PMMI published in January 2026 the report “Trends and Challenges in Pharmaceutical Manufacturing”, based on surveys of international manufacturers and OEMs. Although the study is global in scope and analyzes global trends, it places special emphasis on the U.S. market.

In this note, amec extracts the seven most critical implications for packaging equipment manufacturers.

1. CONNECTIVITY AND DIGITIZATION

Digital connectivity has become a barrier to entry. The US DSCSA (Drug Supply Chain Security Act) requires full electronic traceability with deadlines in November 2025-2026.

Requirements:

• RFID (radio frequency identification)
• Wireless sensors
• QR Codes
• Connection to management systems
• Remote supervision

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Implications:

• Redesigning machines with native digital connectivity
• Software compliant with DSCSA and European regulations
• Ensuring compatibility with multi-market traceability systems

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2. FORMAT FLEXIBILITY

Market diversification penalizes single-product machines. The growth of injectables, blisters and ampoules forces format changes in minutes.

Requirements:

• Quick changeover between formats
• Multi-product capability
• Automatic adjustments
• Configuration by touch screens

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Implications:

• Prioritize modular architectures
• Format changeover in minutes by electronic settings
• Design standardized interchangeable components

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3. AUTOMATION AND ROBOTICS

Personnel costs in clean rooms make the incorporation of robots particularly cost-effective.

Requirements:

• Collaborative robots (cobots)
• Automatic loading/unloading
• FDA and EMA compliant smart cameras
• Robot-ready design

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Implications:

• Design with gaps and connectors for future robotic integration
• Incorporate machine vision validatable according to FDA and EMA
• Ensure scalable architecture without redesign

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4. SPEED AND PERFORMANCE

Speed is a purchasing priority. The growth of new drugs generates the need for greater production capacity.

Requirements:

• Improve overall performance
• Reduce downtime
• Predictive failure systems
• Constant data capture

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Implications:

• Redesign critical components to increase speeds
• Incorporate continuous monitoring sensors
• Integrate predictive diagnostics

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5. SANITARY DESIGN AND CLEANING

Poorly designed machines require 2-3 hours of cleaning per day and generate problems in inspections. Correcting errors afterwards multiplies costs.

Requirements:

• Smooth surfaces
• EHEDG or 3A certifications
• Access for verifiable cleaning
• Resistant materials

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Implications:

• Elimination of corners and horizontal surfaces according to GMP
• Use 316L stainless steel in contact with product.
• Design wide access for visual verification

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6. SUSTAINABILITY

The industry adopts recycled plastics, compostable materials and lightweight packaging, all of which behave differently from traditional materials.

Requirements:

• Processing thin films
• Adapt to paper and vegetable derivatives
• Adjustable tension
• Thickness sensors

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Implications:

• Incorporate dynamic tensioning with automatic adjustment
• Integrate in-line thickness sensors
• Design rollers compatible with variable substrates

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7. REGULATORY COMPLIANCE

Many companies purchase new equipment specifically for GMP compliance, making it clear that the machines must actively facilitate legal compliance.

Requirements:

• Automatic data capture
• Individual and grouped traceability
• Automatic official documentation
• Unalterable records according to 21 CFR Part 11 and Annex 11

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Implications:

• Integrate serialization and automatic aggregation
• Incorporate software that generates GMP documentation without intervention
• Designing data architectures with immutable records for audits