March/April 2011

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Commissioning for regulated and non-regulated industries

Tools for mitigating risk and ensuring project success

Fast Forward

  • Regulated and non-regulated industries require unique approaches to commissioning.
  • Understanding the requirements of the end user is a key to project success.
  • Using the appropriate standard, guidance document, or recommended best practice will eliminate much of the learning curve associated with planning a commissioning project.
 
By Matt Wiencek

web1The construction, start-up, performance verification, and turnover of automated manufacturing facilities are complex endeavors. The complexity is due in part to the large number of systems and sub-components installed and functionally integrated while satisfying schedule milestones, budgetary constraints, code requirements, and regulatory expectations. Commissioning is a tool available to the automation professional, which may assist in overcoming these challenges. This article will compare and contrast commissioning strategies for regulated and non-regulated industries.

What is commissioning?

The correct definition of a commissioning process is dependent on the industrial application. Generally, one may define it as a "well-planned, documented, and managed engineering approach to the start-up and turnover of facilities, systems, and equipment to the end user that results in a safe and functional environment that meets established design requirements and stakeholder expectations," according to ISPE Pharmaceutical Engineering Guides for New and Renovated Facilities. Therefore, the commissioning process and overall project delivery should be specific to the end-user requirements. Who then are the end users, and in what industrial sectors do they operate?

End-user requirements and commissioning plans are developed for a variety of projects that utilize automated systems, including continuous and batch manufacturing processes, regulated pharmaceutical and food manufacturers, building commissioning applications, building automation systems, fire protection and safety systems, machinery safety applications, instrumentation commissioning, heating ventilation and air conditioning start-up, nuclear power, and electrical power construction projects. There are currently over a dozen professional societies, governmental agencies, and other domestic and international regulatory bodies that have issued guidance documents and standards related to commissioning for applications utilizing automated systems. These include: American National Standards Institute (ANSI), American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE), ASME (founded as the American Society for Mechanical Engineers), American Society for Testing and Materials (ASTM), Building Commissioning Association (BCA), German Institute for Standardization (DIN), U.S. Environmental Protection Agency (EPA), International Atomic Energy Agency (IAEA), International Electrotechnical Commission (IEC), Institute of Electrical and Electronics Engineers (IEEE), International Institute of Ammonia Refrigeration (IIAR), International Organization for Standardization (ISO), International Society for Pharmaceutical Engineering (ISPE), National Electrical Contractors Association (NECA), National Fire Protection Association (NFPA), Parenteral Drug Association (PDA), U.S. Department of Agriculture (USDA), and U.S. Green Building Council (USGBC).

Notable commissioning related standards, guidance

Notable examples of guidance documents and standards related to the commissioning of automated systems include:

  • ACG Commissioning Guideline for building owners, design professionals, and service providers provides appendices with system verification start-up check lists and functional performance test recommendations.
  • ANSI/ISA-5.06.01-2007 Functional Requirements Documentation for Control Software Applications addresses the complexity of developing requirements for automated systems. These requirements can become the basis for commissioning verification tests.
  • ASHRAE Guideline 101-2007 HVAC&R Technical Requirements for the Commissioning Process describes the process for commissioning HVAC systems according to ASHRAE Guideline 0-2005, The Commissioning Process.
  • ASTM E1578-06 Standard Guide for Laboratory Information Management Systems describes in part recommendations for establishing the minimal set of functional requirements and functional check lists for verification testing.
  • IAEA NG-T-2.2 Commissioning of Nuclear Power Plants: Training and Human Resource Conditions provides general guidance on the role of automation engineers in the commissioning of these facilities.
  • IEC 62381 Activities During Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and Site Integration (SIT) for Automation Systems is currently being reviewed by the ISA105 committee to describe the best practices related to these deliverables.
  • IEC 62382 Electrical and Instrumentation Loop Check provides a standard methodology to ensure instrumentation loops are properly tested with the control systems.
  • ISO 16484-1:2010 Building Automation and Control Systems (BACS) provides guidelines for the determination of project requirements, installation and commissioning of BACS.
  • ISPE Commissioning & Qualification Guideline for pharmaceutical facilities describes the design, commissioning, and qualification recommended practices endorsed by the U.S. Food and Drug Administration (FDA). The guide is currently being updated by the ISPE.
  • ISPE GAMP 5 A Risk Based Approach to Compliant GxP Computerized Systems provides a cost-effective framework to ensure computerized systems used in regulated industries are installed and functioning per their intended use.
  • NFPA Commissioning Fire Protection Systems describes test procedures for alarm systems, pumps, and smoke control systems.
  • PDA Technical Report No. 48 Moist Heat Sterilization Systems: Design, Commissioning, Operation, and Maintenance describes issues related to user requirements and control system design and commissioning.
  • U.S. General Services Administration Building Commissioning Guide defines the planning, design, construction, and post-construction activities including definition of owner requirements during planning and functional performance testing.

