Cleanrooms are an essential part of industries in which manufacturing processes are vulnerable to the interference of small particles. Similar is the case with pharmaceutical and medicine industries that requires a cleanroom known as GMP Cleanroom. The existence of cleanrooms is very important in this industry because cleanrooms perform the duty of protecting manufactured products from contamination. The contamination is usually caused by humans and processes and is necessary to be eradicated from the air.
What is GMP cleanroom?
GMP is an abbreviation of Good Manufacturing Practices and it demands manufacturers and processers to take dynamic steps making sure that the products are pure, effective, and safe to use. A GMP Cleanroom is a blend of engineering and designing methodologies, fabrication, finish and control strategies that are needed to transform a normal room into a cleanroom. GMP directives need a very quality approach towards cleanrooms that enables manufacturers to shrink or eradicate chances of contaminations and mistakes. This is done to ensure the safety of consumers that they do not end up purchasing a product that will not have any effect or which might risk their lives. This set of rules and regulations has been enforced by the US Food and Drug Administration that comes under the authority of the Federal Food, Drug, and Cosmetic Act.
GMP cleanroom standards
What actually makes a cleanroom “clean”? Rooms having the mentioned characteristics are actually following the GMP cleanroom standards and can be referred to as Cleanroom.
- The Internal Surfaces: To achieve the internal surface as per GMP Standards, the surfaces of the room should be robustly impregnable, and smooth. They should not be causing any contamination like dust particles, corrosion, and habitats for microorganisms. The surfaces should be easily accessible for cleaning and should be strong enough to avoid cracks and leakages.
- Airflow: Cleanrooms require good airflow with keeping temperature and humidity levels under control. The Air Handling Units (AHU) in cleanrooms usually contribute up to 60% of power consumption. A general of thumb says the cleaner the cleanroom has to be, the more air it consumes.
- Operating Cleanroom: The way of operating has to be one of the most important factors for a room to be a cleanroom. This involves reducing the potential contamination escaping from manufacturing processes, regular cleaning, and maintenance, controlled access to the cleanroom i.e. allowing only expert’s entries, etc.
ISO vs GMP cleanroom
The ISO and GMP standards are the top standards for cleanroom, hence it becomes necessary to look at ISO vs GMP cleanroom standards to know the difference between the two.
ISO allows airborne particle sizes to be ≥ 0.5 µm only while GMP allows it to be both ≥ 0.5 µm and ≥ 5.0 µm. The types of the sterile process allowed by ISO are aseptic only whereas those allowed by GMP are both aseptic and terminal sterilization. The occupancy states in ISO consist of “in operation” only and in contrast to that GMP has both “at rest” and “in operation” states. Zone D has no analog in ISO and it exists in the GMP cleanroom.
Grades are equivalent to ISO classes such that
- When a GMP cleanroom is of Grade A, it stands at Class 5 in ISO.
- When a GMP cleanroom is of Grade B, it stands at Class 5 in ISO.
- When a GMP cleanroom is of Grade C, it stands at Class 7 in ISO.
- When a GMP cleanroom is of Grade D, it stands at Class 8 in ISO.