Introduction to Class C Cleanroom

Introduction to Class c CleanRoom

Class C Cleanrooms are designed to meet specific cleanliness and Environmental standards, primarily used in industries such as pharmaceuticals, biotechnology, and Semiconductor manufacturing. These controlled environments play a critical role in ensuring product quality and safety.

• Design and Construction Features

Class C CleanRooms typically require a controlled environment with specific design features. The air exchange rate is generally set at 15 to 30 air changes per hour, ensuring effective dilution of airborne contaminants. Walls, ceilings, and floors are made from smooth, non-porous materials to facilitate cleaning and minimize particle accumulation.

• Air Filtration and Ventilation

Effective air filtration is a fundamental component of Class C Cleanrooms. High-Efficiency Particulate Air (HEPA) filters are employed to capture 99.97% of airborne particles down to 0.3 micrometers. The cleanroom's ventilation system is designed to maintain positive pressure, preventing outside contaminants from infiltrating the controlled space.

• Environmental Control Parameters

Temperature and humidity control are essential in a Class C cleanroom. The typical temperature range is maintained between 20-24°C, while relative humidity is controlled between 45-55%. These parameters help prevent static electricity and ensure the stability of sensitive materials during processing.

• Personnel and Gowning Procedures

Personnel entering a Class C cleanroom must adhere to strict gowning procedures to minimize contamination risks. Standard attire includes coveralls, gloves, masks, and hair covers. Adhering to these protocols significantly reduces the introduction of particulate contaminants into the cleanroom environment.

• monitoring and Compliance

Regular monitoring of particle counts and environmental conditions is crucial in maintaining Class C cleanroom standards. Continuous monitoring systems are often utilized to provide real-time data on air quality, ensuring compliance with ISO standards. Routine audits and maintenance checks help identify potential areas for improvement.

The Microbial Limit in a Clean Room

1. Viable Microbial Limits

For example, in a Class C cleanroom, the acceptable limit is typically 100 CFU/m³ (colony-forming units per cubic meter) for air samples. This limit is crucial in environments like pharmaceuticals and biotechnology.

2. Surface Microbial Limits

Surface microbial limits are also critical. For Class C areas, the acceptable limit is generally 10 CFU/100 cm² for surfaces. Regular monitoring ensures compliance with these standards and maintains cleanroom integrity.

What is a Class C Clean Air Zone?

1. Air Quality Standards：In a Class C zone, the maximum allowable particle count is 3,520 particles per cubic meter for particles ≥0.5 micrometers. This standard helps minimize contamination risks during sensitive manufacturing processes.

2. Temperature and Humidity Control：Class C clean air zones also maintain controlled temperature and humidity levels, typically between 20-24°C and 45-55% relative humidity. This control is vital for preserving product stability and quality.

3. Importance of Positive Pressure：Positive pressure is maintained in Class C zones to prevent the ingress of contaminants from adjacent areas. This pressure differential is crucial for protecting sensitive processes and products from external contamination.

The Requirements for Grade C Cleanroom Gowning

Gowning Protocols

Proper gowning protocols are essential in Grade C cleanrooms to minimize contamination. Personnel must wear a full gown, gloves, masks, and hair covers to prevent the introduction of particles.

Gowning Materials

Gowns should be made from non-linting, breathable fabrics that minimize particle shedding. 

Footwear and Gloves

Personnel must wear dedicated CleanRoom footwear or shoe covers to prevent contamination from outside environments. Gloves should be sterile and made of materials that resist punctures while allowing dexterity for handling materials.

Gowning Procedure

A strict gowning procedure must be followed, including steps like thorough handwashing and sanitizing before donning the gown. Each item should be put on in a specific order to minimize contamination risks.

What is Type C Cleaning in Pharma?

• Cleaning Frequency

Type C cleaning typically occurs on a scheduled basis, often daily or before batch processing. This frequency ensures that the cleanroom remains compliant with regulatory requirements and minimizes contamination risks.

• Cleaning Agents Used

Approved cleaning agents that are effective against a broad spectrum of microorganisms are used during Type C cleaning. These agents must be validated for efficacy and compatibility with cleanroom surfaces.

• Documentation and Verification

All Type C cleaning activities must be documented, including the cleaning agents used and personnel involved. Regular verification through environmental monitoring ensures that cleaning procedures are effective and compliant with standards.