Pharmaceutical Cold Storage

Bespoke Pharmaceutical Cold Storage

Our expert team will work with you to customise our pharma grade storage solutions to your exact specification for hire or purchase.

• Bespoke modular flat pack cold rooms (built to fit within existing facility).
• Varying sizes of mobile cold stores to any required specification.
• Full range of temperature controlled storage including: 2 c – 8c Chill stores, close control freezer stores, hot boxes, incubators, blast chillers/freezers.
• Full in-house project management team.
• Full in-house control of manufacturing environment meaning flexible customisation.
• Designed to fit within your existing operations and procedures.
• ‘First use’ equipment if required.
• CRS Pharma Solutions are fully compliant with current GMP and GDP best practice guidelines.
• CRS Pharma Solutions are fully versed in the challenges faced by the QP and RP in Pharmaceutical companies with regard to audits regulatory compliance.

Full Redundancy on all Critical Components 

Redundancy is the duplication of critical components or functions of a system with the intention of increasing reliability. Our Pharmaceutical Cold Storage units can be equipped with dual independent temperature control units, ensuring reliability.

• Duty standby systems compromising of two independent units configured in 12 or 24-hour cycles to ensure the equal running of both plants.
• Dual close control modulated cooling systems ensure temperature uniformity throughout the chamber.
• Independent environmental monitoring solutions, running either on a cloud based dashboard or installed locally within your site.

Expert Commissioning & Validation Team 

Our experienced in-house validation team can provide a turnkey solution customised to your needs. The validation process is comprehensive and is executed efficiently and in compliance with regulatory requirements, it includes...

• The provision of complete documentation detailing the commissioning and qualification process.
• Equipment can be delivered in a validated state for immediate use or can be fully validated on site as required.
• Full IQ, OQ, PQ Validation, including empty and full load thermal mapping studies.
• Verification of all local audio/visual alarms and any externally forwarded alarms.
• Thermal mapping, temperature recovery, and open-door studies
  Insulation holdover and power failure studies.
• Provision of detailed summary report of the validation process, the data and results recorded during the execution of the IOPQ.
• Three-point calibration of all control and monitoring probes.
• All thermal mapping studies are conducted using the KAYE VALIDATOR 2000 which is CFR part 11 compliant.

The experts in Temperature Controlled Storage

Failure to store pharmaceutical products within the correct temperature ranges can result in sub-potent products and potentially, therapeutic failure. CRS are experts in the storage of temperature sensitive pharmaceutical products.

Our fully trained in-house validation specialists will help ensure that you meet all of your quality and regulatory requirements, providing full installation, operational and performance qualification (IQ, OQ, & PQ) including empty and full state thermal mapping studies.