Finally, the standards that will be examined in greater detail include:

  • ASTM E-2500 Standard Guide for Specification, Design and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment is used in regulated industries.
  • IEC 62337 Commissioning of Electrical, Instrumentation and Control Systems in the Process Industry - Specific Phases and Milestones is utilized in non-regulated industries.

The term regulated in this context will apply to any industry subject to the U.S. Code of Federal Regulations Title 21 Food and Drugs. Regulated industries require a unique approach to commissioning and project management because the safety of healthcare patients is at risk. Non-regulated industries such as specialty chemical, petro-chemical, wastewater, and paper manufacturing instead have an indirect impact on individuals because the products are not administered as a drug.

There are other examples of commissioning guidance documents too numerous to mention here. However, no matter what the application, there is a need to understand the end-user requirements and seek out the appropriate guidance documents and standards to help define the appropriate commissioning process.

Commissioning for non-regulated facilities

IEC 62337 summary

IEC 62337 Commissioning of Electrical, Instrumentation, and Control Systems in the Process Industry is an example of guidance for non-regulated industries. A goal of the standard is to provide the framework in which the owner and contractor agree on project responsibilities and deliverables to be completed prior to the turnover of the facility. The aim is to deliver a high-quality project, on time and within budget.

The standard is organized primarily using the concept of phases on a timeline. Each milestone defined in the standard concludes a phase of activities as summarized below.

Table 1: Summary of IEC 62337 commissioning process

Phase

Phase completion milestone

Milestone definition

1. Construction

Completion of erection

Facility building structures completed prior to installation of mechanical systems. Completion of erection concludes the construction phase.

2. Pre-commissioning

Mechanical completion

Mechanical systems installed and tested according to applicable specifications and project plans. Cold commissioning can begin when mechanically complete.

3. Cold commissioning

Systems start up

Process in which operational tests of the facility systems are completed with inert material or water. Hot commissioning can begin when cold commissioning is complete.

4. Hot commissioning

Production start up

Process that tests the facility with actual chemical/materials using the commercial process. The production phase can begin when hot commissioning is complete.

5. Production

Performance test

A test that occurs during the production phase and marks the facilities ability to run to design capacity.

6. Project turnover

Facility acceptance

The final turnover of the facility to the owner, which satisfies remaining contractual requirements excluding warranty items.


NOTE: Step 1 is the start of the project, and step 6 is the end of the project.

 

Phase completion milestones

Completion of erection

The completion of erection milestone verifies all mechanical systems are installed according to design drawings, applicable codes, and safety requirements, as listed in the project specifications, which are approved by the owner. The contractor is responsible for generating and filling out test forms, which identify, with sufficient detail, the systems being tested, date and time of the test, and the test requirements. The owner should be involved in witnessing tests as required by the contract. Deficiencies recorded during the test may be managed to closure with a punchlist, ensuring the owner approves closure of such items. The completion of erection milestone indicates punchlist items are closed, systems have been turned over, and completed test forms have been approved by the owner.

