Deploying wireless condition monitoring in pharmaceutical manufacturing

Reliable equipment is essential to pharmaceutical manufacturing. Pumps, motors, ventilation systems and supporting utilities, such as steam used for sterilisation, must operate as intended to maintain production schedules and support controlled manufacturing processes. An unexpected equipment failure can interrupt production, require additional investigation and place pressure on maintenance teams.

Condition monitoring can provide additional information about equipment health between planned inspections. Wireless sensors may be particularly useful where additional measurement points would otherwise require extensive cabling or changes to existing infrastructure.

However, pharmaceutical facilities have requirements that extend beyond equipment reliability. Installation environments, cleaning procedures, change control, data management and quality responsibilities must all be considered. A successful deployment therefore begins with a clear understanding of both the engineering application and the facility's quality system.

The most appropriate starting point is generally an asset whose failure has a meaningful operational consequence and whose condition can be assessed using a suitable measurement. Often the most suitable asset is one that needs regular manual inspection.

Potential candidates include selected pumps, motors, fans and other rotating equipment supporting manufacturing or utilities, including steam distribution and steam traps. The precise application depends on the failure modes of interest, the asset's operating conditions and the capabilities of the chosen sensor.

For example, vibration monitoring may help identify changes in the mechanical behaviour of a suitable motor or pump. Temperature monitoring may help identify abnormal thermal changes at a bearing housing, motor casing or utility connection. Neither measurement should be treated as a complete diagnosis on its own.

Before selecting assets, engineering and maintenance teams should review:

The initial deployment should address a specific problem, such as recurring maintenance issues on selected utility pumps or limited visibility of equipment operating outside normal staffing hours.

IMI TWTG NEON non-Ex sensors include options for vibration, temperature, steam trap and pressure monitoring in suitable non-hazardous industrial environments.

The NEON Vibration Sensor (Non-Ex) supports three-axis vibration measurements and spectral analysis for suitable rotating and mechanical assets. The NEON Temperature Transmitter (Non-Ex) accepts compatible thermocouple or RTD inputs.

The selection process should establish which measurement is required, the expected range, the sensor's installation limitations and how the information will be used.

Pharmaceutical environments warrant particular attention to the physical installation.

Assess:

A published environmental rating should not be interpreted as blanket approval for every pharmaceutical environment. For example, a device with an IP rating still needs to be assessed against the actual cleaning regime, chemical exposure and installation conditions.

Similarly, a sensor suitable for a non-product-contact utility area may not be suitable for a cleanroom or a location subject to stringent hygiene requirements. Site engineering and quality teams must establish suitability before installation.

The role of the monitoring system should be defined before equipment is installed.

If the system is intended to provide supplementary information for maintenance planning, the facility should assess its effect on existing procedures and quality controls. If its outputs are used to make decisions affecting a regulated manufacturing process or form part of records supporting product quality, additional controls may be necessary.

The US Food and Drug Administration's guidance on current good manufacturing practice addresses equipment maintenance, calibration and the validation of computerised systems where applicable. It also makes clear that the depth of validation depends on the system's complexity and criticality. The relevant requirements for a particular site will depend on its jurisdiction and intended use.

Before deployment, involve the appropriate representatives from:

Together, they should determine whether the change requires formal approval, a documented risk assessment, qualification activities or updates to standard operating procedures.

The assessment should also consider data ownership, access controls, cybersecurity, records retention and the reliability of data used for maintenance decisions.

Wireless monitoring does not automatically establish pharmaceutical compliance. NEON non-Ex sensors should not be described as inherently validated or compliant with a particular pharmaceutical standard unless that claim has been specifically substantiated for the product and intended use.

Once the application and quality requirements have been agreed, document the installation and commissioning approach.

First, confirm the intended sensor location and verify that it can provide a representative measurement. The mounting arrangement must follow manufacturer guidance, and the sensor must be compatible with the operating conditions.

For vibration monitoring, the quality of the mounting and the repeatability of the measurement are important. For temperature monitoring, the probe type, attachment method and measurement point must match the application. The transmitter's permitted input configuration and measurement range should be verified against its current technical documentation.

Next, establish the communications arrangement. NEON sensors use LoRaWAN wireless connectivity, offering long-range communication, low power consumption and reliable data transmission with minimal cabling and infrastructure. This can simplify installation, reduce deployment and maintenance costs, and support scalable monitoring across large or distributed facilities. The facility must confirm LoRaWAN coverage, gateway or network requirements, and the data transmission route to the intended monitoring application.

Commissioning should confirm that:

Where the installation affects a controlled or validated process, the relevant change-control and qualification requirements must be completed before the system is used for that purpose.

Once the system is operational, monitoring data can help engineers decide which assets need closer attention.

Establish baseline pressure readings under representative production conditions and configure fixed alarm thresholds in line with approved operating limits. When an alarm is triggered, assess the reading against the defined limits, taking account of the production stage, operating conditions and any relevant process variations.

A pressure alarm may indicate a developing issue, such as a leak, blockage or equipment malfunction, but it does not necessarily confirm the cause. Engineers should consider the wider evidence, including equipment history, process conditions and inspection findings, before determining the appropriate response.

Integrate the monitoring system into the site's established maintenance and alarm management procedures. Define who receives and reviews alerts, how alarm severity determines priorities, when an investigation or maintenance action is required, and how findings and corrective actions are documented.

In pharmaceutical production, the distinction between supplementary condition-monitoring data and measurements used for process control or product quality decisions must remain clear. Monitoring systems should operate within approved site procedures and must not bypass validated process controls, established alarm responses or instruments and procedures required to maintain product quality and regulatory compliance.

A controlled pilot can help determine whether wireless monitoring provides useful information in the chosen environment.

Potential evaluation measures include:

The evaluation should also record installation constraints, cleaning compatibility, wireless coverage and any quality-system requirements identified during the trial.

A successful technical installation is only one part of the assessment. The team should determine whether the information improves maintenance decisions and whether the deployment can be managed within the facility's engineering and quality procedures.

Wireless condition monitoring can provide additional visibility of selected assets in pharmaceutical manufacturing, helping maintenance teams investigate changes in equipment condition and plan interventions.

The technology must be deployed within the constraints of the facility's environment, quality system and operating procedures. Selecting suitable assets, verifying the installation conditions and agreeing how data will be used are essential steps towards a useful and sustainable implementation.

Stephen Howes is Product Manager, Connected Devices, at IMI

IMI Process Automation can help identify suitable assets, monitoring strategies and sensor technologies for your environment.

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