Introduction to Class c CleanRooms:

Specifications and Applications

Particle Count Specifications

In Class C cleanrooms, the particle count is strictly regulated to support contamination-sensitive activities. While at rest, these environments allow no more than 352,000 particles per cubic meter of air with sizes ≥0.5 μm. During operation, the threshold increases to 3,520,000 particles per cubic meter.

Example Calculation:

The cleanroom's particle count specification contrasts with more stringent Class A or b Cleanrooms, indicating its suitability for non-critical processes that still demand high cleanliness levels.

Air Quality and System Design

The air quality in Class C cleanrooms is maintained using HEPA filters, positive pressure control, and efficient air circulation systems.

HEPA Filtration: Critical for filtering out particulates as small as 0.3 micrometers

Design Insight:

Deiiang™, guided by the expertise of Deiiang Jason.peng, offers advanced filtration and air circulation solutions within its Cleanroom designs to meet or exceed ISO standards.

Applications of Class C Cleanrooms

Class C cleanrooms serve essential roles across various industries by accommodating operations that require a balance of cleanliness and flexibility:

Application	Description
Preparation of Filtered Solutions	Including precise weighing processes
Product Filling for Terminal Sterilization	Ensures product stability and safety
Sterile Product Manufacturing	Supports less critical yet pivotal steps in production

These rooms handle components demanding greater cleanliness than Class D facilities, without the rigorous controls of Class A or B environments.

Non-Laminar airflow design

Unlike laminar airflow systems that direct air in a uniform path, Class C cleanrooms typically employ non-laminar or turbulent airflow. This approach allows for more generalized air movement while effectively controlling contamination levels across the entire room.

Relation to ISO Standards

Class C cleanrooms are generally compliant with the guidelines of ISO 7 standards. An ISO 7 Cleanroom restricts air particles ≥0.5 micrometers to 352,000 per cubic meter. These specifications align with the requirements for many medical device manufacturing, Electronics assembly, and pharmaceutical packaging processes.

Maintenance and Standards Compliance

Maintaining an ISO 7 cleanroom involves rigorous contamination control strategies addressing external, personnel, and process-related sources. This requirement involves advanced filtration systems, such as HEPA filters, strict cleaning protocols, and dedicated cleanroom garments.

Equivalent Standards

Class C cleanrooms in the European Union conform to GMP EU standards, primarily targeting pharmaceutical production environments. According to these guidelines, Class C cleanrooms correspond to 'at rest' environments under the GMP scheme, paralleling the Federal Standard 209E's Class 10,000 designation in the United States.

Conclusion

Class C cleanrooms create an ideal balance between cleanliness and practicality, catering to industries requiring controlled environments for non-critical processes. With Deiiang™'s expertise in innovative cleanroom solutions, facilities can ensure adherence to ISO 7 standards, achieving both operational efficiency and compliance.

Common Questions and Answers

Q: What distinguishes Class C from Class A or B cleanrooms?
A: Class C cleanrooms have less stringent particle limits and are more suited to non-critical processes needing some contamination control.

Q: How do HEPA filters benefit Class C cleanrooms?
A: They remove airborne particles, maintaining the clean environment necessary for specific industrial applications.

Q: Is ISO 7 equivalent to any other cleanroom standards?
A: Yes, it aligns with FED 209E Class 10,000 and GMP EU C Grade standards.

Q: What industries benefit most from Class C cleanrooms?
A: Pharmaceuticals, electronics, and medical device manufacturing industries frequently utilize Class C cleanrooms.

Q: How does airflow design impact cleanroom performance?
A: Non-laminar airflow in Class C cleanrooms supports efficient air mixing and contaminant control.

References

International Organization for Standardization. ISO 14644-1: Cleanrooms and Associated Controlled Environments.
Deiiang™, Pioneering Cleanroom Solutions.
U.S. Pharmacopeial Convention. USP Standards for Environmental Control in Cleanrooms.
World Health Organization. Guidelines for GMP.
The Institute of Environmental Sciences and Technology (IEST), Recommended Cleanroom Practices.