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Temperature Mapping And Validation Studies For Warehouses, Cold Rooms And Equipment

The question that starts most mapping projects is not a technical one. Somebody has asked for the mapping study for a space that has never been mapped, the audit is six weeks out, and nobody can say with evidence where the warm spot in that warehouse is. Temperature mapping answers that with data, in a report written to survive the audit it was commissioned for.

Validation engineer placing a temperature mapping data logger high on warehouse racking in Singapore
  • Ambient warehouse, cold room, walk in freezer and equipment

  • IQ, OQ and PQ protocols and reports

  • Loggers calibrated in our own Singapore laboratory

  • More than 10 years writing protocols for regulatory audits

  • Singapore based since 2009

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What Temperature Mapping Singapore Facilities Are Required To Produce

A temperature mapping study places calibrated data loggers through the full volume of a space, records at a set interval over a defined period under defined load and door opening conditions, and establishes where the temperature extremes actually sit. The deliverable is a report with the protocol it was run against, the raw data, the analysis, and recommendations.

 

The reason it exists is that a specification is a claim and a mapping study is evidence. A cold room designed to hold 2 C to 8 C usually does, on average, near the sensor the installer fitted. Mapping finds the corner behind the door that runs at 9.4 C in the afternoon, and the pallet position at the top of the racking that a monitoring sensor three metres lower will never see.

 

Asia GMP has delivered these studies in Singapore since 2009, for the regional divisions of global pharmaceutical companies and for global life science logistics providers.

 

What We Map

 

  • Ambient warehouses and racked storage held to a documented range such as 15 C to 25 C

  • Walk in cold rooms and chiller rooms

  • Walk in freezer rooms and blast freezers

  • Refrigerators, freezers and ultra low temperature freezers to -80 C

  • Incubators, ovens, stability and climatic chambers

  • GDP compliant warehouses, cold trucks and shipping containers

  • Thermal packaging and passive shippers, via climatic chamber and simulation

Buying monitoring before mapping is the usual sequence error. Sensors get placed where the cable reaches or where the installer suggested, and the first assessor to ask how those positions were chosen gets no answer. Mapping first costs less overall than mapping afterwards and moving the sensors.

 

Why Singapore Sites Choose Asia GMP For Mapping

Asia GMP has specialised in temperature control for the life science industry since 2009. The validation engineers carry more than 15 years in the pharmaceutical industry, including running GMP certified warehouses and handling warehouse temperature audits from the other side of the table. The company is ISO 9001 certified by SOCOTEC Certification International under UKAS Management Systems 0063.

 

What clients tend to say afterwards is that the value was in the survey rather than the loggers. A mapping study designed by somebody who has been audited on one is a different document from a mapping study run by somebody following a template.

 

Mapping is one of five divisions, alongside cold chain management and warehouse and facility monitoring. See all five at Asia GMP, or speak to our Customer Care Officer on +65 6742 4912.

Frequently Asked Questions

 

What is temperature mapping?

Temperature mapping is a study that places calibrated data loggers throughout the full volume of a storage space or a piece of equipment, records at a defined interval over a defined period under stated load conditions, and establishes where the warmest and coolest points actually are. The output is a report with the protocol, the raw data, the analysis and recommendations.

 

How long does a temperature mapping study take?

The on site recording period is commonly 72 hours for a space in steady operation, with 24 hours used for some equipment and longer periods where seasonal or load variation has to be captured. Including the survey, protocol approval, analysis and report, a typical project runs two to four weeks end to end. Audit deadlines can be worked to if you tell us the date up front.

 

How often should a warehouse or cold room be remapped?

Common practice is an initial qualification study followed by periodic requalification, often annually or every two to three years depending on your quality system, and an immediate restudy after any significant change: new racking, a refrigeration plant replacement, a change in load pattern, a reconfigured door, or a change in the product's storage requirement.

 

What is the difference between temperature mapping and temperature monitoring?

Mapping is a one off study that establishes how temperature behaves across a space and produces qualification evidence. Monitoring is continuous and tells you what is happening now. They are complementary, and mapping should come first, because mapping decides where the monitoring sensors belong.

 

What is the difference between calibration and validation?

Calibration establishes that a single instrument reads true against a reference standard, and produces a certificate for that instrument. Validation establishes that a process, a piece of equipment or a space does what it is supposed to do, consistently, and produces a report. Validation depends on calibration: an uncalibrated logger cannot support a validation conclusion.

 

Do you provide the IQ, OQ and PQ documentation, or just the mapping?

Both. We write and execute Installation, Operational and Performance Qualification protocols for cold rooms, freezers, chambers, incubators and warehouses, and deliver the completed documented reports. Where a supplier has left a partial set, we can run the missing stages rather than starting again.

