Automation in the Pharmaceutical
Automation and software for regulated pharmaceutical lines. PLC, Motion Control, HMI and SCADA development compliant with GMP and FDA 21 CFR Part 11 and PackML models.
Automation of Pharmaceutical Packaging Machines
We develop automation software for packaging machines in the field pharmaceutical and life sciences , adopting PackML models (ISA-TR88) to standardize machine states, alarms and operational behaviors.
Development of PLC logic, safety and motion on Siemens, Rockwell and Beckhoff platforms, with PackML-ready and easily validatable modular architectures.
Qualified augmentation team to support OEMs and engineering departments during new developments, revamping and load peaks.
Areas of application:
- •PackML State Model: machine states standardized according to ISA-TR88
- •PLC Development: validated and modular machine logics
- •Motion Control: consistent synchronisms with PackML states and transitions
- •Commissioning: FAT, SAT and start-up in GMP environments
PLC Validated
PLC software development compliant with GMP and customer standards
Motion Control
Reliable synchronisms for blister and packaging machines
PackML Architecture
Complete implementation of the PackML model
Safety & Compliance
Integrated and documented safety functions
HMI
We design HMI interfaces for operators, maintainers and quality assurance , following PackML guidelines to ensure operational consistency and error reduction.
We develop SCADA systems for multi-line supervision based on PackML state aggregation and batch management.
Compliance FDA 21 CFR Part 11 and Annex 11 with audit trail, electronic signature and user management.
Areas of application:
- •PackML Line Aggregation: line states derived from machine states
- •Batch Management: batch management and production parameters
- •OEE Standard: OEE calculation based on PackML states
- •Compliance: GMP, data integrity, ALCOA
HMI Regulated
Interfaces compliant with data integrity requirements
PackML HMI
Standardized states, alarms and navigation
OEE & KPI
Line performance monitoring and downtime analysis
MES & Serialization
Integration with MES and track systems
Process Optimization and Reliability
The adoption of the model PackML allows objective measurements performance and consistent comparisons between machines and lines.
We optimize performance while maintaining process stability and compliance without introducing non-validable behaviors.
KPIs and structured reports to support quality assurance and continuous improvement.
Areas of application:
- •PackML KPIs: performance analysis by machine status
- •Micro-Stops: precise identification via standard states
- •Benchmarking: comparison between software versions and lines
PackML Performance
Performance analysis based on PackML states and machine transitions
Micro-Stop Reduction
Identification and reduction of micro-stops through standardized diagnostics
Process Stability
Optimization of parameters while maintaining process stability and compliance
Validated KPIs
Validatable KPIs and reports to support quality assurance and continuous improvement
Automation and Supervision of Pharmaceutical Blister Lines
Development of control software for pharmaceutical blister lines based on PackML model, with standardized machine states, batch management, audit trail and integration with serialization systems, in compliance with FDA 21 CFR Part 11.
Challenges Faced
- •Implementation of the PackML model in a GMP environment
- •Machine states aggregation for line supervision
- •PackML alignment with IQ/OQ/PQ validation
- •Integration with MES and serialization systems
Applied Skills
Technologies Used
Results Obtained
- Implementation of a PackML-compliant blister line with standardized machine states
- Full compliance with GMP, FDA 21 CFR Part 11 and Annex 11
- End-to-end traceability of batches, parameters and operations
- Reduction of changeover times thanks to batch management and versioned recipes
- Solid and scalable foundation for OEE, KPIs and continuous improvement
Serialization and Track
Development and integration of serialization and tracking systems
Challenges Faced
- •Integration of serialization systems with PLC and line SCADA
- •Multilevel aggregation management (item, bundle, case, pallet)
- •Alignment between line events and external repositories
- •Regulatory compliance and data integrity in regulated environments
Applied Skills
Technologies Used
Results Obtained
- End-to-end serialization compliant with international regulatory requirements
- Reliable integration between packaging line and IT systems
- Complete and verifiable traceability along the entire supply chain
- Reduction of operational errors thanks to structured event management
- Scalable basis for extension to new markets and future regulations
Pharmaceutical Plant Supervision and Data Integrity
Design and development of supervision systems for pharmaceutical plants with collection, historicization and traceability of process data, guaranteeing data integrity according to ALCOA principles and compliance with GMP, FDA 21 CFR Part 11 and Annex 11.
Challenges Faced
- •Centralized management of process data from multiple lines and plants
- •Implementation of audit trails and access control on critical data
- •Alignment between automation, IT and quality assurance
- •Validation of the system according to CSV and GAMP 5 guidelines
Applied Skills
Technologies Used
Results Obtained
- Centralized and consistent supervision of pharmaceutical plants and lines
- Guarantee of data integrity on critical process parameters and events
- Passed GMP and FDA audits without critical observations
- Better collaboration between production, IT and quality assurance
- Solid and scalable foundation for historical analysis, reporting and continuous improvement
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