Pharmaceutical & Chemical Industries
Every batch must be reproducible, every action auditable, and every system validated.
Validated automation for the most demanding regulators on earth.
GMP-grade automation for pharmaceutical, biotech, and chemical manufacturing — 21 CFR Part 11, GAMP 5, and EU MDR compliant from day one. Reactor automation, batch control, utilities, and validated CIP/SIP systems delivered with the documentation regulators expect.
Where compliance, data integrity, and consistency are non-negotiable
Pharmaceutical and chemical operations face the most demanding regulatory environment in industry. Every batch must be reproducible, every action auditable, and every system validated. The cost of getting it wrong is measured in product recalls, regulatory observations, and lost market access.
Our pharma and chemical practice combines deep process knowledge with the validation discipline regulators expect. We deliver reactor automation, batch and continuous process control, utility systems, CIP/SIP, and the supporting electronic records and audit trails that turn an audit into a routine event rather than a crisis.
Across the pharmaceutical and chemical value chain
Reactor Automation
Jacket temperature control, pressure regulation, dosing automation, agitation profiles,
batch sequencing per ISA-88.
Fermentation
Bioreactor control for APIs, biologics, and specialty fermentation. DO, pH, temperature, and
feed control with substrate optimization
Pharma Water Systems
Purified Water (PW), Water for Injection (WFI), Pure Steam — generation, storage, hot-loop
distribution above 80°C.
Pharma Water Systems
Purified Water (PW), Water for Injection (WFI), Pure Steam — generation, storage, hot-loop
distribution above 80°C.
Distillation & Separation
Continuous and batch distillation with advanced control, solvent recovery, and energy optimization
CIP / SIP
Clean-In-Place and Sterilize-In-Place automation with cycle validation, conductivity
verification, and electronic batch records.
Batch Management
ISA-88 recipe management, equipment modelling, electronic batch records, exception handling and review-by-exception workflows.
Safety Shutdown Systems
ESD, F&G, and process safety per IEC 61511. Hazard analysis, SIL determination, and full safety lifecycle documentation.
Utility Systems
HVAC, compressed air, chilled water, nitrogen, vacuum — integrated control with energy
monitoring and contamination protection.
Audit-ready compliance frameworks
We combine decades of expertise with innovation, safety, and precision to deliver results that last.
21 CFR Part 11
FDA electronic records and signatures
EU Annex 11
European equivalent for computerized systems
ISA-88
Batch control and recipe management
EU MDR / FDA
For combination products and medical devices
ICH Q7, Q9, Q10
Pharmaceutical quality management
ISA-95
Enterprise-to-control system integration
IEC 61511
Functional safety for process industries
GAMP 5
Risk-based validation lifecycle
Validation discipline that turns audits into routine events
GAMP 5 Native
Risk-based validation built into every stage — not a documentation exercise at the end.
FDA & EMA Audit Track Record
Customer plants we have automated have passed multiple FDA and EMA inspections without observations on our systems.
ISA-88 Batch Expertise
Proper recipe modelling, equipment hierarchy, and exception management — not procedural code dressed up
Multi-Platform Validated
PCS 7, PlantPAx, DeltaV, Centum, 800xA — we deliver validated systems on every major DCS platform.
Pharma 4.0 Ready
Paperless batch records, MES integration, and continuous manufacturing approaches when you are ready.
Brownfield Discipline
We modernize legacy systems with phased validation that keeps existing licenses intact.
Why Choose VALORPLUS
Got questions about our engineering process or project delivery? Discover how we make engineering simple and effective.
Can you deliver fully validated systems?
Yes. We can deliver fully validated automation and control systems with comprehensive documentation, testing, and qualification support. Our approach follows industry best practices to ensure compliance, traceability, and operational reliability.
Do you have experience with paperless batch records?
Yes. We support the implementation of electronic batch record (EBR) and paperless manufacturing solutions that improve data accuracy, streamline workflows, and enhance production traceability while reducing manual documentation efforts.
Can you handle hazardous-area solvent applications?
Yes. We design and integrate systems for hazardous-area environments using appropriate safety standards, certified equipment, and risk-based engineering practices. This ensures safe and compliant operation when handling flammable solvents and chemicals.
What about API and biologics manufacturing?
We support automation and process control solutions for both Active Pharmaceutical Ingredient (API) and biologics manufacturing facilities. Our expertise helps maintain process consistency, product quality, and regulatory compliance across critical production stages.
Do you support continuous manufacturing?
Yes. We develop automation solutions for continuous manufacturing processes, enabling real-time monitoring, process optimization, and enhanced production efficiency. This approach helps improve product consistency and operational flexibility.
Can you handle CIP/SIP cycle development?
Yes. We provide control strategies and process development support for Clean-in-Place (CIP) and Sterilize-in-Place (SIP) systems. Our solutions help ensure repeatable cleaning performance, validation readiness, and compliance with industry standards.
Will you support our regulatory inspection?
Yes. We can assist during regulatory inspections by providing system documentation, validation records, testing evidence, and technical support. Our goal is to help clients demonstrate compliance and respond confidently to auditor requirements.
