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Feasibility and Front End Design Containment engineering Facilities engineering Process design Project management Validation Validation management Facilities and utilities validation Process validation Cleaning validation
 

Cleaning validation

Our experts at GRC have the cleaning validation knowledge and experience to design a specific cleaning regime tailored to your requirements, or to perform a clean on an already constructed system to identify any particular areas of poor cleaning such as pipe drops/elbows, additive lines.


AREAS OF EXPERTISE

SIP

  • ValidationUse of Kaye Validator to ensure pipework and contact surfaces achieve sterility and sanitisation.
  • Report construction to graphically and statistically represent data.
  • Identification of any specific cold spots/lag areas.
  • UV/Riboflavin testing to confirm effective cleaning of all areas eg Fermenter vessels.
CIP

  • Product Recovery
  • Multidirectional stationary sprays v 360° rotation
  • Once through v recirculation of cleaning agents
  • Intensity of cleaning regime
  • Number of steps
  • Automated v Manual cleaning
Swabbing

  • Identification of difficult to clean/reach areas
  • Provides level of contamination risk
  • Identifies any areas of potential buildup which may result in pathogens
Rinse Water Testing

  • Bioburden
  • Total Organic Carbon
  • Endotoxin
  • Conductivity
  • pH
  • Nitrates


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