The validation of an environment with controlled contamination is a procedure that verifies whether a clean room, operating theater, or cleanroom meets the legal requirements for quality and safety. In particular, during validation, contamination or, better said, non-contamination of surfaces and airborne particles in the areas is checked and certified according to two standards:
ISO 14644 for special, non-living contaminants and ISO 17141 on contamination by living microorganisms.

Testing and validation make it possible to check the conformity of a location with the acceptance criteria set out in the standards of good practice, the guidelines of the INAIL institute, and in the UNI 11425 standard.

Guarda Medical offers assistance and support at all times in defining requirements, controlling, checking documentation, acceptance testing, and regular validation for the commissioning of environments with controlled contamination.

Our areas of expertise include the departments for HEMATOLOGY, HEMODYNAMICS, OPERATING ROOMS, INTENSIVE CARE UNITS, STERILIZATION CENTERS, and ENVIRONMENTS WITH CONTROLLED CONTAMINATION, where we perform the following activities:

  • Functional testing of ventilation systems, including determination of airflow and air exchange
  • Evaluation of Recovery Time with respect to the efficiency of air exchange components inside treatment systems
  • "Smoke Test" to assess airflow within a specific environment
  • "Emery Test" to check the integrity and efficiency of high-efficiency particulate air (HEPA) filters and ensure
  • Tests of the microclimate, temperature, and humidity
  • Control of pressure gradients ΔP to test pressure in ventilation and cooling systems
  • Testing of ISO class for air quality
  • Analysis of microbiological contamination of air with active sampling and sedimentation
  • Monitoring of anesthesia gases: nitrous oxide and/or halogens
  • Monitoring of medical personnel regarding exposure to volatile organic compounds (VOCs) such as formaldehyde, xylene, ethanol, etc.
  • Testing of lighting, sound pressure, and thermal comfort in operating rooms
Our scope of activity in LABORATORIES for NUCLEAR MEDICINE, STERILE PHARMACEUTICAL PREPARATIONS, CYTOSTATICS UNITS (UTA), TISSUE BANKS for storing skin and PMA LABORATORIES includes the following activities:

  • Functional testing of ventilation systems, including determination of airflow and air exchange
  • Evaluation of Recovery Time with respect to the efficiency of air exchange inside ventilation systems
  • "Smoke Test" to assess airflow within a specific environment
  • "Emery Test" to check the integrity and efficiency of high-efficiency particulate air (HEPA) filters and ensure
  • Tests of the microclimate, temperature, and humidity
  • Control of pressure gradients ΔP to test pressure in ventilation and cooling systems
  • Analysis and testing of microbiological contamination of air and surfaces with active sampling and sedimentation
  • Testing of good manufacturing practice (GMP)
  • Swab and pad tests to test contamination with residues of chemotherapeutic cytostatics
  • "Media-Fill Test" for process simulations
We organize REGULATORY ACTIVITIES and TRAINING COURSES on the following topics:

  • Technical functions of the systems for personnel
  • Planning and description of procedures and processes
  • Risk assessment, also on the finished product
  • Staff training using work instructions
  • Thematic courses

The world of environmental validation has been a fascinating discovery for Guarda Medical. A market with enormous potential that will be a real challenge in the future: managing and controlling healthcare environments against bacterial and viral threats.