Provision of Validation Probes and Associated Software

Descriptions

Public Health England (PHE) requires the provision of validation probes and associated software for use in its National Infection Service (NIS) GxP test facility. Due to the nature of the work, the equipment must be able to fulfil the following requirements:-The proposed solution must have a minimum temperature measurement range of -196C to 85C.-The proposed solution must have an accuracy of +/- 0.1C.-The proposed solution must have a minimum logger timing accuracy of +/- 5 seconds per 24 hours.-The proposed solution requires the following sensor tip types:- A rigid type up to ø2mm 35mm long.- A Semi flexible type ø1.5mm and 30cm to 50cm long.- A Smart flexible type ø1.8mm and 30cm to 50cm long.-The proposed solution must have a minimum sample rate of 1 second.-The proposed solution must ensure that the loggers can be easily programmed via a 'reader station' that connects to a PC via USB. The 'reader station' must capable of reading up to 160 loggers in one study.-The proposed solution must contain loggers that can log up to 60,000 data points.-Any data collection and reports software packages included as part of the proposed solution must be compatible with Windows 10, 64-Bit.-The proposed solution must contain loggers that are made from AISI 316L stainless steel to ensure easy decontamination.-The proposed solution must be able to operate in environments ranging from -80C to 85C.-The proposed solution must be compatible with common cleaning agents used in ACDP2 laboratories such as 70% IPA and weak hypochlorite solutions.-The loggers' software offered as part of the proposed solution must be fully validated and compliant with FDA 21 CFR, part 11.-The proposed solution must be CE marked.Suppliers proposing a solution which can meet the above requirements must be approved via the supplier GxP approval system (TFQA/001). Validation plans and protocols must include the appropriate tests, procedures and programmes. These must be in place for each validation or qualification exercise and must be pre-approved by PHE in writing. If you feel that you have a solution which can meet the requirements outlined above, please contact Anna Gibson anna.gibson@phe.gov.uk and Kallie Rivers kallie.rivers@phe.gov.uk with details of your proposed solution/ to access the tender documents through: https://phe.bravosolution.co.uk, by no later than 31st January 2018.