Sterile barrier packaging, defined.

A medical packaging grade of Tyvek®. It is the heaviest and strongest medical grade, chosen for strength and puncture resistance with heavy or sharp devices such as orthopedic implants and surgical kits.

See also2FSTyvek^®Heat-seal coatingLiddingRead more about 1073B

A lighter medical packaging grade of Tyvek® than 1073B. It is a cost-effective choice for lighter devices and high-speed form-fill-seal lines.

See also1073BTyvek^®Form-fill-seal (FFS)Read more about 2FS

Storing packages at a raised temperature to simulate time passing, so shelf-life claims can be supported before real-time data is complete. ASTM F1980 is the usual guide. Real-time aging still has to confirm the result.

See alsoDistribution testingSeal strengthISO 11607

Opening a sterile package and transferring the device to the sterile field without contaminating it. Package design, such as a chevron seal and a clean peel, makes this easier.

See alsoChevron pouchSterile barrier systemPeel tabRead more about Aseptic presentation

A laboratory measure of the share of bacteria in a test aerosol that a material stops, reported as a percentage. It is used mainly for face masks and wraps. For porous packaging such as medical paper and Tyvek®, microbial barrier is more often reported as a log reduction value (LRV) to ASTM F1608, or measured with the aerosol method in ASTM F2638. See Microbial barrier (LRV).

See alsoMicrobial barrier (LRV)PorousSterile barrier systemRead more about Bacterial filtration efficiency (BFE)

The mass of a material per unit area, given in grams per square meter (gsm). North American paper is also given in pounds per 3,000 sq ft ream, so 60 and 70 gsm paper is about 37 and 43 lb.

See alsoRollstockMilRead more about Basis weight (gsm)

The ISO 10993 series evaluates whether device materials are safe for their contact with the body. Packaging that touches the device may be part of that assessment.

See alsoMedical gradeISO 11607

A single purchase order that covers a set quantity or period, with deliveries called off as scheduled releases. It fixes price and terms while letting the buyer take parts as needed.

See alsoKanban (scheduled release)MOQLead time

A porous patch sealed over an opening in an otherwise non-porous package. It lets sterilant gas and air pass in and out while acting as a barrier to microorganisms.

See alsoPorousEtOFoil barrierHeader bagRead more about Breather patch

A document from a supplier stating that a delivered lot meets the specification on the order. Buyers often file it as part of incoming inspection and lot records.

See alsoFirst articleISO 9001

Advance written notice from a supplier before it changes a material, material source, process, tool or site for a part the customer has approved, so the customer can assess the change and decide whether any validation needs repeating.

See alsoQuality agreementLot traceabilityContract manufacturer (CMO)

A pre-made pouch with a V-shaped seal at the opening end. The peel starts at the point of the V, which gives a controlled, low-force opening for aseptic presentation.

See alsoHeader bagAseptic presentationPET/PEMounting card (insert card)Read more about Chevron pouch

A cohesive coating that seals to itself when two coated surfaces are pressed together, with no heat. It is used where heat sealing is not wanted, for example with gloves and dressings.

See alsoLatex-freeHeat-seal coatingRead more about Cold-seal coating

A company that builds, packages or sterilizes devices for a device maker. A CMO often buys packaging components to the device maker's specs and validation requirements.

See alsoSupplier questionnaireQuality agreementChange notification

The tube that rollstock is wound on, usually specified by its inside diameter. Common core sizes are 3 in (76 mm) and 6 in (152 mm), and the core must fit the unwind shaft on your line.

See alsoRollstockForm-fill-seal (FFS)Read more about Core

The Canada–United States–Mexico Agreement. Goods that meet its rules of origin can enter the other countries without duty when the importer holds a valid certification of origin.

See alsoIncoterms

Reviewing a part design for how it will be made, and changing features that would cut badly, tear or add cost, before the design is frozen.

See alsoDie-cuttingFirst articleFlangeRead more about Design for manufacture (DFM)

Cutting a set shape from sheet or web material by pressing a shaped blade, the die, through it. It produces repeatable parts such as lids, cards and film components.

