Medical Packaging Glossary
A reference glossary of medical and pharmaceutical packaging terminology. Use it to decode standards documents, supplier specifications, and regulatory guidance.
A
Accelerated Aging (AA) — A laboratory method for estimating product shelf life by exposing packaging to elevated temperature and humidity. Governed by ASTM F1980. Used to establish expiry dates before real-time aging data is available.
Aseptic Packaging — Packaging assembled under sterile conditions to maintain product sterility. Distinct from terminally sterilised packaging where sterilisation occurs after sealing.
B
Barrier Film — A packaging film engineered to restrict the transmission of gases (oxygen, water vapour) or microorganisms. Characterised by MVTR and OTR values.
Blister Pack — A packaging format consisting of a thermoformed or cold-formed cavity sealed with a lidding foil or film. Common in pharmaceutical unit-dose and medical device packaging.
Burst Test — A test method (ASTM F1140) measuring the pressure required to rupture a sealed package. Used as an indicator of seal integrity.
C
CE Marking — A conformity marking indicating that a medical device (and its packaging) meets EU regulatory requirements. Required for market access in the European Economic Area under EU MDR (2017/745).
Child-Resistant Packaging (CRP) — Packaging designed to be difficult for children under five to open, while remaining accessible to adults. Requirements defined in ISO 8317 and regional regulations.
Cold Form Foil — A laminate foil (typically Alu/OPA/PVC) cold-pressed into blister cavities without heating. Provides higher moisture barrier than thermoform alternatives. Also called Alu-Alu blister.
Combination Product — A product comprising a drug, device, and/or biological component. Packaging must satisfy requirements from multiple regulatory frameworks simultaneously.
D
Dye Penetration Test — A visual seal integrity test (ASTM F1929) using coloured dye solution to detect channels or defects in heat-sealed packaging.
E
EU MDR — EU Medical Device Regulation 2017/745. Defines packaging requirements for medical devices placed on the European market, including labelling, sterility maintenance, and UDI.
G
GMP (Good Manufacturing Practice) — Regulatory framework governing pharmaceutical manufacturing, including packaging operations. Defined in EU GMP Annex 1 (sterile products) and FDA 21 CFR Parts 210/211.
H
Heat Seal — A bond formed by applying heat and pressure to thermoplastic packaging materials. Seal strength and integrity are critical quality attributes validated per ISO 11607-2.
I
ISO 11607 — The primary international standard for terminally sterilised medical device packaging. Part 1 covers materials and systems; Part 2 covers validation of forming, sealing, and assembly processes.
ISO 13485 — International quality management standard for medical device manufacturers, including requirements for packaging and labelling controls.
IVD (In Vitro Diagnostic) — Diagnostic medical devices used on samples taken from the human body. Governed by EU IVDR (2017/746) with specific packaging and labelling requirements.
L
Lidding Foil — The top web of a blister pack, sealed over the formed cavity. Materials include aluminium foil, paper, and polymer films depending on barrier and peel requirements.
M
MVTR (Moisture Vapour Transmission Rate) — The rate at which water vapour passes through a packaging material. Critical for moisture-sensitive drugs and devices.
Microbial Barrier — The ability of a packaging system to prevent microbial contamination of a sterile product. A key property tested per ISO 11607-1.
O
OQ (Operational Qualification) — Validation phase demonstrating that packaging equipment operates within defined process parameters. Part of the IQ/OQ/PQ validation sequence per ISO 11607-2.
OTR (Oxygen Transmission Rate) — The rate at which oxygen permeates through a packaging material. Critical for oxygen-sensitive products.
P
Peel Strength — The force required to peel apart a sealed joint. Measured per ASTM F88. Used to characterise seal integrity and ease-of-opening.
Primary Packaging — Packaging in direct contact with the drug or device. Subject to the strictest material compatibility and regulatory requirements.
PQ (Performance Qualification) — Validation phase demonstrating that a packaging process consistently produces a product meeting specifications under normal operating conditions. Final phase of IQ/OQ/PQ per ISO 11607-2.
R
Real-Time Aging (RTA) — Shelf-life testing conducted at ambient storage conditions over the intended product lifetime. Provides definitive expiry date data; often run in parallel with accelerated aging.
S
Secondary Packaging — Outer packaging that does not contact the product directly. Provides protection, identification, and logistical handling.
Seal Integrity — The ability of a package seal to maintain its barrier properties throughout the product lifecycle. Assessed by methods including dye penetration, burst, and vacuum tests.
Sterile Barrier System (SBS) — The minimum packaging required to maintain sterility of a terminally sterilised product to point of use, as defined in ISO 11607-1.
T
Terminal Sterilisation — Sterilisation of a sealed, finished product by exposure to heat, radiation, or ethylene oxide (EO). Distinguished from aseptic processing.
Thermoforming — A process in which plastic sheet is heated and formed into a shape using a mould. Used to create the cavity of a blister pack or tray.
Tyvek® — DuPont's brand of flash-spun high-density polyethylene (HDPE) sheet. Widely used as a breathable, microbial barrier material in medical device sterile packaging.
U
UDI (Unique Device Identification) — A system for identifying medical devices through their supply chain via a unique numeric or alphanumeric code. Required on packaging under EU MDR and FDA UDI regulations.
Unit Dose Packaging — Packaging containing a single dose of a pharmaceutical product. Provides dose accuracy and reduces contamination risk.
V
Validation — Documented evidence that a packaging process consistently produces a product meeting its predefined specifications. Required by ISO 11607-2, ISO 13485, and GMP frameworks.
How to Use This Glossary
This glossary is designed as a companion reference to the MedicoPax knowledge base articles. Terms are defined in the context of medical device and pharmaceutical packaging — specifically how they are used in ISO 11607, ASTM test standards, EU MDR technical documentation, FDA submissions, and good manufacturing practice frameworks. Where a term has a formal normative definition in a standard, the glossary entry reflects that definition and notes the source. Where industry usage diverges from the formal definition, or where the same term is used differently across different regulatory frameworks, both usages are explained.
Sterile barrier system terminology in particular has precise meanings within ISO 11607 that differ from colloquial usage. The standard draws specific distinctions between a sterile barrier system, a protective packaging system, and a packaging system — distinctions that matter both for design documentation and for regulatory submissions. Entries in this glossary flag cases where terminological precision is important for compliance purposes.
Abbreviations Used in Medical Device Packaging
The medical device packaging field uses a dense set of abbreviations across standards, regulatory documents, and technical specifications. Common abbreviations encountered throughout this knowledge base include: SBS (sterile barrier system), OTR (oxygen transmission rate), MVTR (moisture vapour transmission rate), EO (ethylene oxide sterilisation), PQ (performance qualification), OQ (operational qualification), IQ (installation qualification), CSSD (central sterile services department), MDR (Medical Device Regulation), IVDR (In Vitro Diagnostic Regulation), and DHF (design history file). Each is defined in the relevant glossary entry and explained in context in the associated knowledge base articles. If you encounter an abbreviation that is not defined here, please use the contact page to suggest an addition.