User requirement specification, plant design

Specifications include dimensions of length, width, and depth, in that order (Fig. 21-40 ). When boxes are set up and closed by automatic equipment, dimensional tolerances become critical. Cartons are shipped knocked down to the user from plants located in all industrial centers. Because order lead time is 4 to 6 weeks, inventories of empty boxes require considerable space. A useful booklet describing all aspects or corrugated box designs and materials is the Fiber Box Handbook available from The Fiber Box Association, 2850 Gulf Road, Rolling Meadows, IL 60008. 

The European standard EN 12186 (formerly the DIN G491) and more specific the EN 14382 (formerly DIN 3381) has been used for the past decades in (mechanically) instrumented overpressure protection systems. These standards prescribe the requirements for the overpressure protection systems, and their components, in gas plants. Not only the response time and accuracy of the loop but also safety factors for oversizing of the actuator of the final element are dictated by these standards. Independent design verification and testing to prove compliance to the EN 14382 standard is mandatory. Therefore, the users often refer to this standard for HIPPS design. 

Healthier people a potential market of 3-5 million patients is typically required to justify the investment in a conventional plant to manufacture a specific drug. The lower capital cost and increased flexibility of a facility designed to take advantage of single-use technology mean an order of magnitude reduction in the number of required users, so treatments become available that otherwise would not exist. 

---