See alsoKiss-cutFirst articleRead more about Die-cutting

Lab tests that put packaged product through the shocks, vibration, compression and climate of shipping, often to ASTM D4169 or an ISTA procedure, before package integrity and seal strength are checked.

See alsoAccelerated agingSeal integrityWorst case

Electron beam sterilization, a form of radiation sterilization. It works quickly and passes through sealed packages, so porous materials are not needed, but it penetrates less deeply than gamma.

See alsoGammaEtOSteam (autoclave)Read more about E-beam

A European standard series for packaging materials and systems for medical devices that are sterilized in their final package. EN 868-5 covers sealable pouches and reels, and EN 868-3, EN 868-6 and EN 868-7 cover papers.

See alsoISO 11607Sterile barrier systemRead more about EN 868

Ethylene oxide, a low-temperature gas sterilization method. The gas must reach the device and then leave the package during aeration, so the package needs a porous material such as Tyvek®, medical paper or a breather. Residual limits for devices are set in ISO 10993-7.

See alsoPorousBreather patchHeader bagGammaRead more about EtO

Fibers pulled from a porous web when a seal is opened. It is usually a sign the seal is outside its window.

See alsoSeal strengthHeat-seal coatingPorousRead more about Fiber tear

The first parts made from a new die, spec or process, measured and checked against the spec before production starts. Approval of the first article confirms the setup is right.

See alsoDie-cuttingCertificate of conformance (CoC)

The flat rim around a tray cavity that the lid seals to. Its width and flatness have a large effect on seal quality.

See alsoThermoformed trayLiddingDesign for manufacture (DFM)Read more about Flange

An aluminum foil layer in a laminate that blocks oxygen, moisture and light almost completely. Because it is not gas-permeable, foil packs are typically radiation sterilized. For EtO, a foil pack needs a built-in porous vent that is sealed off after the cycle.

See alsoPA/Alu/PEBreather patchHeader bagRead more about Foil barrier

A packaging process that forms packages from rollstock, loads the product and seals them in one continuous line. In medical packaging, a bottom web is often thermoformed into cavities and a lidding web is sealed on top.

See alsoRollstock2FSLiddingThermoformed trayRead more about Form-fill-seal (FFS)

Radiation sterilization using gamma rays. It penetrates deeply through sealed packages, so porous materials are not needed, but some plastics can discolor or weaken with exposure.

See alsoE-beamEtOSteam (autoclave)Read more about Gamma

A heat-seal coating applied in a grid, dots or another pattern rather than over the whole surface. The uncoated areas keep a porous web breathable, while the coated areas form the seal. An allover coating covers the full surface.

See alsoHeat-seal coatingPorousRead more about Grid and pattern coating

High-density polyethylene, a stiff, tough and chemically resistant plastic. It is used for rigid mounting and insert cards, film and some trays.

See alsoLDPEMounting card (insert card)MilRead more about HDPE

A film bag with a porous strip, the header, across one end. The header lets sterilant gas in and out, while the film body carries bulky or heavy devices and kits.

See alsoChevron pouchBreather patchEtOLDPERead more about Header bag

An adhesive coating that bonds a material to a tray, film or blister when heat and pressure are applied. It lets materials such as Tyvek® and medical paper seal to rigid trays and peel cleanly when opened.

See alsoGrid and pattern coatingCold-seal coatingLiddingRead more about Heat-seal coating

High-impact polystyrene, an economical, rigid plastic that thermoforms well. It is a common material for trays.

See alsoThermoformed trayPETGPPRead more about HIPS

Standard trade terms, published by the International Chamber of Commerce, that set who pays for shipping and carries the risk at each stage, for example FCA or DAP.

See alsoCUSMA (USMCA)

The international standard for packaging of medical devices that are sterilized in their final package. Part 1 sets requirements for materials, sterile barrier systems and packaging systems. Part 2 sets validation requirements for forming, sealing and assembly processes.

See alsoSterile barrier systemEN 868Protective packagingRead more about ISO 11607

The international standard that classifies cleanrooms by the concentration of airborne particles. Classes run from ISO Class 1, the cleanest, to ISO Class 9.

