Home · Industries · Life Science & Pharma
Industry

Life Science & Pharma

Cleanroom-capable automation for pharma, medical technology and biotech — with our NEXOS.Cube stainless steel variant as the basis.

Context

Modular automation for the Life Science & Pharma industry

Life science and pharma place the highest demands on automated production: GMP compliance, complete traceability, cleanroom-capable materials and surfaces that withstand daily wipe-disinfection cycles.

Specifically for these requirements we offer the NEXOS.Cube stainless steel variant — fully manufactured in stainless steel, with smooth surfaces free of dirt traps, GMP-compliant seals and a cleaning-friendly frame concept. Combined with the white NEXOS.Nova cobot (smooth plastic housing, cleanroom-capable) and the traceability layer of NEXOS.DSP, this creates a fully documentable production cell for regulated environments.

From vial filling to syringe assembly to automated lab handling — the same modular building blocks, in the specification for the industry.

Challenges

What makes this industry challenging to automate

GMP + cleanroom + traceability at the same time

Each of the three requirements can be solved individually — combined they quickly become a cost driver. Modular, GMP-capable building blocks noticeably reduce the engineering effort per project.

Validation is expensive

IQ/OQ/PQ qualification often takes longer than the actual design work. Repeatable cells with documented pre-qualification shorten the time-to-validation.

Low batch sizes for personalized medicine

Cell and gene therapies are manufactured patient-individually — batch size 1. Classic series automation does not fit; flexible, reconfigurable cells are the alternative.

Typical applications

What NEXOS automates in the Life Science & Pharma industry

Relevant products

Components that make these applications possible

Why NEXOS for Life Science & Pharma

Three reasons for modularity in this industry

Cleanroom-capable specification

NEXOS.Cube in stainless steel (V2A / V4A on request), smooth surfaces, GMP-compliant seals. NEXOS.Nova with white plastic housing and cleanroom-capable transitions.

Complete traceability

NEXOS.DSP logs batches, process parameters and equipment states. Reports for audit, batch release and regulatory evidence at the push of a button.

Validatable processes

Repeatable, standardized cells simplify IQ/OQ/PQ qualification. Changes remain local and traceable — change control becomes plannable instead of a project risk.

How we work

From inquiry to running system in four steps

1

Analysis

Free initial discussion (30–60 min). We clarify the parts spectrum, cycle times, environmental conditions and integration into your existing IT/OT.

2

Concept

Component selection, layout, schedule, cost framework. On request with virtual commissioning in NEXOS.XR before manufacturing starts.

3

Quotation

Fixed-price or milestone contract, with clearly documented scope of delivery, acceptance criteria and maintenance options.

4

Implementation

Prefabrication in the workshop, on-site assembly, programming, acceptance per documented FAT/SAT. Optional: remote service via NEXOS.DSP.

Standards & Certifications

Relevant standards for the Life Science & Pharma industry

These regulations are considered in our conception, implementation and documentation. Not every standard applies to every project — the specific selection is clarified in the project kick-off meeting.

EU GMP Annex 1Manufacture of sterile medicinal products — fundamentally revised in 2022, requirements for a Contamination Control Strategy (CCS).
FDA 21 CFR Part 11Electronic records and electronic signatures — mandatory when exporting to the USA.
FDA 21 CFR Part 210/211Current Good Manufacturing Practice — requirements for pharmaceutical manufacturing.
ISO 13485Quality management for medical devices — MDR-relevant.
MDR 2017/745 (EU)Medical Device Regulation — tightened requirements for clinical evaluation and post-market surveillance.
ISO 14644Cleanrooms and associated controlled environments — classification by particle count (ISO Class 5 to 9).
Frequently asked

FAQ on automation in the Life Science & Pharma industry

How do you support us with IQ/OQ/PQ qualification?
We provide structured URS templates, design specifications and test protocols. For installation qualification (IQ) and operational qualification (OQ) we support execution on site. Process qualification (PQ) you carry out yourself with your products and recipes — we ensure the necessary equipment and data transparency.
Is the system CFR Part 11 compliant?
NEXOS.DSP provides the building blocks required for Part 11: audit trail, electronic signatures, role concepts, data integrity. The configuration per site is part of the qualification — you define which processes and data are Part 11-relevant, we implement the technical basis.
Which cleanroom classes are feasible?
NEXOS.Cube stainless steel and NEXOS.Nova can be used directly in ISO Class 7/8 (GMP Class C/D). For Class 5/6 (Class A/B) we integrate the cell into isolators or RABS systems from our cleanroom partners — enclosed process handling is possible but designed on a project basis.
How quickly can change requests be documented?
Configuration changes to a standardized cell are locally limited and can be documented in a few days. Full change control processes take longer and are your responsibility — we deliver the technical documentation for the change as the basis.

Discuss your application?

Talk to us about your specific automation task in Life Science & Pharma.

Get in touch All applications