Pharma

Pharmaceutical and biotechnology organisations place the highest demands on temperature control, humidity, reliability and documentation. Whether it concerns stability studies, GMP storage, laboratory research or process development, deviations can lead to loss of research results, product rejection or compliance risks.

Nijssen designs, builds and maintains climate chambers, stability chambers, pharmaceutical cold and freezer rooms and conditioned storage areas for critical processes within the life sciences sector.

From our location at the Leiden Bio Science Park, we work every day for organisations active in pharmaceutical research, biotechnology and advanced product development. As a result, we understand not only the technology behind climate control, but also the requirements around GMP, validation, audit readiness and business continuity.

From engineering and construction to commissioning, validation and maintenance, we manage the complete process.

Climate control for critical processes

Reliable climate conditions form the basis for reproducible research results, product quality and process safety. That is why we develop climate solutions in which temperature, humidity and other environmental conditions are continuously regulated, monitored and recorded.

Our installations are used for:

• Stability studies in accordance with ICH guidelines
• Pharmaceutical and biotechnological research
• GMP storage of medicinal products
• Storage of APIs and raw materials
• QC and R&D laboratories
• Pilot plants and development environments
• Clinical research programmes
• Conditioned storage of critical materials

Through precise climate control and continuous monitoring, processes remain demonstrably within the specified requirements.

GMP-compliant climate and stability chambers

Each climate chamber is designed based on the specific user and process requirements of your organisation. From the initial design phase, we take GMP guidelines, validation requirements and future audits into account.

Our climate chambers are characterised by:

• Precise temperature and humidity control
• Continuous recording of measurement data
• Full traceability
• Comprehensive technical documentation
• High availability
• Support for validation and qualification processes

This gives you a controlled environment that demonstrably meets the required specifications throughout the entire lifetime of the installation.

Stability chambers according to ICH guidelines

For stability studies, we realise climate chambers suitable for long-term and accelerated stability studies in accordance with ICH Q1A(R2).

Our systems provide stable and reproducible climate control, allowing research results to be recorded and documented reliably. Thanks to integrated monitoring and data logging systems, all relevant data is available for reports, inspections and audits.

In this way, the installation supports not only the research itself, but also the underlying quality and compliance processes.