Pre-commissioning

The pre-commissioning phase of the project begins the second sequence of testing by the contracting personnel. IEC 62337 includes an extensive list of specific pre-commissioning test procedures in Appendix B. These tests ensure project documents and project specifications have been satisfied. The relevant specifications include P&IDs, equipment and instrumentation indexes, vendor equipment drawings, loop diagrams, electrical one line diagrams, software documentation, and operation manuals. The contractor and the owner must agree on the scope of responsibilities related to the general and equipment specific test procedures. Examples of these procedures are listed below.

Table 2: Pre-commissioning general procedures and recommended tests

Vendor assistance requirements

Utility and process tie-ins at unit limits

Spare parts and maintenance

Permitting requirements

Leak and pressure tests of piping and equipment

Noise surveys

Work instructions

Mechanical systems inspection tests

Safety inspections

Removal of rust preventatives

Pressure/Vacuum Safety Relief

System dry out

Lubricant verification

Equipment and piping flushing and chemical/mechanical cleaning

Vessel packing and fixed beds requirements

Packing/seals installation

Removal of temporary screens

Removal of temporary bracing

Rotation and alignment of motors

Purging and inerting requirements

General housekeeping


The pre-commissioning phase tests are an opportunity for the owner's personnel to begin training on the systems along side contractors. Finally, a mechanical completion certificate is issued by the contractor and is accepted by the owner to indicate completion of the pre-commissioning phase.

Cold and hot commissioning

Upon the acceptance of the mechanical completion certificate, the contractor may begin cold commissioning followed by hot commissioning. Unlike the pre-commissioning phase, which generally speaking, includes inspection tests, the cold and hot commissioning phase involves functional testing. The carryover of contractor and owner's personnel involved in the pre-commissioning phase is recommended. Examples of general categories of functional test procedures used during cold and hot commissioning are listed below.

Table 3: Cold and hot commissioning general procedures and tests

Motor rotation

Instrumentation check out

PLC/controller checkout

Pump and compressor adjustments

Furnace adjustments

General vendor recommended equipment verification

Water batching and transfers

Steady state operations

Batch or recipe parameter verification

Temperature, flow and pressure control

Valve and equipment sequencing verification

Operating manual or procedure development

Mixing and agitation

Initial loop tuning

Thermal expansion, vibration and noise requirements verification


The functional testing should be carried out in the proper sequence and in a planned manner to ensure systems are operated safely. Commissioning test plans and forms should be pre-approved by the owner and used by the contractor to record observations and data from the control system. Only properly trained contractor or vendor personnel should verify the acceptability of the test data. If the data does not satisfy the requirements and a change to the system is required, the change should be documented in the manner approved by the owner.

Performance test

After successful completion of the commissioning phase and closure of any relevant punchlist items, the contractor may proceed to the performance test verification phase with approval of the owner. The purpose of the performance test is to verify the process is operating in a state of control. The test should be reviewed and pre-approved by the owner and should include acceptance criteria, measurement requirements, sample requirements, and reference to any necessary analytical procedures. The owner, not the contractor, should carry out sample testing unless permission is given to use a third party. The contractor is responsible for submitting a report to the owner evaluating the results and noting any failed observations. The owner should provide a written response accepting the results or in the case of a failure, require the contractor to remediate the situation according to contractual requirements. The commissioning process should conclude with a formal acceptance of the plant by use of a certificate approved by the contractor and owner.

In summary, IEC 62337 is a standardized approach to commissioning for non-regulated industries in which the contractor and the owner agree upon contractual obligations for delivering a facility from the construction phase through the final performance test. A well-planned commissioning process serves the best interests of the contractor and the owner by minimizing the risks associated with project quality, schedule delays, and budget constraints. 

Commissioning for regulated facilities

Having established a framework for commissioning of non-regulated industries, a question may be, "Why do regulated industries require a different approach?" Simply stated, in addition to the contractor and the owner, the FDA is a stakeholder with its own set of requirements. As such, compliance with Current Good Manufacturing Practices (cGMPs) as defined in Title 21 CFR is an additional project requirement.

