Qualification of Walking Type Stability Chamber

7/12/22, 6:52 PM Qualification of Walking Type Stability Chamber
Qualification of Walking Type Stability Chamber

pharmaceuticalsky.com/2022/06/qualification-of-walking-type-stability.html
User requirement specification

User requirement specification (URS) is a list of all the requirements from the user, like
equipment to be purchased. After the preparation of the list, the documents are sent to the
manufacturer to get the required materials as per the given criteria.

The user department will raise the indent for his requirement regarding machine equipment
or software. He/She will give all the requirements in the format of URS, which include the
functional and technical specifications for the machine equipment or software. This
specification in the written format is defined as URS. It shall be very specific.

There should not be any confusion during the preparation for approval. Functional as well as
technical aspects shall be clearly mentioned. The number of spare change parts required
shall be mentioned in URS.

Qualification of Walking Type Stability Chamber

For a chamber to receive a certification to conduct stability tests, it must undergo a
three-part qualification process. The qualifications must also include calibration
records of all instrumentation used and evidence of their calibrated state.
The three qualification types are:
1. Installation Qualification (IQ)

2. Operation Qualification (OQ)
3. Performance Qualification (PQ)
These tests are conducted by validation personnel using calibrated measuring and
testing equipment; records are kept by the Quality Assurance department for a
specified length of time.
PEOPLE ALSO READ: SOP for Operation and Calibration Procedure for Stability Chamber

Installation Qualification
https://www.pharmaceuticalsky.com/2022/06/qualification-of-walking-type-stability.html 1/4
The first step is to check the correct positioning of the chamber and then check if the
chamber and all components are correctly installed, and also the presence of
documentation. Documentation usually includes the user’s manual, certificates, and
SOP's. Utilities can be verified at this phase: electrical feeding, water (pressure, pumps,
filters and connections), and exhaust.
If the chamber has a control panel/ system, this can be checked too: buttons and
commands, screens, etc. Finally, check for all components part of critical systems:
measuring and control, ventilation, heating and cooling, and safety. All associate
connections should be properly done.
Overview:
The first qualification verifies whether or not the stability chamber meets its design
specifications. All parts are accounted for and checked that they are correctly installed.
Proper documentation must also be present, including the user manual and any
certifications and standard operating procedures (SOPs).
Requirements:
All components must be properly installed and functional for a stability chamber to
pass installation qualification. If the chamber has a control panel with a human-
machine interface (HMI) or other pilot devices such as pushbuttons and selector
switches, they must work as designed. All calibration and safety equipment also need to
pass inspection.
Operation Qualification
At this phase, start by testing all individual functions of the stability chamber, including
switches and controls, alarms, doors, etc. Check the sensors calibration if this was not
covered on IQ. The final OQ test is to perform a thermal/humidity mapping of the
chamber for the established set point. At this point, the mapping is performed with an
empty chamber and for a determined period of time (not less than 24 hours).
Mappings
The purpose of this study is to assure that temperature and humidity are evenly
distributed inside the chamber and that the established acceptance criteria are met at
any point of the chamber.
Use at least ten sensors evenly distributed inside the chamber. For example on the
chamber’s corners and at the center, or 3 sensors on each shelf, depending on the size
of the chamber. If you use thermocouples for temperature, assure that the chamber is
prepared for it, or in case you pass them through the door, that the door is perfectly
closed. The easiest is to use wireless probes, with the only disadvantage is that you will
only see the results at the end of the study, instead of doing it online.
Program the sensors to acquire data for example every 5 minutes. Wait for temperature
and humidity stabilization for a while and let it run for the established time.
Door Opening Study

At the end of the study, and before removing the sensors, perform a door opening
study. This can be achieved for example by opening the door for a certain short time
and keep recording temperature and humidity at a short-range (every 10 seconds for
example). Once you close the door let it stabilize again. Usually, perform 3 door
opening trials and at the end and calculate the chamber’s average recovery time.
Overview:
The operation qualification tests the individual functions of the stability chamber
and verifies that the systems and subsystems perform as intended under normal
operating ranges including testing all doors, switches, controls, and alarms.
Requirements:
The operation qualification test verifies that temperature and humidity have equalized
inside the chamber. To ensure accurate temperature and humidity readings, the
operator waits a few minutes until they stabilize, then runs the test for the specified
time.
PLC Validation Report

Performance Qualification
For performance Qualification, only perform a full load thermal/humidity mapping,
using the same configuration for the sensors as in the empty chamber study. The
minimum study time now is 24 hours. Again at the end of the study, we perform door
opening trials and calculate the average recovery time.
Overview:
The performance qualification verifies that the stability chamber meets performance
specifications under a full load. Usually, the test is performed at the chamber’s
operating setpoint with a simulated product loaded to replicate a typical environment.
Temperature and relative humidity uniformities are measured using thermocouple and
relative humidity (RH) sensors.
Requirements:
The stability chamber must perform under full load for at least 24 hours to pass
performance qualification. After the initial study is complete, the trial gets repeated
with a door-opened study to calculate its average recovery time.
The performance qualification process is done annually using the same procedures as
past tests. After each requalification, the results should be compared with previous
years to track the chamber’s overall performance.
Requalification
Performance qualification is done on an annual basis, using the same sensor location
and for the same time. You can use the same protocol or SOP describing the method
for mapping. After each requalification, it is recommended to compare the results with
the previous qualifications to see if the chamber is maintaining its performance. If you
eventually intend to change your temperature or humidity set points, both empty
chamber and full load studies should be performed again using the new set point.
PEOPLE ALSO READ: Qualification Protocol for Air Handling Unit (HVAC)


Qualification of Walking Type Stability Chamber

Uploaded by

Copyright:

Available Formats

Qualification of Walking Type Stability Chamber

Uploaded by

Document Information

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Qualification of Walking Type Stability Chamber

Uploaded by

Copyright:

Available Formats

7/12/22, 6:52 PM Qualification of Walking Type Stability Chamber

Qualification of Walking Type Stability Chamber

User requirement specification

Qualification of Walking Type Stability Chamber

1. Installation Qualification (IQ)

Door Opening Study

PLC Validation Report

PEOPLE ALSO READ: Qualification Protocol for Air Handling Unit (HVAC)

You might also like