Why pharmaceutical package testing is under pressure
In the pharmaceutical industry, pharmaceutical package testing is not just about durability or shelf appeal — it is a critical safeguard for patient safety, product integrity, and regulatory compliance. Every element of pharmaceutical packaging — from blister packages to pre-filled syringes, vials, and bottles — must meet strict industry-wide quality standards to ensure that pharmaceutical products arrive intact, sterile, and effective.
As regulatory agencies introduce new guidance documents and regulatory requirements, and as the demand for supply chain transparency increases, pharmaceutical companies are under growing pressure to document every stage of their packaging testing processes. This includes quantitative test methods, reliable test methods, and evidence of performance under temperature variations and other environmental conditions.
That’s where Digital Link steps in, offering a streamlined, standardized way to manage pharmaceutical package testing data through Digital Product Passports (DPPs). These scannable, digital profiles turn traditional packaging into an intelligent hub of test results, compliance records, and safety data.
With Digital Link QR codes, pharmaceutical manufacturers can track, store, and share packaging material performance data in real time, directly through the product itself.
How Digital Product Passports support pharmaceutical package testing
Digital Product Passports are structured, scannable digital profiles that carry essential information about a product, including test methods, batch traceability, safety documentation, and stability studies. For pharmaceutical packaging formats — from primary containers to medical devices — they provide a central point for storing and sharing critical package testing information.
Here’s how Digital Link supports the process:
Create a passport linked to each GTIN
Generate a Digital Link QR code using the product’s GTIN (Global Trade Item Number), connecting the physical product to its dynamic online profile.
Attach package testing data
Upload documents and metrics directly into the Digital Product Passport, including:
- Seal integrity and internal pressure resistance
- Temperature variations and humidity tolerance
- Drop, crush, and vibration resistance for drug delivery systems
- Light and moisture barrier performance for primary sterile barriers
- ISO/FDA compliance and industry gold standard reports
Customize tabs and views
Organize your packaging testing information into branded, structured sections. Show public information for pharmacists or patients, and keep sensitive data for regulatory bodies, distributors, or inspectors.
Enable real-time access via scan
With one scan of the QR code, authorized users can view test results, version histories, and functional component details — critical for audits, recalls, or quality assurance in pharmaceutical manufacturing.
Update dynamically without reprinting
If packaging materials are upgraded or retested, the DPP can be updated instantly — no need to reprint or redistribute labels.
Use cases: How pharma brands use Digital Link for package testing
In pharmaceutical manufacturing, packaging material validation is essential, but documentation has often been fragmented. Digital Link centralizes these records and makes them accessible with a scan.
- Clinical trials – Track how trial batches respond to environmental conditions, document production performance, and share results instantly with regulatory bodies.
- Prescription and OTC drugs – Prove compliance with quality standards and regulatory requirements by providing scannable access to certificates and test methods.
- Cold chain pharmaceuticals – Store temperature variation data and insulation test results to protect temperature-sensitive drug products.
- Contract manufacturing – Ensure alignment in packaging testing across partners to prevent costly disputes.
- Medical devices – Document performance of primary sterile barriers in functional components like syringes, vials, or diagnostic kits.
- Global market compliance – Adapt to local regulatory agencies by dynamically showing relevant guidance documents and test results.
Make pharmaceutical packaging smarter and safer
Pharmaceutical package testing has a significant impact on both patient safety and pharmaceutical manufacturers’ ability to meet industry-wide quality standards. By integrating Digital Product Passports powered by Digital Link, pharmaceutical companies can streamline packaging testing processes, reduce zero waste risks through optimized life cycle management, and provide regulators with instant access to verified test results.
From blister packages in stability studies to pre-filled syringes in drug delivery systems, DPPs ensure that every test — from reliable test methods to quantitative test methods — is securely documented, instantly shareable, and compliant with regulatory requirements.
With Digital Link, compliance, patient safety, and environmental conditions resilience are not just met — they are proven, documented, and accessible at the speed of a scan.
