COMMISSIONING

Maetrics has done extensive work in commissioning facilities and equipment for pharmaceutical, biotech, and medical device
manufacturers. Maetrics engineers have degrees in engineering, including chemical, mechanical, industrial, biomedical, and
related disciplines coupled with experience in FDA-regulated industries. Our consultants have successfully:
Developed and managed projects for commissioning, qualification, and validation, including such tasks as:
Project plan development and execution
Balancing progress vs. schedule vs. cost
Management of project teams of all sizes
Executed commissioning, qualification, and validation programs, including:
Process validation
Facility commissioning
Capital-project equipment protocols, including
o CSV
o FAT / SAT
o IQ, OQ, PQ
Equipment qualification and validation for:
o Autoclaves
o Cleaning equipment
o Filling equipment
o Freeze dryers
o HVAC
o Mixing equipment
o Packaging equipment
o Purified water systems.
o Vessels
o WFI
Developed and documented processes
Assessed vendor documentation

CASE STUDY 1

INITIAL STATE
The Biologics Client was converting a multi-product vaccine production start-up facility into a full-time product manufacturing
facility that would require full GMP compliance.

OBJECTIVE
The primary objective was to bring the non-GMP Research and Development facility into a state to full compliance with GMP
regulations.

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MAETRICS ENGAGEMENT
Maetrics brought all applicable systems and equipment into compliance. Our team:
Qualified process systems and equipment in a newly constructed manufacturing facility used for the production of
Phase II/III clinical material.
Collaborated on pre‐purchase specifications, design drawings and sketches, P&IDs, PFDs, vendor submittal and bid
tabulation reviews, project coordination and scheduling.
Participated in project functions from the design phase through production start‐up and remained on site for all stages
of construction.
Participated in cross‐functional team meetings, quality audits, FATs, commissioning reviews, system troubleshooting,
and root‐cause analysis.
Developed and reviewed SOPs, equipment qualification protocols (IQ, OQ), and templates.
Developed and delivered training on new SOPs and protocol formats.
Coordinated and reviewed metrology and equipment certification efforts while maintaining and organizing records.
Developed a calibration matrix to support efficient monitoring of dates, contractors, and instrument identification
numbers.
Developed and executed equipment qualification protocols (IQ, OQ, PQ), SOPs, and final reports for various process
equipment including legacy equipment following recommissioning.
Proposed and implemented modifications to procedures and equipment, in compliance with quality system
regulations.
Coordinated validation efforts with internal corporate departments (Manufacturing, Engineering, Facilities
Management, and Quality Assurance).

RESULTS
By applying the strengths of Maetrics’ engineering experts, this Biologics facility efficiently and cost‐effectively realized GMP
compliance. They were able to begin production in their new capacity on schedule, saving money, and most importantly, time.

CASE STUDY 2

INITIAL STATE
The air-handling units (AHUs) for a global manufacturer were being commissioned. The manufacturer regularly provides
conditioned, and often filtered, air supply to its Manufacturing, Packaging, Fill, Amenities, and Support areas.

The Building Management System (BMS) HVAC controlled and monitored the air supply to these areas. AHU control was
maintained through the controllers, and the BMS Human‐Machine Interface (HMI) provided a window to the controllers for
maintenance and troubleshooting. The HMI and AHUs interfaced with the Network Control Unit (NCU) to provide status
verification of all field equipment. The NCU stored data for AHUs and related devices to perform controller programs for data
upload and download. For BMS communication, interface between HMI and NCU IP addresses was provided through low-level
communication with Plant Automation Ethernet (information) system.

OBJECTIVES
The primary objective was to verify that the BMS HVAC connected to AHU controllers and provided an interface to the
controllers for maintenance and troubleshooting of the AHU operation. A secondary objective was to bring the system and
facility into compliance with the master validation plan.

MAETRICS ENGAGEMENT
All of the activities and tasks within the scope of the commissioning effort were satisfactorily completed. The activities
challenged the system and demonstrated that the BMS HMI, BMS network controller, and AHUs were correctly interfaced, and
displayed the system’s current operational status.
The Maetrics team reviewed four commissioning test cases and executed these successfully, with no deviations.
Our team documented installation requirements and IP addresses of the BMS HMI and network control module.

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 Maetrics wrote a disaster-recovery procedure for the BMS, bringing the building and system into compliance with the
site IT master validation plan.

RESULTS
This manufacturer has documented evidence that the BMS systems are working cohesively, and that there is a well‐designed
backup plan for disaster recovery.

CASE STUDY 3

INITIAL STATE
A global manufacturer sought to update its commissioning, validation, and decommissioning procedures. Its staff had no time
for this extensive project in addition to the regular business responsibilities.

OBJECTIVE
The primary objective was to revise the corporate procedures for commissioning, validation, and decommissioning to ensure
compliance and efficiency.

MAETRICS ENGAGEMENT
Maetrics deployed a team of engineers with varied expertise and backgrounds, who collaborated closely and consulted
guidance documents from the FDA, ISO, ICH, ISPE, and other sources to inform a comprehensive approach to the quality
infrastructure.

The Maetrics team developed procedures for all stages of the product life-cycle and the system-development life-cycle,
including the following:
Change Control Management
Commissioning
Decommissioning
Installation Qualifications
Operational Qualifications
Performance Qualifications
Periodic Reviews
Process Specifications
Product Requirement Specifications
Risk Assessments
Summary Reports
System Specifications
Traceability Matrices
Training
Validation Master Plans
Validation Template Usage
Validation Testing Procedures

RESULTS
The client’s personnel were able to focus on business needs while Maetrics developed a comprehensive quality infrastructure.
The combined expertise of Maetrics’ personnel allowed on-time completion

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