Environmental Process and Storage Equipment Qualification

What is Qualification and Validation?

What is meant with equipment qualification? Qualification is the process of establishing documented evidence that this specific equipment is fit and ready for its intended use. Once an equipment is qualified, the process, where the equipment is used, can be validated.

To resume, equipment is qualified, and a process is validated.

Process and Storage Equipment examples:

Here is an overview of Process and Storage Equipment:

• Climatic chambers,
• Freezers,
• Freeze dryers,
• Fridges,
• Incubators,
• Cold rooms,
• Hot rooms,
• Autoclaves,
• Sterilizers,
• Warehouses,
• Transport vehicles,
• Transport containers…

Environmental process and storage equipment is traditionally controlled with a sensor and an analogue output, where the customer defines a set point and the system will control the generated environment comparing the set point and the sensor.

Temperature/Heat Mapping

Temperature mapping is a mandatory requirement for the qualification of environmental process and storage equipment when used within a regulated environment. A temperature mapping study will show the heat distribution within the area and will document the areas with the same thermal environmental conditions.

During the operational qualification of this equipment, where the technical specifications of the product are tested, the temperature distribution within the equipment is measured to ensure that there is an equal temperature distribution that match the users requirements, based upon the user requirements recovery tests can also be performed. If the chamber also controls relative humidity, the user can also measure the relative humidity at all temperature points or measure the dew point at one point within the equipment.

To comply to the regulatory standards, the qualification of the process and storage equipment needs to be requalified at prescribed intervals based upon risk assessment and scientific proof.

HG2-XL Mapping Setup

Temperature Mapping with the HG2-XL temperature and relative humidity generator

Rotronic have carried out the qualification of the relative humidity and temperature generator, the HygroGen HG2-XL.

In the first stage, the users requirements must be met, all necessary data can found on the device datasheet.

Rotronic used the RMS-OQ-L-SET that contains the following hardware:

• 5*RMS-LOG-T30-L
• 10*T30-00010 (Pt100 Class B (1 / 10Din), 4-wire, DIN EN 60751).
• 1*RMS-LOG-L-D
• 1*RMS-HCD-S

The Optidew dewpoint mirror can be used and is available in the RMS-OQ-DPM-L-SET.

All of the units can be ISO-17025 calibrated within one of our accredited laboratories.

Installation

Based upon the ISPE Good Practice Guide: Controlled Chamber Mapping and Monitoring, the chamber mapping was setup as follows:

The RMS-HCD-S, the dew point mirror and temperature probe were placed inside the chamber.

In order to cover all of the temperature and relative humidity points used, the HG2 has a ramp function where the required temperature, relative humidity and time for each set point are covered.

Chamber Results compliant to FDA 21 CFR Part 11 & EU Annex 11.

Rotronic offer a continuous monitoring system, RMS, helping regulated users comply to GxP regulations as well as FDA 21 CFR Part 11 and EU Annex 11 requirements. RMS was used for the qualification of the HG2-XL.

Chart View:

Data View:

Statistical View:

Via the data analysis function, it is possible to extract all of the data in .CSV format and create averages and standard deviations to define a complete analysis for equipment qualification:

Service Provider Temperature Mapping

Rotronic can offer a partial or a complete solution:

• Process and Storage equipment Qualification/Mapping based upon the DIN12880 guidelines.
• Warehouse Mapping. For warehouse mappin based upon the USP1079 guidelines.
• Environmental Monitoring solutions (required for FDA 21 CFR Part 210 and 211)
• Validation of the complete process (based upon the GAMP5 recommendations and EU Annex 15).
• Validation templates, including the IQ/OQ/PQ documentation.
• Calibration services (ISO 17025 and ISO 9001).
• Training.

Rotronic can help monitor various parameters during the qualification phase:

• Temperature,
• Dew point temperature,
• Mean kinetic temperature,
• Relative humidity,
• Carbon dioxide,
• Oxygen,
• Set points,
• Door monitoring…

Temperature Monitoring

• RMS-LOG-T30-L/868/915 data loggers:
• Temperature measurement range: -200…850°C.
• Measurement reproducibility: 0.1°C (-100…200°C).
• Measurement reproducibility: 0.2°C (-200…850°C).,
• T30-0010 sensor: Pt100 1/3 DIN Class B: 0.1K.
• Pt100 accuracy defined by the IEC 60751:

Relative Humidity Monitoring

• RMS-LOG-T30-L/868/915 data loggers:
• Temperature measurement range: -200…850°C.
• HCD relative humidity and temperature sensors:
• Temperature range: -100…200°C.
• Relative humidity range: 0…100%rh.
• Temperature accuracy: 0.1°C (10…30°C).
• Relative humidity accuracy: 0.8%rh (10…30°C).

Dew Point Monitoring

• Optidew 401/501:
• Temperature range: -40…120°C.
• Dew point range: -40…120°C.
• Dew point accuracy: 0.15°Cdp.
• Dew point repeatability: 0.05°Cdp.
• Dew point sensitivity: 0.01°Cdp.

Any Questions? Contact us today!