA-Secure is extremely robust, flexible to integrate and allows both a quick in-field test and an ultimate forensic proof in the lab. It provides excellent value for the investment, and complements our portfolio of integrated authentication features on the high-security end.”
This labeling segment also has new technology at its disposal. Smart labeling, with RFID specifically, can provide track and trace capabilities, temperature tracking, anti-counterfeiting properties and a plethora more. Medical labels must also perform well in humid or chilly conditions, especially in storage.
“Medical labels have to include crucial product info, must be clearly legible and leave room for subsequent imprint of variable data such as batch number and expiration date,” states Gene Dul, president of Schreiner MediPharm US. “Labels can include additional functionalities that support healthcare personnel in drug administration, such as detachable parts for the medical records, integrated hangers to suspend infusion bottles or multiple layers for extensive texts in several languages.”
According to Paavo Sillanpaa, business segments manager, specials, Americas, UPM Raflatac, medical labels are designed to protect, inform and secure. “Medical labels need to safeguard the integrity of the product and the safety of the patient, and they must meet or exceed strict industry regulations and safety requirements,” he says. “The material needs to comply with the local regulatory environment and have robust performance in the application itself.”
ID Images, a label converter based in Brunswick, OH, USA, sees medical labels as application driven. Various considerations might include where the substrate is being applied, how the label is being applied – machine or by hand – and environmental factors like temperatures, chemical exposure, sterilization and more.
“Any component within the label and/or packaging can be a key element,” says Tim Mlnarik, director of sales and marketing at ID Images. “Perhaps the most important element is any material or product specifications – and or drawings – and ensuring the converted label adheres to those specifications.”
For ID Images, the converting process does not change for medical labels. Flexo, digital and offset all remain viable options to print these labels. However, the environment might change, as a clean room could be required. Plus, quality inspections are crucial, as well.
Medical labels feature a wide range of substrates, and the industry is seeing a trend toward films. “Papers are the most common substrate, but we are beginning to see a shift to more films with the growth of drug products being packaged in vials and syringes,” says Agata Kowalska, product manager, pharma, at Avery Dennison. “Films can provide clarity and better performance for tight mandrel packages. Avery Dennison offers a selection of papers and films that can address a wide variety of applications.”
The next generation of medical labels features an endless array of possibilities. “The concept of smart technology is making inroads to various industries, and healthcare is no exception,” notes Jay Wittmann, product manager of intelligent labels at Avery Dennison. “Hospitals today are taking bold steps toward making use of modern solutions to better manage their resources and ensure the best service to their patients.”
Smart labeling allows hospital staff to engage in more patient-facing activities, and tracking medications and other medical supplies can reduce waste and help fight theft. There is also a significant advantage when facing inventory.
“With high-value supplies, you’re saving time taking inventory, more accurately capturing chargebacks, and reducing waste from expired products, which is a common trend,” says Wittmann. “RFID enables specimen tracking, which enhances labor productivity and error reduction. When it comes to controlled drugs, the technology can better prevent and monitor theft and abuse. Additionally, high-value medication carrying costs are reduced through better inventory management, including expiry date visibility.”
According to Wittmann, this process is already underway for some brands–specifically with RFID technology for the authentication of prefilled syringes and shipment tracking. “RFID is a great solution in the pharmaceutical and medical space because of its unique identification and tracking capability,” he says. “Manufacturers are able to verify that authentic products leave their facility and reach the consumer safely.”
Durability is also a key concern. While durability extends to various markets, such as a wine label’s ability to withstand an ice bucket, medical labels deal with life and death circumstances. “The durability of this kind of label is vital, as the label contains essential dosage or safety information that needs to remain in place and legible for the entire life of the product, even during and after sterilization,” says Sillanpaa. “The application might require the label material to perform well in labeling of tight mandrel containers, being tested and validated for low leachable characteristics, adhere and retain the adhesion in different low and high temperatures and withstand various sterilization methods, just to mention a few.”
“While all labels are important, some medical label applications can impact the health or life of a person,” notes Mlnarik. “Whether labeling for dosing of medication, lab testing/vial labeling, medication warnings, IV-line tracing, patient identification and records, etc. – an error could result in more than a packaging line going down.”
The right substrate
Choosing the right substrate for a medical label is no small task. Avery Dennison and UPM Raflatac have both invested heavily in R&D to ensure optimal quality in this space. There are a number of considerations, including small diameters and contoured surfaces.
“Numerous substrates present their own challenges for label face materials and adhesives – from glass, PET and PVC to cardboard, polypropylene and squeezable LDPE and COC,” explains UPM Raflatac’s Sillanpaa. “In many cases, label materials are classified as primary packaging materials due to indirect contact with the medicine through containers. Anything that leaches from the packaging into the drug can directly affect patient safety due to its inherent toxicity, indirectly affect patient safety due to its interaction with the product, affect the product’s general, chemical or physical characteristics (pH level, appearance, etc.), or affect the product’s efficacy or stability.”
The adhesive also plays a role, too. “Since labels have to adhere reliably to primary and secondary packaging, adhesive strength plays an important role, as well as a tailored approach, when it comes to finding the right adhesive and material for a specific application,” says Schreiner MediPharm’s Dul. “In addition, such aspects like environmental conditions and mechanical abrasion have to be considered.”
