Every industry uses cleanrooms in varying degrees. To ensure that the products created are of high quality and safe, a controlled environment is a prerequisite. It helps you implement precision in research, manufacturing, and technology.
Cleanrooms play a crucial role in securing mission-critical procedures from harmful contaminants that can affect the integrity and quality of products. But not every cleanroom is developed with equal standards. This is because industry requirements tend to vary.
In this article, we will discuss the cleanroom classification based on the requirements of different sectors.
The Classifications for Cleanrooms
If you have heard or are aware of the ISO 5 cleanrooms, there’s more to them. The ISO (International Organization for Standardization) states that cleanrooms get categorized depending on the amount of particles present in every cubic meter of air. It comprises nine classifications, from ISO 1 to ISO 9, with ISO 1 being the cleanest and ISO 9 being the dirtiest.
Cleanrooms that comply with the GMP (Good Manufacturing Practice) are essential for industries that develop sterile medicinal products. Having a clear understanding of the distinctive classifications that directly affect compliance with international and federal standards, such as the PIC/S Guides to GMP or Annex 1 of the EU.
Here are the cleanroom classifications based on a few verticals:
Biotechnology and Pharmaceuticals
The cleanrooms used in the biotechnology and pharmaceutical industries are classified as ISO 5 or ISO 6. They are essential for developing vaccines, medications, and other biological products. This type of cleanroom with 3520 particles/ cubic meter is effective in maintaining a very clean environment that is required for pharmaceutical procedures.
Also, for sterile injectable drug production, an ISO 5 cleanroom reduces the chances of particulate contamination and caters to stringent regulatory standards.
According to American Cleanroom Systems, a stick-built ISO 5 cleanroom needs gyp board walls that are painted using epoxy paint. In terms of cost, it is cheap compared to the modular ones. However, it might take a long time to build and is slightly challenging to modify. A similar cleanroom with a soft wall should be one pass and doesn’t integrate air conditioning.
Additionally, the pharmaceutical industry makes it necessary to opt for GMP cleanrooms to ensure patient well-being. Complying with these strict guidelines ensures that the cleanrooms reduce contamination. As a result, the medicine production process is effective and free from dangerous contaminants.
On the other hand, if this industry vertical fails to keep up with the GMP standards, it can make the production process highly ineffective.
Aerospace and Defense
The controlled environment in the defense and aerospace industries varies from ISO 5 to ISO 8. Mostly, it is an ISO 7 cleanroom that has 352,000 particles/ cubic meters. When it comes to a satellite assembly, a cleanroom with ISO 5 classification makes sure that foreign particles don’t hurt the electronic components and their functioning.
Semiconductor and Electronics Manufacturing
Equipped with a few of the most stringent rules, electronics and semiconductor manufacturing domains are all about precision. Hence, cleanrooms here range between ISO 2 and ISO 6. A Class 1 cleanroom or an ISO 3 cleanroom with a particle count of 35,200/ cubic meters is necessary for chip fabrication.
This type of cleanroom ensures that the environment is free from any invisible particles adversely affecting the structure of a semiconductor device in microprocessor production. Additionally, this industry vertical needs to manage electrostatic discharge as one more form of hazardous contamination that can cause damage to the equipment.
Medical Device Manufacturing
This industry domain requires a cleanroom environment, so that there is product compliance and safety. The cleanrooms, which are certified as ISO 4 and ISO 5, are standard classification here, as it balances manufacturing efficiency with the need for cleanliness. Medical device manufacturing, which involves devices or implants that come in close contact with humans, possesses strict cleanroom standards for product safety.
The medical device cleanrooms adhere to GMP guidelines to ensure patient safety and health. All these guidelines secure the medical devices that are in close contact with membranes and tissues and can affect the well-being of patients. GMP compliance is essential for regulating consumables, such as devices and medicines designed to assist with their use.
Furthermore, medical devices are classified into three categories by the FDA GMP guidelines:
- Class 1: It includes low-risk elements such as tongue depressors and bandages which pose slight harm to patients, where it is essential for manufacturers to comply with basic GMP outlines.
- Class 2: It includes medium-risk items such as infusion pumps and powered medical tools that have strict documentation and quality control.
- Class 3: It includes high-risk devices such as life support and implantable devices. It requires a strict safety check that can impact a patient’s health to a huge extent.
Summing up, the cleanroom classifications provide a base for various industry verticals to keep up to high-quality, precision, and safety standards. By having a clear understanding of certain cleanroom requirements of various industry verticals, companies can establish a controlled environment that caters to regulatory standards as well as optimize the production process.
