Solutions
Automation
PLC-SCADA automation for sterile and biopharmaceutical facilities, engineered for process control, data integrity and 21 CFR Part 11 compliance.
Overview
Control, Data Integrity and Traceability
Esteril designs and implements pharmaceutical automation systems that improve process control, operational efficiency, data integrity and regulatory compliance for sterile and biopharmaceutical facilities.
The systems integrate PLC-SCADA architecture, HMI and IPC controls, and Electronic Batch Record functionality for accurate, repeatable operation. Each system is engineered to US FDA 21 CFR Part 11 requirements and follows GAMP guidelines, developed alongside process and validation teams to reduce human error, provide complete traceability and deliver audit-ready documentation.
Architecture
PLC-SCADA, open platform
Compliance
21 CFR Part 11 · GAMP
Records
EBR with audit trail
Platforms
Siemens · Schneider · Allen Bradley
Where it fits
Applications
Applications
Built for
Open platforms that expand and customise to plant requirements.
How it’s engineered
Advantages and Key Features
Why it's specified
What's built in
Specifying questions
Frequently Asked Questions
Open PLC-SCADA platforms built on Siemens, Schneider, Allen Bradley and Mitsubishi, selected to the plant standard and expansion needs.
Through secure data logging, audit trails, user access control and Electronic Batch Records, so electronic records and signatures meet USFDA 21 CFR Part 11 and GAMP expectations.
EBR replaces paper batch records with automatic digital data logging, audit trails and documentation, reducing manual entry and strengthening compliance during inspections.
Yes. The systems integrate with process equipment and utilities including CIP / SIP, vessel skids, filtration and transfer systems, with localised and centralised control.
The open PLC-SCADA architecture allows flexible expansion and customisation, supporting localised control panels and centralised monitoring as the facility grows.