Module 3 - Strategic case studies in practice

Wrafton Laboratories Limited

Confidential

Module 3

Analytical Procedures

The following tables provide descriptions of the methods for tests performed on the immediate packaging components when tested by the drug product manufacturer.

PVC Film

Test

Test Method

Appearance

Visual assessment

Thickness

Measure the thickness twice of five pieces of PVC film. Weigh five pieces of PVC film taken from across the web.

Grammage of film

Colour

Visual assessment

On a sample of the film perform an FTIR scan on the product contact side and compare the spectra with the standard spectra.

FTIR

Specification Glassine, Aluminium Foil

Test

Test Method

Appearance

Visual assessment

Grammage of foil

Weigh five pieces of foil taken from across the web.

Text Matter and Colour

Visual assessment

FTIR

On a sample of the film perform an FTIR scan on the product contact side and compare the spectra with the standard spectra.

Technical Data

The following are provided overleaf:

- FTIR Spectra of the Foil and the PVC - Certificate of Analysis from the Printed Foil typical supplier. - Technical Data Sheet from the Printed Foil Supplier typical supplier. - Declaration of Conformity from the PVC Film Manufacturer typical supplier. - Technical Data Sheet from the PVC Film Manufacturer typical supplier.

June 15