BAS in a PAT Framework :
©2007 Stevens Institute of Technology 2 BAS in a PAT Framework PAT Approach
PAT-Methodology for designing, analyzing, and controlling manufacturing processes
Goal of PAT: to understand and control manufacturing process
Way to achieve this goal: dynamic process that manage variable and using validated control
PAT framework components
A set of scientific principles and tools to support innovation
Regulatory implementation strategy which will include innovation
Building Automation System
concept arise from manual room temperature systems which is replaced by electric thermostat
In Pharmaceutical industries, As manufacturing complexity increases, more complex BAS/HVAC requirements for aseptic and sterile spaces occurs
BAS in a PAT Framework :
©2007 Stevens Institute of Technology 3 BAS in a PAT Framework BAS use computer-based monitoring to coordination, organize and optimize building control sub-systems like security, elevators, fire/life safety.
Applications:
Equipment scheduling
Optimum start/stop
Operator adjustment
Monitoring
Alarm reporting
BAS in a PAT Framework :
©2007 Stevens Institute of Technology 4 BAS in a PAT Framework WHEN TO VALIDATE:
Anything that can affect directly quality of product is called as direct impact. There are following steps to decide if BAS need to be qualified or not.
An impact assessment performed to determine that a device is "direct impact," "indirect impact," or "non-impact."
A risk analysis performed to decide the extent to which the product can be at risk due to the BAS or HVAC
BAS in a PAT framework :
©2007 Stevens Institute of Technology 5 BAS in a PAT framework by design BAS and HVAC are closed-loop feedback systems which provide continuous process control. Increasing automation to improve operator safety and reduce human errors
PAT tools include:
Multivariate tools for design, data attainment, and analysis
Process analyzers
Process control tools
Continuous improvement & Knowledge management tools
Advantage for implementation of PAT are:
no rework, no scrap, little or no waste
cost reduction in manufacturing , process and product uniformity
higher yield, less rejection to no rejection
less validation, tighter process parameter
BAS in a PAT Framework :
©2007 Stevens Institute of Technology 6 BAS in a PAT Framework Q&A