Pharma & life sciences
Cleanroom data your QA team can sign off with confidence at inspection
AMADSAS builds the environmental monitoring, LAF monitoring, AHU BMS and door interlock systems that keep a pharma cleanroom within limits, and records the data with the audit trail and electronic signatures that 21 CFR Part 11 and EU Annex 11 expect.
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Operating challenges
A cleanroom is held within limits by a pressure cascade, temperature and humidity control, HEPA-filtered air and disciplined access. Each of these produces data, and each excursion has to be detected, acknowledged and explained in a record QA can stand behind.
Our centralised monitoring platform brings EMS, BMS, LAF monitoring, water systems (PW, RO, WFI, PSG), nitrogen, compressors, chillers, boilers and production machines such as filling, washing, tunnel sterilisation and autoclaves into one validated system. One pharma deployment runs on 8 servers with around 65,000 tags per server — about 520,000 tags in total — and 50 web clients.
Pharma clients named in our reference lists include Somerset Therapeutics, Cipla, Serum Institute of India, Mylan and Wacker. Every system is delivered with the GAMP 5 validation documents your QA team needs, from URS to the validation summary report.
- 01
Holding the pressure cascade
Differential pressure between rooms protects product and operators. A door left open or a failing AHU collapses the cascade quickly, and the deviation has to be detected and recorded as it happens.
- 02
Data integrity to ALCOA+
Inspectors expect records that are attributable, contemporaneous and complete. Shared logins, editable logs and gaps in audit trail turn an ordinary excursion into a data-integrity finding.
- 03
Alarm response and excursions
High, low, warning-high and warning-low limits on temperature, RH, differential pressure and particle counts must reach the right person by screen, email, SMS or WhatsApp, with acknowledgement time and comment recorded.
- 04
LAF and HEPA filter condition
ISO Class 5 and Class 7 zones depend on HEPA and ULPA filters. Differential pressure across each LAF unit’s filter shows loading and tells maintenance when to replace it.
- 05
Validation and change control
Every computerised system that touches GMP data must be validated per GAMP 5 and kept in a validated state. Setpoint changes need double electronic signatures and changes need documented control.
- 06
Utilities that feed GMP areas
PW, WFI, pure steam, nitrogen, compressed air and chilled water each sit on their own controls. Without a common view, a utility trend that will cause tomorrow’s excursion goes unnoticed.
How we address them
- 01
URS and risk assessment
We agree the user requirement specification, monitored points, alarm limits and data-integrity controls with your engineering and QA teams, and record the risk assessment that drives validation scope.
- 02
Design and cleanroom hardware
DDC panels with BACnet/Modbus controllers, VFD panels with bypass switch and harmonic filters, and cleanroom hardware such as stainless steel flush-mount monitors, IP65 keyboards and flush signal towers.
- 03
Installation and qualification
Sensors, transmitters, DP gauges and door interlocks are installed and looped, then qualified through IQ, OQ and PQ against approved protocols and the traceability matrix.
- 04
Centralised records and reports
Data, alarm, event, audit and trend reports are produced as PDF with “Reviewed by user” and “Reviewed by QA” signature blocks, from a platform with role-based access and a non-editable audit trail.
- 05
Support in the validated state
Maintenance, upgrades and configuration changes run under change control so the system stays validated after handover.
Solutions for this sector
- Cleanroom MonitoringEMS, LAF monitoring and door interlocks that keep cleanroom conditions in limits and on record.
- Centralised MonitoringRedundant SCADA, historian and compliance reporting that puts every site system on one screen.
- Building Management System (BMS)DDC-based control of HVAC, CRAH/CRAC, lighting and access with fire and environmental monitoring.
- Energy, Load & Lighting ManagementEnergy metering, PUE tracking, load control and smart lighting with dashboards and reports.
- Plant AutomationPLC, DCS and SCADA engineering, drives, legacy migration and IoT from design to commissioning.
- Control Panels & Electrical InstallationMCC, PCC, APFC, VFD, MV and IEC 61439 panels and E-House, built in-house and installed on site.
Delivered projects
| Client | Site / scope | System | Year |
|---|---|---|---|
| Somerset Therapeutics | Centralised system on virtual machines with historian, EMS, BMS and utilities | 8 servers, around 65,000 tags per server, about 520,000 tags | 2023 |
| Somerset Therapeutics | — | BMS, HSD, CPM and EPMS automation | — |
| Wacker | Centralised system | Server, historian, analytics and reporting | 2022 |
Frequently asked questions
Is the monitoring system compliant with 21 CFR Part 11?
The platform provides the technical controls Part 11 requires: secure electronic records with retention, electronic signatures linked to records, a non-editable audit trail, role-based access and encryption. Compliance is confirmed for your site through validation, which we support with the full GAMP 5 document set.
Which regulations and guidance do you design to?
cGMP, WHO GMP, EU GMP, 21 CFR Part 11, EU Annex 11, GAMP 5 and ALCOA+ data integrity, with PIC/S PI 006 as the reference for validation practice. The Saudi Food and Drug Authority participates in PIC/S, so PIC/S guidance is a sound basis for sites in the Kingdom.
What does the audit trail record?
A chronological list of events with date and time, variable, previous value, modified value, user and comment. It cannot be edited, and setpoint changes require a double electronic signature.
Can you connect the sensors and AHU controls we already have?
Yes, where they offer an analogue signal or a standard protocol such as Modbus, BACnet IP or OPC UA. We assess each existing device at survey stage and state in the URS which points will be reused and which replaced.
Which validation documents do you deliver?
URS, functional specification, design specification, IQ, OQ and PQ protocols and reports, traceability matrix, risk assessment and validation summary report, prepared per GAMP 5 for approval by your QA team.
How do door interlocks support the pressure cascade?
The door interlock system keeps one airlock door closed until the other is shut, with secure entry, free egress and restricted entry/exit modes. Each access event is written to the audit trail.
Let’s start by understanding your facility
Send us a short description of the site and its current systems, and an engineer will come back with clear next steps.