Temporary temperature and environmental monitoring
Is a permanent monitoring setup not yet available when your thermal mapping is finished? Agidens helps you to bridge this period with a temporary setup to measure temperatures, relative humidity and other pre-defined environmental parameters. The used systems are 21 CFR Part 11 compliant and temporary monitoring is also possible in ATEX zoned spaces.
From thermal mapping to temporary monitoring
Thermal mapping and validation maps out how temperature and humidity behave in a space and identifies hotspots, coldspots and critical zones. Temporary monitoring, which usually takes about 3 to 12 months, doesn’t repeat the study but follows the mapping strategy defined during a thermal mapping. The measurement equipment is placed at critical locations and uses the same risk insights as an endpoint. This way, the environment stays monitored when a mapping is complete, without having to fall back on a generic division of sensors.
The natural flow is as follows:
Thermal mapping
Analysis of empty and loaded spaces, placing dataloggers and identifying hot/coldspots and risk zones.
Temporary monitoring
A monitoring system on critical locations in the mapping, immediately fully operational and Part 11 compliant, even in ATEX zones.
Permanent monitoring
When the permanent monitoring system is implemented, we transfer acquired data and insights to the new system so there aren’t any gaps in monitoring.
WHEN IS TEMPORARY MONITORING RELEVANT?
Temporary monitoring provides a solution when a space needs to be followed up demonstrably but a permanent installation is not yet available.
Typical situations include:
- the waiting period between thermal mapping and implementing a definitive monitoring system
- seasonal follow-up of hot or coldspots
- new or temporary storage or production facilities, renovations or expansion projects
- temporary GMP or GDP storage
- follow-up after a temperature deviation as part of a CAPA-trajectory
WHAT DOES THE MONITORING SERVICE INCLUDE?
This monitoring service is part of a wider range of thermal validation services by Agidens. We take on temporary monitoring as a full trajectory:
Review of mapping results
The hotspots, coldspots and risk zones from the thermal mapping are reviewed as a base for the measurement setup.
ATEX classification when needed
In potentially explosive spaces, we take the effective ATEX zone classification into account when selecting the appropriate Ex equipment.
Placement & configuration
Sensors and registrators are installed in critical locations and configured according to Part 11. We rent the temporary equipment for the entirety of the assignment.
Follow-ups & reporting
The service includes continued datalogging, alarming when trespassing occurs, trending, periodic reporting and, when needed, deviation analysis. Cloud connectivity and realtime follow-up can be a part of the technical setup.
Transfer to permanent monitoring system
While transferring over to the definitive monitoring system, we also transfer the acquired data and insights so there’s no unnecessary gap in monitoring.
DATA INTEGRITY AND COMPLIANCE
Monitoring solutions can be implemented in GMP, GDP and GLP environments and support, when needed, ISO 14644 and GAMP principles as well. The used systems are compliant with 21 CFR Part 11 and contain audit trails and traceability of changes, alarms and user actions, electronic signatures for approval of measurements and reports, user management and electronic data integrity, ALCOA+ principles and alarming when deviations occur.
The measurement data and reports can be used in quality, validation and compliance processes and as support during inspections and audits.
TEMPORARY MONITORING IN ATEX ZONES
Even in potentially explosive environments, Agidens can provide temporary monitoring setups. The equipment is selected based on the effective zone classification and use case. This makes temporary monitoring possible in production, storage and process environments where standard monitoring equipment isn’t suitable.
The validated scope contains:
- Zone 1 and 2 for gas or damp atmospheres, for example while storing solvents or when using alcohol
- Zone 21 and 22 for dust atmospheres, for example with powder handling, lactose or other active ingredients
- Ex certified sensors and registrators that are qualified for the present zone classification
- placing and cabling following the ATEX guidelines to prevent the monitoring setup from becoming a ignition source
- the same risk analysis and sensor positioning as endpoint, supplemented with the requirements for explosion safety
VOORBEREIDING OP PERMANENTE MONITORING
The data from a temporary setup remains available when you implement a permanent monitoring system later. It shows how a space behaves throughout a longer operational period and can be used to optimize the number of measurement points, refine measurement positions, align alarm limits and levels, further substantiate critical zones, and design the future monitoring architecture in a more targeted manner.
In this way, the permanent setup is based on actual operational data rather than solely on assumptions.
EXPERIENCE IN THERMAL VALIDATION
25+ years of experience in thermal validation
500+ qualified CTU’s
30 specialized validation technicians
8,1 Net Promotor Score
TALK TO US ABOUT YOUR TEMPORARY MONITORING SETUP
Do you need temporary monitoring between a mapping and permanent monitoring, or for a temporarily regulated or ATEX environment? Tell our validation specialists about your challenges, they’re ready to find the right solution for you.
