ISO 14644-1:2015 – Cleanrooms and Associated Controlled Environments

Key Definitions

• Cleanroom: A controlled environment where the concentration of airborne particles is maintained within specified limits to prevent contamination during manufacturing or research processes.
• Air Cleanliness Class: A classification system that defines the level of cleanliness in a cleanroom based on the maximum allowable concentration of airborne particles.
• Airborne Particles: Solid or liquid particles that are suspended in the air within a cleanroom or controlled environment.
• Controlled Environment: An environment where parameters like temperature, humidity, and airborne particle concentration are controlled to specific levels.

Clause-wise Structure of ISO 14644-1:2015

What are the requirements of ISO 14644?

ISO 14644-1 requires that cleanrooms and controlled environments be classified according to the level of airborne particles present. To comply with this standard, organizations must ensure the following:

1. Cleanrooms must be monitored for airborne particles, and measurements should be taken at specified locations and conditions to classify the cleanliness level accurately.
2. The cleanroom must be classified according to the ISO 14644-1 classification system, which sets limits on the allowable concentration of particles of various sizes.
3. The conditions for particle measurements must be controlled, including factors such as temperature, humidity, and airflow.
4. Regular monitoring and verification must be conducted to ensure that cleanrooms continue to meet the required cleanliness standards.

For more information on standard requirements, contact us at support@pacificcert.com.

What are the benefits of ISO 14644-1:2015 Certification?

ISO 14644 certification offers several important benefits for organizations that operate cleanrooms and controlled environments. Below are some of the key advantages of obtaining ISO 14644 certification:

• Certification ensures that cleanrooms meet the necessary cleanliness levels, reducing contamination risks and improving product safety.
• Compliance with ISO 14644 helps organizations meet industry regulations and guidelines for cleanroom operations.
• Certification provides credibility in the global marketplace, facilitating trade and demonstrating commitment to quality standards.
• ISO 14644 helps organizations maintain consistent operational processes by monitoring and controlling airborne particle concentrations.

As industries continue to prioritize product safety and contamination control, the demand for cleanrooms and controlled environments is expected to increase significantly. ISO 14644 certification will be crucial for organizations in sectors like pharmaceuticals, biotechnology, electronics, and food safety, where even the slightest contamination can have severe consequences. As the need for higher standards in environmental control and cleanliness grows, the adoption of ISO 14644 will be essential for organizations aiming to stay competitive and compliant with global regulations.

Certification Process: ISO 14644

The certification process for ISO 14644 involves several key steps:

1. Pre-Certification Assessment: A gap analysis to assess current cleanliness standards and identify areas for improvement.
2. Documentation Review: Review of procedures and records related to cleanroom classification, particle measurement, and environmental control.
3. Stage 1 Audit: Initial audit to verify that the cleanroom meets the necessary particle concentration and environmental control requirements.
4. Stage 2 Audit: A more thorough on-site audit to assess the cleanroom’s ongoing compliance with the standard.
5. Certification Decision: Certification is awarded if all requirements are met and the cleanroom meets the necessary classification levels.
6. Ongoing Monitoring: Regular audits and recertification every three years to ensure continued compliance.

For audits and certification, contact support@pacificcert.com.

Timeline – ISO 14644-1:2015 Certification

The timeline for ISO 14644 certification spans several months. Initially, the pre-assessment and preparation phase takes around 1-2 months, during which the organization reviews and adjusts its practices to meet the standard’s requirements. The Stage 1 audit, which involves reviewing documentation and systems, takes around 1 month. The Stage 2 audit, a more comprehensive on-site assessment, lasts about 1-2 months. Certification issuance occurs within 3-6 months, depending on the audit outcomes and the organization’s readiness.

What is the cost of ISO 14644?

The cost of ISO 14644 certification varies depending on the size and complexity of the organization and its cleanroom operations. Costs mostly cover:

Audit Fees is the fee for the external audit process carried out by a certification body. Training Costs are the expenses for training personnel on the ISO 14644 standard and cleanroom management. Ongoing Maintenance Costs for ongoing monitoring and recertification, which are generally required every 3 years.

How Pacific Certifications Can Help?

At Pacific Certifications, we provide comprehensive auditing and certification services for ISO 14644. Our team of experts will guide you through the entire certification process, ensuring your cleanroom operations meet the necessary standards for particle concentration and environmental control. We offer:

• Stage 1 and Stage 2 audits to evaluate particle measurement systems and cleanroom classification.
• Objective conformity assessments aligned with ISO 14644.
• Certification issuance upon successful completion of the audit.
• Ongoing surveillance audits to ensure continued compliance.
• Support for multi-site or global operations.

For audits and certification, contact support@pacificcert.com.

ISO 14644-1-11 Training and Courses

Various training courses are available to help organizations comply with ISO 14644, including:

• Lead Auditor Training – Equips professionals to conduct external third-party audits.
• Lead Implementer Training – For those responsible for planning and executing ISO 14644-1-11 implementation.

• Internal Auditor Training– Preparing internal auditors for certification audits

Pacific Certifications provides accredited training programs. If your organization is looking for ISO training, our team is equipped to help you. Contact us at support@pacificcert.com.