What is the difference between process windows and specifications?
A process window defines the manufacturing parameters (machine settings) under which the sterile barrier system will be produced. Specifications, on the other hand, detail the various properties and characteristics of the sterile barrier system, establishing limits where appropriate. Examples of properties that may be included in a specification are dimensional requirements, seal strength, and seal integrity to name a few. ASTM F99 and F2559 are excellent references when developing specifications. Sterile barrier systems that are produced within a validated process window should yield product that falls within the specification.