Case Study: Pharmaceutical & Process Equipment - OEM
Pharmaceutical & Process Equipment Automation - GMP, 21 CFR Part 11 & GAMP 5 Aligned
End-to-end PLC, HMI, and SCADA automation for the full range of pharmaceutical process and utility equipment - GMP-ready, 21 CFR Part 11 aligned, engineered on Siemens S7-1200/1500.
Project Overview
Project Information
Hive Automation is a specialist automation partner for pharmaceutical and process equipment manufacturers - providing end-to-end PLC, HMI, and SCADA programming, control panel integration, system testing, and on-site commissioning for the full range of pharma production and utility equipment.
All our solutions are engineered to meet 21 CFR Part 11, GMP, and GAMP 5 requirements, using Siemens Automation Products - S7-1200, S7-1500, ET200SP, TP/MTP HMI panels, WinCC SCADA, Drive, and Servo - as the primary platform.
Whether you manufacture single-purpose process skids or integrated plant-wide pharmaceutical production lines, our automation team integrates seamlessly with your mechanical and validation teams.
Project Details
Project Delivery Snapshot
System Architecture
Technical Architecture
Siemens S7-1200, S7-1500, and ET200SP PLC platforms selected based on machine complexity, I/O density, and validation requirements.
Siemens TP and MTP series local HMI panels with WinCC SCADA in PC-based or server-client architecture for plant-wide visibility and operator control.
Siemens SINAMICS drives and SIMOTION servo for motion control, with 21 CFR Part 11 configuration covering electronic records, signatures, audit trail, and user access management.
Delivery Scope
Scope of Work & Key Deliverables
- Powder Handling & Containment: PHT powder transfer, weighing and dispensing; Isolators with differential pressure and VHP; Big Bag filling and discharge; Drum filling automation
- Mixing, Blending & Milling: Batch Mixer and Blender with recipe management; Micronizer with airflow and pressure regulation
- Sterilization & Washing: VHP sterilizer, Dry Heat Sterilizer, Ventilator Sterilizer, and Pharmaceutical Washer automation
- Water & Steam Systems: Multicolumn Distilled Water still automation; Pure Steam Generator; PW and WFI Storage and Distribution systems
- Liquid Process Equipment: Aseptic process vessels and Super Skids with CIP and SIP; Liquid Oral Manufacturing; Reactors and Sterile Heat Exchangers
- Specialty Systems: pH Dosing closed-loop control and ANFD filtration, washing, and drying automation sequences
Project Impact
Challenge & Outcome
Challenge
Supporting a wide range of pharmaceutical OEM equipment on a standardised automation framework requires balancing machine-specific control needs with repeatable PLC, HMI, SCADA, and validation structures that can scale across multiple product lines and customer environments.
Outcome / Result
Hive Automation continues to support pharmaceutical OEM manufacturers with an ongoing automation programme spanning process, containment, sterilization, utility, and specialty systems - all engineered on validated Siemens-based frameworks aligned to GMP, 21 CFR Part 11, and GAMP 5 expectations.
Process Coverage
Processes Automated
- Single automation partner for the entire pharma equipment range, reducing handoff complexity across OEM product lines.
- Deep Siemens platform expertise across S7-1200, S7-1500, WinCC, TIA Portal, and pharma-specific library development.
- 21 CFR Part 11 and GAMP 5 alignment built into every project from the design phase rather than added during validation.
- Standardised HMI templates and recipe management frameworks that reduce validation effort across machine models.
- Factory Acceptance Test protocols developed and executed in-house to reduce commissioning risk and timeline.
- Seamless coordination with OEM mechanical, process, and validation teams for integrated delivery.
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Frequently Asked Questions
Pharmaceutical & Process Equipment - OEM Automation Questions, Answered
Yes. We are a specialist automation partner for pharma OEM manufacturers, providing PLC, HMI, and SCADA programming for the full range of pharmaceutical process and utility equipment - aligned to 21 CFR Part 11, GMP, and GAMP 5.
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