How and What Do U.S. Government Agencies Regulate Standards for Cleanrooms?

Introduction to U.S. Government Agencies: Regulations and Standards for Cleanrooms

United States government departments and agencies develop cleanroom standards and regulations for certain industries that use cleanrooms, such as pharmaceuticals and food.

The standards and regulations protect the health and safety of the public and government and military personnel.

U.S. Food and Drug Administration (FDA)

 The FDA exists to protect and promote the health, safety, and efficacy of foods and drugs for people and animals. The FDA regulates a wide range of products, including foods and drugs for people and animals, biologics (including vaccines), medical devices, dietary supplements, cosmetics, radiation-emitting products, and tobacco products.

The FDA was founded in 1906 when the U.S. Congress passed the Pure Food and Drug Act. The parent organization is the U.S. Department of Health and Human Services. The FDA is headquartered in Silver Spring, MD. In 1938, the FDA began regulating cosmetics. In 1971, the FDA began to regulate medical devices. In 2009, Congress passed the Family Smoking Prevention and Control Act which now regulates tobacco products.

The regulations for a specific industry are found in the Code of Federal Regulations (CFR). There are some CFRs that apply to all industries such as 21 CFR Part 11 which is about electronic records and computer systems

Here are FDA regulations that cover good manufacturing practices and relate to cleanroom standards and operation.

Pharmaceuticals

The pharmaceutical industry regulations are 21 CFR Part 210 – current good manufacturing practice in manufacturing, processing, packing or holding of drugs; general and 21 CFR Part 211 – current good manufacturing practice for finished pharmaceuticals.

The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use published guidelines ICH Q8(R1) Pharmaceutical Development, ICH Q9 Quality Risk Management, and ICH Q10 Pharmaceutical Quality System as well as the ICH Good Manufacturing Guide for Active Pharmaceutical Ingredients. The FDA regulates Orphan Drugs in 21 CFR Part 316.

Medical Devices

21 CFR Part 820 Quality System Regulation Medical Devices is moving toward harmonization and modernization with ISO 13485 Medical devices – Quality management systems – Requirements for regulatory purposes. ISO 13485 is a voluntary international standard that provides a framework for manufacturers and suppliers to meet common regulatory requirements worldwide and serves as a strong foundation to meet FDA Part 820 requirements, as well as the requirements of other regulatory bodies around the world. 21 CFR Part 806 regulates Medical Devices: Reports of Corrections and Removals.

Biological Products

The FDA regulates the biological industry in 21 CFR Part 600, Biological Products: General, 21 CFR Part 601 Licensing, and 21 CFR Part 610 General Biological Products Standards. 21 CFR Part 640 regulates Additional Standards for Human Blood and Blood Products. 21 CFR Part 1270 regulates Human Tissue Intended for Transplantation, and 21 CFR Part 1271 regulates Human Cells, Tissues, and Cellular and Tissue-Based Products.

Food, Dietary Supplements, Infant Formula

21 CFR Part 110 Current Good Manufacturing Practice in Manufacturing, Packing or Holding Human Food was revised in the Food Safety Modernization Act which created 21 CFR Part 117 Current Good Manufacturing Practice, Hazard Analysis and Risk Preventive Controls for Human Food. Additional current good manufacturing practices for dietary supplements is 21 CFR Part 111 Current Good Manufacturing Practices for Dietary Supplements. 21 CFR Part 106 regulates infant formula, 21 CFR Part 113 regulates low-acid canned foods, and 21 CFR Part 129 regulates bottled water.

U.S. Department of Agriculture (USDA)

The USDA is the federal executive department responsible for developing and executing federal laws related to farming, forestry, rural economic development, and food. It aims to meet the needs of commercial farming and livestock food production, promotes agricultural trade and production, and works to assure food safety.

In addition to current USDA government regulations, AIB International (a member organization focused on food safety) has published consolidated standards for agricultural crops, beverage plants, distribution centers, food safety, nonfood contact packaging manufacturing, dairy plants, food contact packaging manufacturing facilities, fresh product, and fruit packinghouses and fresh-cut produce. USDA inspectors are typically on-site performing inspections 24/7/365.

National Aeronautics and Space Administration (NASA)

Established in 1958, NASA is the agency responsible for the civil space program, aeronautics research, and space research. NASA has its own standards but many of the test methods are similar to the test methods described in MIL-STD-810 (H) and NASA adapts its test methods from MIL-STD-810(H).

NASA or companies such Space X or Virgin Galactic will have their own standards but the basis of the statement of work is from MIL-STD-810(H). Independent test labs performing tests for companies supplying materials to NASA and DOD must perform the tests as described in MIL-STD-810(H) or NASA’s adaptation of the test methods.

All aircraft in the U.S. are qualified by Radio Technical Corporation of America DO160. These industry-vetted and endorsed recommendations on technical performance standards can be used as a means of compliance with Federal Aviation Administration regulations and other aviation regulatory authorities.

U.S. Department of Defense (DOD)

The DOD is an executive branch department charged with coordinating and supervising all agencies and functions of the U.S. government directly related to national security and the U.S. Armed Forces. MIL-STD-810(H) version was issued 2021. (G) version introduced two naval standards from MIL-STD-167 as new methods so clarification of these new test methods is described in the MIL-STD-810(H) version.

Any organization supplying any material or equipment to the military must use the test methods as described in MIL-STD-810 (H). MIL-STD-810 is a process so the RFQ will state that the material or equipment supplied by the customer must be tested in accordance with MIL-STD-810(H). Within 810 there are approximately 30 test methods with a guidance section on how to use and interpret the test methods. Test methods were originally written by military contractors to meet their supplied equipment test requirements to the U.S. Air Force and U.S. Army.

The U.S. Air Force split with the U.S. Army just before the first MIL-STD-810 in 1950s. Therefore, all materials and equipment for the U.S. Air Force planes are compliant with the specifications outlined in MIL-STD-810(H). The U.S. Army maintains an office for MIL-STD-810 and constantly receives requests for changes to 810. The standard contains several areas pertaining to environments such as dynamic environments (shock, vibration, and acoustics). Within MIL-STD-810(H) are standards such as Standard 167 for the U.S. Navy which is a test method for vibration.

Climatic environments such as (hot, cold, rain, ice, hail, smoke, and humidity) have their own section of test methods in MIL-STD-810(H) as well as combined environments. Test method 27 combines vibration, temperature, humidity, and altitude. There are specialty test methods for explosive atmospheres for any situation where combustible gases could be exploded by the test article.  Within each test method are procedures that are equipment-specific. Diagrams and different procedures are within each test method and apply to different categories within the procedure. Guidance information in the appendices is valuable to execute and evaluate the test results.

 

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