Chemicals, compounds and raw materials used in the manufacture of pharmaceutical products must be stored under conditions that ensure their quality and effectiveness are maintained. Manufacturers’ recommendations concerning storage temperatures should be observed and, in doing so, this may involve the use of specialised storage facilities.
Do you know what is actually going on inside your storage facility? Probably not. Temperatures and humidity can vary by tens of degrees particularly in large installations; pockets of inactive air coupled with ineffective air management can give rise to localised hot spots, creating an imbalance of tolerance. If undetected, the outcome could be devastating with items stored in such areas ruined, resulting in considerable financial loss. Small storage areas are equally vulnerable, where even the ingress and movement of staff can cause temperature and humidity issues.
In order to avoid such catastrophes, monitoring with the right apparatus is paramount. Hanwell has a range of such equipment suitable for most monitoring requirements: the Hanwell RadioLog system.
Comprising small, self-contained, wireless telemetry units, a system can be commissioned promptly and used effectively to monitor and demonstrate compliance with the supplier designated storage temperature ranges. Being wireless, cables are obviously negated, however, we can supply compatible 'wired' units.
All units, wired or wireless, are calibrated to traceable national standards. Our validated software complies with FDA 21 CRF part 11 certification for controlled access and archival storage and reporting is a standard feature with bespoke options available.
Good warehousing and distribution practices require that storage areas for medicines should be maintained within acceptable temperature limits and, where special storage conditions are specified by the manufacturer, these should be provided, checked and monitored. Further, Hanwell's Radiolog Software calculates MKT (Mean Kinetic Temperature) which is a calculated, fixed temperature that simulates the effects of temperature variations over a period of time. It expresses the cumulative thermal stress experienced by a product at varying temperatures during storage and distribution.
To ensure compliance with required conditions, temperature monitoring must be performed and documented in order to ensure that the appropriate conditions are maintained - a practice that should be reviewed and approved on a regular basis.
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