ABSTRACT

Instrumentation is the critical link between the manufacturing process and the control system. Instruments are the eyes (i.e., transmitters, sensors) and limbs (i.e., actuators, positioners) of a process control system and enable it to perform the actions that were once performed by operators and laboratory technicians. If an instrument should malfunction, data integrity and the predefined control actions will be affected. Indeed unsatisfactory instrumentation can cause significant operational problems. It is essential that an instrument is carefully chosen to be fit for purpose (i.e., correct type, size, materials, accuracy, repeatability, reliability, documentation, etc.) to enable confidence to be gained in its ability to perform its intended function.2,3

This case study embraces the design and validation of both standard and intelligent instrument applications, and briefly discusses special instrument systems (shutdown systems and analyzer packages). The number of instruments that can be involved with the dynamic operation of a pharmaceutical manufacturing process can be large (2000 to 3000 items). In most cases, they are remotely installed from the control room environment and operate unsupervised except during routine maintenance work.