Introduction

According to the International Society for Pharmaceutical Engineering (ISPE), pharmaceutical HVAC commissioning is a quality-oriented process that involves verifying and documenting that the system’s performance meets defined objectives and criteria. The Food and Drug Administration (FDA) emphasizes that proper facility design and commissioning activities must precede Process Performance Qualification (PPQ).

Commissioning is not limited to the pharmaceutical quality life cycle and is also commonly used in non-regulated industries. However, in GMP-related industries, commissioning reports are essential for the later stages of the Qualification (IQ and OQ).

This post will discuss a few recommended tests that are typically required for satisfactory commissioning work.

Inspection Tests

This set of tests requires a visual inspection of the installed components. Based on the engineering specification datasheets, the following verifications we should perform:

• Air Handling Unit (AHU): Check the dimensions, cleanliness, module integrity, sections (including filter type, fan model, coils, etc.), and identification.
• Instrumentation: Verify the model, range, manufacturer calibration certificate, location, wiring, and tag.
• Terminal HEPA Filters: Inspect the layout, dimensions, sealing, manufacturer MPPS certificate, and tag.
• Dampers: Ensure accessibility, performance, and tag.
• Walkthrough for P&ID and ductwork layout verification.

Fan Performance

During this test, the commissioner engineer will check the performance of the supply and extract fans and record the operating data for future reference.

To perform this test, we will take readings of pressure, flow, and Hz or consumed power to reflect a few points on the manufacturer’s curve. Also, we will need installed instrumentation readings from static pressure transmitters and airflow transmitters.

As shown in the example above, we measured an airflow of 4,500 m³/h and static pressure of 1780 Pa, which matches the consumed power of 2.5 kW and motor speed of 3,460 rpm for this specific motor.

The datasheet for the fan can include additional data such as the manufacturer, model, serial number, amps, rpm, and power.

We can read many of these values directly from modern Variable Speed Drives (VSD).

Ductwork Leakage Test

In this test, we will verify that air leaks are within the specified limits. We will determine the representative area of ducting to test, based on the criticality of the areas. For more details on the requirements, please refer to our post Pharmaceutical HVAC ductwork

Vibration analysis

We can perform another typical test which is vibration analysis, which is applicable for AC fan motors and critical for understanding whether the motor is in good condition. The results report includes a graphical analysis, as we can see below:

By the last, we should confirm that the fan is installed according to ISO 14694 “Industrial fans – Specifications for balance quality and vibration levels”

Traverse Pitot

Another important test for Pharmaceutical HVAC commissioning is the traverse Pitot test. Traverse Pitot sampling points must be strategically defined and available in the installation to check that the airflow in the branch meets the specified requirements. These points are openings in the ductwork that allow a Pitot sampling tube to be inserted for measurements.

For a detailed explanation of this test, please watch this informative video:

Duct Traverse Youtube link

We should find in the commissioning report, that the sampling points are clearly defined graphically and identified in the layout.

System setup

The commissioning report should document all the activities required to ensure that the system functions properly. The commissioning engineer is experienced in the activities listed below:

• Adjusting chilled water and low-pressure hot water flows in accordance with specifications
• Tuning temperature PID/PI control
• Tuning relative humidity PID/PI control
• Tuning airflow PID/PI control
• Tuning pressure PID/PI control
• Developing the sequence of operations as specified in the functional specifications (performance, safety, fire detection, controls, etc.)
• Conducting admissible noise measurements

System balance

At this point, it is crucial to balance the airflow of the room and set the differential pressures in the correct order. It is a common mistake to hand over the system without performing these important steps and expect the qualification personnel to be in charge of them. The qualification personnel should find a system that is perfectly tuned and balanced to take readings and complete operational test reports. The design specifications described in the Cleanroom Air Balance post are a good starting point.

The system balance should include the following to meet the design specifications:

• HEPA filter integrity testing to ensure the filter is not damaged.
• Airflow measurement for each terminal HEPA filter, balanced for its nominal capacity. It is highly recommended to use an adequate size ballometer.
• Air return velocities (and airflow).
• Room pressure balance.

Conclusion

Pharmaceutical HVAC commissioning plays a crucial role in the lifecycle of a facility. It is noteworthy that many of the tests involved in HVAC commissioning overlap with the IQ/OQ testing activities. Hence, an IQ/OQ protocol can reference a well-documented commissioning report to avoid duplicating certain tests.