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U.S. PACKAGING REGULATIONS
U.S. Food & Drug Packaging Regulations
Although the United States has no all-encompassing federal legislation regulating the packaging industry, the federal government has asserted its authority to regulate food, drug, and cosmetic packaging to preserve consumer safety and confidence. There have also been a number of regulatory programs introduced by states or local jurisdictions to reduce the use and disposal of certain packaging materials and mandate minimum recycling requirements. Here we summarize some current regulations – issued at both a federal and state-level – that have impacted several sectors of the packaging industry.
The U.S. Food and Drug Administration (FDA) regulates the packaging and labeling of food and drugs. The intent of these regulations is to enhance the safety of food/drugs distributed throughout the United States and keep consumers informed about the food/drugs they're consuming.
To read more in-depth regulations for:
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Environmental Impact of Materials Used in Food Packaging
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Use of Recycled Content
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Prescription Drug Packaging
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Local and State-Level Regulations on Packaging Disposal and Recycling
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Polystyrene Containers
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Rigid Plastic Containers
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Heavy Metal Restrictions
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Push for Endocrine Disruptor Ban
Read more U.S. Packaging Regulations
Looking for state-specific packaging information?
Use these resources:
Fair Packaging and Labeling Act (FPLA) - www.ftc.gov
Ingredients, Packaging & Labeling Regulations (FDA) - www.fda.gov
Packaging and Environmental Legislation in the United States: An Overview - www.packaginglaw.com
COMMON PACKAGING
TEST STANDARDS & METHODS
ASTM International (The American Society for Testing and Materials) Standards - Download FAQ Sheet
ASTM E96 - Test Methods for Water Vapor Transmission of Materials
ASTM F1249 - Test Method for Water Vapor Transmission Rate Through Plastic Film and Sheeting Using a Modulated Infrared Sensor
ASTM D3985 - Test Method for Oxygen Transmission Rate Through Plastic Film and Sheeting Using a Coulometric Sensor
ASTM E398 - Standard Test Method for Water Vapor Transmission Rate of Sheet Materials Using Dynamic Relative Humidity Measurement
ASTM F1307 - Standard Test Method for Oxygen Transmission Rate Through Dry Packages Using a Coulometric Sensor
ASTM F1927 - Standard Test Method for Determination of Oxygen Gas Transmission Rate, Permeability and Permeance at Controlled Relative Humidity Through Barrier Materials Using a Coulometric Detector
ASTM F1140 - Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
ASTM F2029 - Standard Practices for Making Laboratory Heat Seals for Determination of Heat Sealability of Flexible Barrier Materials as Measured by Seal Strength
ASTM F2095 - Standard Test Methods for Pressure Decay Leak Test for Flexible Packages With and Without Restraining Plates
ASTM F2096 - Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
ASTM F2622 - Standard Test Method for Oxygen Gas Transmission Rate Through Plastic Film and Sheeting Using Various Sensors
DIN 53380-2 - Testing of plastics - Determination of gas transmission rate - Part 2: Manometric method for testing of plastic films
ASTM F2714 - Standard Test Method for Oxygen Headspace Analysis of Packages Using Fluorescent Decay
ASTM F3136 - Standard Test Method for Oxygen Gas Transmission Rate through Plastic Film and Sheeting using a Dynamic Accumulation Method
International Organization for Standardization (ISO) Standards - View ISO Process & Deliverables
ISO 9001:2015: Quality Management Standards
ISO/IEC 17025:2005: General requirements for the competence of testing and calibration laboratories
ISO 11607: Packaging for terminally sterilized medical devices -- Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 15103-2: Plastics -- Poly(phenylene ether) (PPE) moulding and extrusion materials -- Part 2: Preparation of test specimens and determination of properties
ISO 15106-1: Plastics -- Film and sheeting -- Determination of water vapor transmission rate -- Part 3: Electrolytic detection sensor method
ISO 15106-2: Plastics -- Film and sheeting -- Determination of water vapor transmission rate -- Part 2: Infrared detection sensor method
ISO 15106-3: Plastics -- Film and sheeting -- Determination of water vapor transmission rate -- Part 3: Electrolytic detection sensor method
ISO 15105-1: Plastics -- Film and sheeting -- Determination of gas-transmission rate -- Part 1: Differential-pressure methods
ISO 15105-2: Plastics -- Film and sheeting -- Determination of gas-transmission rate -- Part 2: Equal-pressure method
TAPPI - The American Paper & Pulp Association
An ANSI-Certified Standards development organization, TAPPI’s peer-reviewed Standards ensure that products meet industry recognized best practices.
TAPPI T 557 - Water vapor transmission rate through plastic film and sheeting using a modulated infrared sensor
The Japanese Industrial Standards Committee (JISC) or Japanese Industrial Standards (JIS)
GLOSSARY OF COMMON TERMS & DEFINITIONS
A
Adsorbed:
To be taken into the structure of a barrier.
Adsorption Curve:
The absorption curve is defined by the increasing flux values versus time necessary for an analyzed film to become fully saturated with a specified permeant. Two types of curves can be generated, a one sided absorption rate curve and a two sided absorption rate curve. The one sided curve represents the time necessary of a film to become fully saturated when only one side (face) of the film is challenged by the permeant. A two sided curve represents the time necessary to fully saturate the film when it is challenged by a permeant on both sides of the film.
Accuracy:
Degree of agreement of a measurement with an accepted reference level or value.
Adsorbent:
The material on whose surface adsorption takes place.
Adsorption:
The incorporation of a substance in one state into another of a different state (e.g., liquids being absorbed by a solid or gases being absorbed by a liquid. Part of the permeation process.
Absorbent packing: The inclusion of absorbent material within a package to take up liquids resulting from leakage or lique-faction of the product.
Accelerated Test:
Laboratory performance test of a container or coating to evaluate its performance in a shorter time interval than that required under actual service conditions.
