Cleanroom Commissioning and Qualifications
GxP Cellators: Cleanroom Commissioning, Qualification & Environmental Control Services
Cleanrooms are designed to control environmental conditions by limiting sub-micron particles and regulating temperature, humidity, and pressure. Non-compliant or poorly designed cleanrooms are frequently cited during regulatory inspections, increasing the risk of product contamination and the need for costly remediation.
At GxP Cellators, we support clients in designing, commissioning, and qualifying cleanrooms to meet US FDA, EU GMP Annex 1, ISO 14644, and Health Canada (GUI-0001 / GUI-0119) standards. Our comprehensive approach ensures your cleanrooms remain compliant and controlled throughout their operational lifecycle.
Our Cleanroom Qualification Methodology
A Lifecycle Approach
We approach cleanroom qualification as a continuous lifecycle of design, verification, monitoring, and maintenance. Our methodology aligns with ASTM E2500, ISO 14644 series, and revised EU GMP Annex 1 requirements for contamination control.
Concept & Design Review
Commissioning & Installation
Operational & Performance Qualification
Ongoing Control & Re-Qualification
How We Help in Your Cleanroom(s) Readiness Program
We provide comprehensive support for cleanroom projects, from initial concept to final regulatory inspection and routine operations. Our services are tailored for both new construction and renovation or upgrading projects.
Planning Phase: Design, Risk Assessment & Documentation
A compliant cleanroom begins with careful planning. We guide you in making key decisions early to prevent costly changes later.
Finalizing the Proposed Cleanroom(s) Design
We review architectural and engineering designs to ensure they meet regulatory requirements and operational needs.
- Contamination Control Strategy (CCS): We assist in developing the initial framework for your CCS, as required by EU GMP Annex 1. This includes assessing potential risks from personnel, materials, equipment, and the facility itself.
- Cleanroom Classification & Layout: We review classification requirements for each area and verify that the layout supports proper material and personnel flow to prevent cross-contamination.
- Material & Personnel Flows: We assess gowning room configurations, airlocks, and material transfer hatches to ensure effective segregation of clean and dirty zones.
- Finishes & Materials: We review specifications for walls, floors, ceilings, and lighting to ensure they are smooth, impervious, non-shedding, and capable of withstanding repeated cleaning and disinfection.
Designing User Requirement Specifications (URS) &Validation Plans
We prepare essential planning documents that define cleanroom requirements and outline verification methods.
- Cleanroom URS Development: We draft comprehensive User Requirement Specifications that capture all functional and regulatory requirements for the cleanroom and its supporting utilities. This includes:
- Required room classification (ISO 14644-1)
- Environmental parameters (Temperature, Humidity, Pressure differentials)
- Air change rates and unidirectional flow requirements
- Material of construction for finishes
- Validation Master Plan (VMP) – Cleanroom Annex: We develop a dedicated section of the VMP for cleanroom qualification, defining scope, approach, responsibilities, and acceptance criteria.
- System Risk Assessments: We conduct and document risk assessments, such as FMEA, to identify critical design elements and prioritize qualification efforts on areas with the highest risk to product quality and patient safety.
Designing “Cleanroom Operational SOPs” & System Risk Assessments
We prepare you for operations by drafting procedures that govern cleanroom use.
- Cleanroom Behavior & Gowning SOPs: We author detailed procedures for aseptic gowning, cleanroom behavior (slow, deliberate movements), and material transfer to minimize particle generation.
- Cleaning & Disinfection SOPs: We develop science-based cleaning programs, including rotating sporicidal agents, validating disinfectant efficacy, and spill cleanup procedures.
- Environmental Monitoring (EM) Program Design: We design the initial EM program, including sampling locations (worst-case locations identified during mapping), frequencies, alert/action limits, and a glossary of indicator organisms.
- System Risk Assessments: We document HVAC system risk assessments, identifying potential failure modes and corresponding controls.
Qualification Phase: Execution & Documentation
With the plan in place, we move to execution. Once planning is complete, we manage or oversee the entire qualification lifecycle to ensure rigorous testing and thorough documentation. Itself, we ensure the supporting utilities are fully qualified.
- HVAC System Qualification: We oversee the HVAC system’s IQ, OQ, and PQ, verifying fan operation, ductwork integrity, filter installation, and control-system functionality.
