Using heat and pressure, the product is quicker to the shelf. The process is based on conditions that stimulate the effects of aging on materials.
Anti-counterfeiting - methods of ensuring the validity of products to prevent occasions of counterfeit. Drugs can be stolen, inaccurately reproduced, resold, or merely replaced with a placebo. This can cause problems in brand protection, and in the health and safety of consumers. Tamper-evident seals, unique carton numbers, bar code printing, and RFID are methods of product tracking that prevent counterfeiting.
CFR 21 part 11 - an FDA (US Food and Drug Administration) code of federal regulations (CFR) issued March of 2000 requiring electronic records and signatures for products. Importance of keeping up-to-date with technology was stressed. Systems validation, audit trails, time stamps, general security and archiving became requirements. The current requirements are under constant revision as technology changes.
Child-resistant - a way of sealing a product to prevent a child from opening it, usually in the line of pharmaceuticals or products that would cause children harm. Packages often require a dexterity that comes with age, or a series of opening steps that have to be read on the package.
Clinical trials - trials done on set groups of consenting patients to determine the effects of a product. Medical research on real humans provides the best clue into consumer reactions and they have the best results when staff and patients follow the protocol and keep in frequent contact. Ethical and legal medical practice codes still apply and though there are risks, there are great medical benefits as well.
Cold chain - a temperature-controlled supply chain. Hopefully uninterrupted, its a series of storage and distribution activities which maintain a given temperature range. Temperatures depend on the product, but many products like vaccines are ineffective if cold is not maintained. Often the range is 2-8 degrees celsius.
Combination product - a product comprised of two or more components, drug/device, drug/biologic, or drug/device/biologic either mixed into one entity, packaged separately but bought together as a unit, or bought separately with the intention of using them together. An inhaler is an example, where a drug is intended to be taken with a device, and though they are bought separately, they combine in intention.
Current good manufacturing practices (cGMP) - regulations issued by the FDA as minimum requirements. Most countries have their own, and they require quality systems of design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices. Going beyond samples, the entire system is expected to be up to par, and documentation facilitates this.
Dietary supplement - vitamins, minerals, herbs, or amino acids. Dietary substances intended to supplement the diet and intended for ingestion in pill, capsule, tablet, powder, or liquid form. Labeled as a dietary supplement, and not represented as real food or as a sole ingredient to a diet.
FDA recalls - the action needed when the FDA doesn't approve of a food or drug item. If it doesn't fit into the guidelines for safety and efficacy of pharmaceuticals, the company often will recall the item themselves, but in serious situations the FDA will have to inform the public. Class I recalls - reasonable probability that it'll cause injury or death. Class II - exposure may cause temporary injury. Class III - unlikely to cause adverse health reactions, but just wrong labeling or manufacturing regulations.
Inhalers - a medical device used to deliver medication into the body via the lungs. It's a combination product combining a drug and a device that need to be delivered together.
Lyophilized drugs - freeze-dried drugs. Vaccines are transformed from liquid to solid powder. This process enhances shelf-life and stability of vaccines. Vapor products can be transformed directly to solid without the liquid phase, easing production.
Medical device packaging - wrapping, packaging, preparing a medical device for shipping, display, and purchase. Devices, like the drugs themselves often need certain requirements for safe packaging, requiring sterility, shape and delicate protection, certain temperatures, or other such necessities. A difficult business to be in, because of the requirements for entry and procedure.
Nutraceuticals - refers to foods claiming to have a medicinal effect on human health. Also called functional foods. Some examples are Flavanoids, Anti-Oxidants such as gamma linolenic acid, beta carateins, anthocyanins, etc.
OTC Products - Over The Counter products. Medical or healthful products that can be purchased over the counter without a prescription.
Package design - the art and technology of enclosing or protecting products for distribution, storage, sale, and use. More specifically it is the design and layout of the package structure and labeling integrated with the products use and necessities.
Package testing - tests to ensure that packaged products will survive the environmental hazards of temperature, humidity, shock, vibration, compression, altitude or impacts when shipped to customers.
Packaging automation - the world of machinery and production behind packaging controls and information technologies. Relating physical machinery and design imagery.
Parenterals - medicine taken into the body or administered in a manner other than through the digestive (alimentary) tract, as by intravenous or intramuscular injection. Total parenteral nutrition (TPN) is meant to drip through a needle or catheter placed in a vein. TPN is used for patients who cannot or should not get their nutrition through eating.
Patient compliance - refers to a patient both agreeing to and then undergoing some part of their treatment program as advised by a medicine package, their doctor, or another healthcare worker.
Personalized medicine - personalized medicine would allow a doctor to prescribe precisely the right drug at the right dose to an individual based on that person•s unique DNA. A possibility stemming from the human genome project that would revolutionize the healthcare packaging industry.