Accelerated Shelf Life Study:
Applying modified physical conditions, such as increasing temperature, in order to arrive at a shelf life calculation faster than normal physical conditions.
Active Packaging:
Packaging with features that change to protect the contents in changing circumstances.
Adsorb:
(of a solid) hold (molecules of a gas or liquid or solute) as a thin film on the outside surface or on internal surfaces within the material.
AIHce:
Environment health and safety professionals. Trade show and conference
Air Quality:
Measuring the quality of air both indoor and outdoor.
AIHce:
Environment health and safety professionals. Trade show and conference
Airlaid:
Way of laying down shortcut staple fibers to form a continuous web and is defined as a material within the nonwoven materials group Nonwovens are defined as manufactured sheets, web or batt of directionally or randomly oriented fibers, bonded by friction, and/or cohesion and/or adhesion
Aging:
The process of developing specific properties of a product over a period of time. The process can be accelerated by the application of heat, pressure, chemical agents or catalysts.
Aliquot:
In chemistry, a portion of a total amount of a solution. In pharmaceutics: a method of measuring ingredients below the sensitivity of a scale by proportional dilution with inactive ingredients
Ampoule:
Sealed glass capsule containing a liquid, especially a measured quantity ready for injecting
Anaerobic:
Literally means "living without air"(opposite of aerobic)
Analytes:
A substance whose chemical constituents are being identified and measured
Anisotropic:
The property of being directionally dependent, as opposed to isotropy, which implies identical properties in all directions.
Arrhenius equation:
Formula for the temperature dependence of reaction rates
Arrhenius Plot:
A plot of data on a graph with the x-axis marked in the inverse Kelvin temperature and the y-axis marked in a Log10 format. It derives its name from the chemical reaction versus temperature relationship equation postulated by Svante Arrhenius. Loosely taken, any plot of data that is intended to show a Log10 relationship between the temperature of the test and the resultant data from that test.
Aseptic:
Free from the living germs of disease, fermentation, or putrefaction; commercially sterile
ASTM International:
ASTM International is one of the largest voluntary standards developing organizations in the world. We are a not-for-profit organization that provides a forum for the development and publication of international voluntary consensus standards for materials, products, systems, and services. ASTM standards are used by individuals, companies and other institutions around the world.
ASTM Standard:
A standard is a document that has been developed and established through ASTM's consensus principles and which meets the requirements of our procedures and regulations. Full consensus standards are developed with the participation of stakeholders with an interest in their development and use.
Aw:
Water Activity is a measurement of water content.
Assay:
The testing of a metal or ore to determine its ingredients and quality
B
Bactericidal:
Capable of killing bacteria outright
Bacteriostatic:
Capable of inhibiting the growth or reproduction of bacteria
Barometric Pressure:
Pressure of the atmosphere. This is usually expressed in terms of the height (in millimeters mmHg) of a column of mercury.
Barrier:
Object or device, such as a polymer film, that is designed to restrict the free movement and mingling of populations or areas of higher and lower concentrations.
Barrier Plastics:
Plastics that impede the passage of water vapor, water vapor, and other vapors and gasses.
Biaxially Oriented Polypropylene (BOPP):
Film that has been stretched in both the machine and cross directions. BOPP film has become one of the most popular, high growth films in the world as it features: Excellent clarity, Good dimensional stability and flatness, Low electrostatic charge, Good barrier to water vapor, High gloss, Good performance on high speed printing, Resistant to oils and greases. Good puncture and flex-crack resistance over a wide range of temperatures, not affected by moisture and does not wrinkle or shrink with environmental changes, Recyclable.
Bioavailability:
Subcategory of absorption and is the fraction of an administered dose of unchanged drug that reaches the systemic circulation, one of the principal pharmacokinetic properties of drugs. By definition, when a medication is administered intravenously, its bioavailability is 100%.
Biofilm:
Any group of microorganisms in which cells stick to each other on a surface. These adherent cells are frequently embedded within a self-produced matrix of extracellular polymeric substance (EPS).
Biologics:
Commercial products derived from biotechnology
Bioplastics:
Plastics derived from renewable biomass sources, such as vegetable fats and oils, corn starch, pea starch or microbiota. Bioplastic can be made from agricultural byproducts and also from used plastic bottles and other containers using microorganisms.
Biosimilar:
A biopharmaceutical drug designed to have active properties similar to one that has previously been licensed (aka “generic”?)
Biotechnology:
The exploitation of biological processes for industrial and other purposes, especially the genetic manipulation of microorganisms for the production of antibiotics, hormones, etc.
Blister Pack:
Package with multiple small compartments for individual products. Common in, but not exclusive to pharmaceutical capsules.
Block:
The machined block of stainless steel within a permeation instrument which forms part of the test cell and contains channels for the movement of gases and/or water vapor.
Blown Films:
Plastic films produced from synthetic resins (such as polyethylene) by the blown process. In this process, the molten resin is extruded through a circular die into a tube. This tube is expanded (blown) by internal air pressure into a larger bubble with a much-reduced wall thickness and cooled with external air quenching.
Burst Strength:
Measurement of internal pressure necessary to rupture a package or seal
C
Calibration:
A comparison between measurements – one of known magnitude or correctness. Many instruments require calibration in order to give an accurate reading.
Can Piercer:
Used to piece a can when measuring the headspace of a can. Part of package testing.
CAP:
Controlled Atmosphere Packaging: Steady state environment comprising of a special blend of oxygen, nitrogen, and carbon dioxide
Carrier Gas:
In a permeation test, the gas used to challenge the film.
Challenge the film:
In permeation. One side of the film is exposed to a gas which contains the permeant.
CIBUSTEC:
Food and Packaging trade show in Europe
CFR 21 Part 11 Compliant:
Code of Federal Regulations deals with the United States Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures (ERES). Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper
CGMP:
Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA). CGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
Channel:
An unimpaired pathway across the width of an intended seal
Chemical Potential:
(µ) The actual driving force for permeation. A thermodynamic property related to pressure.
