The Poison Prevention Packaging Act (PPPA) defines special packaging as “Packaging that is designed or constructed to be significantly difficult for children less than 5 years of age to open or obtain a toxic or harmful amount of the substance contained therein within a reasonable time and not difficult for normal adults to use properly. Human performance tests were developed to measure child resistant and adult use effectiveness. Children aged 42 to 51 months were chosen as the test subjects. The test method was developed to try to mimic the situation found at home. Child resistant packaging is a useful deterrent in preventing accidental poisoning of young children. However, it is intended to be a last line of defense with safe and appropriate storage of medicines being the primary preventative measure in harm reduction. A child resistant package is a package which is difficult for young children to open (or gain access to the contents) but which is not difficult for adults to use properly. Before any medicine is authorised for use in adults, the product must have undergone extensive testing including pre-clinical tests and clinical trials to ensure that it is safe, of high quality and effective. Child resistant packaging reduces child mortality from the unintentional ingestion of oral prescription drugs.
The American Society for Testing and Materials (ASTM) gives a list of Classifications of child-resistant packages: –
- Type I: Reclosable packaging – continuous thread closure
- Type II: Reclosable packaging – lug finish closure
- Type III: Reclosable packaging – snap closure
- Type IV: Unit non-reclosable – flexible (strip/pouch)
- Type V: Unit non-reclosable – rigid
- Type VI: Unit reclosable packages
- Type VII: Aerosol packages
- Type VIII: Non-reclosable packages – semi-rigid (blister)
- Type IX: Dispensers (not intended to be removed)
- Type X: Box or tray package
- Type XI: Reclosable packaging – flexible
- Type XII: Dispenser (may be removed)
- Type XIII: Reclosable packaging – semi-rigid (blister)
TESTING PROTOCOL FOR CHILD RESISTANT PACKAGING
- On full scale production batch
- Adult test must be carried out initially
- A new package must be used for every test
- Test panel may involve up to 200 children in the ages between 20 and 42 months, almost equally distributed between either sexes.
- 100 normal adults between 18 and 65
- Adults are asked to open within 5 minutes using the direction that appear on the package and reclose it if it is reclosable type.
- Then children are asked to open totally for 10 minutes after being demonstrated by an adult.
- For full 10 minutes 80% of the children shall not be succeeded in opening
- In 5 minutes 90% of the adults must be successful in opening.
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