If you specify child resistant caps for a pharmaceutical product — whether for domestic Indian market or export — your regulatory submission will almost certainly require a CRC test report from an accredited laboratory. But test reports are dense documents filled with panel demographics and failure rate statistics. This guide explains exactly how the testing works and what to look for in a report.
The Two Main Standards: ISO 8317 and 16 CFR 1700
ISO 8317 is the international standard for reclosable child resistant packaging, used in most markets outside North America including India (IP references it), UK (MHRA references it), EU, and most of Asia and the Middle East.
16 CFR Part 1700 is the US Consumer Product Safety Commission (CPSC) standard, required for any OTC or prescription drug sold in the United States. If you're exporting to the US, 16 CFR 1700 compliance is mandatory and ISO 8317 alone is not sufficient.
The Child Panel Protocol
Both standards require testing with a panel of children aged 3.5 to 4.5 years. Under ISO 8317, the panel consists of at least 200 children (tested in groups of 50). Each child is given 10 minutes to open the package without any instruction other than "try to open it." After 5 minutes, if they haven't opened it, the tester demonstrates opening and the child has another 5 minutes.
The key metric is the child failure rate — the percentage of children who failed to open the package within 10 minutes. To pass, the child failure rate must be:
- ≥ 85% without demonstration (no instruction given)
- ≥ 80% with demonstration (after showing how to open it)
A higher child failure rate = better child resistance. Our CRC products consistently achieve ≥ 90% failure rates in accredited testing.
The Adult Senior Panel Protocol
Child resistant packaging that adults cannot open creates its own safety risk — elderly patients who can't open their medicine may skip doses. Both ISO 8317 and 16 CFR 1700 require testing with a panel of adults aged 50–70 years to ensure adequate adult usability.
The adult success rate must be ≥ 90% — at least 90% of adults must be able to open (and for reclosable packages, re-close and then re-open) the package within 5 minutes.
What to Look For in a CRC Test Report
When reviewing a supplier's test report, check:
- Accreditation: The testing laboratory must be ISO 17025 accredited for CRC testing. Unaccredited in-house tests are not accepted by regulators.
- Sample identification: The report must specify the exact cap dimension, batch number, and bottle neck size tested — a 28mm cap on a 60ml bottle behaves differently from the same cap on a 100ml bottle.
- Child failure rate ≥ 85% without demonstration.
- Adult success rate ≥ 90%.
- Test date: Most regulators accept CRC test reports for 5 years. Confirm the report is current.
Right Angle Pharmapack's CRC Testing
All our child resistant caps carry current third-party test certificates from ISO 17025 accredited laboratories. Test reports are provided with samples and are available on request for regulatory dossier submissions. We test across the full range of bottle neck sizes and capacities we supply, so you receive a report that exactly matches your bottle-cap combination.
For technical questions about CRC testing requirements for your specific market, contact our regulatory support team.