The scale-up of a chemical process is an excercise in many subdisciplines. The bench chemist has to do his/her magic in finding a suitable reaction and purification scheme. Process R&D managers must exercise managerial art in shepherding people through a timely execution of the project. Purchasing managers must arrange for just-in-time arrival of raw materials and inventory managers must see to it that they are properly staged.
Technical writers must have a batch record written and signed off. Process hazards and EH&S folks must have procedures to evaluate for safety and regulatory compliance. Regulatory affairs people must have submitted forms for TSCA compliance. PSM processes must have all of the requirements in line for OSHA compliance. Air and water permits must be in place as well as provisions for capturing VOC’s and shipping of waste. Procedures for handling liquid waste streams and filter cakes must be in place. Successful kilo lab and pilot plant validation of the process must be signed and passed along. The analytical department must have procedures for raw material validation, in-process checks, and final analysis for certification.
In order to go forward, a sales person must have already worked out acceptable price and shipping terms. The customer must issue a purchase order and the terms must be accepted by the manufacturer. Production management must then schedule a production run once the scale-up effort is complete. The QA/QC folks must have acceptable specifications by which to issue a document certifying conformance to the specifications.
Once the PO has arrived, it’s show time.