brian scott, jeff hargroves, and jerry bauers validation

Special Edition: Utilities Qualification32

Brian Scott, Jeff Hargroves, and Jerry Bauers

VALIDATION OF HVAC SYSTEMS IN

PHARMACEUTICAL & BIOTECHNOLOGY FACILITIES PART 1

Editor's Note: The following article is the first in a two-part series. Part One addresses the fundamental requirements and installation qualification of HVAC systems. Part Two, which will appear in the May issue of the Journal, will discuss the operational qualification and performance qualification of these systems.

An HVAC system, which encompasses heating, ventilation, and air conditioning, is an integral component of a facility's functionality. It impacts the safety of scientists and technicians working in a lab or production facility, the integrity of processes, and the environment outside.

There are three core phases of HVAC system validation: installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). An important element of successful HVAC validation is prevalidation design work. This article explores the correlation between preliminary design and each phase of validation.

HVAC SYSTEM FUNDAMENTALS

Construction and validation of an HVAC system usually involves compiling the following documents, which typically are developed in the order presented in Figure 1:

• Functional Specification (the conceptual design) • Design Drawings, Plans, and Specifications • Validation Master Plan • Contractor Documents (e.g., shop drawings

and submittals) • Testing, Adjusting, and Balancing (TAB) and

Start-up Reports • Commissioning Report (The actual execu

tion of validation protocols may commence; commissioning may be performed as part of the "development" phase of validation.)

• Validation (IQ, OQ, & PQ)

When PQ is complete, process validation commences and product manufacture (or laboratory processes) can begin.

Whatever the components of an HVAC system, the functional requirements must be determined up front. In fact, functional specifications are the cornerstone of any project.

It is important that design criteria is not the sole basis for establishing validation acceptance criteria. Design criteria may be written with extreme precision, but acceptance criteria for validation may not need to be so stringent. This determination comes from understanding the process in question. The design team must understand and assist in determining what a system needs to "do" in the context of processes and other operations carried out within a facility.

Special Edition: Utilities Qualification 33

Brion Scatt, JeH Hargraves, and Jerry Bo uers

Figure 1 DOCUMENTATION SUPPORTING CONSTRUCfION

AND VALIDATION OF AN HVAC SYSTEM

CODI.ltdOr

Operational Qualification (OQ)

Performance Qualification (PQ)



A description of functional requirements should include:

• HVAC system functionality as it relates to processes.

• Points in a process that expose a product to the environment.

• Source of design guidelines (e.g., an existing similar facility, a domestic or foreign regulatory body).

The following is an excerpt from a functional requirements description for a typical manufacturing facility:

"Air handling unit AHU-Ol seroes an aseptic filling suite in the New Product Facility. The suite includes an aseptic area, clothes changing room, two equipment pass-throughs, and an incubator room.

The air handling unit draws a mixture of makeup air and return air into a mixing section, through a series of filters, and a cooling coil; then blows the air through a heating coil and discharges it into distribution ductwork. Filtration is prOVided by 30% ASH RAE efficiency pre-filters, 95% ASHRAE efficiency bag filters, and 99.97% HEPA filters. Terminal 99.995% HEPA filter diffusers provide final filtration and air distribution in each room. Air is returned through low wall louvered return grilles. Temperature is maintained at 66 ±2° F. Humidity is maintained between 20% and 50% RH. Space pressurizations are shown on Drawing XX-lOJ-AA."

Once deSigners understand the functionality of a faCility, the next questions are who or what holds regulatory responsibility and what are the particular performance requirements. The answers to these questions lead to perhaps the most significant issues in validating an HVAC system: The processes that the system is supporting and who monitors the performance of the facility. Validation criteria must be established within this context and not in a vacuum or against arbitrary "right" or "wrong" conditions.

Personnel responsible for HVAC validation should be involved in the design process from early conceptual meetings through periodic design

reviews to final design approval. In doing so, they have a voice in identifying the criteria against which a system should be validated and can offer observations and recommendations about design which might ultimately impact validation.

VENDOR REQUIREMENTS

There are many reasons that a validation team should participate in the design phase of a project. One is to identify the documentation that equipment vendors must provide. Documentation should specify the following requirements and tolerances:

• Material certification (e.g., serial numbers for HEPA filters)

• Performance characteristics (e.g., CFM for air flow on air handling units; air flow vs. static pressure for fans)

• TAB • Pressure ratings (for ductwork and the

distribution system) • Factory performance testing of critical

equipment • Factory leak testing for cooling or heating

coils

If contractors and equipment vendors are not told up front what they are required to provide, it's very difficult to get necessary information as a project progresses. In many scenarios, specifications typically are written just for acquisition and installation of equipment. A better procedure--one that will make the validation process more efficient-is to require vendors to supply supporting documentation. Requirements also should be applied to any software that may be part of controls or building management systems.

In addition to outlining documentation that vendors must furnish, this is the time in the validation process to define responsibilities for delivery, installation, and start-up or commissioning. This procedure encompasses activities such as starting air handling unit motors, verifying correct fan rotation, and point-to-point verification of control loops.


INSTALLATION QUALIFICATION

The goal of IQ is to verify and document the quality, installation, and integrity of HVAC system components. Use design documents and literature provided by vendors to develop IQ protocols, which often take the form of inventories or checklists. Execution of IQ protocols provides assurance that an HVAC system is installed according to the manufacturer's recommendations and requirements for the specific facility being validated. (Note: Some readers may find that the requirements listed in the following discussion are more typical of aseptic areas and may not be universal for all HVAC systems.)

