Pharmaceutical Measurement in Malaysia: GxP Environmental & Process Monitoring

Planning a new pharmaceutical facility, upgrading your cleanroom or replacing an existing sensor? Start with what you need to measure and how your team will use the reading.

Engineering may need a transmitter for the air-handling system or production equipment. QA may need continuous records, alarms and reports for review. Many facilities need both. Seacom helps customers in Malaysia select Vaisala instruments and monitoring systems to suit these different requirements.

1. Transmitters and Probes for Pharmaceutical Facilities

Transmitters and probes measure conditions at the room, equipment or process. Depending on the model and connection, readings can be sent to your building management system (BMS), PLC or another compatible system for display, control or monitoring.

Humidity and Temperature — Cleanrooms, Laboratories and HVAC

Room conditions depend on more than the air-conditioning set point. Measuring humidity and temperature at suitable locations helps your engineering team check actual conditions and gives the control system the feedback it needs.

• Vaisala Origo10: A modular transmitter option for room and duct installations. Select the probe and output to suit your measurement and BMS requirements.
• Vaisala XMP10: Humidity and temperature probes for compatible installations, including Origo10. Choose the probe configuration against the required range and accuracy.
• Vaisala HMP1: A compact humidity and temperature probe for indoor ambient measurement, used with a compatible Indigo transmitter.
• Vaisala HMD60: Duct humidity and temperature measurement for air-handling systems, including supply and return air.

Function: Provide readings for checking room conditions and controlling HVAC equipment. If these readings are also needed as quality records, define how they will be recorded, reviewed and retained.

For existing HMT120 or HMT130 installations, share the model number and output details before arranging a replacement. For an upgrade, review Origo10 against the existing wiring, mounting and control-system requirements.

Differential Pressure — Cleanrooms, Corridors and Airlocks

The pressure difference between adjoining spaces is important when maintaining a specified cleanroom pressure cascade. An open door or a change in the air-handling system can affect that relationship.

Vaisala PDT101 and PDT102 measure low differential pressure. Select the range and configuration for the room-to-room, room-to-corridor or HVAC measurement required.

Function: Check pressure relationships and provide a signal for display, monitoring or control. Connecting the transmitter through a suitable monitoring interface also allows the readings to be recorded and alarmed.

CO₂ — Incubators and Controlled Atmospheres

An incubator has different measurement requirements from a room ventilation system. Percentage-level CO₂ measurement needs a probe designed for that concentration and operating environment.

Vaisala GMP251 is a percentage-level CO₂ probe for applications such as life-science incubators. It can be integrated into suitable equipment or used with a compatible Indigo transmitter.

Function: Provide CO₂ readings for checking or controlling the atmosphere inside the equipment. Where an independent monitoring record is required, review that requirement separately from the equipment's own control sensor.

Vaporised Hydrogen Peroxide — Bio-Decontamination Processes

During a hydrogen peroxide bio-decontamination cycle, a room humidity reading alone does not show the H₂O₂ concentration. A purpose-designed probe is needed for the measurement.

The Vaisala HPP270 Series measures vaporised hydrogen peroxide. HPP271 measures H₂O₂ concentration, while HPP272 also provides humidity and temperature measurements.

Function: Supply measurement data for developing and monitoring cycles in applications such as isolators and transfer hatches. The measurements support process assessment; cycle effectiveness still needs to be demonstrated through the facility's validation work.

Dew Point — Compressed Air and Dry Process Gases

For dry compressed air and process gases, dew point helps your team assess moisture levels and dryer performance. The required dryness depends on how the air or gas is used.

Vaisala DMP8 is a dew point probe for applications including pressurised pipelines. The process pressure, gas compatibility and installation arrangement should be checked when selecting the probe.

Function: Monitor moisture in dry air or gas and identify changes that may require attention. Dew point measures moisture; it does not establish the air's particle, oil or microbiological quality.