A significant focus of the FDA is to, "minimize the risks to the public health associated with pharmaceutical product manufacturing." The FDA's general approach to risk minimization is explained in their guidance document, "Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach." It describes methods such as risk management and the use of quality systems to minimize the risk to public health from adverse events occurring at pharmaceutical manufacturing facilities. These concepts were adopted for the ASTM Standard E2500, Standard Guide for Specification, Design and Verification of Pharmaceutical and Bio-Pharmaceutical Manufacturing Systems and Equipment. This standard serves as a model for the regulated industrial commissioning process.

ASTM E2500

What exactly does ASTM E2500 say about the commissioning of automated manufacturing systems? One must begin with a definition of the term verification: A systematic approach to verify that manufacturing systems, acting singly or in combination, are fit for intended use, have been properly installed, and are operating correctly. This is an umbrella term that encompasses all types of approaches to assuring systems are fit for use such as qualification, commissioning and qualification, verification, system validation, or other.

Therefore "commissioning" and "verification" are understood as identical processes.

Several key concepts, which are defined in E2500, highlight the differences between regulated and non-regulated commissioning. These are:

  • Risk-based approach
  • Science-based approach
  • Critical aspects of manufacturing systems
  • Quality by design
  • Good engineering practice
  • Subject-matter expert
  • Use of vendor documentation
  • Continuous process improvement

Risk-based approach

Risk assessments are used to determine the magnitude of the potential harm and probability that it will occur. This principal should be applied to the commissioning (verification) process to determine, for example, which automated manufacturing systems pose the greatest risk to patient health if not installed or operated correctly. A contractor for instance, might focus on those manufacturing steps when generating test forms to ensure the verification procedures are robust and well-documented. These deliverables are also referred to as "enhanced documentation."

Science-based approach

Patient safety is not a concern in a non-regulated commissioning project. For a regulated system or facility, the manufacturing process must be analyzed to determine critical quality attributes (CQAs) and critical process parameters (CPPs), which effect patient safety. The commissioning activities should focus on enhanced documentation and verification of these attributes.

Critical aspects of manufacturing

Commissioning activities should also focus on critical aspects of manufacturing. They have been defined as, "functions, features, abilities, and performance or characteristics necessary for the manufacturing process and systems to ensure consistent product quality and safety." For example, commissioning an air handler temperature control loop for a chilled water supply line, which services an office area, would be within the scope of a non-regulated commissioning plan. However, this would not be considered a critical aspect of manufacturing and therefore would not be an important stakeholder interest for the FDA. The commissioning plan should clearly identify critical aspects as well as the rationale used to determine the criticality.

Quality by design

Design specifications, which directly relate to CQAs and CPPs, should be verified after installation and during the performance runs and monitored during the lifecycle of the facility. The verification process continues after the turnover to the owner until the point of decommissioning in a regulated facility.

Good Engineering Practice (GEP)

GEP is a principle equally relevant to regulated and non-regulated industries and underpins successful commissioning efforts. The ISPE GEP Guideline is a useful reference document in that regard. There are fundamental concepts applicable to all manufacturing process industries. Specifically, GEP is defined as those activities associated with Project Engineering, Engineering Common Practices, and Operation and Maintenance. Examples of each category are listed below.

Project Engineering

Engineering Common Practices

Operation and Maintenance

Project infrastructure

Standards and procedures

Documentation

Project organization

Documentation practices

Manuals and records

Value analysis

Change management

Routine maintenance

Planning and monitoring

Continuous improvement

Breakdown maintenance

Design

Calibration

Internal audits

Design reviews

Asset management

Waste management

Construction

Vendor/supplier management

Decommissioning and retirement

Non-GMP regulatory compliance

Engineering storage

Facility equipment inheritance and recycling

Commissioning and qualification

Turnover to owner


Subject-matter experts (SMEs)

SMEs are those individuals who have the training and experience to properly plan, execute, and approve verification activities. They should lead during the verification effort for manufacturing systems. It is a regulatory requirement that only properly trained individuals sign and approved verification test forms.