See alsoISO Class 8ParticulateRead more about ISO 14644-1

The international standard for quality management systems. Certification shows that a company runs documented, audited processes and works to improve them. It certifies the company, not a product.

See alsoCertificate of conformance (CoC)ISO Class 8Read more about ISO 9001

A cleanroom class under ISO 14644-1 that allows no more than 3,520,000 particles of 0.5 µm or larger per cubic meter of air. It is roughly equal to Class 100,000 in the retired US Federal Standard 209E.

See alsoISO 14644-1ParticulateRead more about ISO Class 8

A replenishment method in which parts are released against a standing order when stock falls to a set level, or on a set schedule, instead of through a new purchase order each time.

See alsoBlanket purchase orderLead time

A cut that goes through the top layer of a material but not through its liner or carrier. The parts stay on the liner for easy handling and are peeled off when used.

See alsoDie-cutting

Made without natural rubber latex. Some cold-seal coatings use natural rubber latex, which can cause allergic reactions. Device labeling guidance generally prefers the wording “not made with natural rubber latex”.

See alsoCold-seal coatingRead more about Latex-free

Low-density polyethylene, a soft, flexible plastic that seals well. It is used for bags, liners and the sealant layer of many laminates.

See alsoHDPEHeader bagPET/PERead more about LDPE

The time from order to shipment. It depends on the product, the quantity, and any custom size, print or tooling.

See alsoMOQFirst articleRead more about Lead time

Material sealed across the top of a tray or blister to close it. It can be supplied as die-cut lids or as rollstock for form-fill-seal and lidding lines.

See alsoThermoformed trayHeat-seal coatingPeel tab1073BRead more about Lidding

The ability to trace a delivered lot back to its material lots, production records and inspection results, and forward to the orders it went into, so a problem can be traced and contained.

See alsoCertificate of conformance (CoC)Change notificationFirst article

On this site, medical grade means the material maker supplies and controls the material for medical packaging under its quality system, with ISO 11607-1 material statements, and EN 868 declarations for paper, available on request.

See alsoBiocompatibility (ISO 10993)Change notificationLot traceabilityRead more about Medical grade

How well a porous packaging material stops bacteria while letting air through. It is commonly reported as a log reduction value (LRV) to ASTM F1608, or measured with the aerosol method in ASTM F2638.

See alsoPorousBacterial filtration efficiency (BFE)Tyvek^®Read more about Microbial barrier (LRV)

A unit of thickness equal to one thousandth of an inch, or 25.4 µm. For example, 10–35 mil is 0.25–0.89 mm, and 4 mil is about 100 µm.

See alsoBasis weight (gsm)HDPERead more about Mil

Minimum order quantity, the smallest quantity a supplier will accept for an order. It can be set per item, size or print run.

See alsoLead timeRead more about MOQ

A rigid card placed inside a pouch or tray with the device. It holds the device in position and protects it, and keeps sharp edges away from the package walls.

See alsoHDPEChevron pouchMilRead more about Mounting card (insert card)

A low-temperature gas sterilization method used as an EtO alternative for some devices. Packaging compatibility is assessed case by case.

See alsoVaporized hydrogen peroxide (VHP)EtORead more about Nitrogen dioxide (NO2)

A laminate of nylon (PA), aluminum foil and polyethylene (PE). The nylon adds strength, the foil gives a near-total barrier to oxygen, moisture and light, and the PE is the sealant layer.

See alsoFoil barrierPA/PEPET/PERead more about PA/Alu/PE

A laminate of nylon (PA) and polyethylene (PE). The nylon gives higher puncture resistance than PET/PE, which helps with sharp or pointed devices.

See alsoPET/PEPA/Alu/PEChevron pouchRead more about PA/PE

Loose particles such as dust, fibers or plastic fines that can shed from materials or from cutting. Controlling particulate matters because packaging components sit next to the device.

See alsoISO Class 8ISO 14644-1Read more about Particulate

An unsealed extension of a lid or pouch that the user grips to start opening the package. It makes the peel easier to find and control.

