Validating a process from beginning to end is a daunting task which can involve an entire trail of quality assurance, not only of the equipment involved in the production of your product but also storage conditions. Process Validation should verify that procedures and processes, used in the manufacturing of your product, are suitable for their purposes, and guarantee that the process used will consistently meet its predetermined specifications and quality characteristics. The procedure must outline the way of carrying out an activity. The process is a set of methods and actions which interact to convert what goes in to what comes out. Process Validation is a requirement of regulatory bodies.
We have validated 100s of different equipment, some of them are listed here – Packaging Equipment – Dosing, Sachet, Auger Filler, Tablet Fillers, Capping Machines, Ultrasound Sealers, Heat Sealers, Foil Sealers, Overwrapping machines, Blister Packaging Machines, Clinical trial, phase I, II and III, Multivac, Mespack, Doyen, Harro Hofliger, Noack, Uhlmann and lots more.
Validating a cleaning method is a way of ensuring there is no cross contamination between products when using the same equipment. The cleaning methods must ensure there are no micro-organisms left post cleaning. The cleaning method may involve manual cleaning or Clean In Place solutions. In either case the agents used, design and construction will be challenged for effectiveness.