Controlled Environments for Product Integrity, Testing, and Regulatory Compliance

We design, build and maintain high-precision stability and quarantine chambers to meet the strict requirements of the

pharmaceutical and life sciences industries.

Our systems provide tightly regulated temperature and humidity control for ICH-compliant stability testing, product quarantine, and pre-release storage, ensuring that every product remains within

validated parameters.

With decades of experience delivering mission-critical controlled environments, we work with pharmaceutical manufacturers, contract development organisations, research facilities and clinical trial teams to build chambers that deliver uncompromising performance, data integrity, and regulatory readiness.

Designed for Regulatory Precision

Our chambers are engineered to meet the environmental conditions required under ICH Q1A (R2) and related stability guidelines for long-term, intermediate, accelerated, and stress testing, including:

• 25°C / 60% RH (long-term)
• 30°C / 65% RH (intermediate)
• 40°C / 75% RH (accelerated)
• Custom profiles for zone-specific or product-specific conditions
• -20°C or +2°C to +8°C for refrigerated and frozen product hold

All chambers are built with the precise, repeatable control needed to ensure that test results are valid and that products remain compliant throughout their shelf life or quarantine period.

Applications

Our stability and quarantine chambers are suitable for:

• ICH-compliant stability testing (Zone I–IVb)
• Raw material quarantine storage
• Batch hold and QA release storage
• Temperature cycling and stress testing
• Photostability testing (with light integration)
• Clinical supply chain testing environments
• Biologics and cell therapy holding rooms

Whether you need a small walk-in chamber or a fully integrated bank of climate- controlled rooms for large-scale batch testing, we can provide a customised, scalable solution.

Features & Performance Standards

Every chamber we deliver includes:

• Tight temperature and humidity control (±0.5°C / ±2% RH or better)
• High-quality insulated panelling with hygienic, cleanable finishes
• Validated control systems with secure, auditable data logging
• Fully integrated alarms with email, SMS and/or BMS alert options
• Redundant sensors and auto-failover where required
• Backup power, dual refrigeration, and resilient design options
• Racking, access control and lighting tailored to use case

We can also integrate remote monitoring, Part 11-compliant logging software,

and automated report generation to simplify audit readiness and reduce manual

record-keeping.

Validation & Documentation

Our chambers are supplied with full validation and compliance documentation, developed to support MHRA, FDA, EMA and internal QA inspections.

Available documentation includes:

• User Requirement Specification (URS)
• Design Qualification (DQ)
• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Temperature & humidity mapping reports
• Equipment calibration and certification
• Risk assessments and change control records

We also offer full on-site validation support including sensor placement, test. execution, and report writing.

Custom Build – Not Off-the-Shelf

We do not offer generic, prebuilt chambers. Every solution is engineered to your specific product, space and regulatory needs, whether for small-batch clinical trials or multi-chamber commercial use.

Our team works directly with your QA, engineering and validation teams to ensure the final product fits your workflow and your inspection expectations – without compromise.

Projects Across the UK & Europe

With operations in the UK and across Western Europe, we install stability and quarantine chambers at:

• GMP pharmaceutical facilities
• Contract development and manufacturing organisations (CDMOs)
• Clinical trial depots
• QA testing laboratories
• Biotech campuses and academic research centres
• Global pharma distribution and packaging sites

From London to Lyon and Manchester to Munich, we ensure that your systems meet local regulatory requirements with international engineering quality.

Service & Support

All chambers are supported by our Planned Preventative Maintenance (PPM) and

24/7 breakdown cover options, ensuring continuous, compliant operation.

Services include:

• Annual requalification and mapping
• Routine system health checks
• Alarm system testing
• Refrigeration servicing and gas checks
• Remote support and monitoring integration
• Rapid on-site repair where needed