Validations

Validation of medical devices confirms their compliance with all sets of product requirements. The aim is to demonstrate and document the process, installation and procedure and prove it consistently leads to expected results, as per medical devices regulations ISO 13485, MDD and FDA 21 CFR: Part 820. Validation at SteriPack starts with a thorough validation plan and ends with a detailed final report. The main subjects of validation are:

•  Injection molding validation EN ISO 13485 | FDA 21 CFR: Part 820
•  Cleaning validation EN ISO 19227 | ASTM F3127
•  Welding validation EN ISO 13485 | FDA 21 CFR: Part 820
•  Packaging | Sealing | Sterile Barrier Systems validation EN ISO 11607-1 | EN ISO 11607-2
•  Sterilization validation EN ISO 11135 | EN ISO 11137
•  Stability study validation Accelerated Aging ASTM F 1980-16 | Real Time Aging ICH Q1A(R2)
•  Test method validation (i.e. seal integrity, microbiology)
•  Printing validation ISO/IECn15414:2016
•  Computerized systems validation ISO 13485 | GMP Annex 11 | FDA 21 CFR: Part 11 | GAMP

Once the validation is completed there will be documented evidence that the processes are controlled and produce repeatable outcome within set parameters. Outsourcing manufacturing or packaging processes is inseparable with outsourcing their validation. Often, it enables freeing up customer’s engineering resources and accelerates validation lead-time, especially if it is processed on external supplier validation standard protocols.

Based on the experience of validating many manufacturing processes, SteriPack offers a set of standard validation protocols, including injection molding, cleaning, welding, sterile barrier packaging, sterilization and stability study. Additionally, our protocols can be modelled to accommodate any specific requirements from the customer to ensure all processes are qualified and operate within a set process window.

Validation for medical devices consists of the following steps:

•  Installation Qualification IQ
•  Design of Experiments DoE
•  First Article Inspection FAI
•  Operational Qualification OQ
•  Performance Qualification PQ
•  Design Qualification DQ
•  Design Verification
•  Design Validation