 

Can you map a cold truck or a shipping container?

Yes. Mobile cold chain trucks, transportation vehicles and shipping containers are mapped against the route and the ambient profile they actually run, and thermal packaging is qualified separately via climatic chamber and simulation.

 

Will mapping disrupt our operation?

Rarely. Logger placement and retrieval are short interventions and the recording period runs through normal operation, which is the point: a study run on an empty, undisturbed space does not describe the space you actually use. Access is scheduled around your hours.

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Validation loggers operate from -80 C to +140 C, with external temperature probes available for use alongside thermal barriers at higher temperatures. Relative humidity loggers measure across 0 to 100% RH with a sintered cap protecting the sensor where it may be immersed or exposed to contaminants.

 

IQ, OQ And PQ: Fixing Gaps Before The Audit

Equipment and facility validation runs in three stages and each answers a different question. Installation Qualification establishes that the equipment was installed as specified, in the right place, with the right services and the right documentation. Operational Qualification establishes that it performs across its operating range, including at the limits. Performance Qualification establishes that it holds under real loaded conditions over time, which is the stage mapping sits inside.

 

In practice most Singapore sites come to us with a partial set: the supplier left an IQ, nobody ran an OQ, and the PQ was a single sensor logged for twenty four hours in an empty room. That gap is what an assessor finds. Thermal validation of cold rooms, freezers, chambers and warehouses, fully documented, is what closes it.

 

Validation also depends on the instruments behind it. A qualification run with loggers whose calibration certificates do not cover the study dates has to be repeated, which is why our calibration services and our temperature data loggers sit alongside this work rather than after it.

How A Mapping Study Runs

Four stages, and the first one happens before any logger is placed. A study designed without a site survey produces a technically correct report that answers the wrong question.

 

  1. Site survey, planning and preparation. Volume, zoning, load pattern, door opening behaviour, HVAC and refrigeration configuration, and the regulatory basis for the acceptance criteria. This produces the protocol, which is approved before the study starts.

  2. Conduct of the mapping exercise. Calibrated loggers placed to the approved position plan, recording at the defined interval over the defined duration, under stated load. Empty and loaded studies where the product requires both.

  3. Collection, analysis and report. Raw data, distribution analysis, identification of warm and cold extremes, excursion assessment against the acceptance criteria, and a written report with recommendations.

  4. Implementation of recommendations and follow up. Including where the permanent monitoring sensors belong, which is one of the most valuable outputs of the study.

 

Studies are commonly run across both the warmest and coolest parts of the year where seasonal variation matters, and in Singapore that question is more about the building's HVAC behaviour than the weather.

 

What The Report Has To Withstand

A mapping report is read by people looking for reasons to reject it. Our engineers have more than 10 years drafting protocols and reports for regulatory and quality audits, and the format reflects what those audits ask: a protocol approved before execution, loggers with calibration certificates covering the study period, a position plan that explains why each logger sat where it did, raw data retained, deviations recorded rather than smoothed, and conclusions tied to stated acceptance criteria.

 

Loggers are calibrated in our own Singapore laboratory, traceable to national standards. That matters for a reason beyond convenience: if the calibration certificate does not cover the dates the study ran, the study is not usable, and that is a surprisingly common way for a mapping exercise to have to be repeated.

 

Mapping, Monitoring And Calibration Together

These three get bought separately and work as one. Mapping tells you where the risk is and produces the qualification evidence. Temperature monitoring then sits at the positions mapping identified and watches them continuously. Calibration services keep both the mapping loggers and the monitoring sensors defensible year on year.

Numbered data loggers with position labels and calibration stickers laid out before a temperature mapping study
Temperature mapping report showing temperature distribution charts and a logger position plan
Mapping data loggers hung at three heights inside a walk in freezer during a temperature mapping study

Want to find out more?

Please contact us to discuss about your cold chain requirements in greater detail. Our Customer Care Officer is easily reachable by phone or email at your greatest convenience.

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Our Full Suite of Solutions

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Design, Procurement, Installation and Commissioning of Temperature and/or Humidity Monitoring Systems

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Non-wireless Temperature Monitoring Solutions

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Strive to provide value added consultancy services at every point of the cold chain from source to destination.

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Temperature Mapping

Installation Qualification, Operational Qualification and Performance Qualification of cold chain areas and appliances

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Ambient Warehouse Mapping

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Cold Room and Walk-in Freezer Mapping

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Temperature Calibration Services

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Humidity Calibration Services

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Asia GMP Pte Ltd

 

Address:

6 Ubi Road 1, #06-13,

Wintech Centre, 

Singapore 408726

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Tel: +65 6742 4912

Whatsapp: +65 8035 7085

Email: customercare@asiagmp.com.sg

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