Expertise / EMS & Instrumentation
Environmental monitoring and instrumentation for pharma and biotech.
From sensor to data, a coherent measurement chain.
Our team works on EMS in pharmaceutical and biotech environments: wired or wireless instrumentation, installation, configuration, integration and qualification.
Temperature, humidity, differential pressure, particle counting, air velocity, states and signals: we handle what is at stake in measurement, alarms, traceability and data integrity in a GxP context.
We also write IQ/OQ/PQ protocols, with hands-on experience of performance qualification (PQ) on EMS.
A complete EMS project to run?
Explore our EMS engineering service
Parameters & technologies
Every parameter calls for its own measurement choices
Range, accuracy, placement and acquisition: a usable measurement depends as much on its environment as on the technology chosen.
Temperature & humidity
Ranges and accuracies suited to rooms, storage areas and equipment. Locations backed, where needed, by a mapping study.
Differential pressure & airflow
Pressure cascades between areas, air velocity and alarm delays justified by the operating conditions.
Non-viable particle counting
Choice of sampling points, flow rates and sampling lines, taking their length and bends into account.
Gases and specific measurements
O₂ measurement, integration of the associated thresholds and alarms, according to the requirements of the installation.
States & signals
Door contacts, equipment faults and alarm relays to put events in context.
Acquisition & interfaces
Transmitters, acquisition modules, Modbus TCP or Profinet communication depending on compatibility, exchanges with EMS and BMS according to their respective roles.
Wired or wireless?
Wireless can reduce cabling work in existing installations. The choice also depends on criticality, radio coverage, battery life and how measurements and data are kept if communication is lost. Each architecture has to fit the constraints of the site.
GxP requirements & qualification
From URS to PQ, one traceability thread
Between user requirements, EMS configuration and qualification, gaps often come from incomplete traceability. Our team links GxP needs, the functions implemented and the test evidence.
Requirements & configuration
Review of URS and risks, identification of GMP functions and their interfaces with the BMS. Traceability between requirements, configurations and tests.
Alarms & notifications
Alert and action limits, delays, acknowledgements, sensor faults and communication losses. Configuration and verification of notification and escalation chains.
Data integrity
Access management, audit trail, timestamping, historisation, backup and restore of data, according to the system’s features and the applicable requirements.
IQ/OQ/PQ qualification
Writing and executing protocols: installation conformity and calibration checks in IQ, functions and failure scenarios in OQ, monitoring performance under representative operating conditions in PQ, notably recording continuity and alarm handling within the agreed scope.
Standards, where applicable: EU GMP Annexes 1, 11 and 15, 21 CFR Part 11, GAMP 5 and ISO 14644.
Diagnosis & evolution
Diagnose the chain, not just the sensor
Recurring alarms, inconsistent readings or missing data do not always come from the instrument. We investigate the whole chain, look for the causes and document our findings to support quality investigations and corrective actions.
Recurring alarms
Analysis of trends, limits, delays, door events and notifications. Reducing nuisance alarms without masking real deviations.
Discrepancies between readings
Analysis of calibrations, response times, placements and operating conditions. Comparison with a reference measurement where needed to explain the differences.
Missing data
Investigation of communications, acquisition, local buffers and historisation to identify the affected periods and tell unavailable data from actual losses.
Extension & evolution
Adding points, replacing instruments or evolving interfaces. Impact analysis, change control and targeted testing or requalification of the functions concerned.
Ways we work
When to call on MAJ for your EMS?
Targeted intervention
You have a technical problem to solve, a URS to review or a budget to draw up.
We step in for a diagnosis, an architecture review, a GxP documentation review or a budget estimate, with a defined scope and deliverables.
Team reinforcement
Your Engineering, Automation or Validation teams, or your EMS supplier, need specialist support.
We provide hands-on reinforcement for installation, configuration, integration, testing or IQ/OQ/PQ qualification, on a defined assignment.
Complete EMS project
You want to entrust an entire environmental monitoring project to a single point of contact.
MAJ Solutions can coordinate the study, instrumentation, integration and qualification, within the agreed scope.
Contact
An installation to instrument, or a measurement that raises questions?
Describe the areas to monitor, the equipment in place and your monitoring needs. We will tell you which capabilities to bring in and which interfaces to examine first.
Discuss your needDirect contact: info@maj-solutions.be +32 475 92 05 37