For the safe production and rock-solid research on medicinal products, the life sciences industry relies on the controlled environment of cleanrooms. The microbial load in the room and the number of particles present in the air determines the cleanroom class. Depending on the activities taking place in the room, the space must meet a certain cleanliness level.
For example, experts perform the most critical steps in the life sciences industry in a Class A (=ISO 5) cleanroom. In these rooms, the air is 10,000 times cleaner than the average city air. Besides, the room itself must also be built in a way to avoid build-up of contamination on edges, corners and hard-to-reach places. And because people are the biggest source of contamination in a cleanroom, they have to adapt their attire and behaviour to the specific class according to strict procedures.
Heating, ventilation and air conditioning - or HVAC - is the umbrella term for the various systems that take care of the temperature, humidity and cleanliness of the air in a given area. Those systems are also indispensable in the life sciences industry because they ensure that the cleanroom meets the specifications of the assigned class with flying colours. How?
- By adequately filtering, cooling, heating & mixing the air with fresh outdoor air.
- By ensuring that the cleanroom is at an overpressure relative to areas with less clean air, contamination can be kept out.
Extremely important tasks performed by the various air groups that make up the HVAC:
- Fresh air group for outdoor air supply
- This fresh air supplies oxygen. The filters in the group already perform initial filtration and the group brings the air to the desired temperature and humidity.
- Recirculation group for recirculation of air over several filters
- The air is sufficiently filtered and possible heat loads from the room are eliminated.
- Extraction group for expelling excess air
- This air group regulates the excess pressure in the room by controlling the amount of extraction air.
“Due to the high complexity of processes and requirements within the life sciences industry most HVAC systems are quite unique. Therefore, each specific situation should be carefully analysed.”Bart - Principal Project Engineer
During the medicine manufacturing process, various utilities are required which come under the heading of facilities. The standard utilities, including electricity, softened water, power, compressed air, nitrogen, CO2, etc. that we find in every industry.
In addition, in the life sciences industry also has the purer utilities used within cleanrooms. Think about process air and clean steam, both purified for direct contact with medicinal products. But also WFI (Water for Injection), which has different levels of purity. Soft water is filtered into demineralised water and can be further purified into water for injection, i.e. pure enough to be used directly in medicines.
Facilities – Advipro @ your service
- Validating & delivering new & upgraded cleanrooms
- Analysing & resolving audit observations regarding contaminants & operations within the cleanroom
- Performing, testing & reporting the specifications in cleanrooms for both initial validation and periodic re-qualifications and sampling. This is the specialisation of our MoVE department.
- Training on cleanrooms, cleanroom behaviour & clothing, both standard and customised
- Validating & delivering new & existing air groups
- Starting up and adjusting new & existing air groups & testing HEPA filters periodically. Our MoVE department has it covered.
- Training on how HVAC works
- Validating & delivering new & existing installations
- Performing risk analyses from a GMP or technical perspective to identify plant weaknesses & suggest improvements
- Analysing & resolving audit observations in relation to utilities
- Performing, testing & reporting the purity of various utilities for both initial validation and periodic requalifications and sampling (MoVE)