Medical Device – Packaging Engineering
Network Partners’ design & development services support packaging activities for new product launches and sustaining legacy product lines. Our designs meet testing standards and demonstrate compliance to ISO 11607 Part 1 and Part 2.
Packaging Design & Development
Creating a safe and effective sterile barrier system requires a deep understanding of packaging materials. Developing appropriate levels of packaging provides the necessary product protection to survive challenging distribution environments.
- Primary packaging:
- Thermoformed trays and die-cut lids
- Peel pouches and header bags
- Kit systems and multi component
- Labeling systems for primary packaging
- Secondary packaging & tertiary packaging:
- Cartons and structural, interior components –
- Shipper configurations for varying pack outs: overnight parcel, LTL, palletized loads –
- Shipper and pallet load systems for global distribution –
- Temperature controlled packaging systems, active and passive
EU MDR Packaging & Labeling Compliance
Broad technical and regulatory expertise enables a robust technical review and, if necessary, remediation efforts to comply with the EU MDR.
- Gap analysis: Current state vs. MDR requirements
- Design control traceability: ISO 11607, EU MDR, ISO 13485 & 21 CFR 820.130 compliance
- Technical file review & remediation plan development
- Technical documentation & new procedure development
- Defensible testing strategies, test plans, rationales and justifications
- Labeling requirements traceability: 21 CFR 11.10, 21 CFR 801, ISO 15223, EU MDR sections 23.1 and 23.2 and 21 CFR 820.120
- Notified body submission report
Protocols & Procedures
Broad technical and regulatory expertise enables the generation of robust protocols and procedures to support packaging manufacturing operations.
- Develop SOPs, specification templates, guides, work instructions, best practice documents, and training curriculum for GMP SOPs.
- Conduct gap analysis of legacy packaging systems
- Documentation required for audit remediation, root cause analysis and CAPA closure
- Complete pre-production packaging documentation including manufacturing procedures, end item specifications and inspection procedures.
- Global regulatory strategies for packaging systems
- Audit responses & justification of audit observations
- Process development
Meeting global regulations for design, performance and test methods requires expertise in developing strong defensible testing strategies.
- Author master validation plans, protocols, reports
- Efficient and compliant validation strategies
- Design qualification activities: materials qualification, package design, package testing
- Process validation: packaging equipment qualification (IQ/OQ), performance qualification (PQ)
- Process development using FMEA & D.O.E tools
- Conduct shelf life studies; accelerated and real time
Test Plans & Testing Services
Drawing from our deep knowledge of Global Regulations, Guidance and Standards allows efficient and effective development and execution of testing plans.
- Defensible testing strategies, plans and test method protocols
- Testing required to demonstrate ISO 11607 compliance
- Develop test method protocols and validate test methods in the client’s laboratory