A cleanroom is a highly controlled and pristine environment for manufacturing medicines, semi-conductors, microchips, microelectronics, and more. Hence, cleanrooms are an integral part of many manufacturing units among industries that need a controlled environment. Aerospace, automotive, commercial vehicles manufacturing, microelectronics, pharmaceutical, and rail industries need cleanrooms to manufacture highly sensitive products in a controlled environment.
Various factors such as airborne dust, mold particles, air composition, microorganisms, etc., can affect a cleanroom’s purity. Furthermore, the cleanroom needs temperature and humidity to be kept under control as well.
Types of Cleanroom Monitoring
There are two types of monitoring of the particles in the cleanrooms.
Viable monitoring is the testing, detecting, and enumerating of tiny living organisms such as bacteria, fungi, molds, algae, etc. It includes monitoring personnel, air and area surfaces for microbial contamination.
Non-viable monitoring refers to testing, detection, and enumeration of particles formed by the disintegration of large-sized materials or condensation of small-sized particles or droplets. e.g., mist, smoke, fume and dust. Non-viable monitoring is measured via laser counter.
Purpose of the Cleanroom Monitoring System
A cleanroom is an activity ground with people, processes, and products in motion. These active factors can contaminate the cleanroom despite precautions.
If there is any contamination when the product is manufactured, there will be a detrimental impact on the quantity and quality of the goods produced inside the facility. Good clean room design and construction ensure a monitoring system is in place so that contamination cannot seep in or stay undetected.
Viable monitoring of the cleanroom offers statistics on the likelihood that a product line may be contaminated and proof that a clean room is operating as intended and being adequately maintained. The asepsis of the product production operation is visible via surface and air monitoring.
How does a Cleanroom Monitoring System Benefit the Business?
Cost of Faulty Product
Without a system to continuously monitor the environment, these occurrences may go unnoticed for days or even weeks, causing contamination of millions of dollars worth of products. A contaminated production line results in a costly product recall or permanent disposal.
For example, clean rooms are necessary for the microchip production sector. During manufacturing, there should not be any particles of dust or humidity polluting the microchips. If the environment in the cleanroom is not monitored, it can manufacture faulty chips.
Cost of Leave of Absence
Controlling the air quality in cleanrooms is essential for manufacturing high-quality products and the safety and health of the personnel working there. A business cannot afford to manufacture faulty goods. Neither can a business afford too many leaves of absence of its personnel. Both situations result in absolute loss to the company. So, it is self-explanatory; where would your cleanrooms be without appropriate monitoring systems, and where would the business profits be without cleanrooms being appropriately monitored?
Certification Requirement
Constant monitoring is a part of the certification standards as well. Thus, the manufacturing facilities that are FDA or ISO certified must employ cleanroom manufacturing companies that follow the laid standards when designing and constructing the cleanroom.
How to construct a cleanroom monitoring system?
There is a five-stage process to design a regulatory-compliant cleanroom monitoring system. The process is not easy; thus, hiring a cleanroom design and construction company or clean room manufacturers with the required expertise is highly recommended.
Stage 1: Planning
Even before the system design process begins, it is imperative to know the industry standards and guidelines for the specific industry for which the cleanroom and cleanroom monitoring system is being designed.
The monitoring standards that need to be complied with are issued by
- a) ISO 14644-2: 2015 and are in two parts.
- b) EU GMP Annex 1. Section “Cleanroom and clean air device monitoring”
- c) FDA Guidance
- d) World Health Organization (WHO) Environmental Monitoring of Clean Rooms
- e) PDA Technical Report (TR) No.13R Fundamentals of an Environmental Monitoring Program.
- f) ISPE Standards and
- g) Guidelines from the local authorities that would audit the facility.
Stage 2: System design
Depending on various factors and variables, the system design is finalized.
Stage 3: System deployment and installation
The final designed system is deployed and installed in the facility. It ensures that the sampled data supports monitoring and controlling the contamination and contaminating factors.
Stage 4: System use
Once the system is deployed correctly and functioning well, it regularly gives data that helps the manufacturing facility ensure the production is aseptic.
Stage 5: System maintenance
Though the modern-day cleanroom monitoring systems are based on advanced technology, the system needs to be maintained regularly to ensure that all is perfectly well.
Should You Invest in Cleanroom Monitoring System?
Unless a manufacturing facility is ready to risk hundreds and thousands of dollars, investing in a cleanroom monitoring system should not be left out as an option. Since too many permutations and combinations must be considered in designing, constructing, and maintaining a cleanroom and the cleanroom monitoring system, it would be wise to let the cleanroom design and construction experts handle the job.