Determination of the thickness of plastic sheets used in blister packaging by near infrared spectroscopy: development and validation of the method.

A near infrared (NIR) quantitative analysis method was developed for determining the thickness of PVC-based plastic sheets used as pharmaceutical packs. Samples that can be analyzed are transparent films made of polyvinyl chloride (PVC), PVC coated with polyvinylidene dichloride (PVDC) or PVC coated with Thermoelast (TE) and PVDC. The method, based on a partial least squares (PLS) algorithm, is used together with a previously developed NIR identification method to acquire simultaneously qualitative and quantitative information about the samples. Validation of the quantitative method was conducted according to the very recent European Agency for the Evaluation of Medicinal Products (EMEA) guidance on the use of NIR spectroscopy. Suggestions were made for a better statistical evaluation of the calibration model prior to validation. Validation consisted of the study of specificity, accuracy (mean recovery from the reference values was 99.56%), precision (repeatability and intermediate precision were <0.6%), linearity, quantification limit (41 microm), and robustness of the method. This demonstration of the applicability of NIR spectroscopy as a validated quality control tool for pharmaceutical packaging films will hopefully facilitate the acceptance of NIR spectroscopy in pharmaceutical laboratories.