End UserEmynent, Russia
Case Study: Pharmaceutical
GAMP 5 Compliant Pharmaceutical Material Handling Automation - Siemens S7-1500 & WinCC SCADA
GAMP 5 & 21 CFR Part 11 compliant automation for powder transfer, tablet injection, FBD, RMG, AHU and isolator systems - delivered for a Russian pharmaceutical manufacturer.
Project Overview
Project Information
Hive Automation delivered a fully automated, GAMP 5-compliant control system for a pharmaceutical powder transfer and production facility for Emynent, Russia - executed through one of our established OEM partners.
The scope covered multiple integrated pharmaceutical processes from a single unified control architecture, including Powder Transfer, Tablet Injector, Isolator, Fluid Bed Dryer (FBD), Rapid Mixer Granulator (RMG), Comil, Air Handling Unit (AHU), and Heating & Cooling systems.
The entire solution was engineered for full compliance with 21 CFR Part 11, ensuring secure operations, tamper-proof electronic records, and complete audit trail coverage suitable for regulated GMP environments.
PLC, HMI, and SCADA programming were developed in-house and subjected to a rigorous Factory Acceptance Testing (FAT) programme before on-site commissioning in Russia.
Project Details
Project Delivery Snapshot
Completion DateMarch 2024
Delivery ScopePLC Programming | WinCC SCADA | HMI | Wireless Tablet | FAT | Site Commissioning
Execution FootprintRussia (developed and tested in OEM Place)
System Architecture
Technical Architecture
Siemens S7-1500 series CPU-1517-3 PN (CPU) with 18 ET200SP distributed I/O stations.
Supervisory layer: WinCC SCADA with Wireless Tablet operation using WinCC Explorer for mobile operator access.
Full 21 CFR Part 11 configuration including electronic signatures, audit trail, and user access management.
Delivery Scope
Scope of Work & Key Deliverables
- PLC programming - Siemens S7-1500 (TIA Portal), all process units integrated under a unified control architecture
- SCADA development - WinCC SCADA with custom process mimics, alarms, trends, and 21 CFR Part 11 audit trail
- Wireless Tablet HMI - WinCC Explorer configuration for mobile operator access across the facility floor
- In-house Factory Acceptance Testing (FAT) of the complete integrated system before shipment
- On-site commissioning at the customer facility in Russia
- 21 CFR Part 11 compliance - electronic records, electronic signatures, user access control
- GAMP 5-aligned software lifecycle documentation
Project Impact
Challenge & Outcome
Challenge
Delivering a fully compliant, multi-process GAMP 5 automation system across 18 distributed I/O stations for an international pharmaceutical client - with FAT completed in India and commissioning executed in Russia - required tight documentation discipline, remote coordination, and a control architecture that could be validated end-to-end without on-site access during development.
Outcome / Result
System successfully commissioned in Russia with full 21 CFR Part 11 and GAMP 5 documentation package. 910 I/O points across 18 ET200SP stations integrated into a single, unified WinCC SCADA with wireless tablet access - enabling paperless batch operations and continuous audit trail generation from day one of production.
Process Coverage
Processes Automated
- Powder Transfer - vacuum transfer, weighing, dosing, and containment interlock sequences
- Tablet Injector - automated feed, compression monitoring, and ejection control
- Isolator - differential pressure management, gloveport access interlocks, VHP integration
- FBD (Fluid Bed Dryer) - inlet air temperature, product temperature, and drying cycle control
- RMG (Rapid Mixer Granulator) - impeller/chopper speed, torque monitoring, granulation endpoint logic
- Comil - rotor speed, screen selection, and load monitoring
- AHU (Air Handling Unit) - zone pressure, temperature, humidity, and fresh-air damper control
- Heating & Cooling - utility loop management with setpoint tracking and alarm management
I/O Summary
I/O Capacity & Configuration
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Frequently Asked Questions
Pharmaceutical Automation Questions, Answered
Yes. The Emynent project was fully engineered for 21 CFR Part 11 compliance, including electronic records, electronic signatures, and audit trail generation on WinCC SCADA.
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