“The time taken for labeling before the product returns to cold storage should also be considered, as this is when adhesion will develop,” says Sillanpaa. “If the container is being sterilized after labeling, your choice of sterilization method will affect your choice of label material. Typically, the label must be heat and moisture resistant, but not all label materials are suitable for all types of sterilization.”
Avery Dennison’s adhesives provide high initial tack and excellent adhesion on a variety of substrates, as medical facestocks must be high strength and offer top print quality. “Adhesives used within the pharmaceutical industry must undergo comprehensive FDA testing to ensure they comply with toxicology requirements,” says Avery Dennison’s Kowalska. “Avery Dennison pharma adhesives reduce the risk of contamination with our industry proven low-migration adhesives. They offer excellent label stability throughout the manufacturing and sterilization process – even on small applications.”
As is to be expected, the complex nature of this labeling segment can lead to several challenges, especially for converters. “One on-going trend that is making these demands more difficult to obtain is the fact that material suppliers continue to downgauge liners and facestocks, which makes it even more challenging to convert some products, as well as providing the attributes required in certain applications,” explains ID Images’ Mlnarik.
Rising regulations
Medical labels face strict requirements and regulations. Unlike the average label that is designed to pop off the shelf, improper labeling could lead to dire consequences.
“Regulations for pharmaceutical and medical labels are very important and drive a host of labeling and packaging decisions,” explains Avery Dennison’s Kowalska. “REACH is another good example where we monitor regulations to ensure compliance of our adhesives. Since there are so many different applications for pharmaceuticals, we offer application-specific portfolios such as syringe, cold chain, blood bag, security and more.”
According to Kowalska, regulations could impact the content of the labels, traceability of the product, among others. The medical product being labeled may drive the design and size of the label, as well as substrate’s durability.
“The Falsified Medicine Directive in the European Union and the Drug Supply Chain Security Act in the US have increased the requirements and urgency for supply chain security,” says UPM Raflatac’s Sillanpaa. “An increased need to secure the pharmaceutical supply chain offers opportunities in tracking and tracing, serialization and brand protection and tamper evident label solutions.”
According to Schreiner MediPharm’s Dul, the EU Falsified Medicines Directive requires a unique ID and a tamper-proof device for each medicine pack. He says that special sealing solutions can help to ensure the integrity of the pack while clearly and irreversibly indicating first opening.
Since proper labeling is of paramount importance, inspection is also a critical step in ensuring the accuracy of the label. “Due to the high-quality demands of the pharmaceutical industry, continuous inspections and 100% camera control play a major role in medical labeling,” adds Schreiner MediPharm’s Dul.
“Mislabeled or illegible labels can pose a threat to patient safety, and therefore label converters of medical labels need to follow cGMP processes in order to make sure there is no chance of mixing, missing or contaminating the labels. They also must perform 100% quality control of the label image by scanning it to a computer and using a camera to cross check every label for potential misprint or contamination, which could make the text unreadable or get a wrong interpretation of the dosage,” adds Sillanpaa. “For example, a dirt spot could be mistaken for a decimal point, like 3.0 mL instead of 30 mL.”
At Avery Dennison, a Pharma and Complete Compliance Expert Team offers converters and pharmaceutical companies detailed information, full transparency and technical support. The goal is to ensure that labeling applications are successful and compliant.
In the future, changing healthcare regulations – in North America specifically – could lead to a rise in demand. “When dealing with universal healthcare, more standards and record keeping requirements will drive labeling needs,” concludes ID Images’ Mlnarik. “There are other regulatory issues like HIPAA.”
Schreiner MediPharm is now offering a new forensic authentication feature for pharmaceutical labels in cooperation with Applied DNA Sciences. SigNature DNA is a high-security feature based on DNA markers with which pharmaceutical manufacturers can protect products against counterfeiting, and patients against potential health risks.
DNA markers are deemed to be impossible to counterfeit and recognized as forensic authentication evidence in courts of law.
A secure supply chain is indispensable in the pharmaceutical industry. If counterfeit medicines are put into circulation, this may result in claims for damages by affected patients. Pharmaceutical manufacturers are able to counteract such illegal practices by providing their original products with forensic anti-counterfeiting features such as DNA markers. Using conventional printing techniques, Schreiner MediPharm flexibly and invisibly integrates this high-security technology from Applied DNA Sciences into existing label designs.
Robust and counterfeit-proof, DNA molecular tags are covert authentication features based on uniquely modified, encrypted DNA sequences. Various multi-level methods to verify the authentication feature along the supply chain are available to informed experts. For example, Beacon technology enables fast and reliable on-site verification by means of a decryptant liquid and UV lamp. Specialized mobile devices also may be used to authenticate the SigNature DNA molecular tags. An extensive forensic DNA analysis by a laboratory provides results that qualify as admissible evidence in courts of law.
With the SigNature DNA marker, Schreiner MediPharm has expanded its portfolio of multi-level security systems and customized solutions for supply chain integrity. “The integration of SigNature DNA, in combination with Beacon in our functional pharma labels, will set a new security standard in the pharmaceutical industry,” says Nadine Lampka, product manager Pharma-Security at Schreiner MediPharm. “DNA-Secure is extremely robust, flexible to integrate and allows both a quick in-field test and an ultimate forensic proof in the lab. It provides excellent value for the investment, and complements our portfolio of integrated authentication features on the high-security end.”