Process analytical technology (PAT) - a way to approach validation for pharmaceuticals since the FDA regulations associated with CFR 21 part 11.
RFID - Radio-frequency identification (RFID) is an automatic identification method, relying on storing and remotely retrieving data using devices called RFID tags or transponders. The current thrust in RFID use is in supply chain management for large enterprises. RFID increases the speed and accuracy with which inventory can be tracked and managed thereby saving money for the business.
Risk management - Risk management is the human activity which integrates recognition of risk, risk assessment, developing strategies to manage it, and mitigation of risk using managerial resources. Evaluate and work to prevent risks in the packaging field. Identify every possible risk scenario for all identified functions. Match those scenarios with their likely effect(s). For instance, if a stopper is not placed properly in a vial (a possible risk), the possible effects could include spilled product, product that•s underweight/under dose, or product that appears to have been tampered with.
Senior friendly - a package that is designed with the elderly in mind, perhaps easy-open for those with less agile hands, perhaps with large-print type for those with failing vision, etc.
Sterilization - any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses and prions) from a surface, equipment, foods, medications, or biological culture medium. Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Packaging medical devices and medicines to remain sterilized is then necessary.
Tamper evident - a device or process that makes unauthorised access to the protected object easily detected. This may take the form of seals, markings or other techniques. Tamper-evident design is perhaps most visible in the area of product packaging and labelling, where it can be vital to know that the product has not been altered since it left the manufacturer.
Track and trace - the process of recording the past and present whereabouts of a shipment, as it passes through different handlers on its way to its destination. Typical applications for Track & Trace are to identify where a product was "diverted" from its intended course (parallel importing), or where a fake product was introduced.
Unit - of - use packaging - packaging designed to be taken one dose at a time, often in a blister pack, to prevent the rest of the medication from being contaminated, or to easily keep track of how many have been taken and how many remain. This makes patient compliance easier.
Validation - a total process involving the identification and control of materials and processing variables that affect the ability of a packaged device to meet its acceptance requirements. Involves knowing that the medicine you're taking is the medicine you're supposed to be taking, and that it hasn't been tampered with.
Wound care - the process of helping to heal a wound with correct bandages, antibiotics, or medications as directed by a medical professional.
Anti-counterfeiting - methods of ensuring the validity of products to prevent occasions of counterfeit. Drugs can be stolen, inaccurately reproduced, resold, or merely replaced with a placebo. This can cause problems in brand protection, and in the health and safety of consumers. Tamper-evident seals, unique carton numbers, bar code printing, and RFID are methods of product tracking that prevent counterfeiting.
CFR 21 part 11 - an FDA (US Food and Drug Administration) code of federal regulations (CFR) issued March of 2000 requiring electronic records and signatures for products. Importance of keeping up-to-date with technology was stressed. Systems validation, audit trails, time stamps, general security and archiving became requirements. The current requirements are under constant revision as technology changes.
Child-resistant - a way of sealing a product to prevent a child from opening it, usually in the line of pharmaceuticals or products that would cause children harm. Packages often require a dexterity that comes with age, or a series of opening steps that have to be read on the package.
Clinical trials - trials done on set groups of consenting patients to determine the effects of a product. Medical research on real humans provides the best clue into consumer reactions and they have the best results when staff and patients follow the protocol and keep in frequent contact. Ethical and legal medical practice codes still apply and though there are risks, there are great medical benefits as well.
Cold chain - a temperature-controlled supply chain. Hopefully uninterrupted, its a series of storage and distribution activities which maintain a given temperature range. Temperatures depend on the product, but many products like vaccines are ineffective if cold is not maintained. Often the range is 2-8 degrees celsius.
Combination product - a product comprised of two or more components, drug/device, drug/biologic, or drug/device/biologic either mixed into one entity, packaged separately but bought together as a unit, or bought separately with the intention of using them together. An inhaler is an example, where a drug is intended to be taken with a device, and though they are bought separately, they combine in intention.
Current good manufacturing practices (cGMP) - regulations issued by the FDA as minimum requirements. Most countries have their own, and they require quality systems of design, manufacture, packaging, labeling, storage, installation, and servicing of medical devices. Going beyond samples, the entire system is expected to be up to par, and documentation facilitates this.
Dietary supplement - vitamins, minerals, herbs, or amino acids. Dietary substances intended to supplement the diet and intended for ingestion in pill, capsule, tablet, powder, or liquid form. Labeled as a dietary supplement, and not represented as real food or as a sole ingredient to a diet.
FDA recalls - the action needed when the FDA doesn't approve of a food or drug item. If it doesn't fit into the guidelines for safety and efficacy of pharmaceuticals, the company often will recall the item themselves, but in serious situations the FDA will have to inform the public. Class I recalls - reasonable probability that it'll cause injury or death. Class II - exposure may cause temporary injury. Class III - unlikely to cause adverse health reactions, but just wrong labeling or manufacturing regulations.