Chevron (pouch):
Pouch with an entire peelable side with a seal pattern shaped like a back jean pocket. The outer area is square. The unsealed area on the bottom corners allow for an easy pull grip.
Clam:
A package that opens on a hinge. Common in the electronic industry and often is transparent (i.e., see-through).
Closure:
Mechanism to seal a container (e.g., bottle cap).
Coefficient of Friction (COF):
The force required to move two sliding surfaces over each other, divided by the force holding them together. This is important in packaging when the film is slid over a form (see Vertical Form Fill) and made into a package just before filling. RDM instruments measure the coefficient of friction.
Coextrusion:
Process by which two or more plastic streams are forced simultaneously through one or more shaping orifices to become one continuously-formed multilayered structure (flexible barrier materials)
CO2:
Carbon dioxide. Colorless, odorless gas, vital to life on Earth. This naturally occurring chemical compound is composed of a carbon atom covalently double bonded to two oxygen atoms
CO2 Transmission Rate:
CO2TR, the rate CO2 moves through a barrier
Combination Product:
Product that has a drug component integrated with a medical device
Companion diagnostic:
A form of in vitro diagnostic (IVD) and a subset of the medical device industry - that is used with a drug.
Conditioning:
Exposure of a material to the influence of a prescribed atmosphere for a given period of time or until a specified relation is reached between material and atmosphere. In permeation testing, before a film or package can be tested, the barrier must have time to acclimate to the environment and reach equilibrium. Before a film or package can be tested, the film (barrier) must have time to acclimate to the environment and reach equilibrium.
Conformal Coating:
Protective chemical coating or polymer film 25-75µm thick (50µm typical) that 'conforms' to the circuit board topology. Its purpose is to protect electronic circuits from harsh environments that may contain moisture and or chemical contaminants.
Convergence cycle:
In permeation, the sample will continue to be tested until the computer has determined that equilibrium has been reached.
Coulometric:
In this industry: Measuring every molecule that enters the sensor.
Coulox® coulometric sensor:
MOCON’s patented sensor. Conforms to ASTM F1307, F1927 and D3985. It is an absolute sensor and no calibration is required.
Creep:
Deformation of a material occurring with time due to an externally applied constant stress. "Creep testing" may refer to test methods for determining the ability of packages to withstand internal pressurization. The creep test maintains a specified pressure for a specified time or until the package fails.
D
Dispersion Coating:
(Flexible barrier materials) the process of applying a material, suspended or dispersed in a vehicle, to a surface such that a continuous, coalesced, adherent layer results when the vehicle liquid (e.g., water) is evaporated
Dissolved Oxygen:
The oxygen dissolved in a fluid. Important to the wine industry among others. Can be measured with the OpTech.
Distribution Study:
Determining how a package will perform after leaving the factory.
Downgauging:
Refers to reducing the amount of material in a product while still maintaining, or even improving, the properties of the material.
Driving Force:
Prompts a molecule to diffuse within a polymer. Substances naturally tend to move from a higher chemical potential to a lower one.
Ductility:
When a solid material stretches under tensile stress
E
Effusion:
A process in which a gas escapes through a small hole. This occurs if the diameter of the hole is considerably smaller than the mean free path of the molecules.
Elute:
To remove (an adsorbed substance) by washing with a solvent, especially in chromatography.
EMAP:
When packaging vegetables and fruits the gas atmosphere of package is not air (O2 21%; CO2 0.038%; N2 78%) but consists usually of a lowered level of O2 and a heightened level of CO2. This kind of package slows down the normal respiration of the product to prolong its shelf-life.
Environmental Challenging:
Process of subjecting a sterile barrier system or packaging system to extremes of temperature and/or humidity with the goal of determining sensitivities of the packaging system to environmental street. Often includes conditions/transitions of temperature/humidity that equal or exceed those that can be encountered in a packaging system lifecycle.
Environmental Chamber:
A chamber where temperature and RH can be controlled. Package testing for permeation is often done with the package in an environment chamber.
End of Shelf Life Parameters (EOSL):
Acceptable shelf life is to allow desired sensory, chemical, functional, microbiological and physical characteristics of the product to be retained. This is unique for each product.
ePTFE:
Material made from expanded PTFE offers more than standard properties of PTFE. Expanded PTFE is soft, flexible and porous. Porous PTFE is permeable to air, yet watertight under low pressure. The structure of porous PTFE is key.
Equilibrium:
A state in which opposing forces or influences are balanced.
EVA:
Ethylene-Vinyl Acetate copolymer. Much softer and clearer than LDPE or LLDPE and has lower melt temperature. Its melt temperature goes down, while its softness increases with increasing vinyl acetate (VA) content. EVA resins with 2-18% VA content are used for cast and blown packaging films.
EVOH:
Ethylene vinyl alcohol is a formal copolymer of ethylene and vinyl alcohol.
Eutectic:
The proportion of constituents in an alloy or other mixture that yields the lowest possible complete melting point. In all other proportions, the mixture will not have a uniform melting point; some of the mixture will remain solid and some liquid. At the eutectic, the solid’s and liquid’s temperatures are the same.
Excipient:
An inactive substance that serves as the vehicle or medium for a drug or other active substance.
Extractables:
Organic and inorganic chemical entities that can be released from a pharmaceutical packaging/delivery system, packaging component, or packaging material of construction under laboratory conditions, sometimes aggressive.
Extrusion Polymers:
Include polyethylene (PE), polypropylene (PP), polyamide (nylon) and recycled polyethylene terephthalate (rPET)
F
Faraday’s Law:
Quantity of electricity is directly proportional to the electrolysis during electrode. Any change in the magnetic environment of a coil of wire will cause a voltage (emf) to be "induced" in the coil. No matter how the change is produced, the voltage will be generated. Faraday's 1st Law of Electrolysis:
"The mass of a substance altered at a Quantity of electricity refers to the quantity of electrical charge, typically measured in coulomb."
