Setting up a cleanroom in the pharma industry needs careful considerations, starting from the design phase to the way you utilize it. Cleanroom is an essential part of scientific research, manufacturing processes and quality control. Setting up a cleanroom requires you to assemble various parts like pharmaceutical cleanroom doors, glazed partition, etc.
What is a cleanroom?
In layman terms, a cleanroom is a controlled zone within a wider institute where a specific level of air particles and other contaminants are maintained. This is achieved in these three ways:
- By controlling the air quality
- All these surfaces and equipment maintain a certain standard of cleanliness
- Its operation is done in a precise manner — for example, the staff members working in the room are limited
Why you need cleanrooms?
There are various reasons for which a company might need a cleanroom. You might be into manufacturing products that can get easily contaminated by airborne particles or the products are hazardous to keep them in an open environment. Modular Cleanroom Partitions supplier and Manufacturers make cleanroom equipment for a variety of industries like:
- Research facilities
- Chemical suppliers
How to set up a cleanroom?
The standards for cleanroom set up and operations are given by The International Organization for Standardization (ISO).
The first step in setting up a pharmaceutical cleanroom doors is to design the room as per your requirements. You must decide the location and use of the set-up, manufacturing process and budget. Your Modular Cleanroom Partitions supplier and Manufacturers will have an in-depth conversation with you to ensure that all your needs are captured in this phase.
This step largely depends on the type of industry and if the type of material manufactured in the cleanroom is hazardous or not.
12 points to consider when setting up a cleanroom
- HEPA (High-Efficiency Particulate Air) filters: These filters help to control contamination by filtering particles as tiny as 0.3 microns. Air must be circulated through HEPA filters continuously to eliminate the contaminants from the air and to supply clean air to the staff inside the cleanroom.
- Ventilation: Ventilation is needed to preserve the air quality and replacement of process exhaust. This process requires a lot of energy, so you need extra space to keep the cooling unit components in addition to larger air passageways, a backup generator, noise suppressors and exhaust stacks.
- Air pressure: A static pressure higher than the atmospheric pressure will ensure the prevention of infiltration by the wind. These airlocks will also minimize the changes in pressure which could have compromised the process.
- Temperature and humidity: Temperature control will ensure stable and consistent conditions for production on the other hand humidity control stops corrosion and condensation of internal surfaces thus, eliminating static electricity. These are the two most important factors in the functioning of a cleanroom as well as for the safety of the team working inside it.
- Architecture: For maintaining a consistent airflow within a cleanroom, the air must flow in an unrestricted path. If the airflow is restricted, it will cause turbulence causing movement of particles. This in turn raises the risk of airborne contaminants.
- Measuring equipment: Cleanrooms need to be measured time and again to ensure that factors like airflow, particle count, humidity, cleanliness and temperature are at the desired levels.
- Electrostatic discharge: Electrical charge can be caused by both moving air and moving people. To avoid any damage electrostatic discharge protective materials should be installed.
- Lighting: Dimly lit cleanrooms can hinder a lot of your activities. You would be unable to clean properly so dirt will build up gradually. Therefore, we need consistent lighting in the pharmaceutical cleanroom doors with few dark spots.
- Future-proofing: Ensure that the cleanroom you get for your institute is flexible in order to compensate for future changes. Many people these days are opting for modular solutions because of this reason.
- Materials used for internal surfaces: Any surface material that shed particles is prohibited from the pharmaceutical cleanroom doors. They must be resistant to breakdown during the cleaning process so they become compatible with cleaning products.
- Showers and laundry facilities: If it is possible provide showers and laundry facilities to keep people decontaminated. To have these facilities you must consider the plumbing and hazardous waste treatment.
- Hazardous materials: If your cleanrooms handle hazardous substances, extra considerations like using a negative air pressure system, personal protection, the special treatment of waste air and separate entrances and exits.
Should you have a certified cleanroom?
Cleanrooms must be validated by undergoing a series of tests. It must be updated regularly to maintain high standards. Everything should be maintained as per the latest ISO standards. Then only you will get certified.