This project involved the assessment of several locations for a new Production Area, Laboratories and Offices. Trident provided a survey of existing spaces, preliminary space programming and development of preliminary concepts for each of the areas to assess the acceptability for use with the operation. In addition, a summary was created of advantages, disadvantages, and relative costs.

Trident provided the design of a renovation to an existing building to create a Biopharmaceutical Manufacturing Operation. The facility consists of various Class 100, 10,000 and 100,00 manufacturing suite with clean room utilities including, Purified Water, Clean Steam, and Compressed Air. The upgrades were focused on increasing the current manufacturing capacity and increasing level of cGMP control within the facility.

Trident prepared a facility wide Validation Philosophy Overview Document to provide an outline of validation requirements so that the client's management would have an idea of the magnitude of involvement required to qualify the Facility,Utilities and Processes. The overview document addresses new Air Handling Systems, Utilities and Process Equipment. This document was then used as an outline for a Validation Master Plan for the operation.