Packaging validation shows that the packaging keeps a device sterile and
functional from sealing through transport and storage to the point of use.
Shelf life is the period for which that holds; the date on the label
marks its end. Both concern medical devices and IVD in the EU and the US.
| Question | Where it is set | What has to be shown |
|---|
| Sterile barrier system and packaging system | ISO 11607-1, MDR Annex I Sections 11.4 to 11.6 | Materials and design that maintain sterility until the point of use |
| Sealing and assembly | ISO 11607-2, ISO 11607-3 for process development | A validated forming, sealing and assembly process |
| Transport | MDR and IVDR Annex I Section 7, ASTM D4169, IVDR Annex II Section 6.3.3 | No adverse effect from transport and storage; for IVDs, shipping stability on one lot |
| Shelf life | ASTM F1980, IVDR Annex II Section 6.3.1, MDR Annex II Section 6.1(b) | Accelerated data for the first claim, real-time data to the claimed date |
| Expiry date | MDR Annex I Sections 23.2 and 23.3, IVDR Sections 20.2 and 20.3, 21 CFR 801.18 | The time limit for safe use on label and sterile packaging |
A sterile barrier system is the part of the packaging that keeps
microorganisms out. The packaging system adds the protective packaging around
it. MDR Annex I Section 11.4 requires the integrity of the packaging that
maintains sterility to be clearly evident to the final user, so a damaged
pouch has to be recognizable as damaged.
Under ASTM F1980 an expiry date from accelerated aging is tentative until
the real-time results are complete. The guide also calls for conservative
aging factors where little is known about the material. This page sets no
value for the factor; it is justified per material and documented in the
protocol.
Transport is a separate test. ASTM D4169 evaluates in a laboratory whether
shipping units withstand the distribution environment, through a sequence of
anticipated hazards. The FDA recognizes the edition D4169-22, while ASTM lists
D4169-23e1 as the active edition; which one a test plan cites is decided per
submission.
For IVDs the IVDR spells out the stability evidence in Annex II Section
6.3: claimed shelf life on at least three lots, in-use stability and shipping
stability on one lot each. In the US, 21 CFR 809.10 requires storage
instructions for reagents and, among other options, an expiration date based on
them.
In the US, 21 CFR Part 820 (QMSR) incorporates ISO 13485:2016 and adds
§ 820.45: procedures for the integrity, inspection, storage and operations of
labeling and packaging, and an examination before release that includes the
expiration date and the storage instructions.
This page does not cover the sterilization process itself
(Sterilization Validation), general
process validation, the label and instructions
for use beyond the expiry date (Labeling & IFU)
or the design evidence as a whole
(Verification & Validation).