Faraday's 2nd Law of Electrolysis:
"For a given quantity of D.C electricity (electric charge), the mass of an elemental material altered at an electrode is directly proportional to the element's equivalent weight". The equivalent weight of a substance is equal to its molar mass divided by the change in oxidation state it undergoes upon electrolysis (often equal to its charge or valence).
Faraday's law of induction:
A basic law of electromagnetism predicting how a magnetic field will interact with an electric circuit to produce an electromotive force (EMF)—a phenomenon called electromagnetic induction
Fenestration:
Openings in the walls of a structure. Windows, Doors.
Fick's Laws of Diffusion:
They can be used to Adolf Fick (diffusionDescribes solve for the diffusion coefficient, D. Fick's first law can be used to derive his second law which in turn is identical to the diffusion equation. Fick's first law relates the diffusive flux to the concentration under the assumption of steady state. It postulates that the flux goes from regions of high concentration to regions of low concentration, with a magnitude that is proportional to the concentration gradient (spatial derivative), or in simplistic terms the concept that a solute will move from a region of high concentration to a region of low concentration across a concentration gradient.
Film:
Usually a number of layers of resin used to make the package barrier.
Film Converter:
A company that takes resin and turns it into film with specific barrier measurements to meet a packaging company’s requirements.
Film Profile:
The measurement of a particular film’s transmission rate of a particulate permeant at a known temperature and RH (or number of temperatures and RH’s).
Fin Seal:
On a package, a seal that runs down the back side. Also called flow wrapping, a high-speed, high quantity process of loosely containing a product in sealed tamper-resistant material which can be clear or opaque, printed or plain, films, etc.
Flash:
Thin layer of plastic that flows outside of the cavity where two halves of an injection mold meet.
Flavor:
The precise way a manufacturer wants something to taste.
Flexible Package:
A package that is not rigid. For example a potato chip bag.
Flexography (aka flexo):
A type of printing process which utilizes a flexible relief plate for printing on almost any type of substrate, including plastic, metallic films, cellophane, and paper. It is widely used for printing on the non-porous substrates required for various types of food packaging.
Flow:
In permeation: The flow of the gases though the permeation instrument
Fluorescence:
A method of determining oxygen levels by exciting chemicals with light.
Flux:
In this industry, flow of a physical property through a surface.
FMCG Industry:
Fast Moving Consumer Goods, aka Consumer Packaged Goods
Food Scientist:
Usually works for the manufacturer to determine everything needed to create the food as per the business plan.
Form Fill:
See Vertical Form Fill
Formulation:
Creating a simulated odor or flavor in order to be able to test against a precise known odor or flavor. A service provided by MOCON’s lab.
Fpm:
Unit a measurement: foot per minute
Functional Barrier:
A material that effectively restricts passage of solids, liquids, semi-solids, vapors or energy through itself, across its borders, or interface with another material or substance
Fusion Seal:
A bond formed by combining two or more materials through melting or other means so that the joining layers become indistinguishable at the interface.
G
Gas Mixers:
Online gas mixers are used during the packaging process automatically maintaining the correct percentages of gases for the optimum MAP, maximizing gas usage and saving costs.
Gas Mixture:
The gas or gases used to displace the normal atmosphere inside a package to optimize the shelf life of the product.
Gauging:
In this industry, measuring the thickness of a film.
Geomembrane:
A very low permeability synthetic membrane liner or barrier used with any geotechnical engineering related material so as to control fluid (or gas) migration in a human-made project, structure, or system. Geomembranes are made from relatively thin continuous polymeric sheets, but they can also be made from the impregnation of geotextiles with asphalt, elastomer or polymer sprays, or as multilayered bitumen geocomposites. Continuous polymer sheet geomembranes are, by far, the most common.
Geosynthetics:
Synthetic products used to stabilize terrain. They are generally polymeric products used to solve civil engineering problems. This includes eight main product categories: geotextiles, geogrids, geonets, geomembranes, geosynthetic clay liners, geofoam, geocells and geocomposites.
Glass Transition Point:
Where the polymer goes from “glassy” to “rubbery”.
Gore-Tex:
Waterproof, breathable fabric membrane and registered trademark of W. L. Gore and Associates. Invented in 1969, Gore-Tex is able to repel liquid water while allowing water vapor to pass through and is designed to be a lightweight, waterproof fabric for all-weather use.
Graham’s Law:
Rate at which gases effuse (i.e., how many molecules pass through the hole per second) is dependent on their molecular weight. Gases with a higher molecular weight effuse more slowly than gases with a lower molecular weight; the number of smaller molecules escaping will be greater but the mass of the larger molecules will be greater.
Gravimetric Method:
Also known as cup test – measuring loss or gain by weight.
Gradient:
An increase or decrease in the magnitude of a property (e.g., temperature, pressure, or concentration) observed in passing from one point or moment to another
Gravure:
An advanced, high-tech printing process operating the fastest and widest printing presses in the world, and was the first printing process to employ a totally digital environment.
Gurley Hill Porosity (test method):
Air resistance of paper (Gurley method) TAPPI T460
Gusset:
A bracket strengthening an angle of a structure.
H
Hazard Analysis & Critical Control Points (HACCP):
Management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.
Hagen-Poiseuille Law:
A physical law that gives the pressure drop in an incompressible and Newtonian fluid in laminar flow flowing through a long cylindrical pipe of constant cross section.
HDPE:
High density, (0.95-0.965) polyethylene. Has much higher stiffness, higher temperature resistance and much better water vapor barrier properties than LDPE, but it is considerably hazier.
Headspace:
The part of the package which is empty of product. The gas volume left at the top of a filled container (bottle, jar or pouch) after sealing.
Headspace Gas:
The gas in the headspace of a package.
Heatseal Layer:
A heat sealable layer in plastic packaging films and laminates. Can be either adhesive laminated or extrusion coated onto a non-sealable film (or foil).