- Critical Utility Qualification: We ensure that utilities entering the cleanroom (e.g., Purified Water, WFI, Clean Compressed Air, Gases) are qualified and delivered at the point of use with the required quality.
Qualification of the Cleanroom(s) Areas (IQ, OQ, PQ)
We execute protocol-based qualifications of the physical cleanroom environment.
- Installation Qualification (IQ): We verify and document that the cleanroom is built in accordance with approved specifications.
- Material Verification: Inspection of wall, floor, and ceiling panels for correct materials and finish.
- Fixture Verification: Verification that light fixtures, pass-throughs, and door seals are properly installed and sealed.
- HEPA Filter Installation: Verification of filter model, serial numbers, and installation integrity (leak testing).
- Operational Qualification (OQ): We test room functionality under both “at-rest” and “dynamic” conditions.
- Air Change Rates: Measurement and verification of air changes per hour (ACPH) against design specifications.
- HEPA Filter Integrity Testing: Execution of aerosol challenge tests (e.g., PAO/DOP) to verify filter and housing integrity.
- Pressure Differentials: Verification of cascade pressure differentials between adjacent rooms of different classifications (e.g., ISO 8 to ISO 7 to ISO 5). Alarms are tested for pressure failures.
- Unidirectional Airflow (Smoke Studies): For critical zones, we conduct smoke visualization studies to confirm airflow effectively removes particles without turbulence or dead spots.
- Recovery Test: We measure the time required for the room to return to its classified state after a controlled particle challenge.
- Performance Qualification (PQ): We demonstrate the room consistently meets its classification over time under dynamic conditions.
- Non-Viable Particulate Counting: We conduct comprehensive particle counts at multiple locations to verify the room meets its ISO classification (e.g., ISO 5, 7, 8) as per ISO 14644-1.
- Microbiological Monitoring (Baseline): We establish baseline microbiological data using air samplers, settle plates, and contact plates to characterize the facility’s normal flora before production.
- Temperature & Humidity Mapping: We map the room to identify temperature and humidity variations and confirm control within specified ranges throughout the occupied area.
Execution of Environmental Monitoring (EM) & Routine Cleaning Programs
Qualification is just the beginning. We help you transition from validation to routine operation.
- EM Program Implementation: We provide on-site support for the initial implementation of the environmental monitoring program, ensuring technicians are proficient in sampling techniques and media handling.
- Routine Cleaning Program Implementation: We oversee the initial cleaning cycles, ensuring technicians follow new SOPs and apply disinfectants correctly.
- Data Review & Trending: We review initial EM data, identify trends or excursions, and implement corrective actions.
Ongoing Control: Cleanroom Release, Periodic Re-Qualification & Operational Support
Cleanrooms require ongoing maintenance to remain compliant. We provide continued support to ensure long-term control.
Cleanroom(s) Release & Support During Routine Operation
- Qualification Summary Report: We prepare a comprehensive report summarizing all qualification activities, results, and deviations, providing the formal basis for cleanroom release.
- Deviation Management: If deviations or out-of-specification results occur during qualification, we investigate root causes and propose remediation.
- Operational Troubleshooting: We provide ongoing consulting to address issues such as particle count spikes, pressure cascade challenges, or unusual microbial findings.
Periodic Re-Qualification & Ongoing Validation Maintenance
Regulations require that cleanrooms be re-qualified. Regulations require periodic cleanroom re-qualification. We help you establish and execute a robust re-qualification program.
- Re-Qualification Scheduling: We develop a risk-based schedule for re-qualification activities (e.g., annual HEPA filter testing, 6-month particle count verification, 3-year full re-classification).
- Re-Qualification Protocol Execution: We author and execute re-qualification protocols, repeating critical tests such as:
- Trend Analysis & Annual Review: We compile a year of environmental monitoring data and perform trend analysis to identify environmental shifts and support the annual Product Quality Review (PQR).
- Change Control Support: If changes are made to the cleanroom, we assess the impact on validation and perform any necessary re-qualification to ensure continued compliance.
Reach Out to Us!
For more details or to discuss your project requirements, please reach out to us. Your query will be handled with complete confidentiality, and we’ll ensure a prompt response.
