Government Regulations

U.S. Government Regulations for Pharmaceutical Vacuums and Cleanroom Vacuums

In recent years, an increased focus on safety and security issues has permeated almost every industry in the United States. Of particular concern is the pharmaceutical industry - with good reason. Pharmaceutical companies face particular challenges, as they generate an array of products that present potential health challenges or hazards to their consumer markets. Below are just a few of the standards and regulations the pharmaceutical industry must uphold.

Current Good Manufacturing Practices (cGMP)

With the introduction of 21 CFR Part 211 in 1963, Good Manufacturing Practices (GMP) were formally developed to bring modern quality assurance and control principles to drug manufacturing. The word "current" was later added to make it cGMP and to imply that the regulation allows for changing technology in attaining GMP.

While cGMP covers a wide variety of pharmaceutical processes, one of the basic requirements is that the equipment and facility remain clean. This is indicated in more than one section of 21 CFR Part 211:

    • Section 211.63 relates to the equipment design, size, and location, and requires that equipment used in the manufacture, processing, packaging, or holding of a drug product shall be of appropriate design, adequate size, and suitable location to facilitate operations for its intended use and for its cleaning and maintenance.

 

  • Section 211.65 (b) states that any substances required for operation, such as lubricants or coolants, shall not come into contact with components, drug product containers, closures, in-process materials, or drug products so as to alter the safety, identity, strength, quality or purity of the drug product beyond official or other establishment requirements.

  • Section 211.67 further requires that written procedures be established and followed for the  cleaning, maintenance, and sanitation of the equipment and the utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality or purity of the drug product.

  • Sections 211.180 and 211.182 relate to the record that should be kept for the maintenance, cleaning, sanitation and inspection of equipment.

Unlike many other industries' regulations, cGMP only states what practices should be implemented; they generally do not specify the proper practices on how to comply.

To read the entire cGMP, please click here. You can also track the changes and revisions to cGMP here.

Cleanrooms

In order for a cleanroom to be FDA certified, it must meet the cleanroom standards for controlled environments set forth in ISO 14644. ISO 14644 replaces the old standard FED-STD-209E (see below) and is comprised of:

ISO 14644-1 Classification of Air Cleanliness

ISO 14644-2 Specifications for Testing and Monitoring to Prove Continued Compliance with ISO 14644-1

ISO 14644-3 Test Methods

ISO 14644-4 Design, Construction, and Start-up

ISO 14644-5 Operations

ISO 14644-6 Vocabulary

ISO 14644-7 Separative Devices (Clean Air Hoods, Gloveboxes, Isolators, and Minienvironments)

ISO 14644-8 Classification of Airborne Molecular Contamination

ISO 14644-9 Classification of Surface Particle Cleanliness

The following table compares FED-STD-209E to the new ISO 14644-1 classifications.

ISO 14644-1

FED-STD-209E

ISO Class

English

Metrics

1

   

2

   

3

1

M1.5

4

10

M2.5

5

100

M3.5

6

1,000

M4.5

7

10,000

M5.5

8

100,000

M6.5

9

   

 

Combustible Dust

Because most pharmaceutical plants regularly follow strict cleaning procedures, combustible dust is often overlooked as a risk in the industry. But in 2003, a fatal combustible dust explosion occurred at a pharmaceutical facility in North Carolina. The culprit: accumulations of dust that had settled on ceiling tiles, light fixtures and overhead beams.

In 2008, OSHA issued a combustible dust national emphasis program (NEP) which identified pharmaceutical facilities as "at-risk" for a combustible dust fire or explosion and announced guidelines to minimize the risk with proper cleaning and maintenance regimens. Until a comprehensive combustible dust standard is developed, facilities must comply with the recommendations set forth in the NEP and those found in the national code for combustible particulate, NFPA 654.

Other resources:

FDA: www.fda.gov

OSHA: www.osha.gov

Institute of Environmental Sciences and Technology: www.iest.org

International Organization for Standardization: www.iso.org

Pharmaceutical Processing: www.pharmpro.com

Pharmaceutical Online: www.pharmaceuticalonline.com

The Pharma Compliance Blog: http://pharmacomplianceblog.blogspot.com/

Nilfisk CFM Blog: www.nilfiskcfmblog.com

About Pharma Processing Vacuums

This Pharmaceutical Processing Vacuum website is your source for cleanroom vacuum information. Nilfisk Industrial Vacuums is a world leader in contamination control and has been providing industrial vacuums for over 100 years.

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