The Difference Between Class B Cleanroom and Class C Cleanroom

The Difference Between Class B Cleanroom and Class C Cleanroom

1. Introduction to CleanRoom Classifications

Cleanrooms are classified based on their cleanliness levels, which are defined by various international standards. The two common classifications are Class B and Class c CleanRooms, as specified in ISO 14644-1 and EU GMP guidelines. Understanding their differences is essential for industries requiring controlled environments.

2. Cleanliness Standards

Class B cleanrooms allow a maximum of 3,520 particles ≥0.5 micrometers per cubic meter, making them suitable for critical processes such as aseptic drug manufacturing. In contrast, Class C cleanrooms permit up to 352,000 particles for the same size, indicating a higher tolerance for contamination.

3. Environmental Control Requirements

Class B cleanrooms require strict environmental controls, including air changes per hour (ACH) rates of at least 90. These conditions help maintain sterility during sensitive operations. Class C cleanrooms, however, can operate with lower ACH rates, typically around 15-25, reflecting their less stringent cleanliness needs.

4. Applications in Industry

Class B cleanrooms are primarily utilized in pharmaceutical operations involving aseptic processing, such as filling vials with sterile drugs. Class C cleanrooms are often used for packaging and assembling non-sterile products, where contamination risks are lower but still monitored.

• iso 14644-1: Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness

• iso 14644-2: Cleanrooms and associated controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness by airborne particulate contamination

• EU Guidelines for Good Manufacturing Practice (GMP): Annex 1, Manufacture of Sterile Medicinal Products

• ISO 14644-3: Cleanrooms and associated controlled environments - Part 3: Test methods

• ISO 14644-4: Cleanrooms and associated controlled environments - Part 4: Design, construction, and start-up

• iso 14644-5: Cleanrooms and associated controlled environments - Part 5: Operations

What is Type B Cleaning in Pharma?

Procedures Involved

The procedures in Type B cleaning typically include thorough surface cleaning, disinfection, and regular monitoring of cleanliness levels. These processes help establish a controlled environment suitable for sterile product preparation.

Frequency of Cleaning

Type B cleaning should be performed regularly, often before and after production runs. The frequency depends on the specific operations being conducted and is dictated by the cleaning validation protocols established.

GMP Clean room

1. Definition of GMP Clean Room：A GMP clean room is a controlled environment that adheres to Good Manufacturing Practices, ensuring that products are manufactured under conditions that minimize contamination risk. It is crucial for industries like pharmaceuticals.

2. Standards and Regulations：GMP clean rooms are governed by stringent standards, including ISO 14644 and FDA regulations. These guidelines define cleanliness levels, environmental controls, and operational procedures necessary for compliant manufacturing.

3. Design and Construction：The design and construction of GMP clean rooms must meet specific criteria, including controlled airflow, temperature, humidity, and particulate matter levels. This ensures a sterile environment for manufacturing processes.

Grade C Gowning

• Required Attire

Personnel in Grade C areas must wear specific attire, including coveralls, gloves, masks, and hairnets. Each piece of clothing is designed to minimize the shedding of skin cells and other contaminants.

• Gowning Procedures

Gowning procedures for Grade C areas typically involve a sequence of steps, starting from handwashing to putting on the gown, followed by donning gloves and masks. This systematic approach ensures optimal protection.

• Training and Compliance

Personnel must receive training on proper gowning techniques to ensure compliance with Grade C requirements. Regular audits and refresher courses help maintain high standards in cleanroom practices.

What is the Criteria for Clean Air Zone?

Definition of Clean Air Zone

A Clean Air Zone (CAZ) is a designated area where air quality is managed to reduce pollution levels, primarily from vehicular emissions. The goal is to protect public health and the environment by maintaining cleaner air.

Regulatory Standards

Clean Air Zones must comply with various regulatory standards, such as the European Union's Ambient Air Quality Directive. These regulations set limits on pollutants like nitrogen dioxide (NO2) and particulate matter (PM10) to ensure safe air quality levels.

Implementation Strategies

Effective implementation strategies for Clean Air Zones often include promoting public transportation, encouraging the use of electric vehicles, and establishing low-emission zones. These measures collectively contribute to improved air quality.