SPIE Life Science Engineering is your competent partner for customized solutions in the fields of pharmaceuticals, biotechnology, and medical technology. With our holistic approach, we cover all core areas from technical building equipment and process simulation to qualification and validation.
Our expertise extends across GMP-compliant factory planning, pharmaceutical process engineering, cleanroom construction, and digital simulation methods to ensure efficient and future-proof production processes. Through our interdisciplinary collaboration, we offer you optimal interface management – all from a single source.
Qualification / Validation
Cleanroom Measurement Calibration
GMP Consulting
QMS Development
Qualifications (DQ, IQ, OQ, PQ)
VMP Risk Analyses
Method, Cleaning, Process Validation
Regulatory Management
Life Cycle Approach
SOP Support
Support in Establishing GMP-compliant Processes
Concept Development
GMP GAP Analyses
CSV – Computer System Validation
Process Simulation
Capacity Analysis
Simulation of Single/Multi-purpose Plants and Processes
Analysis of Central Supply, Buffer, and Disposal Systems
Gantt Chart (Plant Utilization, Debottlenecking)
Representation of Various Production Scenarios (Impact of Shift Model, Supply Capacities, Resources)
Media Demand Analysis Considering Simultaneity (Peak Demand, Average Media Demand, Daily Demand)
Statistical Analyses / Sensitivity Analyses
Technical Building Equipment
We combine all project-relevant trades in-house to achieve optimal interface management:
Electrical Engineering
Media Technology
Ventilation Technology
MSR / Monitoring
CAD / Design
Cleanroom Construction
Biotechnology
Upstream
Downstream
Process Simulation
Process Automation
Flow Chart Development
Equipment Handling
Pharmaceutical Technology
GMP-compliant Factory Planning / Layout Development
Pharmaceutical Process Engineering
Process Consulting
Hospital Pharmacies
Laboratories
ATMP
Clean Media Supply
Architecture
Applied architecture for pharmaceuticals and biotechnology – we perfectly showcase your site externally as well.
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