Guiding Regulatory Frameworks
I provide specialized support for the commissioning and qualification of GMP-critical manufacturing and support systems — including autoclaves, bioreactors, parts washers, depyrogenation ovens, lyophilizers, and clean utilities in alignment with:
ISPE Baseline Guides & ASTM E2500 – Leveraging science- and risk-based approaches to system design, commissioning, and qualification.
EU GMP Annex 1 – Ensuring contamination control strategies (CCS) are embedded across equipment design, utility systems, and critical processing environments.
FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing – Supporting robust qualification strategies that deliver reproducible, compliant, and inspection-ready operations.
ISO 14644 Cleanroom Standards – Applying classification and monitoring principles to air handling, pressure cascades, and controlled environments.
Services Offered
1. Design Qualification (DQ) & Project Initiation
Thorough design review and risk-based assessments to ensure equipment and utility systems are fit-for-purpose and compliant with global regulatory expectations, including:
Process flow and operator safety considerations
Utility and piping and point-of-use planning for clean steam, WFI, and compressed gases
Load configuration/throughput feasibility for autoclaves, lyophilizers, and depyrogenation ovens
Cleanability and sterility assurance of bioreactors, washers, and associated transfer paths
Alignment with CCS and contamination prevention measures
2. Factory Acceptance Testing (FAT) / Site Acceptance Testing (SAT) & Commissioning
Execution and documentation of FAT/SAT and commissioning activities to verify system performance prior to qualification:
Verification of utilities, piping, control logic, alarms, and interlocks
Functional testing of cycle programs for autoclaves, washers, and lyophilizers
Temperature and humidity distribution mapping for thermal equipment and controlled spaces
Verification of safety systems, emergency shutoffs, and HMI functions
3. Installation & Operational Qualification (IQ/OQ)
Development and execution of protocols covering installation and functional verification, including:
Calibration and verification of critical sensors, transmitters, and control elements
HEPA filter leak testing and airflow characterization (for clean utilities and environments)
Temperature uniformity and penetration studies for autoclaves and ovens
CIP/SIP cycle verification for bioreactors and lyophilizers
Software and automation qualification: user access, audit trails, alarms, and reporting
Verification of cleaning, sterilization, and drying cycles for parts washers
4. Performance Qualification (PQ)
Robust PQ studies to demonstrate system performance under routine operating conditions:
Thermal distribution and lethality (F0) studies for autoclaves and depyrogenation ovens/tunnels
Moist heat and dry heat sterilization efficacy
Freeze-drying performance and cycle reproducibility for lyophilizers
Clean utility performance monitoring for WFI, clean steam, and compressed gases
Hold time studies for sterile components and solutions
Integrated system performance under simulated production loads and worst-case scenarios
5. Ancillary Program Development
Supporting long-term operational readiness and regulatory compliance through:
Environmental monitoring program development (static and dynamic)
Preventive maintenance and calibration program design
Routine cycle qualification and requalification strategies
Load pattern and bracketing matrix development for broad component-processing scopes
Continuous improvement and trend-based monitoring programs
System Expertise
Extensive experience supporting a wide range of GMP-critical equipment and utilities, including:
Steam Sterilizers – Terminal sterilization and component preparation
Bioreactors & Fermenters – Cell culture and microbial processes with validated CIP/SIP
Lyophilizers – Freeze-drying systems for bulk drug product and finished dosage forms
Depyrogenation Ovens & Tunnels – Endotoxin reduction and sterilization of glassware
Parts Washers & CIP Systems – Automated cleaning and sanitization