A state of the art cleaning area is available to ensure a high throughput, streamlined cleaning process. Segregation of cleaned equipment from un-cleaned is maintained via dedicated storage rooms and a defined equipment flow path. Proprietary equipment designs allow for easy access to all product contact surfaces during cleaning. A wide range of validated detergents; sonication baths, high pressure rinse equipment and soaking tubs are available to facilitate the removal of the most difficult materials. The water used to clean the equipment is free from microbial activity through UV-light treatment; micro-filtration; continuous re-circulation at elevated temperatures and monitored with quarterly testing.
Cleaning Acceptance Criteria
  • Visually Clean
  • < 10 ppm crossover between campaigns
  • < 1/1000th of a minimum dose of prior API into maximum dose of subsequent API.
Design Attributes of Cleaning Suite
  • HEPA Filtered Air Supply
  • Temperature and Humidity Controlled
  • Segregated rooms for clean and contaminated equipment
  • Wide range of validated cleaning detergents with varying pH
  • Sonication baths/high pressure sprayers.
  • High quality water supply