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Accreditations, Regulatory and Licensing
At Harrow Green’s Cambridge Biorepository, protecting client samples is more than a service, it is a regulated, quality-driven responsibility. Our facility operates under a Human Tissue Authority (HTA)–licensed environment, supported by ISO9001-certified quality systems and aligned to GxP and GDP principles. This integrated regulatory framework ensures that every sample is handled, stored, and documented with absolute integrity, transparency, and compliance.
From human tissue to clinical trial materials, cell banks, research reagents, and cryogenic assets, clients trust Harrow Green because our governance prioritises risk mitigation, data accuracy, and uninterrupted sample protection at every stage of the storage lifecycle.
A Fully Governed, Audit-Ready Storage Environment
Our processes, infrastructure, and documentation have been designed to meet the stringent standards required for regulated sample storage:
HTA-Licensed Workflows
Harrow Green operates under a dedicated HTA licence, ensuring that all HTA-relevant materials are managed ethically, securely, and in full alignment with UK legislation.
We provide:
- Segregated, licence-controlled storage zones
- Enhanced documentation and traceability
- Oversight from a designated individual (DI) and QA team
- Ethical and respectful handling of all human tissue
ISO9001-Certified Quality Management
Our ISO9001 certification underpins a culture of consistency, procedural control, and continual improvement. Every storage activity, intake, audit, sampling, monitoring, shipping, is governed by validated SOPs.
GxP & GDP Alignment
All processes follow GxP expectations, supported by GDP-compliant logistics and audit-ready documentation. Data integrity, chain-of-custody, and environmental monitoring are embedded into our operations.
How We Protect Client Samples
End-to-End Traceability
Every sample is barcoded, documented, and tracked across its entire lifecycle, with electronic audit trails and full chain-of-custody reporting. Nothing moves without controlled approval and logged oversight.
Validated Storage Infrastructure
All storage assets, from cryogenic LN₂ tanks to –80°C ULT freezers, undergo:
- Temperature / level mapping
- Calibration
- Alarm validation
- Independent monitoring checks
- Redundancy and backup testing.
This ensures stability and compliance across all temperature regimes, including vapour and liquid phase –196°C cryogenic storage.
Continuous Monitoring & Redundancy
Our facility includes:
- 24/7 monitored systems with independent alarm paths
- UPS and generator backup
- Automated LN₂ refill systems with fail-safes
- Hot-swap freezer and cryo capacity for emergency transfer
- On-call engineers 24/7.
Your samples are protected even in the unlikely event of equipment failure or power disruption.
Secure & Controlled Access
Storage areas are protected by:
- Restricted, card-controlled access
- 24/7 CCTV
- Logged site entry & visitor management
- Segregated zones for licensed material
Only authorised personnel can access client samples, and every interaction is traceable.
Trusted by Leading Scientific and Clinical Organisations
Our Cambridge facility supports:
- Biopharmaceutical manufacturers
- Clinical research organisations (CROs)
- NHS & healthcare partners
- University and academic laboratories
- Biotech start-ups
- Long-term research and archival programmes.
They trust Harrow Green because our systems are proven, validated, and built around regulatory compliance.
Quality-Assured Specialist Cold Chain Logistics
For clients requiring transport as well as storage, Harrow Green provides validated, fully compliant cold chain solutions.
GDP-Compliant, GxP-Aligned Logistics
Every movement follows strict documentation, packaging, and handling protocols.
ADR-Certified Drivers & In-House DGSA Oversight
Our Dangerous Goods Safety Advisor (DGSA) ensures that all shipments meet legal requirements, while ADR-certified drivers guarantee compliant and safe transport of regulated biological materials.
Temperature Integrity From Door-to-Door
Whether shipping a single cryobox, relocating –80°C freezers, or transporting cryogenic materials, we maintain:
- Real-time temperature monitoring
- Secure chain-of-custody
- Validated packaging
- Unbroken power or LN₂ supply for ultra-low cargo.
This ensures every sample arrives exactly as it was stored, stable, secure, and ready for use.
Why Clients Choose Harrow Green
- HTA-licensed for human tissue storage
- ISO9001-certified quality systems
- GxP-aligned workflows and documentation
- GDP-compliant cold chain capability
- Complete lifecycle traceability
- Validated storage and monitoring systems
- 24/7 security, monitoring, and engineering support
- Trusted by leading research, clinical, and biotech organisations.
A Partner You Can Trust With Your Most Valuable Samples
By choosing Harrow Green, you gain more than a storage provider, you gain a quality-driven, regulated, and fully accountable partner dedicated to protecting your materials with the highest standards of compliance and care.
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