Pharmaceutical
Packaging Engineering
Services
Pharmaceutical-Packaging Engineering
Network Partners provides full packaging engineering services for pharmaceutical applications. Our areas of expertise include design & development, validation testing plans, authoring protocols and procedures, brand protection and technology management.
Packaging Design & Development
Engineering capabilities to design primary, secondary and tertiary packaging for configurations and materials used in pharmaceutical packaging.
- Primary packaging:
- Solid oral dose packaging: blisters and lidding stock, container-closure systems
- Liquid oral dose packaging: bottles, tips and caps, container-closure systems
- Delivery systems for combination products, e.g. syringes
- Packaging systems to provide: child resistant, senior friendly and brand protection, to meet design and user requirements
- Secondary & tertiary packaging:
- Cartons and structural, interior components
- Shipper and pallet load systems for global distribution
- Temperature controlled packaging systems, active and passive
- Obtain design inputs and customer VOC, conduct risk assessments
- Perform analytical, statistical and engineering studies to support development of new packaging solutions
Brand Protection
Keeping products safe across the entire supply chain from raw materials to shelf requires using the right solution for each product. Specialized consulting services lead to optimized solutions.
- Working with the brand owner, conduct risk assessments for determination of brand protection strategies
- Develop brand protection guidance documents & processes, assess supply chain changes
- Troubleshoot packaging issues related to brand protection features – provide creative, timely and cost-effective solutions.
- Work with manufacturing and logistics to insure designs are optimized for manufacturability, distribution practices and field investigation capabilities.
- Develop test scenarios to use in detection of anti-diversion, tampering and fraudulent products.
- End-to-end Supply Chain Security Strategy, Program & Implementation
- Raw material, production and distribution process assessment and gap analysis
- Incident Management approaches and processes
Validation
Pharmaceutical packaging requires validation efforts compliant with FDA and other regulatory bodies around the world. Validation services include:
- Process validation: equipment qualification (IQ/OQ), performance qualification (PQ)
- Design qualification activities: materials qualification, package design, package testing, temperature management and control system qualification (thermal packaging) and package performance (distribution simulation)
- Process development using FMEA & D.O.E tools
- Conduct shelf life studies; accelerated and real time
- Supply chain quality systems support for Good Distribution Practices (GDP)
- Brand protection
- E-pedigree and serialization
- Temperature management
Test Plans & Testing Services
Test plan development and testing services demonstrate the package’s safety and efficacy.
- Establish testing plans and execute testing services for container closure, extractables and leachables evaluation
- Container-closure integrity testing plans and methods
- Develop test method protocols and validate test methods in the client’s laboratory
- Packaging usability studies and human factor protocol development, execution, data analysis and report development
Product Serialization, Track & Trace
Possessing the most current serialization and traceability knowledge provides our clients with effective solutions.
- Serialization strategy, planning, program management and compliance implementation
- Serialization and traceability guidance and training
- Tamper evident packaging strategy, technologies and implementation
- GS1 data carrier expertise including barcodes, Datamatrix, QR codes and RFI
Protocols & Procedures
Technical writers develop effective protocols and procedures.
- Conduct gap analysis
- Develop SOPs, specification templates, guides, work instructions, best practice documents, and training curriculum for GMP and GDP SOPs.
- Documentation required for audit remediation and CAPA closure
- Complete pre-production packaging documentation including manufacturing procedures, end item specifications and inspection procedures.
Technology Management
Specialists provide the latest pharmaceutical packaging technology management options.
- Anti-counterfeiting, brand protection strategy & implementation
- A-C technology assessment and lifecycle management
- A-C technology Identification, Development & Deployment (Site or CMO)
- Technology Print, Application Development and Integration
- Healthcare Provider and Patient Authentication Technologies
- Patient Adherence and Compliance Packaging
