Pharmaceutical Packaging Materials Quality Control and USP Chapter <661.1> Compliance

Significance of the Topic

Pharmaceutical packaging has a direct impact on active ingredient stability and shelf life and is essential to prevent product degradation and recalls. Quality control of packaging polymers helps to detect impurities and composition errors early and reduces the risk of counterfeiting.

Objectives and Overview

This study demonstrates the use of the Agilent Cary 630 FTIR to characterize polymer layers in blister packs and to ensure compliance with USP chapter <661.1>. Key aims include:

• Comparing polymer composition in brand name and generic cold medicine packaging
• Detecting counterfeit packaging through infrared fingerprinting
• Validating FTIR methods for regulatory compliance

Methodology and Instrumentation

Polymer samples from blister pack layers and backings were analyzed using an Agilent Cary 630 FTIR equipped with a diamond ATR module and KBr optics. Spectra were acquired over 4000 to 650 cm-1 at 4 cm-1 resolution with 64 coadded scans. MicroLab FTIR software with optional Pharma package provided automated module recognition, spectral acquisition, and library search against USP chapter <661.1> reference standards.

Main Results and Discussion

Infrared analysis revealed common use of a PVC/PVDC bilayer in generic blister packs and a higher performance PCTFE/PVC bilayer in brand name products. Variations in styrene butadiene rubber content were quantified by measuring characteristic absorbance bands. Unexpected layer inversions were detected in some generic samples and polymer backings in one product were identified as styrene acrylate copolymer with fillers instead of microcrystalline cellulose. Library search hit quality indices exceeded 0.98 for matching USP standards, confirming polymer identity and demonstrating sensitivity to minor compositional differences.

Benefits and Practical Applications

FTIR ATR enables rapid qualification of raw and in process materials for pharmaceutical packaging, supports QA QC workflows, and aids in counterfeit detection by comparing packaging spectra to authenticated references. Automated software thresholds provide actionable green yellow or red alerts for compliance assessment.

Future Trends and Possibilities

Advances may include expansion of spectral libraries to cover emerging polymer formulations, integration with digital lab notebooks and AI assisted spectral interpretation, inline FTIR monitoring for continuous production control, and development of miniaturized spectrometers for field verification of pharmaceutical packages.

Conclusion

The Agilent Cary 630 FTIR with diamond ATR module provides a robust and user friendly platform for polymer identification in pharmaceutical packaging. It meets USP chapter <661.1> requirements and enhances quality control and counterfeit detection through precise fingerprint analysis and library search capabilities.

References

1. USP General Chapter 661.1 Plastic Materials of Construction official December 1 2025
2. USP General Chapter 1661 Evaluation of Plastic Packaging Systems
3. USP General Chapter 854 Mid-Infrared Spectroscopy
4. USP General Chapter 197 Spectrophotometric Identification Test
5. USP General Chapter 659 Packaging and Storage Requirements
6. USP General Chapter 661 Plastic Packaging and their Material of Construction
7. Pilchik R Pharmaceutical Blister Packaging Part I Pharm Technol 2000 24(11) 68–78
8. Sepha Ltd Service Industries Considerations For Selecting Blister Packaging Materials For Pharmaceutical Products Pharmaceutical Online 2012