Electrical Area Classification in Biotech Manufacturing Facilities Part Three: From Research and Development (R&D) to Manufacturing
In the previous installments of this series (Part One and Part Two), we discussed the development of electrical classifications in biotech manufacturing facilities, and examined the ideas of “open” and “closed” facilities. Now we’ll look at solutions to address electrical area classification requirements when transitioning from a R&D environment to full manufacturing.
A comparison of the electrical area classifications for each type of facility will be shown using the state of Massachusetts as an example.
In an R&D laboratory, the electrical area classification is developed using the applicable codes in effect. In the case of a R&D laboratory the applicable Massachusetts code and chapter is:
This code requires construction and protection of new laboratories to comply with NFPA 45. The use of flammables under specific conditions is allowed without electrically classifying the room, area or space.
As the R&D phase completes, and the successful product moves into manufacturing. the applicable chapter in the code changes to:
There is a second pathway through the code for manufacturing, that follows the Massachusetts building code. This code adopts the 2015 International Code Commission codes which includes the International Fire Code (IFC) with amendments.
780 CMR: Ninth Edition of the Massachusetts State Building Code, International Fire Code 2015
The switch from R&D to manufacturing, even with no significant difference in the amount of material or product produced, may have significant effect on process operations. The change of applicable code places additional restrictions on the electrical systems supporting the process. In some instances, processing equipment may not be available to meet the electrical area classification requirements.
When transitioning from R&D to manufacturing, there are four solutions to ensure that facilities are complying optimally with code requirements. These are listed below:
- Prescriptive
- Performance-based option/design alternative
- Technical justification
- Equivalencies, alternatives, and modifications
What follows is a brief overview of each solution.
The Prescriptive Solution
In this case, an organization simply follows the prescriptive requirements set out in the applicable codes. There are two codes that provide specific requirements for defining the electrical area classification: location, class I division, and the extent of classified area.
- 527 CMR 1.00: Massachusetts Comprehensive Fire Safety Code [NFPA 1 - 2021 Edition (NFPA 30)], Chapter 66.17 Processing Facilities and Chapter 66.7 Electrical Systems
- 780 CMR: Ninth Edition of the Massachusetts State Building Code, International Fire Code 2015, Chapter 57 Flammable and Combustible Liquids, 5703.1 Electrical
Developing the electrical area classification following the prescriptive requirements is a low-risk solution that provides the necessary protections to personnel and property. The codes define specific conditions, along with dimensions to define the extents of a classified area.
This code information is used to create bubble diagrams to define the electrical area classification extents. Strict requirements for electrical systems power and control wiring methods are defined, along with the listing and labeling of the processing equipment used within the electrically classified space.
The Performance-Based/Design Alternative Solution
This approach employs a performance-based option (527 CMR 1.00) or a performance-based design alternative (780 CMR, IFC). A performance-based solution follows the same codes as the prescriptive solution by applying different sections of the codes. There are some additional requirements that may require specialized support:
- 527 CMR 1.00: Massachusetts Comprehensive Fire Safety Code, Chapter 5 Performance-based Option
- 780 CMR: Ninth Edition of the Massachusetts State Building Code, International Fire Code 2015, Chapter 50 Hazardous Materials – General Provisions, 5001.3 Performance-based design alternative
Massachusetts has modified the performance-based option in NFPA 1 by replacing Chapter 5 entirely. The requirements under this option include:
- Meet goals and objectives in Massachusetts Comprehensive Fire Safety Code
- (MCFSC) and Building Code
- Submit plan documentation to authority having jurisdiction (AHJ) and Building Code Official for review and approval
- Optional independent review at owners’ expense
- Final determination by AHJ and the Building Official
- Establish an operations and maintenance manual
Figure 1 below details the steps of the performance-based solution
The performance-based design alternative (780 CMR, IFC Chapter 50, Section 5001.3) requires a similar set of points to address:
- Objective
- Functional statements
- Performance requirements
- Reliable power source
- Properties of hazardous materials
- Reliability of equipment and operations
- Prevention of unintentional reaction or release
- Spill mitigation
- Ignition hazards
- Exposure hazards
- Protection of hazardous materials
- Detection of gas or vapor release
- Ventilation
- Process hazard analyses
- Pre-startup safety review
- Operating and emergency procedures
- Management of change
- Emergency plan
- Accident procedures
- Consequence analysis
- Safety audits
Both codes noted above are applicable, so care must be taken to consider each applicable point and incorporate it into the performance-based solution. This process must involve all stakeholders who have a shared interest in the successful completion of the project.
The SFPE Engineering Guide to Performance-Based Fire Protection Analysis and Design of Buildings outlines a process for using a performance-based approach in the design and assessment of building fire safety design.
A performance-based design report documentation should include the fire protection engineering design brief, a performance design report, detailed specifications and drawings, and a facility operations and maintenance manual.
An overall evaluation is recommended at the completion of the final report prior to seeking approval of the AHJ to proceed. The evaluation should confirm the design solution meets the initial goals and objectives as set out and that no undue restrictions have been imposed on the facility for the immediate need and as well as long term operations.
The Technical Justification Solution
A third option in transitioning from R&D to manufacturing is to follow only the Massachusetts Building Code (780 CMR).
Unlike the prescriptive and performance-based solutions, there is no corresponding pathway through the Massachusetts Comprehensive Fire Safety Code (527 CMR 1.00). As a result, this pathway is a more difficult sell to the AHJ for approval.
Similar to the performance-based approach, an overall evaluation is recommended at the completion of the final report prior to seeking approval of the authority having jurisdiction (AHJ) to proceed.
Equivalencies, Alternatives, and Modifications
The fourth possible solution is to follow the Massachusetts Comprehensive Fire Safety Code (527 CMR 1.00). There is a similar pathway through the Massachusetts Building Code (780 CMR) that allows for alternative materials, design and methods of construction and equipment.
To take one specific example, 527 CMR 1.00: Massachusetts Comprehensive Fire Safety Code [NFPA 1 - 2021 Edition (NFPA 30)], Chapter 1 Administration states:
“Nothing in this Code is intended to prevent the use of systems, methods, or devices of equivalent or superior quality, strength, fire resistance, effectiveness, durability, and safety to those prescribed by this Code, provided technical documentation is submitted to the AHJ to demonstrate equivalency and the system, method, or device is approved for the intended purpose.”
As with the performance-based approach and technical justification, an overall evaluation is recommended at the completion of the final report, before seeking approval of the AHJ to proceed.
It is common industry practice to include a code consultant on a project. The code consultant or code specialist is brought on to advise on the applicable pathways through the relevant codes to ensure designs are code compliant, and safe to personnel and property. This type of specialist can be of great support when implementing the performance-based or technical justification solution for the electrical area classification.
The development of an electrical area classification can follow multiple paths through the applicable codes.
The early project stage should place emphasis on evaluation of the client’s process needs, the available processing equipment selections and the level of risk associated with the prescriptive requirements, performance-based, technical justification and or the alternative solution. By having all stakeholders agree on the path forward as early in the process as possible, you can be assured of the best possible outcome on your transition from R&D to manufacturing.
View Electrical Area Classification in Biotech and Manufacturing Facilities: Part One
View Electrical Area Classification in Biotech Manufacturing Facilities: Part Two
