Module 3 - Strategic case studies in practice

3.2.P

Drug Product: Max Strength Cold & Flu Day & Night Capsules

3.2.P.7

Container Closure System

3.2.P.7

Container Closure System Primary Packaging

The container closure system comprises opaque, white, 250 micron PVC blisters lidded with 30 micron hard-temper pyramidal Aluminium foil. Each blister contains eight capsules in a 4 × 2 format, comprising 6 Day capsules and 2 Night capsules. The specifications for the PVC laminate and the 30 micron CRC Aluminium foil are provided overleaf. This pack combination has been approved as BS 8408 compliant in line with current Child Resistant Closure (CRC) regulations. A declaration of conformity and CRC testing report (Burford Report) are provided in 3.2.P.7. along with a blueprint of an example blister pack (approximately 80 mm × 57 mm). The results of the Burford Report indicated that 99 out of 100 adults tested could open the blister and remove a tablet. Certificates of Conformance from the foil supplier, Ethiprint Limited, Sandown Road, Derby DE24 8SR and from the PVC supplier, Alfatherm Industriale S.p.A, 21040 Venegono Superiore, Varese, Italy – Via Marconi, 25 are also provided in overleaf.