Equipment & plant engineering for OEMs
Pharmaceutical equipment and plant engineering for OEMs.
Cotectra develops complete pharmaceutical production equipment and high-purity utility systems, or co-develops them with the OEM. The scope can run from concept, 3D design and construction documentation through component selection, realization, commissioning, qualification and production start-up.
AI-generated illustrationConcept-to-start-up engineering
Define
Develop
Realize
Start up
Built by engineers who have delivered equipment themselves.
- 01
System concepts
- 02
Engineering & design
- 03
Installation
- 04
Commissioning
- 05
Production start-up
When to involve Cotectra
Customer-specific systems need more than a standard machine platform.
Pharmaceutical equipment projects become difficult when process responsibility, hygienic design, clean utilities and start-up requirements are developed as separate topics.
Requirements exceed the standard platform
Customer-specific process functions, GMP expectations and technical interfaces require a purpose-built system solution.
Process responsibility is fragmented
Equipment, automation, clean utilities, CIP/SIP and facility interfaces are designed without one integrated system view.
Pharma requirements arrive too late
URS, hygiene, qualification, operability and maintainability are clarified after core design decisions have already been made.
Design knowledge is lost before start-up
Concept and design teams become disconnected from manufacturing, FAT, installation, commissioning and production ramp-up.
Client benefits
What changes for the OEM.
A complete system concept becomes executable
Process, equipment, utilities, automation and qualification needs are developed as one technical solution.
Development responsibility becomes clear
Cotectra can own the agreed engineering scope or share defined system responsibility in a joint-development model.
Pharma requirements shape the design
GMP, hygiene, cleanability, operability, maintainability and qualification are considered before manufacturing.
Knowledge stays connected through start-up
The technical reasoning remains available through design reviews, FAT, installation, commissioning and production start-up.
How we work
Take technical responsibility—not only an advisory role.
Cotectra engineers have conceived, developed, installed and commissioned equipment and plants themselves. We apply that OEM experience to complete development scopes or joint solutions with clearly owned interfaces.
Concept-to-start-up development
Turn a process need into an operating system.
Concept
3D design
Construction
Commissioning
Qualification
Capabilities & outputs
Develop the complete technical path from need to operation.
The scope can cover an entire production or high-purity utility system, a jointly owned development programme or a defined specialist package.
Process & system definition
Translate the customer need into a reliable development basis.
- • URS and requirement clarification
- • Process and capacity requirements
- • System boundaries and interfaces
Concept development
Create an integrated technical solution before detail multiplies.
- • Process and equipment concepts
- • Technology and component selection
- • Layouts and modularization
Basic, detail & 3D engineering
Turn the concept into coordinated, buildable engineering information.
- • PFDs and P&IDs
- • 3D equipment and plant design
- • Construction and fabrication documentation
GMP-compatible design
Develop hygiene and qualification needs into the equipment.
- • Hygienic design
- • Cleanability and drainability
- • Material and surface requirements
CIP, SIP & media integration
Connect the system with cleaning, sterilization and clean utilities.
- • CIP and SIP concepts
- • PW, WFI and clean-steam interfaces
- • Process gases and utility definition
Automation & functional design
Define how the system operates, protects itself and interfaces with the plant.
- • Functional concepts
- • Control and sequence requirements
- • Automation and data interfaces
Components & suppliers
Select components and delivery partners against the complete system duty.
- • Component specifications and selection
- • Supplier technical evaluation
- • Package and interface coordination
Design assurance
Challenge the solution before manufacturing and installation.
- • Design reviews
- • Technical risk analysis
- • Operability and maintainability review
CE, hygiene & digital integrity
Integrate product safety, hygienic machinery requirements and protected safety-related data into the development process.
- • Hygienic machinery compliance
- • Software and data-corruption risk controls
- • Technical file and declaration support
Realization, qualification & start-up
Maintain engineering continuity through physical delivery and operational release.
- • Manufacturing and construction coordination
- • FAT, SAT, commissioning and qualification support
- • Installation and production start-up
CE conformity by design
Connect hygienic design, digital integrity and CE conformity.
The Machinery Regulation brings product-contact hygiene and digital safety into one machinery conformity framework. Cotectra helps OEMs translate these requirements into system architecture, design criteria, control concepts, verification and traceable technical documentation—while keeping GMP data integrity as a separate, coordinated compliance layer.
CE-related digital integrity focuses on machinery safety and protection against corruption. GMP data integrity focuses on trustworthy production and quality records. Cotectra aligns both without treating them as interchangeable. The responsible manufacturer retains legal responsibility; Regulation (EU) 2023/1230 must be planned for products placed on the market from 20 January 2027.
Hygienic product-contact design
Develop smooth, crevice-free contact surfaces, hygienic joints and assemblies with minimized projections, edges and inaccessible recesses.
Cleanability & drainability
Design for effective cleaning, disinfection and rinsing, sufficient internal radii and complete discharge of product and cleaning media.
Contamination prevention
Prevent ingress, accumulation in non-cleanable areas and contact between pharmaceutical product and hazardous ancillary substances.
Cleaning instructions
Define recommended cleaning, disinfection and rinsing products and methods, including areas that are difficult or inadvisable to access.
Protection against corruption
Assess connected hardware, software and remote access so that manipulation or unintended changes cannot create hazardous machinery behaviour.
Safety-related data & software
Control safety-software versions, interventions and parameter changes; define the required traceability and retention concept for conformity evidence.
GMP data integrity interface
Coordinate CE safety controls with user access, audit trails, electronic records, time synchronization, backup and lifecycle controls required by the intended GMP use.
Integrated evidence package
Trace hygiene, safety, software and verification requirements into risk assessment, specifications, testing, instructions and the technical file.
Typical applications
Develop systems for pharmaceutical production and high-purity media.
Production systems
Process equipment · Preparation and transfer systems · Customer-specific machinery
High-purity utilities
PW and WFI systems · Pure-steam generation · Storage and distribution
Cleaning & sterilization
CIP systems · SIP integration · Media routing and interfaces
Lifecycle delivery
FAT and SAT · Commissioning · Production start-up
Ways to work with Cotectra
Choose the development model that fits the system responsibility.
The scope can range from complete technical development to a clearly defined specialist work package.
Complete system development
Cotectra assumes responsibility for the agreed technical development scope from system definition through start-up.
- Integrated engineering ownership
- Defined interfaces and deliverables
- Concept-to-start-up continuity
Joint development with the OEM
Cotectra and the OEM combine platform knowledge, pharmaceutical engineering and delivery responsibility in one development model.
- Joint technical solution
- Clearly divided responsibilities
- One coordinated delivery path
Specialist work package
Cotectra takes responsibility for a defined high-value package when specific expertise or recovery support is needed.
- High-purity utilities or CIP/SIP
- Hygienic design and reviews
- Commissioning or project recovery
Selected development experience
Development of a new pure-steam generator.
Development challenge
A new pure-steam generator had to be developed as a pharmaceutical utility product rather than adapted from an existing standard system.
Cotectra responsibility
Cotectra contributed equipment-manufacturer experience and assumed the agreed technical development responsibility in coordination with the OEM.
Engineering scope
System and process concept, functional requirements, hygienic and pressure-equipment design, CE-conformity strategy, equipment and control interfaces, design assurance and engineering continuity toward realization and commissioning.
Develop the next system
Turn a pharmaceutical equipment idea into an executable system.
Share the intended application, development status and responsibility model. We will define how Cotectra can lead or co-develop the technical solution.