What Are the 6 Most Important Hospital Cleanroom Standards?

Cleanrooms are specialized environments found in hospitals, laboratories, and other facilities where controlling particulate contamination is critical. These spaces are used for various applications, including the manufacture of drugs and medical devices and the handling of sensitive materials such as stem cells and gene therapies.

According to Industry Arc, the cleanroom technology market in the U.S. was $1845 million in 2021. It is expected to grow at a CAGR of 5.18% CAGR during the forecast period, 2022-2027. The growth is mainly accredited to the increase in the need for regulating cleanroom standards.

To ensure the safety and effectiveness of these materials, cleanrooms must adhere to strict standards. This article explores the six most important hospital cleanroom standards and why they are essential for maintaining a contamination-free environment.

1. ISO Standards That Define Hourly HEPA Air Flow Changes

ISO 14644-3 is the standard that defines the requirements for the air cleanliness classes in cleanrooms and clean zones. It also specifies the testing methods and procedures for measuring the concentration of particles in the air.

HEPA filters also meet the cleanroom ISO standards associated with the HEPA filters used in cleanrooms. One of the key requirements of this standard is the hourly HEPA air flow changes, which refer to the rate at which air is filtered through HEPA filters to remove particles and maintain a clean environment.

It ensures that the air in the cleanroom is continuously being refreshed and that any contaminants that may have entered the room are quickly removed.

2. FDA Food Code: Prevention of Cross Contamination

The FDA Food Code is a set of guidelines and best practices for preventing foodborne illness in food service establishments, including hospitals. One of the key areas of focus in the FDA Food Code is the prevention of cross-contamination, which can occur when harmful bacteria or other contaminants are transferred from one food item to another.

According to FDA, there are about 48 million cases of foodborne illness every year. It causes sickening in 1 out of 6 persons in America. In addition, these illnesses result in 128,000 hospitalization and 3000 deaths each year.

To prevent cross-contamination, the FDA Food Code requires that food service establishments have proper procedures for storing, preparing, and handling food. It includes separating raw meats, poultry, and seafood from other foods. It is done by using separate cutting boards, utensils, and equipment for raw and ready-to-eat foods and properly washing and sanitizing all surfaces that come in contact with food.

Additionally, the FDA Food Code also requires that food service establishments have a designated cleanroom for food packaging and preparation, as well as regular sanitation and cleaning of the cleanrooms.

3. OSHA Physical Hazards and Infection Control Standard

The Occupational Safety and Health Administration (OSHA) has a standard for physical hazards and infection control in healthcare facilities. Federal OSHA is an agency with 1850 inspectors responsible for the health and safety of 130 million employees.

This standard requires employers to provide employees with a safe and healthy working environment by identifying and evaluating physical hazards and implementing appropriate controls to eliminate or reduce the risk of injury or illness. It includes training employees on infection control practices and using personal protective equipment (PPE).

In a hospital setting, this standard also applies to cleanrooms, and employers are required to assess the physical hazards and potential for exposure to harmful agents, such as infectious diseases, in the cleanroom environment.

The standard requires employers to provide appropriate PPE and training on its use, as well as to establish procedures for cleaning, decontamination, and disposal of contaminated materials to prevent the spread of infection. This standard is essential for maintaining a safe environment for hospital employees and patients.

4. NFPA 99, Health Care Facilities Code

The NFPA 99 sets the standard for designing, installing, maintaining, and operating fire protection and life safety systems in healthcare facilities. This standard includes provisions for protecting cleanrooms, which are considered “critical care areas” due to their importance in the production and handling of sensitive materials.

According to this standard, the cleanrooms must be equipped with fire suppression systems, emergency lighting, and alarms and be designed to minimize the risk of fire spread. The standard also requires that cleanrooms have emergency power supplies to ensure that critical systems remain operational in the event of a power failure.

The standard also requires that hospitals conduct regular fire drills and have emergency evacuation plans for patients and staff. This standard is essential to ensure the safety of patients, staff, and the hospital’s critical equipment during a fire emergency.

5. ASHRAE 170, Ventilation of Health Care Facilities

The American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) 170, Ventilation of Health Care Facilities, sets the standard for the design, installation, and operation of heating, ventilation, and air conditioning (HVAC) systems in healthcare facilities.

According to ASHRAE 170, cleanrooms must be designed to maintain a consistent temperature and humidity level and provide sufficient fresh air to prevent the buildup of contaminants.

The standard also requires that cleanrooms have HEPA filters and other air-cleaning devices to remove particulate matter from the air. Additionally, the standard requires that hospitals conduct regular maintenance on HVAC systems, including cleaning and replacing filters, to ensure that the systems operate optimally.

6. AORN Recommended Practices for Surgical Attire

According to AORN, surgical attire must be appropriate for the intended procedure and worn, changed, and laundered according to the manufacturer’s instructions and facility policies. The standard also requires that surgical attire be inspected for tears or other defects before use and that it be removed and replaced if it becomes soiled or otherwise contaminated during the procedure.

Additionally, AORN recommends that healthcare facilities conduct regular training on the proper use, care, and disposal of surgical attire. This standard is essential for maintaining a safe and hygienic environment for the patients and staff and protecting the critical materials in the cleanroom.


Cleanrooms are critical spaces in hospitals that require strict adherence to standards to ensure the safety and effectiveness of the materials produced and handled within them. The six most important hospital cleanroom standards are included above in detail.

Each of these standards plays a crucial role in maintaining a contamination-free environment and protecting patients and staff from potential hazards. Therefore, hospitals must stay updated with the latest standards and guidelines to ensure they meet the highest level of safety and quality.

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