Compliance pilot testing

The purposes of the EDS for each technology were to (1) support the certification decision of the Under Secretary of Defense for Acquisition and Technology, as directed by Public Law 105-261 (2) support the development of a request for proposal (RFP) for a pilot facility and (3) support the documentation requirements for compliance with the National Environmental Policy Act (NEPA) and the Resource Conservation and Recovery Act (RCRA) permit application. Each EDS required the development of an EDP and experimental tests to acquire necessary data that had not been obtained during the demonstration test phase. 

Change in batch size, up to and including a factor of 10 times the size of the pilot/biobatch, where 1) the equipment used to produce the test batch(es) is of the same design and operating principles 2) the batch(es) is (are) manufactured in fuU compliance with CGMP s and 3) the same standard operating... 

Pilot-plant experiments to obtain complementary information - continuous tests, new geometries, new operating conditions, mid-long term fouling, cleaning - and simulation with a strict compliance with basic rules for scaling-up (all the dimensionless numbers are kept constant). 

Other services For chemicals, refer to Section 21.4 for guidance on materials selection for common chemicals. For other chemicals, refer to the available literature. For proprietary technologies, follow the guidance of the process licensor. Such guidance is always subject to review for compliance with safety and design life requirements. Plant experience and pilot plant testing, in some cases, will indicate suitable materials. 

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