Cleanroom commissioning, qualifications, and validations are crucial processes in various industries such as pharmaceuticals, biotechnology, healthcare, electronics manufacturing, and semiconductor production, where maintaining controlled environments is essential. Here’s an overview of each process:

Cleanroom Commissioning:

Definition: Cleanroom commissioning refers to the process of ensuring that a cleanroom facility is built according to design specifications and is capable of meeting the required environmental conditions.
Steps:

• Design Review: Verify that the cleanroom design meets regulatory requirements and industry standards.
• Construction Oversight: Supervise the construction process to ensure compliance with design specifications.
• Installation and Testing of Systems: Install and test HVAC systems, filtration systems, monitoring systems, and other equipment to ensure they function properly.
• Initial Cleanliness Testing: Conduct initial cleanliness testing to verify that the cleanroom meets cleanliness standards.

Cleanroom Qualification:

Definition: Cleanroom qualification involves demonstrating that a cleanroom facility consistently meets predefined criteria for cleanliness and environmental conditions.
Steps:

• Installation Qualification (IQ): Verify that equipment, instrumentation, and systems are installed correctly and meet design specifications.
• Operational Qualification (OQ): Ensure that equipment and systems operate according to predetermined parameters and requirements.
• Performance Qualification (PQ): Validate that the cleanroom operates consistently and meets cleanliness and environmental standards under dynamic conditions over a defined period.

Cleanroom Validation:

Definition: Cleanroom validation is the process of confirming that the cleanroom facility consistently produces the desired level of cleanliness and environmental conditions to meet regulatory requirements and product specifications.

Steps:

• Protocol Development: Develop validation protocols outlining the procedures and acceptance criteria for validation activities.
• Execution of Validation Activities: Perform validation activities such as particle count testing, air velocity measurement, temperature and humidity monitoring, and microbial monitoring.
• Data Analysis and Reporting: Analyze validation data to ensure compliance with predefined criteria and generate validation reports documenting the results.
• Periodic Revalidation: Establish a schedule for periodic revalidation to ensure ongoing compliance with regulatory requirements and industry standards.

These processes are typically conducted by multidisciplinary teams consisting of engineers, validation specialists, quality assurance personnel, and other relevant stakeholders. Compliance with regulatory standards such as ISO 14644 (for cleanroom classification) and cGMP (current Good Manufacturing Practice) is essential throughout the commissioning, qualification, and validation processes.

What We Do:

GMP Site-Readiness Support

Our team includes expert validation specialists in facility design, layout preparation, and commissioning and validating pharmaceutical and biotech facilities. We provide complete validation packages, from master validation plans to project management and execution. We also design validation plans for plant utilities and equipment qualification programs. Our prime services are:

• Preparation of Master Validation Plans
• Designing of the QMS-Controlled Technical Documentation
• Validation Plans for the Site Utilities (Water Systems, Gases, HVAC)
• Validation Plans for the Site Equipment
• Validation Plans for the Computer Systems
• Preparation of the Site Master File

Cleanroom Consultation

The purpose of every cleanroom is to control the environment by limiting the presence of sub-micron particles and modifying inadequate environmental conditions. We help our clients design, commission, and qualify the cleanroom areas as per ISO 14644 and Health Canada standards. Our prime services are:

• Planning Support-Finalizing the proposed cleanroom facility design
• Planning Documentation- Designing of user requirements specification, validation plan for the cleanroom, validation plan for the cleanroom utilities and cleanroom operational SOPs
• Qualification Phase- IQ/OQ/PQ documentation designing for the cleanroom and utilities
• Cleanroom Area Qualification- Developing the environmental monitoring programs, cleanroom cleaning sanitization processes, gowning and gown qualifications; cleanroom certification and efficient cleanroom operations
• Cleanroom Release and Periodic Re-qualification- Finalizing the cleanroom release programs and re-qualification programs

Contact Us:

GxP Cellators provides GMP site-readiness, quality, and regulatory services to the life sciences industry. Our highly qualified experts excel in facility design, cleanroom operations, regulatory affairs, quality assurance/control, and clinical development. Our customized approach to regulatory compliance services has earned us a reputation as one of the premier consulting firms in the industry. For more information, contact us at info@gxpcellators.com.