Manufacturing Process Development

Process development
Process within the medical device manufacturing area such as assembly, inspection, testing, receiving, fabrication, sterilization, packaging, and others all require a careful process development method.  Toltec provides services to help your company development processes that are effective and compliant from regulatory perspective.

Process Analysis
An element required for building effective processes is process analysis.  Two widely used analysis tools are 1) process fmeas and 2) statistical analysis.  Toltec provides engineers with deep experience with these and other process analysis techniques.

Manufacturing Process Selection :

Injection molding Thermoforming Structural foam Composites Machining Sheet metal Ceramics Coatings Fastening techniques Assembly Test

Process validation

• Protocol development 
• I.Q. (Installation Qualification)
• O.Q. (Operational Qualification)
• P.Q. (Performance Qualification)

Manufacturing Transfer Considerations

Prototyping and Manufacturing

  Manufacturing capabilities through Partner Companies

Related Process Development and Validation Links:

  Quality Management Systems – Process Validation Guidance, May, 1987, Center  for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health, Food and Drug Administration (US government). http://www.fda.gov/CDER/GUIDANCE/pv.htm

  Guideline on General Principles of Process Validation, Authoring Group: SG3, Endorsed by: The Global Harmonization Task Force, Edition 2, January 2004. http://www.ghtf.org/sg3/sg3-final.html