Inhalers - a medical device used to deliver medication into the body via the lungs. It's a combination product combining a drug and a device that need to be delivered together.
Lyophilized drugs - freeze-dried drugs. Vaccines are transformed from liquid to solid powder. This process enhances shelf-life and stability of vaccines. Vapor products can be transformed directly to solid without the liquid phase, easing production.
Medical device packaging - wrapping, packaging, preparing a medical device for shipping, display, and purchase. Devices, like the drugs themselves often need certain requirements for safe packaging, requiring sterility, shape and delicate protection, certain temperatures, or other such necessities. A difficult business to be in, because of the requirements for entry and procedure.
Nutraceuticals - refers to foods claiming to have a medicinal effect on human health. Also called functional foods. Some examples are Flavanoids, Anti-Oxidants such as gamma linolenic acid, beta carateins, anthocyanins, etc.
OTC Products - Over The Counter products. Medical or healthful products that can be purchased over the counter without a prescription.
Package design - the art and technology of enclosing or protecting products for distribution, storage, sale, and use. More specifically it is the design and layout of the package structure and labeling integrated with the products use and necessities.
Package testing - tests to ensure that packaged products will survive the environmental hazards of temperature, humidity, shock, vibration, compression, altitude or impacts when shipped to customers.
Packaging automation - the world of machinery and production behind packaging controls and information technologies. Relating physical machinery and design imagery.
Parenterals - medicine taken into the body or administered in a manner other than through the digestive (alimentary) tract, as by intravenous or intramuscular injection. Total parenteral nutrition (TPN) is meant to drip through a needle or catheter placed in a vein. TPN is used for patients who cannot or should not get their nutrition through eating.
Patient compliance - refers to a patient both agreeing to and then undergoing some part of their treatment program as advised by a medicine package, their doctor, or another healthcare worker.
Personalized medicine - personalized medicine would allow a doctor to prescribe precisely the right drug at the right dose to an individual based on that person•s unique DNA. A possibility stemming from the human genome project that would revolutionize the healthcare packaging industry.
Process analytical technology (PAT) - a way to approach validation for pharmaceuticals since the FDA regulations associated with CFR 21 part 11.
RFID - Radio-frequency identification (RFID) is an automatic identification method, relying on storing and remotely retrieving data using devices called RFID tags or transponders. The current thrust in RFID use is in supply chain management for large enterprises. RFID increases the speed and accuracy with which inventory can be tracked and managed thereby saving money for the business.
Risk management - Risk management is the human activity which integrates recognition of risk, risk assessment, developing strategies to manage it, and mitigation of risk using managerial resources. Evaluate and work to prevent risks in the packaging field. Identify every possible risk scenario for all identified functions. Match those scenarios with their likely effect(s). For instance, if a stopper is not placed properly in a vial (a possible risk), the possible effects could include spilled product, product that•s underweight/under dose, or product that appears to have been tampered with.
Senior friendly - a package that is designed with the elderly in mind, perhaps easy-open for those with less agile hands, perhaps with large-print type for those with failing vision, etc.
Sterilization - any process that effectively kills or eliminates transmissible agents (such as fungi, bacteria, viruses and prions) from a surface, equipment, foods, medications, or biological culture medium. Sterilization can be achieved through application of heat, chemicals, irradiation, or filtration. Packaging medical devices and medicines to remain sterilized is then necessary.
Tamper evident - a device or process that makes unauthorised access to the protected object easily detected. This may take the form of seals, markings or other techniques. Tamper-evident design is perhaps most visible in the area of product packaging and labelling, where it can be vital to know that the product has not been altered since it left the manufacturer.
Track and trace - the process of recording the past and present whereabouts of a shipment, as it passes through different handlers on its way to its destination. Typical applications for Track & Trace are to identify where a product was "diverted" from its intended course (parallel importing), or where a fake product was introduced.
Unit - of - use packaging - packaging designed to be taken one dose at a time, often in a blister pack, to prevent the rest of the medication from being contaminated, or to easily keep track of how many have been taken and how many remain. This makes patient compliance easier.
Validation - a total process involving the identification and control of materials and processing variables that affect the ability of a packaged device to meet its acceptance requirements. Involves knowing that the medicine you're taking is the medicine you're supposed to be taking, and that it hasn't been tampered with.
Wound care - the process of helping to heal a wound with correct bandages, antibiotics, or medications as directed by a medical professional.
![Alison Bryant, senior consultant at Antea Group and communications director for the Healthcare Plastics Recycling Council (HPRC), addressed the crowd at the[PACK]out.](https://img.healthcarepackaging.com/files/base/pmmi/all/image/2024/05/Alison_Bryant.6644005a513b0.png?auto=format%2Ccompress&fit=crop&h=167&q=70&w=250)
