A risk assessment needs to be conducted to determine the potential for an area, equipment or process to have an impact on product quality. After analysis, the identified components should undergo qualification. Our method is FMEA (Failure Mode Effects Analysis) in line with regulatory standards.
Considerations are but not limited to:
The opening door study is usually completed during the OQ and evaluates the impact of the external or ambient temperature on the temperature-controlled area. Testing should incorporate a means to assess the ability of the system to recover from the door open condition.
The testing is similar to that described under controls verification. However, under this part of the protocol, the system is subject to an actual hot/cool load. Acceptance criteria for the test requires that the system recovers to the required temperature range within the time as defined in the URS. The open door recovery test should normally be performed for or all temperature zones. The test must be completed when the chamber under test is equipped with the full set of data loggers as required during OQ testing.
Equipment failure compromises the integrity of the temperature-controlled area since heating or cooling stop being provided.
Testing is usually completed during the OQ and should incorporate means to assess the ability of the system to both respond and recover from the power failed condition. Testing is completed by isolating the power (and backup generator if installed) and recording the time after which the chamber is outside the required temperature or in fact how long it will take for temperature to deviate outside of the thresholds (i.e. +2°c to +8°c and +15°c to +25°c) when considering temperature controlled trailers with no generator facility as a backup.
Following failure the equipment functionality will be restored and the system restarted, analysing recovery to the required temperature range must be within a reasonable time, as defined in the protocol.
The test will be completed by isolating the normal power supply and recording the operation / performance of the backup system. The test will be completed when the unit under test is equipped with the full set of data loggers as required during OQ.
Temperature control equipment operating at low temperatures will have a defrost control built into the air handling unit. A test will be performed to understand what effect this change has on the air distribution and product integrity.
We know that extreme seasonal variations will have an impact on temperature profiling whether in transit or in storage. Door openings will expose controlled areas and studies will consider how the units/equipment/temperature area reacts to such instances.
Loading capacity and patterns should preferably reflect minimum/ low weight and maximum volume (e.g. empty cartons on pallets) however other/ real life loads are also acceptable Temperature Technologies will provide expert advice of possible loading scenarios based on normal operations.
Direct affect of AHU’s (Air Handling Equipment) to product in close proximity Heating influences (i.e. skylights, solar energy, charging points etc.)
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