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Understanding Requirements of Client

Understanding requirements of client

Understanding requirements of client is first and crucial phase and our expert team does thorough job by asking pertinent questions & thorough inspections Requirements are further broken into smaller phases for getting complete clarity about the project.

Understanding type of project and classifying it

Project type and its mandatory validations vary from process to process and product to product. Requirements of pharmaceutical or biotech companies / laboratories or IVF laboratories set up will be different and so its mandatory validations.

Understanding Product / process flows

  • Understanding required levels of temperature, relative humidity (RH) and pressure gradients at various stages
  • At what point & at what frequency does the material enters aseptic manufacturing area?
  • How does it change places from aseptic manufacturing area to packaging area?
  • At what point is the product exposed to the environment?
  • How is the product placed into its packaging and conditions around it?

Understanding Component flows

  • Do the components need washing, sterilization?
  • How do components move from one area to other
  • What kind of processes are executed on components including but not limited to cooling heating etc.

Understanding machine and equipment used in the process?

  • What type of washing and sterilization equipment is used before sterilization of components?
  • Is any accumulation of sterilized product final enclosure required?
  • Do any parts of the equipment produce large amounts of particulate loads

General Inspection

  • List of items need to enter the aseptic manufacturing area?
  • Are there any storage requirements of product contact parts (machine parts, filters, etc.) within the aseptic area?
  • Cleaning sterilization regimen?
  • Required hours of operation of the facility?