Clean room classification boundaries

Clean Room Classification Boundaries

1. ISO 14644-1 Classification Standard

iso 14644-1 is an internationally accepted clean room classification standard that classifies clean rooms based on the number of particles in the air. Each level sets specific particle limits to ensure the cleanliness of the environment.

• ISO 1: No more than 10 particles ≥ 0.1 microns per cubic meter.

• ISO 2: No more than 100 particles ≥ 0.1 microns per cubic meter.

  ISO 3: No more than 1,000 particles ≥ 0.1 microns per cubic meter.

• ISO 4: No more than 10,000 particles ≥ 0.1 microns per cubic meter.

2. FDA's GMP Classification Standard

FDA's GMP Standard is mainly aimed at the pharmaceutical and biotechnology industries, combining the requirements of air quality and operating environment to classify clean rooms. This standard ensures the safety and effectiveness of products.

• Grade A: Applicable to areas that come into direct contact with sterile products and require extremely high cleanliness.

• Grade B: Supports Grade A areas and is suitable for drug preparation and processing.

• Grade C: Applicable to production areas that do not require a sterile environment.

• Grade D: Applicable to operating environments that require lower cleanliness.

3. Relationship between ISO 8 and FDA Grade D

ISO 8 Cleanrooms and FDA Grade D cleanrooms are basically consistent in cleanliness requirements and are suitable for applications that do not require high cleanliness. According to ISO 14644-1, ISO 8 cleanrooms allow 3,520,000 particles ≥ 0.5 microns per cubic meter of air. FDA Grade D allows no more than 3,520,000 particles ≥ 0.5 microns per cubic meter. Therefore, the two can replace each other in practical applications.

• ISO 8: The number of particles allowed is 3,520,000 particles ≥ 0.5 microns.

• FDA Grade D: The number of particles allowed is 3,520,000 ≥ 0.5 microns.

4. Cleanroom level and application industry

Cleanrooms of different levels are suitable for different industries and applications, and the cleanroom specifications of each industry are also different. The following is the relationship between the main industries and the corresponding cleanroom levels:

• Pharmaceutical industry: Grade A and Grade B are commonly used.

• Semiconductor manufacturing: Common ISO 5 and higher grades.

• Biotechnology: Grade A and Grade B are mostly used to ensure the sterility of the product.

• Food processing: ISO 7 and ISO 8 grades are generally used.

5. Validation and certification of cleanrooms

Validation and certification of cleanrooms are necessary steps to ensure that they meet international standards. The validation process includes an assessment of air quality, surface cleanliness, and microbial monitoring to ensure that the environment meets specific cleanliness requirements.

• Air quality test: Use a particle counter to measure the number of particles in the air.

• Surface cleanliness test: Use a swab method to detect surface microorganisms and particles.

• Microbiological monitoring: Regularly test the presence of microorganisms in the environment to ensure sterility.

What is Class 100,000 CleanRoom Classification?

Definition and Standards

Class 100,000 cleanroom classification indicates environments with a maximum of 100,000 particles per cubic meter of air. This standard is essential for industries requiring strict control over airborne contaminants.

Applications

Commonly found in pharmaceutical, biotechnology, and electronics sectors, Class 100,000 cleanrooms protect sensitive processes and products from contamination that could affect quality, safety, and efficacy.

Air Cleanliness Measurement

In a Class 100,000 cleanroom, cleanliness is quantified by counting particles of 0.5 micrometers or larger. The limit of 100,000 particles per cubic meter ensures that the environment remains suitable for critical operations.

What are the Class 100,000 Clean Room Requirements?

• Construction Specifications

Class 100,000 cleanrooms must be built with smooth, non-porous surfaces that facilitate easy cleaning. Proper sealing of walls, floors, and ceilings is vital to minimize the risk of contamination.

• Ventilation System

A reliable ventilation system is essential, incorporating HEPA filters to maintain air quality. This system ensures the continuous supply of clean air while effectively removing airborne particles.

• Personnel Protocols

Strict gowning and hygiene protocols must be followed. Personnel are required to wear cleanroom attire, including gowns, gloves, masks, and shoe covers, to limit the introduction of contaminants into the cleanroom.

• Monitoring and Maintenance

Regular air quality monitoring and particle count assessments are necessary. Cleanrooms must adhere to routine maintenance schedules to ensure compliance with Class 100,000 standards and safeguard product integrity.

What is the Microbial Limit of a Clean Room?

Definition of Microbial Limits

Microbial limits define the maximum allowable levels of viable microorganisms in cleanrooms. Maintaining these limits is essential to prevent contamination, especially in pharmaceutical and healthcare settings.

Standard Requirements

For Class 100,000 cleanrooms, acceptable microbial limits typically allow no more than 10 colony-forming units (CFUs) per cubic meter of air. This standard helps ensure product safety and compliance with regulations.

Monitoring Techniques

Microbial limits are monitored using air sampling methods. Air samples are collected on agar plates, incubated, and analyzed to identify and quantify the number of microbial colonies present in the environment.

Importance of Compliance

Adhering to microbial limits is crucial for ensuring product quality and safety. Exceeding these limits can lead to contamination, regulatory challenges,and potential risks to patient safety, especially in sterile environments like hospitals and laboratories.

What is the ACPH Limit for ISO?

Definition of ACPH

Air Changes Per Hour (ACPH) measures how many times the air within a cleanroom is completely replaced in an hour. This metric is crucial for maintaining air quality and cleanliness in controlled environments.

ISO Standard Requirements

For ISO 7 Cleanrooms, the recommended ACPH limit typically ranges from 15 to 30 changes per hour. For cleaner environments like ISO5, higher air change rates are necessary to meet stringent particle count requirements.

Design Considerations

The cleanroom's HVAC system must be designed to achieve the required ACPH. This involves careful planning of ductwork, filter systems, and airflow patterns to ensure efficient air circulation without causing turbulence.

Monitoring and Adjustments

Regular monitoring of ACPH is essential to ensure compliance with ISO standards. Adjustments may be needed based on occupancy, activities, and environmental conditions to maintain optimal air quality effectively.

What is the Maximum Occupancy of a Cleanroom?

1. Definition of Maximum Occupancy

Maximum occupancy refers to the highest number of personnel permitted in a cleanroom at any time. This limit is crucial for controlling contamination levels and ensuring the cleanroom operates within specified cleanliness standards.

2. Factors Influencing Occupancy

Occupancy limits depend on various factors, including cleanroom classification, size, airflow design, and specific processes being performed. Higher occupancy can lead to increased particulate levels and microbial contamination.

3. Calculation of Occupancy

To determine maximum occupancy, calculations consider the cleanroom's volume, air exchange rates, and contamination controls. This ensures that cleanliness is maintained even with personnel present, minimizing contamination risks.

4. Operational Protocols

Strict protocols for personnel entry and movement are essential. Training staff to minimize movement and follow hygiene practices helps manage occupancy effectively and maintains the integrity of the cleanroom environment.