Heatseal Strength:
Strength of heatseal measured after the seal is cooled, (not to be confused with hot tack, see next item).
Heart Cutting:
The transfer of one or more selected groups of compounds eluted from a gas chromatographic column onto a second column.
Heat Seal:
Result of bonding surfaces by controlled application of heat, pressure, and dwell time
Heat Seal Threshold:
Minimum temperature required to achieve acceptable seal strength of 200g/25mm
Henry’s Law:
At a constant temperature, the amount of a given gas that dissolves in a given type and volume of liquid is directly proportional to the partial pressure of that gas in equilibrium with that liquid.
Hot Tack:
Strength of heat seal measured before the seal is cooled, which is very important for high-speed packaging operations.
HPLC grade water:
Water wherein a specific conductivity (16-18) is maintained by ELGA water machine and filtered through 0.22 micron filter to avoid the particulate matter.
HPP:
High pressure processing (aka Pascalization or bridgmanization) method of preserving and sterilizing food, in which a product is processed under very high pressure, leading to the inactivation of certain microorganisms and enzymes in the food.
Humectant:
A substance, especially a skin lotion or a food additive, used to reduce the loss of moisture.
Hydrogel:
A gel [solid, jelly-like material that can have properties ranging from soft and weak to hard and tough] in which the swelling agent is water
Hydrostatic Head (HH):
A way of measuring how waterproof a piece of fabric is. The manufacturer will take a clear tube and clamp their material over the bottom end. They will then fill the tube slowly with water and watch to see how high the column of water can get before the material lets drips through.
Hygroscopic Material/Molecule:
A hygroscopic substance is one that readily attracts water from its surroundings, through either absorption or adsorption. Examples include honey, glycerin, ethanol, methanol, concentrated sulfuric acid, and concentrated sodium hydroxide (lye).
Hydrophilic Material/Molecule:
One whose interactions with water and other polar substances are more thermodynamically favorable than their interactions with oil or other hydrophobic solvents. They are typically charge-polarized and capable of hydrogen bonding. Hydrophilic materials have more thermodynamically favorable interactions with water and other polar solvents, such as ethanol, than they do with oil and non-polar solvents, such as cyclohexane.
Hydrophilicity:
The quality or state of being hydrophilic
Hydrophobic:
Tending to repel or fail to mix with water. Hydrophobic materials are used for oil removal from water, the management of oil spills, and chemical separation processes to remove non-polar substances from polar compounds. Hydrophobic materials are used for oil removal from water, the management of oil spills, and chemical separation processes to remove non-polar substances from polar compounds.
I
Individual Zero:
In permeation. A test to establish how much permeant may be arriving in the cell from sources other than transmission. This additional permeant is deducted from the final transmission rate calculation.
IQ/OQ/PQ:
Verification of machinery and equipment usually consists of installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
ISO:
International Organization of Standards - An international standard-setting body composed of representatives from various national standards organizations to promote worldwide proprietary, industrial and commercial standards. Headquartered in Geneva, Switzerland works in 164 countries.
Isometric:
Same pressure on each side
ISTA - International Safe Transit Association:
International Safe Transit Association (ISTA) is an organization focused on the specific concerns of transport packaging. ISTA is the leading industry developer of testing protocols and design standards that define how packages should perform to ensure the protection of their contents during the ever-changing risks of the global distribution environment. As a nonprofit, member-driven association it sets the standards for optimizing the resources in packages that are designed to be survivable, sustainable and successful. Worldwide, ISTA is the most trusted, knowledgeable and respected authority in predictive package-performance testing helping its members develop more effective packaging.
J
JIS:
Japanese Institute of Standards
K
Kelvin (SI Symbol - K):
The Kelvin is the SI base unit of the absolute thermodynamic temperature scale where absolute zero is -273.15C and which uses the Celsius temperature interval.
Laminar Flow:
In fluid dynamics, laminar flow (or streamline flow) occurs when a fluid flows in parallel layers, with no disruption between the layers.
Lamination:
Process of bonding two or more flexible barriers together
LDPE:
Low density, (0.92-0.934) polyethylene. Used mainly for heat sealability and bulk in packaging.
Leachables:
Organic and inorganic chemical entities that migrate from a packaging/delivery system, packaging component, or packaging material of construction into an associated drug product under normal conditions of storage and use or during accelerated drug product stability studies. Leachables are typically a subset of extractables or are derived from extractables.
Leak:
Any opening in a flexible package that is contrary to intention and either lets contest escape or permits substances to enter
Leak Detection:
Determine if a package has pinholes, channels leaks or gross leaks.
LLDPE:
Linear low-density polyethylene. Tougher than LDPE and has better heat seal strength, but has a higher haze.
LOQ - Limit of Quantification:
A performance characteristic in method validation used to describe the smallest concentration of an analyte that can be reliably measured by an analytical procedure
Low Migration Packaging:
Designates materials used in the packaging structure whose chemicals will not migrate, or move, from the packaging into the product.
Lyophilize:
To freeze-dry (a substance)
L
M
Manometric Test Method:
Involves measuring the rate of decay of a cacuum on the downstream side of a test film.
MDPE:
Medium density, (0.934-0.95) polyethylene. Has higher stiffness, higher melting point, and better water vapor barrier properties.
MET-PET:
Metallized PET film. It has all the good properties of PET film, plus much-improved oxygen and water vapor barrier properties. However, it is not transparent.
MET-OPP:
Metallized OPP film. It has all the good properties of OPP film, plus much-improved oxygen and water vapor barrier properties, (but not as good as MET-PET).
Modified Atmosphere Packaging (MAP):
The practice of modifying the composition of the internal atmosphere of a package in order to improve shelf-life. Often tries to lower the amount of oxygen (O2), moving it from 20.9% to 0%, in order to slow down the growth of aerobic organisms and speed of oxidation reactions. Removed oxygen can be replaced with nitrogen (N2), commonly acknowledged as an inert gas, or carbon dioxide (CO2), which can lower the pH or inhibit the growth of bacteria. Carbon monoxide can be used for preserving the red color of meat. Re-balancing of gases inside the packaging can be achieved using active techniques such as gas flushing and compensated vacuum or passively by designing “breathable” films known as equilibrium modified atmosphere packaging (EMAP). Packets containing scavengers may be used.
