Module 3 - Strategic case studies in practice

Wrafton Laboratories Limited

Confidential

Module 3

3.2.P.7

Container Closure System

Cold Relief Capsules will be packaged in the following:

PVC blister strips with a child resistant lidding foil contained within an outer cardboard carton. The PVC blister strips consist of a base of 250 μm opaque PVC film which is moulded into the correct shape by heating. The capsules are placed in the moulded pockets and a lidding foil comprising of 35 gsm Glassine (Pergamin) paper / 9 μm soft temper Aluminium foil lidding (with heat sealing lacquer on one side) is then added.

The blister strips are placed in the cardboard carton with a patient information leaflet.

Specifications

The following tables provide the specifications for the immediate packaging components applied by the drug product manufacturer.

Specification of PVC film

Test

Specifications

An PVC film with the required base colour. Surface of the film should be smooth and glassy on both sides without any cuts, pinholes, denting, watermarks or foreign matter.

Appearance

Thickness

237.5 – 262.5 micron 324.9 – 359.1 gsm

Grammage of film

Colour

White opaque

FTIR

Concordant with standard spectrum

Specification of Glassine / Aluminium Foil

Test

Specification

Appearance

A printed glassine paper / aluminium lidding foil which should be free from pinholes, denting and ink spots. The winding direction on the core should have printing in the outer side and should comply for quality of printing and identification of product.

Grammage of foil

Total:

69.16 gsm ± 7.24 gsm

(Heat Seal:

7.0 gsm ± 1.0 gsm 24.3 gsm ± 1.9 gsm 2.85 gsm ± 0.85 gsm 35.0 gsm ± 3.5 gsm)

Aluminium Foil:

Adhesive:

Paper:

Text Matter and Colour

Should comply for correct text matter, text colour and artwork code, with approved specimen.

FTIR

Concordant with standard spectrum.

June 15