Validating environmental scan
The main objective of process validation remains that a process design yields a product meeting its pre-defined quality criteria.ICH Q8, Q9 and Q10 provide a structured way to define product critical quality attributes, design space, the manufacturing process and the control strategy.Identifying design problems, and solving them as early in the design cycle as possible, is the key to keeping projects on time and within budget.Too often, product design and performance problems are not detected until late in the product development cycle — when the product is ready to be shipped.At the time of commencing Process Validation, the other related elements of validation should be in place, e.g.: These requirements should be confirmed in a ‘Statement of Readiness to Proceed to Validation’In a multi - step synthesis, the intent is to Validate all steps identified as Critical steps from process development and/or historical data and Control (routinely test) other steps.Critical steps are those containing Critical Parameters and/or Critical Activities.The principles of steam sterilization are applicable to processes conducted within autoclaves as well as sterilization - in - place (SIP) processes. The steam (or super heated water) is used as a heat transfer medium to heat the contents of the vials/ampoules.The moisture required for sterilization is derived from the contents in the vial / ampoule.
These items were triangulated against the results of semi-structured interviews with 26 residents from three teaching hospitals to achieve face validity.
The old adage holds true: It costs a penny to make a change in engineering, a dime in production and a dollar after a product is in the field.
In the prototyping stage, engineers create actual working samples of the product they plan to produce.
For the sterilization of processing equipment, tubing, garments etc a porous load (equipment or hard goods) autoclave cycle is used.
Air must be removed from the chamber and load prior to the sterilization phase of the cycle.