A Description of Operation (System Description) identifies an HVAC system, as well as the processes it supports and areas it serves. It should give a clear and concise description of the system in question, focusing on operational attributes of the system rather than technical specifications of equipment. (In most cases, a one-paragraph description is sufficient, unless a system is unusually complex.) When appropriate and useful, include diagrams showing temperature and humidity control zones, room pressure relationships, and other key information.

It is important to avoid "over specifying" system attributes. For example, a diagram with arrows to indicate room-to-room directional air flows may be more useful than a drawing showing numeric pressure relationships.

Information provided in a Description of Operation should cover the following:

• Brief description of the system • Identification of all the spaces served by the

system • Room temperature setpoints, including

acceptable deviations (±)

• Room humidity setpoints, including acceptable deviations (±)

• Minimum space air change requirements • Space particulate classifications

IQ documentation generally is broken down into the following major sections:


Installation Drawings & Specifications (List) -Documents as-built drawings and design specifications for an HVAC system about to be qualified (validated). As-built drawings normally are supplied by mechanical contractors. These drawings offer a record of system installation in its validated state, provided they reflect changes made to the system during validations.

Document the sheet number, description, and latest revision date of each drawing. Compare the finished installation to as-built drawings to make sure that installation conforms to the drawings. Major discrepancies between as-built drawings and conditions found during validation should be marked on the drawings and reported to the appropriate personnel.

Execution of IQ may be easier if an "installation checklist" is generated based on information in design drawings and specifications. This checklist should include all fans, fan motors, coils, and filters in the air handling unit. Zone reheat coils and terminal HEPA filters also may be incorporated.

If construction is complete before validation starts, some HVAC devices may become concealed by insulation or architectural elements. In these cases, packing lists, purchase orders, or other documentation should provide evidence that installed equipment meets design requirements. The source of information used to verify acceptance should be noted in a protocol. In addition, duct leak test reports may be referenced and attached as evidence that ductwork has been installed in accordance with industry standards (e .g ., ASHRAE, SMACNA standards).

Materials in Product Contact - Normally does not apply to most HVAC systems. However, in a clean process environment where product or ingredients are exposed to air provided by an HVAC system, this evaluation must consider materials used in construction of the system that may become airborne and directly contact product. Because of the risk of contamination to the system, such materials should be appropriate and safe for product contact and "non-particle shedding." In other words, construction materials should not be "reactive, addi-



tive, or absorptive so as to alter the safety, identity, strength, quality, or purity of the drug beyond the official or established requirements." (21 CFR

211.94 - Drug product containers and closures.) IQ documentation may include materials in

final filters, along with any devices downstream of them that serve an area in question. These materials should meet industry-accepted standards for suitability in drug processing, packaging, labeling, or other activities taking place.

Lubricants - Identifies lubricants used to maintain an HVAC system. This list may be as simple as "fan bearing grease." A more detailed list would include lubricants provided with system components prior to installation, such as damper lubricants.

Food or pharmaceutical grade lubricants should be used if there is potential for product contact (where equipment design permits possible product contamination by the lubricant). Consult a maintenance supervisor or other maintenance personnel to ensure that all applicable lubricants are listed here.

Utilities - Lists utilities critical to the operation of an HVAC system. All systems require supporting utilities to function properly. Include applicable design and actual data for utilities as follows:

• Electrical requirements and provisions for each HVAC utility (e.g., fan, pump, condensing unit, etc.) - Document voltage, phase, full load amperage, and conductor size.

• Steam requirements (e.g., plant steam or clean steam, as applicable) for each steam coil or humidifier, including line size and steam pressure for each device - Steam flow (usually expressed in pounds per hour) is not easily measured and usually not included here.

• Hot and chilled water coil requirements, including supply temperature, pressure, and flow rate - If a TAB contractor has made adjustments to a system, reference the TAB report (submitted by a contractor certified by the National Environmental Balancing Bureau) for information provided in this section.

Instrumentation Calibration - Ensures accurate control of critical operational parameters. List all calibrated instruments critical to system operation. Instrument calibration should be current at the time that IQ is performed. Document the dates that calibrations were executed and that recalibrations are due.

In some cases, the only devices included in a routine calibration program are those used for closed-loop control or critical system alarms. For example, pressure gauges in chilled water lines entering and leaving a cooling coil may be considered "non-Critical," but temperature sensors in spaces served by the cooling coil may be considered "critical." If the temperature sensors are critical, they require routine calibration. If calibration data sheets are available, they may be attached to the protocol.

Preventive Maintenance - Identifies procedures used to maintain an HVAC system in good operating condition. Preventive maintenance (PM) also provides assurance that a system will be kept in a validated state.

List preventive maintenance numbers and effective dates. PM procedures for an HVAC system may include inspection of filters, bearings, belts, gaskets, and any other moving parts, as well as parts with limited lifespans. Maintenance personnel normally write PM procedures.

Spare Parts - Identifies filters, belts, or other items that will be replaced according to a regularly scheduled preventive maintenance program. During the life of a typical HVAC system, certain parts will need to be replaced as a result of expected wear and tear. Record the manufacturer and model number of each item. Spare parts should be identical or equivalent to original parts. A facility's maintenance department should keep these parts in stock.

Special Procedures - Identifies special procedures, such as a controls system software walk-through and initial HEPA filter integrity testing. Certain procedures involved in HVAC system start-up should be documented as evidence of proper configuration or performance of system elements. Some of this information may be useful for troubleshooting


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