Bespoke, GMP-Compliant Cold Rooms for Regulated Pharmaceutical Environments

We specialise in the design, specification, installation, and validation of pharmaceutical cold rooms engineered to protect temperature-sensitive pharmaceutical products.

Our cold rooms are more than insulated boxes – they are mission-critical controlled environments built to maintain stability, ensure product integrity, and meet the strictest regulatory requirements. We support clients across R&D, clinical trials, bulk production, and distribution, delivering systems that combine robust engineering, 24/7 resilience, and full compliance with MHRA, FDA, and EU GMP standards.

Engineered for Critical Environments

Our pharmaceutical cold rooms are individually designed to suit your site, workflow, and operational risk profile. Whether you require chilled storage (+2°C to +8°C), freezer rooms (-20°C), ultra-low temperature facilities (-80°C), or dual-zone solutions, our in-house engineers tailor each system to perform reliably under real- world usage conditions.

Key features include:

• Custom-built refrigeration systems for your exact load and usage pattern
• Precision temperature control with tight tolerances (±0.5°C or tighter where required)
• Advanced control panels with digital readout, real-time alarms, and data logging
• Full redundancy options, including dual condensing units and backup generators
• Remote monitoring and telemetry integration for proactive oversight

We don’t believe in off-the-shelf systems for regulated environments. Every cold room we deliver is bespoke, validated, and engineered to perform under pressure.

Supporting Pharmaceutical Processes

Our systems support a wide range of regulated pharmaceutical operations:

• Raw material and active pharmaceutical ingredient (API) storage
• Clinical trial product holding, including investigational medicinal products (IMPs)
• Finished product and distribution-stage storage
• Stability testing environments, including ICH conditions
• Biologics, vaccines and cell-based therapy cold chains
• Controlled drugs and quarantine storage with access control

We work with CMOs, CDMOs, manufacturers, logistics providers, wholesalers, and healthcare systems, and understand the unique technical and regulatory needs of each stakeholder.

Built-In Redundancy & Risk Mitigation

Pharmaceutical environments demand continuous, failsafe operation. That’s why resilience is engineered into every system from day one.

Our cold rooms commonly include:

• Dual refrigeration circuits with auto-changeover
• Multiple independent temperature probes for cross-checking and alarm verification
• Integrated BMS connectivity
• GPRS/4G remote alarms and notifications
• UPS backup for control systems
• Standby generators or dual-feed electricals where required

We can also incorporate validated door interlocks, airlocks, racking systems, lighting, and antimicrobial finishes, where required by your process or regulatory framework.

Compliance, Validation & Documentation

We design with compliance in mind. All cold rooms come with a complete validation and documentation package to support audit and regulatory inspection.

This can include:

• User Requirement Specification (URS)
• Functional Design Specification (FDS)
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Temperature Mapping Reports
• Calibration Certificates
• Ongoing Maintenance Logs

We work closely with your in-house QA, validation or engineering teams to ensuresmooth documentation and successful qualification.

Full Lifecycle Support

We offer a turnkey approach – managing the complete delivery cycle from concept to long-term support:

1. Consultation &Site Survey

We assess your site, compliance requirements and operational priorities.

2. Design & Specification

Our engineering team develops detailed drawings, control strategies and validation plans.

3. Installation & Commissioning

Delivered by experienced in-house engineers with deep knowledge of GMP environments.

4. Validation & Handover

Full IQ/OQ/PQ documentation and sign-off, ready for audit.

5. Ongoing Maintenance & Emergency Cover

Nationwide and European support with 24/7 call-out options and PPM schedules.

Delivered Across the UK and Western Europe

From London to Lyon, Manchester to Munich, we deliver pharmaceutical cold

rooms across the UK and all of Western Europe. Our installation teams are

experienced in working in live GMP production environments, and our designs

meet local and EU-wide regulations including:

• UK MHRA Guidelines
• EU GMP Annex 1 & Annex 11
• FDA 21 CFR Part 11 (where applicable)
• ISO 14644 (cleanrooms, if applicable)
• GDP for temperature-controlled distribution

We support both greenfield builds and retrofit upgrades, integrating with your existing facilities and infrastructure.