Compliance with Regulations of areas environmentally controlled is based on good design and operation of air handling system, so this is one of the critical factors when it comes to designing, building and validating this type of facility.
Temperature, humidity, pressure, speed, distribution, cleaning and air quality are the parameters to be properly monitored and recorded to achieve and maintain specified conditions.
Controlled environment areas may have different uses and special requirements: Clean areas, sterile areas, containment areas and high containment biosafety areas, flameproof areas (ATEX) …
The design of the air handling systems should be customized and adapted to the specific conditions of each project.
The system must not only follow and enforce the general rules specified for each use, but must also be adapted to the particular conditions of each user and their operating characteristics and production growth prospects and future trends of the applicable regulations.
The life expectancy of the facility should also be taken into account and must be designed not only according to durability criteria but also criteria of modernization and continuous improvement.
Finally, the energy consumption of the air handling system is another important factor to consider and is one of the main components in the total energy consumption of the plant; therefore modern design must incorporate energy saving criteria, not only by the selection of more efficient equipment and components, but through an overall design concept based on energy efficiency.
Engineering department INGELYT HVAC deals with design, calculations, execution and control of these air handling systems.
Basically these types of facilities treat and filter the air properly besides controlling other environmental parameters according to USR’s and their adaptation to the specific rules of each case.
The differential pressure control and strict regulation of it, creating overpressure or depressions in different rooms, can reduce and control the introduction, generation and retention of any contamination in rooms: microbiological, dust particles , cross between products, or any other external contamination, including which operators can produce themselves.
Likewise distribution systems and air extraction are designed to achieve maximum environmental cleanning, minimizing the production, generation, and retention of particles in suspension.
Our installations include all necessary equipment:
- Special conditioners for clean rooms.
- Air conditioning fluid production systems (cold water, steam, hot water) and their distribution.
- Air distribution and extraction networks.
- Fluids distribution and extraction networks.
- Humidification and dehumidification systems.
- Absolute filtration.
- Energy recovering systems.
All this equipment usually has an associated control system, command and data acquisition that should be in accordance with international standards and GAMP5 CFR21 part 11 and that lets you manage and view the status of the variables that are relevant to the installation. These systems are used to control all system components, monitoring and alarm management, automatic management of operating cycles, recording, processing and display of all operating parameters for the management of installation analysis and optimization.
Air treatment Cleanroom facilities and controlled environment areas should be qualified and validated periodically, so the design of the installation must be done so that validation operations can be performed quickly and effectively, both to ensure correct and efficient validation and as to reduce the time and resources needed.