Definition of Class C Cleanroom

Definition of Class c CleanRoom

A Class C cleanroom is a controlled environment predominantly utilized in industries where even minor levels of contamination can compromise product quality. According to ISO 14644-1, Class C Cleanrooms must maintain a maximum allowable particulate concentration of 3,520 particles per cubic meter for particles ≥ 0.5 micrometers. This classification is crucial in sectors such as pharmaceuticals and biotechnology, where sterility and precision are paramount.

1. Environmental Control

In a Class C cleanroom, temperature and humidity levels are meticulously regulated. Typically, the temperature should range between 20°C to 25°C, while relative humidity must be maintained at 30% to 60%. These parameters help ensure optimal working conditions, reducing the risk of contamination and enhancing product integrity. Moreover, air changes per hour (ACH) in Class C cleanrooms should be a minimum of 15, which aids in maintaining air quality and cleanliness.

2. Air Quality Standards

The air quality in a Class C cleanroom is critical to its operational effectiveness. As per iso 14644-1, the cleanroom must ensure a maximum of 3,520 particles per cubic meter for sizes ≥ 0.5 micrometers. Additionally, the concentration of viable microorganisms should not exceed 10 colony-forming units (CFUs) per cubic meter, ensuring that the environment is suitable for sensitive processes and products.

3. Personnel and Procedures

Personnel working in Class C cleanrooms must adhere to strict gowning protocols to minimize contamination risks. This includes the use of sterile gowns, gloves, and hair covers. Moreover, training in cleanroom behavior and procedures is essential, as human activity can significantly impact cleanliness. Regular monitoring and auditing of personnel practices are necessary to maintain compliance with established cleanliness standards.

4. Equipment and Materials

The materials and equipment introduced into a Class C cleanroom need to be carefully selected to minimize contamination. All equipment should be non-porous and easily cleanable. Tools and instruments must undergo a rigorous decontamination process before entering the cleanroom, and materials should be stored in designated clean areas to prevent contamination from external sources.

• ISO 14644-1: Cleanrooms and controlled environments - Part 1: Classification of air cleanliness by particle concentration.

• iso 14644-2: Cleanrooms and controlled environments - Part 2: Monitoring to provide evidence of cleanroom performance related to air cleanliness.

• ISO 14698-1: Cleanrooms and controlled environments - Biocontamination control - Part 1: General principles and methods.

• ISO 14698-2: Cleanrooms and controlled environments - Biocontamination control - Part 2: Evaluation of biocontamination.

What ISOis Grade C?

• Particle Count Limit

In Grade C cleanrooms, the maximum allowable particle concentration is 3,520 particles per cubic meter for particles ≥ 0.5 micrometers. This standard ensures that the environment remains sufficiently clean for sensitive operations.

• Air Changes Per Hour

Grade C cleanrooms should have a minimum of 15 air changes per hour (ACH). This rate helps maintain air quality by diluting contaminants and reducing the risk of product contamination.

The Requirements for Grade C Cleanroom Gowning

1. Gowning Protocol

Personnel entering a Grade C cleanroom must follow strict gowning protocols. This includes wearing sterile gowns, gloves, hair covers, and shoe covers to minimize contamination risks.

2. Training and Compliance

All staff must undergo training on proper gowning procedures. Compliance is critical to maintaining the cleanroom’s integrity and ensuring that all personnel understand contamination control measures.

3. Regular Audits

Routine audits of gowning practices are necessary to ensure adherence to protocols. These audits help identify any lapses in procedures, allowing for corrective actions to maintain cleanliness.

The Difference Between Grade B and Grade C Cleanroom

Airborne Particle Limits

Grade b Cleanrooms have stricter particle limits compared to Grade C. Specifically, Grade B allows a maximum of 3,520 particles per cubic meter for particles ≥ 0.5 micrometers, while Grade C has higher limits.

Airflow Requirements

Grade b CleanRooms typically require more stringent airflow specifications. They must achieve a higher number of air changes per hour (minimum of 30) compared to Grade C's minimum of 15.

Usage and Applications

Grade B cleanrooms are primarily used for aseptic processing where sterility is essential. In contrast, Grade C cleanrooms are suitable for less critical operations, such as preparation and staging of materials.

Type C Cleaning in Pharma

Definition of Type C Cleaning

Type C cleaning refers to the cleaning protocols designed for Grade C cleanrooms in pharmaceutical settings. It aims to minimize contamination risks during operations involving less critical processes.

Cleaning Frequency

In Type C cleaning, surfaces must be cleaned regularly to maintain required cleanliness levels. This typically involves daily cleaning of floors, work surfaces, and equipment to reduce contamination risks.

Validation and Documentation

All cleaning processes in Type C environments must be validated and thoroughly documented. This ensures that cleaning protocols are effective and compliant with industry standards, providing traceability and accountability.

What is C in GMP?

1. Role of Grade C

In the context of GMP, Grade C cleanrooms are essential for processes that do not require the highest levels of sterility. They are often used for preparation and staging, where some contamination control is necessary but less stringent than in Grade A or B areas.

2. Compliance Requirements

Compliance with GMP Standards in Grade C cleanrooms involves strict adherence to cleaning protocols, personnel training, and environmental monitoring. This ensures that products are manufactured safely and effectively, reducing the risk of contamination.