SALIENT_CHARACTERISTIC_STATEMENT_OF_WORK.docx

SPECIFICATION SHEET NO. 1

TEMPERATURE MONITORING DEVICE

1. SCOPE

1.1 This Specification Sheet covers the requirements for various types and sizes of wireless cloud-based remote temperature monitoring systems/devices that must meet specific guidelines that are published by other entities such as Centers for Disease Control (CDC), Food and Drug Administration (FDA), AABB (formerly known as the American Association of Blood Banks), American Association of Tissue Banks (AATB), product manufacturers, etc. addressing proper vaccine and other TSMP storage and handling requirements.

1.2 Intended use. The cloud-based temperature monitoring systems/devices shall be suitable for use in medical and scientific facilities and is completely scalable from a single fridge to a fully integrated multi-fixture system across multiple sites - all visible from one web user interface. The interface must be simple to use with minimal training and by using web-based technology, data and records are securely accessible 24/7 anywhere in the world on any device able to support a web-browser. Must be able to monitor a minimum of 150-300 points.

2. CLASSIFICATION

2.1 Remote temperature monitoring systems/devices covered by this document shall be suitable for use in medical and scientific facilities requiring compliance with controlled room temperature/humidity, pressure differential, incubators, and refrigerated or frozen temperature requirements for Vaccines, blood products, tissue products, temperature sensitive reagents and other temperature sensitive items that are collectively referred to as Temperature Sensitive Medical Products (TSMP).

2.2 Related activities in order that this guidance can be fully applied, the following steps also have to be completed:

2.2.1 Identify the storage areas and equipment which will be used for storing TSMP and their relevant temperature regimes – ambient, controlled ambient, refrigerated and frozen.

2.2.2 Map these storage areas and equipment and determine hot and cold points.

2.2.3 Ensure that all storage areas and equipment complies with applicable regulations and guidelines on the storage of TSMP before these products are used.

3. SALIENT CHARACTERISTICS

3.1 Specific requirements for wireless networks.

3.1.1 Wireless sensor networks shall have the following technical characteristics:

3.1.10 Also for a wireless system, the sensor-reader subsystem shall also be evaluated in terms of transmission capability, efficacy (e.g. ability to transmit through walls or doors) and power consumption. In a complex or extended monitoring scenario, wireless configurations shall be tested to avoid dead zones or wireless transmission concerns.

3.2 Web-based systems.

3.2.1 Web-based systems shall be user-friendly, even if they are required to perform complex operations. This minimizes training requirements, reduces the time taken to deploy the system and enables the user organization to obtain maximum performance.

3.2.2 Monitoring system shall operate over existing cellular network and shall provide the ability to manage multiple users, buildings and sites.

3.2.3 Web-based systems generally emphasize ease of use, with system dashboards enabling the user to trace operations and activities, to see and follow-up all alarms, and to compile data into preformatted reports. Web-based systems also allow the data to be stored in the internet ‘cloud’ rather than at a specific facility. Authorized users have access to an online database via secure access arrangements. When systems of this type are adopted they shall be subject to system validation/qualification before any use.

3.2.4 Monitoring solutions shall incorporate a complete management system that includes the following features:

3.3 Alarm system.

3.3.1 The monitoring system shall include an integrated alarm function that reports out-of-range events. Alarms shall be managed automatically. Alarm limits shall only be set by authorized users and shall automatically alert responsible staff via email, SMS text message or other communication medium in case of out-of-range events or incidents.

3.3.2 Available equipment includes combinations of audible and visual alarms and electronic messaging systems; the latter allow authorized users to be alerted via e-mail, phone or text (SMS) message. A fully integrated system shall allow the user to set an alarm schedule for different alert levels – for example work days, weekends and holidays.

3.4 User controls.

3.4.1 Data needs to be recorded accurately and in real-time, and shall be provided in the form of reports, charts, and graphs, which users are able to customize.

3.4.2 The system shall allow all sensor and alarm parameters to be configured and customized by users. For instance, it shall be possible to configure the sensor recording (sampling) rate or set a variety of parameters for the alarm settings. These could include:

3.4.2.4 Reports shall be customizable by users: format (text, pdf, graph…), time period and content (high and low temperature events, MKT analysis).

3.5 Adaptability and expandability.

3.5.1 Unless the user requirement is very simple, it is wise to choose an adaptable and scalable system. A fully flexible system shall support the following features:

3.5.1.1 Ease of configuration for small-scale or large-scale facilities;

3.6 Security and compliance.

3.6.1 There are specific security and compliance requirements which apply to monitoring systems and they shall be installed and managed in accordance with relevant standards and regulations such as 21CFR part 11, and GAMP. Specifically:

3.7 Maintenance and support.

3.7.1 Monitoring systems are a crucial to compliance with industry regulations and any system failures have to be resolved as rapidly as possible. Whether the system is organizational or contractor, this means that a 24/7 technical support plan shall be part of the contract package. This package shall include a requirement for the installer or service provider to cover maintenance, support and warranties for both hardware and software. The support period and the renewal arrangements need to be defined in the statement of work.

3.8 System extent.

3.8.1 A comprehensive monitoring system for Temperature Sensitive Medical Products (TSMP) shall be designed to record temperature and relative humidity for all storage areas where these products are stored or temporarily held. The system shall extend to include the following areas:

3.9 Number of monitoring points.

3.9.1 For ambient warehousing, controlled ambient stores, preparation rooms, temporary holding areas, freezer rooms, cold rooms and other spaces that people can physically enter, the number of monitoring points depends on the size of the space and on the diurnal and seasonal temperature variations observed during the mapping studies. This may change from one facility to another. Refer to Technical Supplement: Temperature mapping of storage areas.

3.9.2 For small-scale reach-in equipment such as refrigerators and freezers, a minimum of one monitoring point or monitoring device shall be installed in the storage chamber. Note: some national regulatory agencies require two sensors: one positioned at the coolest point and one positioned at the warmest point. The correct locations may be determined by on-site temperature mapping, or they may be determined during laboratory testing at the design qualification (DQ) stage.

3.10 Location of monitoring points.

3.10.1 As previously noted, monitoring points shall be located in all places where TSMP are stored or handled. The correct locations are established as follows:

3.10.1.1 Ambient and controlled ambient storage areas: Position sensors in the places where seasonal hot and cold spots have been observed during the mapping studies.

3.10.1.3.1 Monitoring points shall NOT be placed in areas where transient events such as a door opening may affect the monitoring and generate an abnormally high number of alarms. If such transient events generate out-of-range temperatures alarms too frequently and the problem cannot be resolved technically or operationally (e.g. by limiting the number of door opening events), these areas shall not be used to store TSMP and shall not be monitored.

3.11 Complimentary services.

3.11.1 Implementing an effective and reliable monitoring system is a complex task; its installation, operation and maintenance involves a number of complimentary linked services. The scopes of these complimentary services need to be clearly defined in terms of:

Post award site walk required to validate requirement.