TeDaC is proud to offer our growing number of clients a range of mapping and validation services. Furthermore, we understand that temperature control is one of the key components in maintaining product integrity and strive to offer a comprehensive service in order to meet the goal. Currently, our services cover the following primary categories; however, where there is a need to validate, map or monitor temperature and humidity, TeDaC can help you achieve that aim.
This is the prime area where temperature control is utilized; TeDaC have numerous clients, both large and small within this sector. Temperature and humidity mapping of premises and vehicles include, but are not limited to;
TeDaC have worked extensively with Acrobat Vehicle Rental, who are based in Newbury, and have carried out OQ and PQ validation (Operation and Performance Qualification) on their vehicles. Acrobat have a number of Short and Medium Wheel Base vehicle available for hire for both long and short term contracts. Single and dual compartment vans have been validated for both Cold Chain and Controlled Ambient delivery of pharmaceutical products. Vans come with the Transcan fixed monitoring system probes, that have UKAS traceable calibration certificates. The net result is transport solution that conforms to present GDP guidelines for pharmaceutical delivery.
The hospital and medical industry is another substantial sector which requires only the most accurate of temperature controls. The following facilities demonstrate some of the applications where temperature mapping can be carried out;
An important part of the commissioning of new items of equipment is the validation process. A robust validation will ensure that the equipment is fit for purpose and conforms to the User Requirement Specification. TeDaC can offer the following validation documentation, either as a standalone requirement or part of suite of work;
We also work within the life science industry and have undertaken work on the following installations;
Where there is a need for temperature and humidity monitoring, there will be a useful application for temperature and humidity mapping; other facilities include;
TeDaC work closely with SeerPharma UK, recognising each others’ respective expertise. SeerPharma UK are the leading provider of training for Pharmaceutical Distribution in the UK. As part of this collaboration, TeDaC currently delivers the Temperature Mapping segment on ‘The Role of the Responsible Person in Good Distribution Practice’ training course presented by SeerPharma UK. This is a 3 or 4 day course covering the competencies and learning outcomes required for a Responsible Person on a Wholesale Distribution Authorisation (WDA). The course aligns with the ‘Cogent Gold Standard’ framework and has been developed to meet the Medicines and Healthcare products Regulatory Agency (MHRA) requirements.
Consultancy for continuing compliance here – Consultancy – SeerPharma UK
The wide range of training offered through SeerPharma UK here Courses List — SeerPharma UK
Articles guiding you through some of the most difficult aspects of storage and distribution of pharmaceuticals here Articles – SeerPharma UK
Once the temperature mapping has been carried out, a fixed monitoring system would be required to provide ongoing, continuous monitoring of the storage areas providing text and or e-mail alerts for any excursions. TeDaC can also help with the provision of a wireless fixed monitoring system through our partner company JTF Wireless Ltd.
Where a medical laboratory has a requirement to meet the criteria of ISO15189; temperature mapping would be carried out using probes that meet the requirements of ISO17025. This is achieved by carrying out mapping activities with probes that have direct UKAS Calibration. TeDaC provide temperature mapping reports using temperature probes that meet the calibration requirements of ISO17025
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