See alsoLiddingAseptic presentationRead more about Peel tab

A laminate of polyester (PET) and polyethylene (PE). The PET gives strength, clarity and a good print surface, and the PE is the sealant layer. It is the standard film side of many pouches.

See alsoPA/PEPA/Alu/PEChevron pouchRead more about PET/PE

Glycol-modified polyester, a clear, tough plastic that thermoforms well. It is one of the most common materials for rigid medical device trays.

See alsoThermoformed trayHIPSPPPVCRead more about PETG

Describes a packaging material that lets air and sterilant gas pass through while acting as a barrier to microorganisms. Tyvek® and medical paper are porous, while film and foil are not.

See alsoEtOBreather patchMicrobial barrier (LRV)Read more about Porous

Polypropylene, a rigid, chemically resistant plastic used for trays and other packaging parts.

See alsoThermoformed trayPETGHIPSRead more about PP

Packaging that protects the sterile barrier system and its contents from damage between assembly and the point of use, such as cartons and shipping cases. Together, the two make up the packaging system.

See alsoSterile barrier systemISO 11607Read more about Protective packaging

Polyvinyl chloride, a rigid, clear plastic that thermoforms well. It is used for trays and blisters.

See alsoThermoformed trayPETGRead more about PVC

A written agreement between a customer and supplier that sets out quality responsibilities, such as specifications, change notification, nonconformance handling, records and audits.

See alsoChange notificationSupplier questionnaireISO 9001

Packaging material supplied as a continuous web wound on a core, for lidding, pouch-making and form-fill-seal lines. You may also see it written roll-stock.

See alsoCoreForm-fill-seal (FFS)Basis weight (gsm)Read more about Rollstock

Whether a seal is continuous, with no channels or gaps. Common tests are ASTM F1929 dye penetration, ASTM F2096 bubble leak and visual inspection to ASTM F1886.

See alsoSeal strengthDistribution testing

The force needed to peel a seal apart, measured on a strip cut across it, usually to ASTM F88. It shows the seal is consistent, not that it has no leaks.

See alsoSeal integrityHeat-seal coatingFiber tear

Sterilization with moist heat under pressure, typically at 121 to 134 °C (250 to 273 °F). Every layer of the package, including the sealant, must withstand the heat and moisture and let steam reach the device. Steam pouches usually pair a steam grade of medical paper with a film whose sealant melts at a higher temperature than polyethylene.

See alsoEtOGammaE-beamPorousRead more about Steam (autoclave)

A cutting tool made from a sharpened steel strip bent to the part outline and set in a base board. It is a common, lower-cost die for flat packaging parts.

See alsoDie-cuttingKiss-cutRead more about Steel-rule die

The minimum package that minimizes the risk of microorganisms getting in and allows aseptic presentation of the sterile device at the point of use (ISO 11607-1). Examples are a sealed tray and lid, a pouch, or a header bag.

See alsoProtective packagingISO 11607Aseptic presentationRead more about Sterile barrier system

A form a customer sends a new supplier to collect quality, capacity and business information as part of supplier approval.

See alsoQuality agreementContract manufacturer (CMO)ISO 9001

A rigid or semi-rigid tray made by heating plastic sheet and forming it over a mold. Common materials include PETG, PVC, HDPE, HIPS and PP, and the tray is closed with a sealed lid.

See alsoLiddingPETGHIPSPPPVCRead more about Thermoformed tray

A DuPont brand of strong, lightweight, porous sheet material widely used in medical packaging. It lets sterilant gas pass while acting as a microbial barrier, and it resists tearing and peels cleanly. Tyvek® is a registered trademark of DuPont de Nemours, Inc.

See also1073B2FSPorousHeat-seal coatingRead more about Tyvek^®

A low-temperature sterilization method using hydrogen peroxide vapor. Cellulose-based materials such as paper absorb the peroxide and are generally avoided.

See alsoNitrogen dioxide (NO2)EtOPorousRead more about Vaporized hydrogen peroxide (VHP)

The package size, device and material combination most likely to fail, chosen so that validation results can cover the rest of a product family.

See alsoAccelerated agingDistribution testingISO 11607