Packaging Sector Specialisms

Medical Packaging Validation

Validation of the chosen package is an integral part of its technical file and an essential requirement for CE accreditation.

Riverside offers this Packaging Validation service. Each validation is bespoke to customer product requirements and would involve a selection of appropriate tests. Sterilisation Validations for ETO or Gamma Irradiation can also be arranged and monitored in accordance with ISO 11135 and ISO 11137.

Riverside have CE accreditation for Class I sterile devices and a number of Class IIa medical devices.

Validation ensures all packaging and processes are reliable, repeatable and fit for purpose

  • Creation of Validation Protocols covering all aspects of:

        - Design Qualification
        - Component DFM, Mould tool design, URS, Risk Assessment, FAT
        - Installation Qualification
        - R & R, MSA, SAT, Equipment Environment Facility
        - Operational Qualification
        - Process optimisation, Process capability analysis, Functional & dimensional assessment
        - Performance Qualification
        - In-process testing, Product training, Batch traceability, Production control
        - Final Summary Report
        - IQ/OQ/PQ Checklists, FAT & SAT Reports, FOIRs/ISIRs, MSA/R & R Studies,
        - Capability Studies, Interchangeability Studies

  • Full validation of mould tools, processes and equipment

100-percent inspections to get 100% consistency

Medical packaging validation ensures that the products manufactured are packaged consistently meet the applicable requirements and specifications. Validation of processes used to sterilise drug products and equipment are the most critical validation activities undertaken. The objective of Validation is to determine that the sterilisation process will consistently achieve sterility and that it won't have an undesirable effect on the device or its packaging.

Find out more about how Riverside Medical Packaging can help you with your medical device manufacture call 01332 755 622 or complete the enquiry form

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