Overview
ISO 14375:2018 specifies performance requirements and test methods for child‑resistant non‑reclosable packaging for pharmaceutical products. The standard is intended for type approval of a specific packaging design (formed from defined materials) and is not intended for routine quality assurance. It defines how to evaluate whether a non‑reclosable package provides a satisfactory barrier to young children while remaining accessible to adults.
Key Topics
- Scope and purpose: Type approval testing for non‑reclosable child‑resistant pharmaceutical packaging.
- Definitions: Key terms such as child‑resistant package, non‑reclosable child‑resistant package, unit dose, substitute product and type approval.
- Performance criteria:
- Child test: Package is considered failed for unit/strip/blister formats if a child accesses more than 8 unit doses within 10 minutes. Acceptance criteria include sequential panel rules and percentage thresholds (e.g., at least 85 % of children unable to access >8 units within 5 minutes; procedural details provided).
- Adult test: At least 90 % of adults must access at least one unit dose within 1 minute (after familiarization); adult test should be conducted before child test to minimize child exposure.
- Test population & procedure:
- Child panel: typically children aged 42–51 months, up to 200 participants divided into pairs using sequential or full‑panel procedures.
- Adult panel: typically 100 adults; 5 min familiarization then 1 min timed test.
- Use of substitute (inert) product; child test samples presented unprinted; at least 10 unit doses per participant.
- Test documentation: Requirements for test reports, annexes with guidance for supervisors, test charts and procedural justification.
Applications
Who uses ISO 14375:2018 and why:
- Pharmaceutical manufacturers - type approval of primary unit‑dose and non‑reclosable packaging designs.
- Packaging designers and suppliers - validate concepts for child resistance and adult accessibility.
- Conformity assessment and testing laboratories - conduct standardized child/adult panel tests and generate type‑approval reports.
- Regulators and procurement teams - assess compliance of packaging solutions cited in regulatory submissions or tenders.
- Risk managers - support decisions on packaging selection for products with pediatric hazard potential.
Practical benefits include consistent, evidence‑based assessment of child resistance, improved product safety in the home, and a common benchmark for international acceptance.
Related Standards
- EN 14375 (CEN origin): ISO 14375 was prepared from EN 14375 and adopted under a fast‑track procedure.
- ISO 9001: referenced as a useful quality‑management framework for manufacturers (quality control of approved packaging).