“Emphasis on Compliance, Data Integrity, and Automation in Testing Processes”
- Growing regulatory pressure from agencies such as the EMA (European Medicines Agency) and MHRA is driving demand for advanced packaging testing solutions that ensure data integrity, repeatability, and compliance with Good Manufacturing Practice (GMP) standards
- Increasing adoption of fully automated and integrated packaging testing equipment enables real-time monitoring, traceability, and consistent quality across pharmaceutical production lines
- Innovations in non-destructive testing (NDT) technologies, such as vacuum decay, laser-based leak detection, and high-resolution imaging, are improving test accuracy without damaging packaging
- For instance, in February 2024, Sepha Ltd. launched a new generation of vacuum decay testers in the EU market, compliant with USP <1207> standards and equipped with digital data logging systems to support regulatory audits
- This trend reflects the industry’s broader shift toward digitized, standardized, and highly compliant testing infrastructure to meet stringent pharmaceutical packaging validation requirements
Frequently Asked Questions
Key trends include automation in testing processes, integration of AI and machine learning, demand for non-destructive testing methods, and a focus on data traceability and compliance with EU Annex 11 and 21 CFR Part 11.
The major factors driving the growth of the Pharmaceuticals Packaging Testing Equipment market are increased regulatory scrutiny, rising pharmaceutical exports, growth in biologics, and the need for tamper-evident and sterile packaging validation.
The primary challenges include high equipment costs, limited availability of skilled operators, and complex validation procedures required for regulatory compliance.
