Pharmaceutical Support: Parenteral Validation
PROJECT DESCRIPTION
E2i provided validation services for several on-going engineering projects in the client’s parenteral area. The work included:
- Management of the relocation of a Lyopholizer to another building
- Generation of an IOQ protocol for the compressed air piping which services a pilot plant and surrounding labs, and performed field verification and IQ validation
- Generation of as-built drawings for Getinge Autoclave and performed software OQ
- Development of an IOQ for the particle monitoring system (Manufacturer: Particle
- Measuring Systems, Pharmaceutical Net Software application)
- Specification of a pump unit for the pilot plant scale ultrafilter unit and investigated alternative pump vendors
- Development of user requirements and IOQ protocols for ultrafilter components and support equipment (such as water baths, vessels, incubators, instrumentation, chart recorders, ultraviolet detectors)
DISCIPLINES
- Document generation
- Test execution
- Drawing generation and review
- Project management