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Products - Pharmaceutical Sterilizer

  • 7” Multi-color touch screen panel
  • Sliding door horizontally and vertically
  • Keypad control panel on second door of two door autoclaves
  • Stores the last 200 cycles in built-in memory
  • Multiple access levels and user passwords to control access/ operation of the autoclave
  • Sterilization Temperature range 105°C to 138°C
  • 21 CFR part 11
  • Independent Recording for cross-checking cycle measurements

Designed for general purpose, sterile room supply, media preparation, or terminal sterilization applications performed in biopharmaceutical and pharmaceutical facilities, and biotech research and development facilities.

The KEC STERILIZER GMP steam sterilizer is designed, manufactured, tested and documented according to the latest global practices and standards to facilitate Customers’ compliance with current Good Manufacturing Practices (CGMP) and Good Automated Manufacturing Practices (GAMP). Temperature distribution within the chamber, including drain temperature, is guaranteed to be within ±0.5°C (±0.9°F) of the process sterilization temperature (exposure set point). This exact temperature distribution verifies the repeatability needed for validation cycles. The sterilizer is fully tested and pre-validated during factory qualification. Prequalification reports of the installation, operational, and performance qualifications are provided, along with complete documentation on machine design, construction and control software.