A clean room, or clean room concept is a facility implementation ordinarily utilized as a part of a specialized industrial production or scientific research plant. Clean rooms are usually most important in the production of pharmaceutical and computer hardware items.
The basis of controlled workspaces containing sterile fittings is getting to know all the necessary information about safety standards and quality assurance for the future staff’s wellbeing.
That is why we can identify several different clean room classification systems within the controlled spaces, as well as their adaptation to different risk levels.
According to these categorizations, most cleanrooms are positive-pressure rooms, but to ensure employee safety and production efficiency people many other clean room solutions are popular, such as:
- Retractable clean rooms,
- Custom-configured with multi-layered industrial air filtration,
- Modular clean rooms
Given that clean rooms have many designs and operating regulations, it can seem too complicated to understand and implement all the necessary standards, but the thing is – it doesn’t have to be as hard to build such an environment.
Focusing on the key questions and needs of your lab for a clean room concept, I will try to provide all the information needed to devise the most effective clean room environment.
A Basic Introduction to Clean Rooms
What is a clean room environment? As the name implies, a clean room concept is a clean and low pollutant environment, free of dust, microbes, aerosols, and chemical vapors.
What is a clean room used for? In a way, a clean room is a “contained area” with requirements made to minimize the introduction, generation, and retention of faulty particles inside the chamber.
Several controls of many environmental parameters are carefully implemented and used to control temperature, humidity, and pressure.
Why Is a Clean Room Environment Important?
Some industrial products are sensitive and receptive to pollutants that get them contaminated or even destroyed when in contact. For example, medical/pharmaceutical products or electronic goods and medical devices with nanotechnology and artificial intelligence (AI) – all require a clean room, and even a healthy building to condition them.
What’s the difference between a lab and a cleanroom?
Although contamination in the laboratory can be controlled with the use of high-efficiency particulates, such as HEPA filters, their specifications for measurement of particulate air quality pollutants are not as effective.
Reliable and accurate measurements of particles at trace and ultra-trace concentrations are frequently required in a variety of scientific activities related to environmental, nutritional, and high-tech materials.
A lab is a space where scientists do their research, experiments, testing as well as manufacturing, but with no need for a (heavily) controlled environment.
For example, some pharmaceutical manufacturers need a highly controlled laboratory environment, while a local high school can have a lab where students conduct experiments under control because no environmental risks are expected with their actions.
A serious lab that needs to control temperature, humidity, static, etc, implements a clean room for the sake of protection of their products from contamination, and the integrity of examination processes.
Equipment is put in place to maintain the cleanroom conditions, including air filter and flow systems, as well as methods for accessing the used space.
Many cleanrooms come with special chambers called air showers where contaminants are blown off of the staff before they enter the clean room. Scientists working in the clean room are often required to wear clean room gowns or lab coats.
Clean Room Classification
The level of cleanness and disinfection in a laboratory is usually defined by a maximum permissible amount of particles (also of a particular size) per unit of air volume. Several standard clean room classifications are currently in use worldwide.
Depending on the level of required contamination control, clean room classifications are led by the International Standards Organisation (ISO), and it is based on the number and size of particles permitted per volume of air. The lower the ISO Class Number (the size and consistency of the particles), the ‘cleaner’ space is.
Likewise, higher clean room classifications require special features, protective equipment, and filters necessary to remove contaminants.
Clean Room Environment – Personnel Safety And Quality Assurance
For a cleanroom to be sustainable, all of its operations and protocols that secure a cleaner environment need to be designed and executed properly, to avoid any contamination areas, and make room for later maintenance and procedures that ensure running and maintaining a clean room facility effectively.
Continuous monitoring of the clean room parameters is the best way to ensure that the level of cleanliness inside the facility/cleanroom complies with the specifications of a clean room classification level.
Personnel Safety in a Clean Room
All clean room facilities require the use of clean room attire in order to minimize the release of polluting particles generated by the workers.
Normal, everyday clothing generates a very large amount of particles and may introduce corruption into the laboratory environment and processes.
Especially today, as the COVID-19 pandemic has imposed special needs for cleanliness, and clean rooms now serve to prevent staff dorm getting infected, as well as disseminate dangerous pathogens.
Clean Air and Contamination Control – Monitoring Facility Parameters
To achieve the required (de)contamination control, both air handling and filtration are important.
Depending upon the ISO clean room classifications designated, keeping positive pressure in the cleanroom is determined by the airflow type, velocity, and air changes.
Continuous monitoring of critical clean room and facility parameters is the best way of ensuring that the level of cleanliness complies with its expectations.
Moreover, these records can simplify the detection of malfunctioning components, signaling that additional maintenance is required or that even certain parts, like filters, have reached their effective life span.
Monitoring clean room parameters
Monitoring clean room parameters can be as simple as determining the number and size of the particles present in the air. More sophisticated clean rooms have a central ventilation system that is partly or fully automated to do this monitoring. For sure, every ventilation system must be certified, maintained, and regularly calibrated.
Temperature, humidity, and lighting are also critical parameters in a clean laboratory environment. These measurements can be automated via sensors or using inexpensive handheld thermometers and hygrometers.
Adequate monitoring systems need to be installed, starting with dehumidifiers and humidifiers, air-conditioning systems for temperature control, etc.
Testing and accepting of a facility
Upon implementation of the clean room, an acceptance test should be performed and documented for all future references. This test can be performed as a simple recording and particle counts, but in more complex facilities tests and validations are provided by trained specialists who follow strict protocols according to the ISO standards ISO 14644-1.
Engineering and work orders
Clean rooms are usually run by using sophisticated and complex engineering. Changing the airflow path by introducing some obstacles or changing the initial settings on purpose can adversely affect the facility’s performance.
Also, all of the changes, enhancements, and maintenance practices need to be recorded, and those records must be stored safely, so they can be helpful in identifying possible problems in the future.
Cleanroom technology is the foundation for highly sensitive spaces in modern manufacturing, whether you work in pharmaceutical production, biotechnology, or else. IPG can be of service in finding a solution for all of your demands for a clean room.