Calibration and Validation Services

ICH Nominal Guidelines

Cold Chain

Bespoke Conditions

Equipment we Service

 

Environmental Chambers

Incubators

Refrigerators

Freezers

Ovens

Autoclaves

DI water systems

BMS / RMS systems

Photostability Cabinets

Warehouse Mapping

CALIBRATION
TESTING

CALIBRATION

Temperature - Humidity - Voltage - Resistance

We offer a fully compliant calibration service for laboratory and pharmaceutical equipment. Our services include:

  • Single point Temperature Calibration
  • Single point Temperature and Humidity Calibration
  • PID Controller Calibration
  • RTD Calibration
  • Chiller Temperature Calibration
  • Air Flow Calibration
     

All Traceable instruments are Calibrated to UKAS and NIST industry standards.

Temperature Calibration

 We offer single and multi-point temperature calibration testing to UKAS and NIST industry standards for cold chain and ICH conditions. We specialize in Freezers, Fridges, Ovens, Incubators, Autoclaves, Environmental Chambers and Laboratory equipment.

-80°C, -70°C, -40°C, -20°C, 0°C, 5°C, 50°C

Temperature & Humidity
Calibration

Temperature and relative humidity calibration is available for single or multi point verification.  We specialize in Freezers, Fridges, Environmental Chambers and Laboratory Equipment.

5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH

40°C/25%RH, 40°C/75%RH, BESPOKE

VALIDATION
TESTING

VALIDATION SERVICE

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.

Conditions: 5°C, 25°C/60%RH, 30°C/65%RH, 30°C/75%RH 40°C/25%RH, 40°C/75%RH, BESPOKE

Cold Chain: -80°C, -70°C, -40°C, -20°C, 0°C

Environmental Chambers

     Mapping Points

  • 8 x Temperature Probes
  • 8 x Temperature & 8 x Humidity 
  • 12 x Temperature Probes
  • 12 x Temperature &12 x Humidity
  •  24 Hour Unloaded Performance Test
  • 1 Minute Unloaded Door Open Recovery Test
  • 24 Hour Loaded Performance Test
  • 1 Minute Loaded Door Open Recovery Test
  • Power failure simulation Test

Refrigerators &
Freezers

     Mapping Points

  • 8 x Temperature Probes 
  • 12 x Temperature Probes
  • Single Point Mapping
  • Custom
  •  24 Hour Unloaded Performance Test
  • 1 Minute Unloaded Door Open Recovery Test
  • 24 Hour Loaded Performance Test
  • 1 Minute Loaded Door Open Recovery Test
  • Power failure simulation Test

Ovens & 
Incubators

     Mapping Points

  • 8 x Temperature Probes 
  • 12 x Temperature Probes
  • Single Point Mapping
  • Custom
  •  24 Hour Unloaded Performance Test
  • 1 Minute Unloaded Door Open Recovery Test
  • 24 Hour Loaded Performance Test
  • 1 Minute Loaded Door Open Recovery Test
  • Power failure simulation Test

Cold Chain Chambers

     Mapping Points

  • 8 x Temperature Probes 
  • 12 x Temperature Probes
  • Single Point
  • Custom
  •  24 Hour Unloaded Performance Test
  • 1 Minute Unloaded Door Open Recovery Test
  • 24 Hour Loaded Performance Test
  • 1 Minute Loaded Door Open Recovery Test
  • Power failure simulation Test

Photostability
Cabinets

     Mapping Points

  • Single Point Temperature Mapping
  • UVA light saturation test
  • LUX light saturation test
  • PID accuracy Test
  • Single point Temperature Test
  • LUX Multi Point Mapping Test
  • UVA Multi Point Mapping Test
  • PID accuracy Test

Controlled
Warehouses

     Mapping Points

  • 24 x Temperature Probes 
  • 24 x Humidity Probes
  • Single Point Mapping
  • Custom
  • 24 Hour Unloaded Performance Test
  • 24 Hour Loaded Performance Test

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

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