Use of vendor documentation

Vendor documentation may be used for verification activities, provided the vendor has an acceptable quality system. A quality system can be defined as those procedures and processes necessary to produce a product, which consistently meets approved quality standards. Should the owner determine that gaps exist in the quality systems of the vendor or vendor provided documentation, they may use additional verification tests to mitigate the risk or repeat the test altogether. Examples of vendor documentation that can be leveraged are FAT, SAT, and SIT.

Continuous improvement

Change management should be used during the life cycle of the facility and involve the quality unit when critical aspects of the manufacturing process are being changed. After final release and acceptance of the facility, but prior to production batches, the operational change management system should be applied. Operational change management is a more rigorous system that requires pre-approval of all changes related to critical aspects.

E2500 verification process overview

The verification process, as defined by E2500, is one phase within the overall life cycle of the automated manufacturing facility. The primary phases in the life cycle presented in the standard are listed below.

E2500 Phase

Phase milestone

Milestone definition

1. Requirements definition

End-user requirements approval

End user requirements are defined based on product and process knowledge, regulatory and company quality requirements. Provides the basis for proceeding into Specification and Design.

2. Specification and design

Detailed design is implemented

SMEs develop design documents based on CQAs and CPPs. The design documents form the basis for defining the verification activities.

3. Verification

Commissioning complete

A systematic approach to ensure systems are installed and operate according to specifications. SMEs verify testing is complete prior to facility turnover.

4. Acceptance and release

Facility turnover

SMEs develop documented approval that manufacturing systems are fit for use. The facility is released for operation.

NOTE: Step 1 is the start of the project, and step 4 is the end of the project.

E2500 verification summary

The verification test forms should be developed to ensure high-risk areas of the manufacturing process receive the greatest amount of rigorous verification by the contractor. Unlike IEC 62337, E2500 requires a risk assessment be conducted to determine the level of detail in the verification tests. In addition, the Quality Assurance unit should approve all verification plans, tests, and acceptance criteria related to CQAs and CPPs. Vendor documentation gathered in turnover packages or vendor supplied testing requires additional levels of scrutiny by the quality unit. No such quality function is required for non-regulated applications. Verification tests should be independently reviewed and approved by SMEs who did not execute the test. The SME also reviews and approves deviations from the verification test plan or failed tests and approves corrective actions.

E2500 supporting processes

The standard defines the role of Quality Risk Management (QRM). QRM should be used to develop the scope of the commissioning program, which includes the controls and verification methods for critical aspects of the manufacturing operation. The greater the risk to the patient, the more rigorous the verification process should be. Design reviews should be a planned activity completed by SMEs during every phase of the life cycle of the facility. The scope of design reviews includes project specifications, design documents, and continuous improvement changes. Change Management should be used during the life cycle of the facility and involve the quality unit when critical aspects of the manufacturing process are being changed. After final release and acceptance of the facility but prior to production batches, the operational change management system should be applied. Operational change management is a more rigorous system that requires pre-approval of all changes related to critical aspects.

In summary, E2500 is not a prescriptive standard defining the commissioning requirements but rather outlines the general approach to verification testing requirements. The standard relies on risk-based and science-based methodologies to ensure manufacturing systems operate in a manner that meet end-user requirements and protect the health and safety of the patient.

Keys to completing a successful commissioning project involve:

  • Understanding the differences between regulated and non-regulated industry
  • Using relevant standards and guidance documents to plan and execute the project
  • Developing accurate user requirements and design specifications
  • Writing and executing robust tests based on an approved design
  • Managing change using the appropriate procedure
  • Completing the turnover to the end user in a manner that satisfies contractual, code and regulatory requirements.

A well-planned and executed commissioning project will help satisfy the needs of all stakeholders including most importantly, the end user.

ABOUT THE AUTHOR

Matt Wiencek, P.E., CAP (matt.wiencek@cagents.com), is a project manager for Commissioning Agents, Inc., with 14 years of experience in the fields of engineering design, facility start-up, commissioning, qualification, validation and supplier auditing. He has worked in the specialty chemicals, biotechnology and aseptic processing manufacturing industries. He is a Professional Engineer (OH) and ISA Certified Automation Professional.