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Option 1 - New or Relocated Chamber Validation (CTUs)

Option 1 - New or Relocated Chamber Validation (CTUs)

Typically undergo full IQ/OQ/PQ, but some clients only require IOQ. Often new chambers require adjustment to ensure that they not only pass qualification, but perform optimally to provide the highest level of confidence in the safety of your products/samples. Our team of engineers is experienced and knowledgeable about adjusting your chambers to perform optimally, and will involve you in making decisions such as these.

This is an example of a common IQ/OQ/PQ qualification:

Validation Protocol Development:

  • We will work with you to determine whether leveraging your validation protocol or having Ellab generate the validation protocol is best for your project. We can generate custom validation protocols to meet your requirements or we also have standard industry leading validation protocols that may be the right fit.  

Verifying Installation Qualification (IQ):

  • Ensuring that the equipment specified is correct along with system data & documentation, installed correctly and includes information necessary for FDA requirements.
    - Test equipment and materials identification
    - Manufacturer documentation and procedure list verification
    - System identification and installation verification
    - Calibration and preventative maintenance verification
    - System utilities verification
    - System safety inspection checklist
    - Installation requirements verification
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Verifying Operational Qualification (OQ):

  • Testing Operational Controls, Parameters & System Alarm Verifications.
  • Performing an empty chamber temperature distribution thermal mapping study. Environmental Chamber Temperature Mapping, Humidity Mapping, CO2 Mapping, Rotation and Light may also be tested depending on the unit-under-test (UUT) requirements.
  • We have both wired (thermocouple-based) and wireless data logger validation systems to perform temperature, humidity, and CO2 mapping of the environmental conditions throughout the storage area.
  • We will place mapping sensors in pre-defined locations throughout the environment to ensure that critical data has been captured. This will include where the product will be stored, storage racks & areas, heating & cooling spots and potential influences on conditions.  
  • Additional qualification tests may include:
    - Open door recovery verification test
    - Power interruption recovery verification test
    - Power Loss Temperature Rise test

Verifying Performance Qualification (PQ):

  • Performing a loaded chamber temperature distribution thermal mapping study. Environmental Chamber Temperature Mapping, Humidity Mapping, CO2 Mapping, Rotation and Light may also be tested depending on the unit-under-test (UUT) requirements.
  • We will place mapping sensors in pre-defined locations throughout the environment to ensure that critical data has been captured. This will include where the product will be stored, storage racks & areas, heating & cooling spots and potential influences on conditions.  
  • Additional qualification test may include:
    - Open door recovery verification test
    - Unconditioned load recovery verification test

Report completion including summary report and review:

  • We deliver to you a high-quality qualification package containing a clear presentation of testing performed, documented results and summary report with a conclusion based on the system’s ability to meet the requirements. The final package is presented in a 3-ring binder with dividers and includes the summary report, the executed validation protocol, all relevant supporting documentation and a USB storage device with soft copies of raw data.
  • Our completed environmental mapping report includes:
    - Presentation of testing performed
    - Graphs of mapping performed
    - Qualification Summary Report
    - Executed Validation Protocol
    - Calibration Certificates for all validation mapping equipment used
Option 2 - Existing Chamber Qualification

Option 2 - Existing Chamber Qualification

The timeframe for periodic re-validation varies from client to client based on the documented level of risk they are willing to accept. Some of our clients re-validate on an annual basis, every three years, every five years, and still some clients never revalidate their chambers.

A typical mapping performed for revalidation qualifies the chamber as it is in use. It is often executed while the chamber is in routine operating conditions, meaning whatever is being stored in unit at the time the mapping exercise is performed remains there throughout the test. However, some clients move all of their product or samples into a neighboring chamber so that a full OQ/PQ can be performed.

Validation Protocol Development:

  • Decide whether we will be qualifying using either Ellab’s validation protocol or Client’s validation protocol.

Verifying Performance Qualification (PQ): Also called Re-Validation, Re-Qualification, or Continuous Qualification

  • Performing an “As-is” chamber temperature distribution thermal mapping study. Environmental Chamber Temperature Mapping, Humidity Mapping, CO2 Mapping, Rotation and Light may also be tested depending on the unit-under-test (UUT) requirements.
    • We will place mapping sensors in pre-defined locations throughout the environment to ensure that critical data has been captured. This will include where the product will be stored, storage racks & areas, heating & cooling spots and potential influences on conditions. 
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Option 3 - Decommissioning Chamber Qualification (CTU)

Option 3 - Decommissioning Chamber Qualification (CTU)

At the end of an environmental chamber’s life, there is still testing that may be required before the unit is shut down forever. At a minimum, most of our clients typically require an as-found calibration of the controller and/or continuous monitoring system, and many require a temperature mapping of their chamber prior to decommissioning. This process still requires a formal validation protocol and SOPs to ensure that testing has been completed properly. The final report provides documented evidence to confirm that the material being stored was in fact within the specified range. 

Validation Protocol Development:

  • Decide whether we will be qualifying using either Ellab’s validation protocol or Client’s validation protocol.
  • Verifying Performance Qualification (PQ): Also called Re-Validation, Re-Qualification, or Continuous Qualification

  • Performing an empty or “As-is” chamber temperature distribution thermal mapping study. Environmental Chamber Temperature Mapping, Humidity Mapping, CO2 Mapping, Rotation and Light may also be tested depending on the unit-under-test (UUT) requirements.
    • We will place mapping sensors in pre-defined locations throughout the environment to ensure that critical data has been captured. This will include where the product will be stored, storage racks & areas, heating & cooling spots and potential influences on conditions. 
Get a qoute
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