Environmental Storage and Process Equipment Qualification

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.

Specifications	Details	Qualification Questions
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.
Test...
Test...

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:

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:

Logger Serial	Input Number	Location
80100171	2	1
	1	2
80100173	2	3
	1	4
80100174	2	5
	1	6
80100175	2	7
	1	8
80100176	2	9
	1	10 (External)

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