Moisture Vapor Transmission Rate (MVTR):
See Water Vapor Transmission Rate (WVTR)
Molecular Diffusion:
Thermal motion of all (liquid or gas) particles at temperatures above absolute zero. The rate of this movement is a function of temperature, the viscosity of the fluid and the size (mass) of the particles.
Monoaxial Orientation:
The orientation of plastic films by stretching in one direction, (machine or cross-machine direction) only. These films are generally much stronger and stiffer but have very poor tear strength in the direction of orientation.
Mud Logging:
The creation of a detailed record (well log) of a borehole by examining the cuttings of rock brought to the surface by the circulating drilling medium (most commonly drilling mud). Refers to oil exploration. MOCON’s Industrial Analyzer Business unit provides a variety of gas chromatographs to this industry to assist them in locating oil.
Multilayered:
Film consisting of two or more continuous layers or plies of material
Mycology:
Branch of biology concerned with the study of fungi, including their genetic and biochemical properties, their taxonomy and their use to humans as a source for tinder, medicine, wine, cheese, (edible mushrooms), and entheogens, as well as their dangers, such as poisoning or infection.
N
Non-destructive leak detection:
Method to determine whether a package has a leak without destroying the package. Caution: When being asked about non-destructive leak detection you should clarify with the customer what they understand by the term. It could mean that after testing the package can move into the retail stream or it could mean that the package is not destroyed but the contents are not moving into the retail steam.
Nonwoven:
A fabric-like material made from long fibers, bonded together by chemical, mechanical, heat or solvent treatment. The term is used in the textile manufacturing industry to denote fabrics, such as felt, which are neither woven nor knitted.
Nutraceuticals:
A food containing health-giving additives and having medicinal benefit
Nylon:
Polyamide resins, with very high melting points, excellent clarity and stiffness. Two types are used for films: nylon-6 and nylon-66. The latter has much higher melt temperature, thus better temperature resistance, but the former is easier to process, and it is cheaper. Both have good oxygen and aroma barrier properties, but they are poor barriers to water vapor.
O
Off-Gas:
Some products continue to have gas exit from the product after packaging. Causes the package to blot.
OLED:
Organic Light Emitting Diode. A light-emitting diode (LED) in which the emissive electroluminescent layer is a film of organic compound which emits light in response to an electric current. OLEDs are used to create digital displays in devices such as TV screens, computer monitors, mobile phones. There are two main families of OLED: those based on small molecules and those employing polymers.
Oligomer:
In chemistry, an oligomer is a molecular complex that consists of a few monomer units, in contrast to a polymer, where the number of monomers is, in principle, not limited.
One-way Valve:
Allows gas to flow in one direction only. Commonly seen on coffee bags
On-line Gas Analyzers:
Gas analyzers build into the MAP process for determining the accuracy of the gas mix.
Opacity:
Hiding power of pigmented (mostly white) plastic films. It is beneficial for packing materials sensitive to light (visible or ultraviolet).
OPP:
Oriented PP (polypropylene) film. A stiff, high clarity film, but not heat-sealable. Usually combined with other films, (such as LDPE) for heat-sealability. Can be coated with PVDC (polyvinylidene chloride), or metalized for much-improved barrier properties.
Organic Compounds:
Usually defined as any member of a large class of gaseous, liquid, or solid chemical compounds whose molecules contain carbon.
Organic Permeation:
The permeation of organic compounds (See above for an example)
OTR:
Oxygen Scavenger:
Absorbers added to enclosed packaging to help remove or decrease the level of oxygen in the package in order to help maintain product safety and extend shelf life
Oxygen Transmission Rate (OTR):
Is the steady state rate at which oxygen gas permeates through a film at specified conditions of temperature and relative humidity.
P
Package:
Container providing protection to a product during distribution, storage, retailing, and use
Package Integrity:
A common definition is the package's ability to protect its contents from potential threats—including physical, microbial, and chemical. Unimpaired physical condition of a final package (i.e., leak test), not to be confused with seal-strength testing which measures the mechanical strength of the seal. Package integrity testing involves physically testing the total package to ascertain whether the package will protect its contents from damage and maintain sterile package integrity. Determining if a package has an adequate barrier; testing for leaks and burst and seal strength.
Package Testing:
Package testing or packaging testing involves the measurement of a characteristic or property involved with packaging. This includes packaging materials, packaging components, primary packages, shipping containers, and unit loads, as well as the associated processes. Testing measures the effects and interactions of the levels of packaging, the package contents, external forces, and end-use. Testing can be a qualitative or quantitative procedure.
Packaging Company:
A company that makes packages specifically for a manufacturer.
Packaging Engineer:
An engineer who designs packages: They may work for a packaging company and/or for the manufacturer.
Package leak:
See leak detection.
Packaging system:
The combination of the sterile barrier system and protective packaging.
Parylene Conformal Coatings:
Ultra-thin, pinhole-free polymer coatings that provide a number of high-value surface treatment properties such as excellent moisture, chemical and dielectric barrier properties, thermal and UV stability, and dry-film lubricity.
Parenteral preparations:
Sterile preparations containing one or more active ingredients intended for administration by injection, infusion or implantation into the body. They are packaged in either single-dose or multi-dose containers.
Partial Pressure:
In a mixture of gases, each gas has a partial pressure, the hypothetical pressure of that gas if it alone occupied the entire volume of the original mixture at the same temperature. The total pressure of an ideal gas mixture is the sum of the partial pressures of each individual gas in the mixture. Partial pressure is what would be exerted by one of the gases in a mixture if it occupied the same volume on its own.
