Whatever their intended function, establishing a cleanroom necessitates careful thought, both in the design process and in how it is used. Cleanrooms play a vital role in manufacturing, scientific research, and quality control.
What Exactly Is A Cleanroom?
A cleanroom is a controlled environment within a larger facility that maintains a certain quantity of air particles and other pollutants. It can be classified as clean in three ways:
- The air quality is managed.
- All surfaces and equipment are consistently cleaned to a high quality.
- It is run in a specified manner. For example, the number of employees is restricted cleanroom.
What Is Pharmaceutical Cleanroom?
A pharmaceutical cleanroom is simply a place that has been cleaned to an exceptionally high standard, free from any contamination or infiltration, and is intended for use in the manufacturing of medicines or medical procedures.
Why Do You Require A Cleanroom?
A cleanroom is required by a corporation for a variety of reasons. You may be producing a substance that is readily polluted by airborne particles, or it could be too dangerous to produce in an open area.
Cleanrooms are typically required in the following industries:
- Medical electronics and pharmaceuticals
- Facilities for aerospace research
- Suppliers of chemicals
- Military
How To Create A Cleanroom?
The International Organization for Standardization (ISO) establishes cleanroom setup and operating standards. The design phase is the first step in establishing a cleanroom. During this step, think about how the cleanroom will be utilized, the permissible particle concentration, its location, the production process requirements, and the cost.
Cleanroom designers will need to conduct in-depth interactions with end users to ensure that all demands are met throughout this phase. The design criteria for your sector will largely rely on whether the substance being handled in the clean room is hazardous or non-hazardous.
What is a Modular Cleanroom?
A modular cleanroom is a type of cleanroom that is constructed on-site from pre-fabricated, factory-made components that are installed according to the customer’s exact specifications. These pre-fabricated components contain both wall and ceiling panels, in addition to unique characteristics such as pass-thru chamber panels and airlocks.
12 Factors To Consider While Establishing A Cleanroom
There are several factors to consider in the process of modular cleanroom manufacturing. Along with the realities of how much space you have and how much space your equipment requires, you must also consider the following:
HEPA filters (High-Efficiency Particulate Air): These filters help to control pollution by filtering particles as tiny as 0.3 microns. To eliminate impurities from the air and provide fresh air to those working in the cleanroom, air should be continuously cycled through HEPA filters.
Ventilation: It is necessary to maintain air quality and replace process exhaust. Because this requires a lot of energy, you’ll need more room for cooling unit components, as well as wider air passages, noise suppressors, a backup generator, and massive intake and exhaust stacks.
Air pressure: To avoid wind infiltration, cleanrooms should have a static pressure greater than ambient pressure. Airlocks also serve to reduce or avoid pressure shifts that might jeopardize the process.
Temperature and humidity control: Temperature control implies maintaining constant and stable temperatures for goods and equipment. Controlling humidity reduces corrosion and condensation on interior surfaces, as well as static electricity. These two aspects are critical to the operation of a clean room as well as the comfort of those who work in it.
Architecture: To maintain a continuous airflow throughout the cleanroom, the air must travel as freely as feasible. If the airflow is limited, the ensuing turbulence might promote particle migration, increasing the danger of airborne pollutants.
Measuring equipment: A cleanroom must be measured on a regular basis to verify that parameters such as particle count, airflow, humidity, temperature, and cleanliness are within acceptable limits.
Lighting: A darkly lighted cleanroom will not help you. Because you won’t be able to clean thoroughly, particles may accumulate, and you may misinterpret instrument displays. A cleanroom’s lighting should be consistent and homogeneous, with minimal dark patches.
Future-proofing: Make sure your cleanroom is designed to be as adaptable as feasible to future expansion, new equipment, or process modifications.
Internal surface materials: In a cleanroom, any surface material that sheds particles and contaminates the air is prohibited. They must also be resistant to disintegration when cleaned, which means they must be compatible with your cleaning chemicals.
Showers and washing facilities: Depending on your needs and materials, you may need to provide showers and laundry facilities for decontamination. This implies you’ll have to think about plumbing and hazardous waste disposal.
Hazardous chemicals: If your cleanroom handles hazardous compounds, further precautions should be taken, such as employing a negative air pressure system and specific waste air treatment, as well as personal protection and separate entrances and exits.
Cleanroom Certification
Cleanrooms should be validated and certified, which entails a series of examinations. It should also be checked and revalidated on a regular basis to ensure that the standards are up to current.
Cleanroom certifications vary based on your geographic area and the function of your clean room. The International Standards Organization (ISO) oversees the most recent cleanroom criteria and classifications, and you must fulfill these standards in various categories to obtain cleanroom certification.
Once your cleanroom is put up, it must be carefully maintained to retain its integrity. This includes taking precautions to reduce contamination risks, restricting access to a small number of trained staff at a time, performing routine cleaning and maintenance, maintaining ongoing monitoring, and recertifying on a regular basis.