Indigo Transmitters — Bringing Compatible Probes Into Your System

Vaisala Indigo510 and Indigo520 provide a transmitter platform for compatible smart probes. The selected probe determines the measurement, while the transmitter provides the available display and integration functions.

Function: Make probe readings available to the operator and connected systems. Indigo520 supports two compatible probes, which can be useful where two sensing points or measurement requirements need to share a transmitter.

Confirm the probe compatibility, outputs and communications required for the installation. A transmitter connection does not automatically provide the records and user controls of a complete CMS.

Liquid Concentration — A Separate Process Measurement Requirement

Liquid preparation and production processes may also need inline refractive index or concentration measurement. Selection depends on the solution, concentration range, process temperature, hygienic connection and cleaning conditions. Share the application details so the appropriate instrument and integration can be reviewed.

2. Continuous Monitoring Systems — Records, Alarms and Visibility

Once the measurement points are identified, the next question is how your team will monitor them. A reading on a display is useful during a site check. For critical areas, you may also need to know what happened overnight, who received an alarm and how long an excursion lasted.

Vaisala viewLinc CMS brings readings from compatible loggers and instruments into a central monitoring system. Depending on the connected devices and configuration, this can cover temperature, humidity, differential pressure, CO₂, dew point and other supported inputs.

What Does the CMS Do?

Wired, Wireless or a Combination?

The arrangement should suit your site. Existing rooms may benefit from wireless monitoring where new cabling is difficult. For a new production area, available Ethernet infrastructure may make wired monitoring practical.

• RFL100 with AP10: VaiNet wireless data logging for supported temperature, humidity and CO₂ configurations. Check wireless coverage and probe locations during planning.
• VDL200: Power-over-Ethernet data logging for compatible probes and viewLinc installations. Check the measurement channels, probe support and network requirements.
• CAB100: An industrial monitoring cabinet for bringing suitable transmitter signals and monitoring equipment together, including cleanroom differential-pressure applications.

Not every process transmitter connects directly to viewLinc. Confirm the interface, supported device and software requirements before finalising the system.

3. How Do Transmitters and CMS Support GxP?

GxP refers to the good-practice requirements relevant to an activity, such as manufacturing, laboratory work or distribution. For your project, the important starting point is which measurements affect product quality and which records your quality system requires.

The transmitter provides the measurement. The CMS provides monitoring and record-management functions. Your site's quality system defines how both are selected, qualified, operated and maintained.

• Define the intended use: Identify whether each point is for equipment control, quality monitoring or both.
• Choose and calibrate the instruments: Match the range, accuracy and calibration points to actual operating conditions.
• Justify the locations: Use the process requirements, risk assessment and relevant mapping findings to choose monitoring points.
• Qualify the configured system: Agree the documentation and testing needed, including IQ/OQ where applicable.
• Set up daily responsibilities: Define who checks records, responds to alarms, reviews changes and maintains the system.
• Protect and retain records: Plan access, backups, retrieval and retention with QA and IT.

Where electronic-record requirements such as 21 CFR Part 11 or EU GMP Annex 11 apply, involve QA early. viewLinc provides functions that support regulated monitoring, but compliance depends on the complete implementation and its ongoing management.

A Practical Example: A Temperature Excursion in a Storage Room

The HVAC control sensor helps the air-conditioning system regulate the room. An independently located monitoring logger can record conditions at a justified monitoring point. If the configured limit is exceeded, the CMS can notify the responsible team and retain the measurement and alarm history.

Engineering can investigate the equipment, while QA reviews the duration and extent of the excursion against the applicable product requirements. The records support that assessment; the system does not decide whether the product can be released.

Discuss Your Pharmaceutical Monitoring Requirements

Whether you need one replacement transmitter or monitoring for a new facility, contact Seacom with the area or equipment involved, what you need to measure and the expected operating range.

For a CMS project, include the number of points, preferred wired or wireless arrangement, alarm requirements and any GxP documentation or qualification requirements. For a replacement instrument, a photo of the model label and connection details will help us check the suitable options.

Send us an enquiry by email or discuss your application on WhatsApp.