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