PDA:
Biopharmaceutical and Sterile Manufacturing: Trade Show and conference
PET:
Polyethylene Terephthalate - a type of polymer.
Perforated Film:
A film with holes design to allow gases to escape from the package, common with produce packages.
Permeability:
Property of a material that lets fluids (such as water or water vapor) to diffuse through it to another medium without being chemically or physically affected. Opposite of permeance.
Permeability (measurement):
Measuring the permeant moving through the barrier material when there is equal static pressure on both sides of the barrier, but the partial pressure is different (Fick’s Law).
Permance:
Permeance indicates that water vapor transmission rate over the course of one hour through one square foot of a material of a given thickness at a specified vapor pressure, expressed in perms (gr/hr·ft2·inHg).
Permeation:
Is the flux of molecules through a material (barrier)
Permeant:
Whatever is moving through the barrier (gas or vapor)
pID-TECH Photoionization Sensors:
Photochromic:
Optical lenses that darken on exposure to specific types of light of sufficient intensity, most commonly ultraviolet (UV) radiation. In the absence of activating light, the lenses return to their clear state.
Plasticizers:
AKA dispersants are additives that increase the plasticity or fluidity of a material. The dominant applications are for plastics, especially polyvinyl chloride (PVC).
Polymer:
Substances containing a large number of structural units joined by the same type of linkage. These substances often form a chain-like structure. Starch, cellulose, and rubber all possess polymeric properties. Current applications extend from adhesives, coatings, foams, and packaging materials for textile and industrial fibers, composites, electronic devices, biomedical devices, optical devices, and precursors for many newly developed high-tech ceramics.
Polyolefins:
Collective description for plastics types that include polyethylene - low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE) and high-density polyethylene (HDPE) - and polypropylene (PP).
Polypropylene (PP):
Also known as polypropene, is a thermoplastic polymer used in a wide variety of applications including packaging and labeling, textiles (e.g., ropes, thermal underwear, and carpets), stationery, plastic parts and reusable containers of various types, laboratory equipment, loudspeakers, automotive components, and polymer banknotes. An addition polymer made from the monomer propylene, it is rugged and unusually resistant to many chemical solvents, bases, and acids. In 2013, the global market for polypropylene was about 55 million metric tons.
Polysiloxanes:
Also known as silicone. Any of a large group of oligomers and polymers based on the structural unit R2SiO, where R is an organic group, characterized by wide-range thermal stability, high lubricity, extreme water repellence, and physiological inertness and used in adhesives, lubricants, protective coatings, paints, electrical insulation, synthetic rubber, and prosthetic replacements for body parts.
Porous:
Having minute spaces or holes through which liquid or air may pass
Porosity:
The measure of “gas flow” (e.g., WV) through a barrier material (e.g., paper) when a static pressure difference exists across the barrier
Porous packaging material:
A material used in medical packaging which is intended to provide an environmental and biological barrier, while allowing sufficient air flow to be used in gaseous sterilization methods (e.g., medical-grade papers and Tyvek®)
Preformed sterile barrier system:
The sterile barrier system that is supplied partially assembled for filling and final closure or sealing, e.g., pouches, bags, and open reusable containers.
Pressure Differential:
A pressure that is measured relative to the pressure in the atmosphere around it (vs. absolute pressure which is measured against absolute zero).
Profile:
See Film Profile
Protective Packaging:
The packaging configuration designed to prevent damage to the sterile barrier system and its contents from the time of their assembly until the point of use.
Q
Quality Assurance (QA):
Consists of that “part of quality management focused on providing confidence that quality requirements will be fulfilled.” Relates to how a process is performed or how a product is made. The confidence provided by quality assurance is twofold—internally to management and externally to customers, government agencies, regulators, certifiers, and third parties.
Quality Control (QC):
Is that “part of quality management focused on fulfilling quality requirements.” The inspection aspect of quality management, usually directed at a packages ability to provide the protection required to achieve the calculated shelf life.
R
Range:
In permeation the range of permeant that can be detected by a specific instrument. Oxygen is usually measured as cc/(m2·d). Spoken as cc’s per meter squared day. Water vapor is measured as g/(m2·d). Spoken as grams per meter squared per day.
Relative Humidity (RH):
The ratio of the amount of water vapor in the air to the greatest amount the air could contain at the same temperature. (The warmer the air, the more water vapor it can hold.)
Repeatability:
Measures the variation in measurements taken by a single instrument or person under the same conditions. Is an instruments ability to repeat a test accurately over many tests.
Reproducible:
Measures whether an entire study or experiment can be reproduced in its entirety
Resin:
Resin is a solid or viscous material which gives a polymer after curing. Resins can be synthetic or natural and generally are mixtures of organic compounds. After polymerization or curing, resins form polymers.
Retort:
The process of cooking food in the package it is sold in eg. baby food or soups that have meat or vegetables that need to cook at a temperature to kill off the micro-organisms and avoid botulism. The temperature is generally around 121o C. Amcor is the only company today that has this capability in PET.
Retortable:
Capable of withstanding specified thermal processing in a closed retort at temperatures above 100°C
Rigid Plastic Packaging:
Freestanding plastic bottles and plastic fittings. The main raw materials used are PET, HDPE and PP.
Rigid Package:
A non-flexible package such as a PET bottle
Seal Integrity Testing:
Testing a package’s integrity by checking seal and material strength, leaks and burst pressure and barrier material properties.
Seal Strength:
Measure of the mechanical strength of bond between sealed materials of a package
Sensor:
The part of the instrument that detects the signal indicating the level of gas detected.
Septum:
The partition separating two chambers (e.g., between the nostrils or chambers of the heart). A consumable component used when measuring headspace with a needle that prevents the puncture from affecting test results.
Sequential Testing:
In permeation. Testing the same film at different temperatures and RH’s in order to determine the film’s profile.
Shelf Life:
The calculated use by date of the contents of a package. The length of time a product may be stored before becoming unsuitable for use or consumption.
