Navigating Clean Spaces: Unraveling the Difference Between Classified and Non-Classified Areas in Pharmaceuticals

• by Chaitnaya Senagana
• 28 Mar 2008
• Guidelines

This article delves into the critical distinctions between classified and non-classified areas within pharmaceutical facilities. As precision and adherence to strict standards are paramount in the industry, understanding the purpose, regulations, and operational nuances of these spaces is essential. From controlled environments ensuring sterility to general workspaces with different cleanliness requirements, this comprehensive guide provides valuable insights for pharmaceutical professionals, ensuring clarity on the significance and management of classified and non-classified areas.

In the pharmaceutical industry, facilities and manufacturing areas are often categorized into "classified" and "non-classified" areas based on the level of cleanliness, environmental control, and adherence to specific standards and regulations. These classifications are crucial for maintaining product quality, safety, and compliance with Good Manufacturing Practices (GMP). Here are the key differences between classified and non-classified areas in pharmaceuticals:

Classified Areas:

1. Cleanliness and Environmental Control:

   • Classified areas are designed and maintained to stringent cleanliness standards. They are subject to controlled air quality, temperature, humidity, and particulate levels.
   • Air in classified areas is typically filtered and conditioned to remove contaminants and maintain a controlled environment.

2. Stringent Standards:

   • Classified areas adhere to strict GMP guidelines and regulatory requirements, such as those outlined in the United States Pharmacopeia (USP) and other international pharmacopeias.
   • Classification levels, such as ISO cleanroom classifications or Federal Standard (FED-STD) classifications, are often applied to classified areas to define the level of cleanliness and environmental control.

3. Personnel Requirements:

   • Personnel working in classified areas are required to follow strict gowning procedures, including the use of specialized cleanroom attire, such as gowns, gloves, hairnets, and shoe covers.
   • Personnel may need to undergo training on aseptic techniques and environmental control.

4. Usage:

   • Classified areas are typically used for critical pharmaceutical manufacturing processes, including aseptic filling, sterile compounding, and packaging.
   • These areas are suitable for the production of injectable drugs, vaccines, and other sterile products.

5. Monitoring and Validation:

   • Continuous monitoring and validation of environmental conditions, including particle counts and microbial contamination, are standard practices in classified areas.
   • Regular testing and validation activities ensure that the environment remains compliant with specified standards.

Non-Classified Areas:

1. Less Stringent Requirements:

   • Non-classified areas have less stringent environmental control and cleanliness requirements compared to classified areas.
   • While cleanliness is important, non-classified areas may have higher permissible particulate levels and do not require the same level of air filtration and control.

2. Personnel Dress Code:

   • Personnel in non-classified areas may not require the same level of cleanroom attire as those in classified areas. Standard lab coats, gloves, and safety glasses may be sufficient.

3. Usage:

   • Non-classified areas may include laboratories, administrative offices, warehousing, and other areas where the manufacturing and packaging of critical pharmaceutical products do not occur.
   • Some pharmaceutical operations, such as tablet compression and capsule filling, may take place in non-classified areas if they do not require aseptic conditions.

4. Monitoring and Validation:

   • While environmental conditions may be monitored in non-classified areas, the frequency and intensity of monitoring are typically lower than in classified areas.

In summary, the primary difference between classified and non-classified areas in pharmaceuticals lies in the level of cleanliness, environmental control, and adherence to regulatory standards. Classified areas are maintained at higher standards to support critical pharmaceutical manufacturing processes, while non-classified areas encompass a range of operations with fewer environmental control requirements. Both types of areas play crucial roles in pharmaceutical production, quality control, and research and development.