Challenge
In order to obtain CE mark certification for an innovative medical device, the Medical Device company was required to perform Validation of the production line with their subcontractor (CMO).
The production line
The device production line includes either automatic and manual processes: soldering stations, visual tests (according to IPC A 610 standard), assembly, and gluing stations. Besides, there are machines for cutting and exposing electrical wires, plastic pipes, a laser soldering machine, packing machine. The line includes various jigs and aids for assembly.
Skills and people required for this project
- Experienced process validation engineers, with in-depth knowledge of medical device regulatory requirements for process and software validation: GPSV, GAMP 5, 21 CFR part 11, part 820, cGxP, GHTF, ISO 13485:2016, CSV, and more.
- Ability to learn quickly and control all tasks and perform them while fully communicating with all relevant parties according to both Quality Departments (CMO’s and customer’s).
- Ability to identify the gaps between the various requirements for the situation on the ground, to identify the potential risks, and provide the solutions.
The steps of the project
- Carrying out a pFMEA risk assessment together with the customer team.
- Preparing the Validation Master Plan including the equipment in the production line, the software at the test stations, and the process validation.
- Preparing specification documents for the stations (URS and SW).
- Working with the customer’s statistics department and writing Test Method Validation (TMV) protocols, choosing a validation strategy according to the nature of the GR&R / attribute / variable test, the number of samples, the number of operators, and the number of repetitions required. Analysis of the results in statistics software to complete a final report.
- Writing Protocols and Final Reports IQ, OQ, PQ, TMV, CSV.
- Reviewing and updating drawings.
- Aligning and adapting the line to the requirements, the various test stations were upgraded to meet the level of reliability required for Test Method Validation (TMV).
In conclusion
The company received the CE mark and began to successfully market its device in Europe.
The Process Validation project was done on a tight schedule of about 4 months; saving the company several months due to the experience and knowledge of the RS NESS’s engineering team.
How we support Process Validation projects
The background and experience of our validation engineers came from various fields. This knowledge helps our customers to be focused and avoid mistakes and unnecessary work. “Target Oriented Arrow”. This focus is super critical to the success of this type of project, with the limited resources of start-up companies.
Contact us info@rs-ness.com to inquire for more information regarding our Process Validation engineering services.
Glossary
- CMO- Contract manufacturing organization
- IQ/OQ/PQ- Installation Qualification/Operational Qualification/Performance Qualifications
- TMV- Test Method Validation
- URS- User Requirement Specifications
- SW- Software
- GR&R- Gage repeatability and reproducibility
- GPSV- General Principles of Software Validation
- GAMP 5- Good Automatic Manufacturing Practices issue 5
- 21 CFR part 11 -Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food and Drug Administration (FDA) regulations on electronic records and electronic signatures
- cGxP- current good manufacturing, clinical or laboratory practices
- GHTF- Global Harmonization Task Force
- CSV- Computer Software Validation
