Validated control systems for pharmaceutical manufacturing. GMP, FDA 21 CFR Part 11 and complete traceability in every project.
The pharmaceutical and biotechnology industry has the highest regulatory requirements in industrial automation. Every control system must be qualified and validated per Good Manufacturing Practices (GMP), FDA 21 CFR Part 11 for electronic records and EMA guidelines.
At Bluemation we develop automation systems for pharmaceutical manufacturing: synthesis reactors, formulation and packaging lines, cleanrooms, purified water systems and bioreactors. We deliver complete validation documentation: URS, FS, IQ/OQ/PQ protocols and validation reports.
Our pharmaceutical SCADA systems include user management with roles and approvals, electronic signatures, immutable audit trails and electronic batch record management, facilitating the transition to paperless batch records.
All automation systems in pharmaceutical environments must be qualified: IQ (Installation), OQ (Operational) and PQ (Performance). We develop the complete documentation and execute the qualification protocols with the client's validation team.
FDA regulations require that electronic records are secure, auditable and unalterable. We implement systems with user management, biometric or password electronic signatures, complete audit trail and data integrity (ALCOA+).
Pharmaceutical manufacturing requires reproducible execution of complex recipes with multiple steps, critical process parameters (CPPs) and critical quality attributes (CQAs). We implement electronic master batch record management with approval workflows and change traceability.
Automation equipment in cleanrooms must meet particle classification requirements. We design with suitable materials, no dust-accumulating edges, no loose cables and validated pressurisation and HVAC control systems.
Regulatory agencies require that manufacturing data be attributable, legible, contemporaneous, original and accurate (ALCOA). We design to prevent data overwriting, unauthorised access and manipulation of historical records.
Any modification to a validated system requires a controlled change process and may require partial or total re-validation. We design to facilitate change impact assessment and maintain documentation throughout the lifecycle.
GMP SCADA systems with user management, immutable audit trail, electronic signatures, alarm management and batch reporting. Siemens WinCC, Rockwell FactoryTalk and Ignition Sepasoft platforms.
Automation of chemical synthesis reactors and bioreactors: PID temperature and pH control, reagent dosing, agitation control, continuous parameter recording and process alarms with batch record entry.
Electronic master batch record systems: master recipe creation and approval, production download, guided execution with verifications at each step, automatic parameter recording and completed batch record generation.
Automation of purified water (PW) and water for injection (WFI) production and distribution systems: TOC, conductivity, temperature control, quality alarms and monitoring records for QA.
Automation of ampoule, vial and syringe filling and closing lines: dose control, 100% automatic visual inspection, closure verification, serialisation and full batch record parameter recording.
Control of cleanroom HVAC systems: temperature, relative humidity, differential pressure, air changes and particle classification. Automatic alarms, continuous records and GMP audit reporting.
Services we apply in the pharmaceutical sector
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