We offer a fully compliant calibration service for laboratory and pharmaceutical equipment. Our services include:
All Traceable instruments are Calibrated to UKAS and NIST industry standards.
-80°C, -70°C, -40°C, -20°C, 0°C, 5°C, 50°C
5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH
40°C/25%RH, 40°C/75%RH, BESPOKE
Our fully 21 CFR Part 11 compliant Data Logging system, combined with Rotonic HC2A Temperature / Humidity probes, allows us to accurately monitor and record your equipment. We provide all protocols specific to your requirements and provide Charted, Raw Data and a full process audit trail. All documentation is completed to CGMP standards and prechecked prior to customer submission.
5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH 40°C/25%RH, 40°C/75%RH, BESPOKE
We validate using a 48 channel Eurotherm 6000 series data logger. Recording real-time data using 21 CFR part 11 software.
We use Rotronic HC2A-S Temperature and Humidity probes. their reliability and test specification allows us to accurately map and document equipment performance
We specialize in testing ICH stability conditions in line with FDA , MHRA, and HPRA regulatory standards
ICH
We test stability equipment to ICH nominal Guidelines, all environmental chambers, incubators, ovens are tested to ensure performance with in the alarm criteria for each condition.
Cold Chain
Cold chain solutions, we test and map all cold chain conditions down as low as -80°C
Bespoke
Our Data loggers can be calibrated to perform custom conditions for bespoke requirements.
All Validation protocols are controlled and generated specifically to the customers' requirements. Each protocol will include a Validation Chart, Raw Data sheet and a full audit trail of the performance test completed. All documentation is completed to GDP and cGMP standards and will have a pre-Quality check prior to being received by the customer.
Our Service Level agreements allow our customers to schedule in advance annual or biannual services, we offer services packages catered to your exacting standards and requirements. There are many advantages to having the knowledge that your service is prioritized and scheduled. The main benefit is we offer discounted pricing to all contracted customers for our services. Annual contracts are invoiced at time of service so there is no impact on your yearly CAPEX obligations.
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