Medical Device
Packaging Engineering
Services

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

Validation

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

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