Specialised process automation for
pharma production

Specialised process automation for
pharma production

Specialised process automation for
pharma production

We design and implement process automation in regulated environments. Working closely with our clients as a trusted advisor, we take responsibility from early clarification to operation.

We design and implement process automation in regulated environments. Working closely with our clients as a trusted advisor, we take responsibility from early clarification to operation.

About us

Specialised automation consultancy for regulated production environments

Gienova is a specialised process automation consultancy with experience from GMP-regulated pharma production.

We design, implement and optimise PCS and DCS solutions with a focus on reliability, compliance and stable operation. Working with platforms such as DeltaV, we support our clients from system design and implementation to commissioning, validation and ongoing operation.

As a small, focused team, we work closely with our clients as a trusted advisor throughout the process — from early clarification and design to commissioning, validation and operation. Combining strong technical expertise with a structured and collaborative approach, we help ensure reliable and compliant solutions that work in practice.

Specialised automation consultancy for regulated production environments

Gienova is a specialised process automation consultancy with experience from GMP-regulated pharma production.

We design, implement and optimise PCS and DCS solutions with a focus on reliability, compliance and stable operation. Working with platforms such as DeltaV, we support our clients from system design and implementation to commissioning, validation and ongoing operation.

As a small, focused team, we work closely with our clients as a trusted advisor throughout the process — from early clarification and design to commissioning, validation and operation. Combining strong technical expertise with a structured and collaborative approach, we help ensure reliable and compliant solutions that work in practice.

Early clarification

Clarify scope and identify risks from the start.

Compliant design

Design solutions aligned with regulatory requirements.

Verified performance

Validate systems in a GMP environment.

Full system overview

Map systems, interfaces and dependencies.

Controlled implementation

Ensure consistent and reliable execution.

Operational support

Maintain and optimise in real operation.

Our process

Structured automation projects from early clarification to operation

Gienova delivers process automation projects for GMP-regulated production environments with a focus on reliability, compliance and long-term operation.

Define. Design. Deliver.

Our approach is built around clear scope definition, structured system design and controlled implementation — ensuring robust and compliant solutions ready for operation in practice.

Structured automation projects from early clarification to operation

Gienova delivers process automation projects for GMP-regulated production environments with a focus on reliability, compliance and long-term operation.

Define. Design. Deliver.

Our approach is built around clear scope definition, structured system design and controlled implementation — ensuring robust and compliant solutions ready for operation in practice.

What we do

We work across the full lifecycle of process automation in regulated environments.


1: DEFINE

2: DESIGN

3: DELIVER

Projects

Selected automation projects in GMP-regulated environments

Due to the nature of our work, many projects are confidential.
The examples below are based on real project experience from regulated production environments.

Selected automation projects in GMP-regulated environments

Due to the nature of our work, many projects are confidential.
The examples below are based on real project experience from regulated production environments.

01

Crossflow filter implementation in live DeltaV environment

Implementation of a new crossflow filtration unit in an active GMP production environment using DeltaV PCS. The solution enabled switching between existing and new filter systems directly through the PCS, supporting OQ and validation activities without interrupting production. Scope included process analysis, FDS updates, DeltaV configuration, commissioning and qualification.

Case 1: Crossflow filter implementation in live DeltaV environment

Implementation of a new crossflow filtration unit in an active GMP production environment using DeltaV PCS. The solution enabled switching between existing and new filter systems directly through the PCS, supporting OQ and validation activities without interrupting production. Scope included process analysis, FDS updates, DeltaV configuration, commissioning and qualification.

02

Implementation of in-process sterile filter replacement system

Implementation of an additional sterile filter solution for two 5,000 kg fermenters in a GMP production facility. The solution enabled sterile filter replacement during production while maintaining sterility and operational efficiency. Scope included electrical design, DeltaV configuration, integration with PAS-X, commissioning, testing and reporting activities.

Case 2: Implementation of in-process sterile filter replacement system

Implementation of an additional sterile filter solution for two 5,000 kg fermenters in a GMP production facility. The solution enabled sterile filter replacement during production while maintaining sterility and operational efficiency. Scope included electrical design, DeltaV configuration, integration with PAS-X, commissioning, testing and reporting activities.

03

From pilot plant to market scale production

Participation in a large-scale rebuild of a purification line combined with establishment of a new 800xA PCS platform. Gienova acted as work package owner for several critical automation packages — from basic design and implementation to startup support and performance verification. The project included flexible batch strategies, advanced control design and close collaboration with skid suppliers, chemists and API plant specialists.

Case 3: From pilot plant to market scale production

Participation in a large-scale rebuild of a purification line combined with establishment of a new 800xA PCS platform. Gienova acted as work package owner for several critical automation packages — from basic design and implementation to startup support and performance verification. The project included flexible batch strategies, advanced control design and close collaboration with skid suppliers, chemists and API plant specialists.

Contact us

Meet our team of specialists

If you are looking for a specialised partner in process automation,
we are always open for a dialogue.

Meet our team of specialists

If you are looking for a specialised partner in process automation,
we are always open for a dialogue.

Alexander Gøricke Laursen

Partner / Owner
Senior Process Automation Engineer

agl@gienova.dk
+45 29 21 32 10

Alexander works with automation in regulated environments, with experience across design, commissioning and validation.

Claus Giemsa

Partner / Owner / CEO
Automation Specialist

cg@gienova.dk
+45 20 15 67 65

Claus is a Subject Matter Expert (SME) in process automation for regulated environments, specializing as a Batch Systems Specialist with deep expertise in design, commissioning, and validation.

Martin Thomsen

Partner / Owner
Automation Specialist

mt@gienova.dk
+45 21 81 69 66

Martin is a Subject Matter Expert (SME) in automation for regulated environments, with extensive experience as an IT/OT architect across design, commissioning, and validation.

Tommy Vu

Automation engineer

tmv@gienova.dk
+45 50 45 48 64

Tommy works with automation systems in regulated production environments, focusing on design, software development and commissioning.

Ivan Štulhofer

Automation engineer

is@gienova.dk
+45 71 47 15 34

Ivan works with process automation in pharmaceutical production, focusing on control solutions, validation and reliable operation.

Contact us

Get in touch with our specialists

Get in touch with our specialists