The evaluation of controlled environments and their processes aims at ensuring and monitoring the compliance of environments, equipment, and procedures with current regulations.
All monitoring and validation activities must be tailored to the intended purpose and the type of controlled environment: fume hoods, clean rooms, biological safety laboratories (PCL3, BL3, and P3), mini-environments, incubators.
Environment compliance is based on an approach envisaging a Risk Analysis and controls carried out in line with current regulations for clean rooms and related controlled environments:
In addition, White Lab offers an environment monitoring service to the public and private hospital sector.
- ISO 14644 standard focusing mainly on air and surface cleanliness
- ISO 14698 standard on biocontamination control divided into 'General Principles and Methods' and 'Evaluation and interpretation of biocontamination data'
The physical, chemical, and microbiological testing is carried out in line with ISPESL (Italian National Institute of Occupational Safety and Prevention) standard (Guidelines on Standards of Safety and Occupational Health in the Operating Department) and are compulsory for the most critical wards such as operating rooms, NICUs (Neonatal Intensive Care Units), MARs (Medically Assisted Reproduction), etc.
The guidelines focus on three main aspects:
The two main goals are ensuring that these environments have an adequate level of health and hygiene safety and that they comply with current laws and regulations on occupational safety (Italian Legislative Decree 81/08).
- Structural, technological, and instrumental requirements
- Hygienic-environmental requirements
- Environmental and system characteristics
The acceptable values for clean rooms and operating rooms as regards specific parameters such as airborne particle contamination vary depending on their class group:
Other parameters such as the Total Microbial Count do not have legal maximum levels. It is however necessary to set target values, warning values and action values, as the purpose of the sampling is to ensure that the contamination-controlled ventilation and conditioning system and the disinfection procedures work properly.
- Clean rooms have a ranking system running from ISO 1 to ISO 9 (from the cleanest to the least clean)
- UNI 11425:2011 standard on operating rooms sets out ISO class 5 for very good air quality, ISO class 7 for good air quality, and ISO class 8 for standard air quality
Perform the evaluation of controlled environments and their processes with White Lab, in order to ensure and monitor the compliance of environments, equipment, and procedures with current regulations.
- Measurement of airborne particle and microbial contamination
- Measurement of flow rates and recirculation rate
- Microbiological control of compressed air in line with ISO 8573-7 standard
- Measurement of microbial contamination of surfaces and/or work tools
- Recovery time
- Validation of sterilisation and disinfection processes
- Validation of washing and disinfection processes
- Monitoring of equipment calibration (P, T°, etc.)
- Drawing up of Staff and Sanitation Operating Procedures
- Evaluation of the effectiveness of treatment, air conditioning, and process fluid systems
- Staff training
Analysis and services
Soils and Sediments
Testing any type of soil and sediment for agronomic evaluation and remediation activities.
Testing and services to ensure that materials in contact with food are in compliance.
Consultancy, sampling and testing regarding CEMS, biogas, soil gas, biofilters, and odorous emissions.
Testing and services for tanning industry
Find out White Lab's comprehensive offer for companies operating in the tanning industry.
Indoor & Outdoor
Physical, chemical and microbiological testing to monitor air quality.