Shelf Life Study:
An objective means to determine how long a product can reasonably be expected to keep, without an appreciable change in quality, safety or character. Also see: Accelerated Shelf Life Study
Shelf Stable:
Often referring to food (aka ambient food) that can be safely stored at room temperature in a sealed container. This includes foods that would normally be stored refrigerated but which have been processed so that they can be safely stored at room or ambient temperature for a usefully long shelf life.
Solubility:
Represents the dissolution of a permeant into a polymer and relates the concentrations within the film to the partial pressure of the permeant. Solubility is dependent upon permeant concentration or driving force. The process by which a gas compound is molecularly mixed with a solid is called a solution and provides a relationship between the concentration in the solid and the concentration (or partial pressure) in the gas.
Solution Coating:
Process in which substrate is covered with a homogeneous solution containing the coating material, followed by removal of the solvent
Sorption:
A physical and chemical process by which one substance becomes attached to another.
Specialty Gas:
Gases used in food and beverages, such as CO2 in beverages. MOCON’s Industrial Analyzer Business Unit offers analyzers to measure the purity of these gases.
Spun-Bonded Polyolefin:
Polymers, usually either polyethylene or polypropylene, made up of long chains of carbon and hydrogen (e.g., Tyvek)
Spunlace:
Nonwovens manufacturing system that employs jets of water to entangle fibers and thereby provide fabric integrity.
Stability Testing:
How well a product retains its quality over the life span of the product
Static Pressure:
Force applied perpendicular to the surface of an object per unit area over which that force is distributed
Staling:
Physical/chemical changes occurring in a product that results in a progressive firming of texture during storage with an associated loss in flavor and mouth-feel.
Steady State:
Attained when the amount of gas absorbed in the film is in equilibrium with the flux of gas through the film
Sterile:
Free of any viable microorganisms, either active or dormant
Sterile Barrier System (SBS):
The minimum packaging that prevents ingress of microorganisms and allows aseptic presentation at the point of use.
Sterility Testing:
A very tedious and artful process that must be performed by trained and qualified laboratory personnel. The investigation of sterility test failures is a process that requires attention to environmental data as well as many other factors including training and sample difficulty.
Sterilization Autoclave:
A pressure vessel that can be used for the thermal sterilization of pharmaceutical products.
Sustainable Packaging:
Development and use of packaging which results in biodegradability or recyclability to reduce environmental impact and ecological footprint.
Surface Science:
The study of physical and chemical phenomena that occur at the interface of two phases, including solid-liquid interfaces, solid–gas interfaces, solid–vacuum interfaces, and liquid–gas interfaces. It includes the fields of surface chemistry and surface physics.
S
T
TBA:
2,4,6-tribromoanisole (TBA) causes a musty odor associated with nausea, stomach pain, vomiting, and diarrhea. It can permeation into packages and has led to a number of very expensive recalls in the pharmaceutical industry.
Tensile Strength:
The maximum stress that a material can withstand while being stretched or pulled before failing or breaking.
Tensile Stress (aka tension):
Stress state leading to expansion; that is, the length of a material tends to increase in the tensile direction. The volume of the material stays constant. When equal and opposite forces are applied to a body, then the stress due to this force is called tensile stress
Tertiary Packaging:
One of the three types of wrapping used to protect manufactured goods, typically not seen by consumers since it is usually removed by retailers before products are displayed for sale (e.g., brown cardboard boxes, wood pallets and shrink wrap).
Test Cells:
The cells on a permeation instrument where the test sample is challenged.
Test Gas:
In permeation, the gas that carries the permeants to the sensor
Test Temperature Range:
The range of temperature an instrument can test at AND the range at which the sample needs to be tested.
TCEQ:
TEXAS Commission on Environmental Quality. Conference.
Thermochromism:
Property of substances to change color due to a change in temperature
Thermoforming:
A manufacturing process where a plastic sheet is heated to a pliable forming temperature then formed to a specific shape in a mold and trimmed to create a usable product.
Throughput:
Amount of material or items passing through a system or process
TIR 22:
Technical Information Report: AAMI guidance document regarding medical device packaging and serialization and covering design inputs and the selection and evaluation of materials, as well as system elements of package and process validation
Tortuous Path (Closure):
Permeant molecules must make wide detours while traversing the film
Total Package Oxygen:
Measuring the amount of oxygen in a package whether it be from permeation, headspace or dissolved.
Transmission Rate:
The rate at which a gas or vapor permeates through a barrier. ASTM definition: the quantity of a given gas passing through a unit of the parallel surfaces of a plastic film in unit time under the conditions of test.
Transportation Study:
Test used to determine how a package will perform during transportation.
Tritration:
Process of calculating how much of a substance is in a substance with a known volume.
U
N/A
V
Vertical Form Fill:
A type of automated assembly-line product packaging system often used for food. The machine constructs plastic bags out of a flat roll of plastic film while simultaneously filling the bags with (solid or liquid) product and sealing the filled bags.
Water Reservoirs:
In Permeation: In order to be able to generate relative humidity testing a permeation needs a built in water source.
Water Vapor Transmission Rate (WVTR):
The standard measurement by which films are compared for their ability to resist moisture. Lower values indicate better moisture protection. Only values reported at the same temperature and humidity can be compared, because transmission rates are affected by both of these parameters. Also known as Moisture Vapor Transmission Rate (MVTR)
Wicketed Bags:
Bags that are stacked and held together on a metal wicket that acts as a dispenser. There is a lip (usually 50mm) where two holes are punched out that enable the wicket to hold the bags. Plastic washers hold the stack of bags securely on the wicket.
W
X
N/A
Y
N/A
Z
Zahm-Nagel:
A procedure determines the CO2 shelf life of a bottle by evaluating the CO2 level within sample bottles.
Zeroing:
Operation that provides a new "zero point' (baseline) for a permeation test instrument. Zeroing gives the computer a reference point to use when generating transmission data.
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