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,
- Freeze dryers,
- Cold rooms,
- Hot rooms,
- 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 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.
|Working Volume||17 litres||Can the full volume of then chamber be used during calibrations? Test the thermal gradients via a heat mapping of the HG2-XL loaded|
|Humidity changes 5…95%rh (±0.1%rh stability)||less than 15 minutes||In order to define the calibration procedure, the time for a relative humidity change must be taken into account. Test the relative humidity time change for the required set points.|
|Temperature changes 23…50°C (±0.1°C stability)||less than 15 minutes||In order to define the calibration procedure, the time for a temperature change must be taken into account. Test the temperature time change for the required set points.|
|Thermal gradients 15…50°C||less than ±0.05°C||The thermal gradients will be tested during the chamber mapping|
|Thermal gradients 15…60°C||less than ±0.1°C||The thermal gradients will be tested during the chamber mapping|
|Thermal gradients 15…60°C||less than ±0.15°C||The thermal gradients will be tested during the chamber mapping|
Based upon how the chamber is used, various other tests can be implemented during the qualification phase:
- Test the recovery time.
- Test the long-term stability.
- Test the chamber performance with varying laboratory temperatures.
Should the relative humidity also require qualification, then two options are available:
- 1. Measure the relative humidity at each temperature measurement point.
- 2. Measure the dew point at one point only.
Why measure dew point? The National Standards Authority of Ireland NSAI is Ireland’s official standards body and have created a document called: Determining the uncertainties associated with Mapping. This paper was created to accompany the ISPE Good Practice Guide: Controlled Temperature Chamber Mapping and Monitoring and offers recommendation to ensure the accuracy of the mapping process. As the dew point mirror measurement is more precise than the relative humidity measurement, using a dew point mirror can help reduce the uncertainty budgets and ensure the perfect mapping.
Rotronic used the RMS-OQ-L-SET that contains the following hardware:
- 10*T30-00010 (Pt100 Class B (1 / 10Din), 4-wire, DIN EN 60751).
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.
Based upon the ISPE Good Practice Guide: Controlled Chamber Mapping and Monitoring, the chamber mapping was setup as follows:
|Logger Serial||Input Number||Location|
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.
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).
Rotronic can help monitor various parameters during the qualification phase:
- Dew point temperature,
- Mean kinetic temperature,
- Relative humidity,
- Carbon dioxide,
- Set points,
- Door 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.
RMS-LOG-L-D – Data logger with displayThe RMS-LOG-L-D stores up to 44,000 pairs of measured values from the interchangeable CO2, differential pressure, humidity, temperature or low dew point probe, and transmits them to the RMS database via LAN link. Learn More
RMS-HCD-S - Humidity and Temperature Probe
The HCD-S is a completely digital probe designed for the Rotronic Monitoring System RMS. It measures humidity and temperature and calculates the dew/frost point.Learn More
Michell SF82 Dew-Point Transmitter for Compressed Air
Simple to install and maintain, the SF82 transmitter series measures dew point and moisture content and is available with a range of industry standard process connections and electrical connectors.Learn More
MICHELL Easidew Dew-Point Transmitter for Compressed Air
Simple to install and maintain, the Easidew sensor is a moisture meter measuring dew point and moisture content and is available with a range of process connections and electrical connectors.Learn More
RMS-MADC-915-A - Wireless Mini Data Logger - Current input (0...20mA)
RMS-MADC-868-A - Wireless Mini Data Logger - Current input (0...20mA)
RMS-MADC-868-V - Wireless Mini Data Logger - Voltage input (0...10V)
The T30 temperature sensors are resistance thermometers (Pt100 = positive measurement resistance), meaning that the resistance increases with increasing temperature. The sensors are compatible with the RMSLOG- T30-L, RMS-LOG-T30-868 and RMS-LOG-T30-915 data loggers.Learn More
RMS-LOG-T30-L - Data Logger
The RMS-LOG-T30 is a data logger with two integrated analog-to-digital converters, to which two PT100 sensors can be connected for high-precision temperature measurement.Learn More