POL: 08:VP:003:03:NIBT PAGE : 1 of 7

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1 POL: 08:VP:003:03:NIBT PAGE : 1 of 7 Northern Ireland Blood Transfusion Service POLICY DOCUMENT Document Details Document Number: POL:08:VP:003:03:NIBT No. of Appendices: 2 Supersedes Number: 08:02:VP:003:NIBT Document Title: NIBTS TEMPERATURE AND RELATIVE HUMIDITY MAPPING POLICY ISSUE DATE: 13 AUGUST 2012 EFFECTIVE DATE: 10 SEPTEMBER 2012 Document Authorisation Written By: Eileen Taylor, Validation Officer Signature: Date: Authorised By: Angela Macauley, Regulatory Affairs & Compliance Manager Signature: Date: Authorised By: Dr K Morris, Chief Executive Officer Signature: Date: CROSS REFERENCES This Policy refers to the following documents: Doc Type Doc. No. Title POL LP:004 The NIBTS Policy for the Storage and Transportation of Blood Components SOP VL:015 Admin & Maintenance of Ellab Thermal Monitoring Equipment SOP VL:016 To run a session using Ellab TS Pro Probes SOP VL:017 Result retrieval and analysis using Ellab Probe Data SOP VL:018 Quick Guide to Using Ellab Probes SOP VL:020 NIBTS SharePoint Mapping Calendar SOP VL:021 To Edit the NIBTS SharePoint Mapping Calendar SOP VL:022 External Calibration, Maintenance and Repair SOP VL:023 Preparing A Mapping Report APP 1 How to interpret mapping results in relation to Continuous temperature monitoring probe results (referred to as monitoring probe ) APP 2 Mapping Calendar Monthly reminder

2 POL: 08:VP:003:03:NIBT PAGE: 2 of 7 Key Change from Previous Revision: Document in new format for NIBTS Policy documents. General changes. Addition of reference to section in mapping report document that requires justification of monitoring probe positions or change to temperature range used to offset from average hottest or coldest temperature positions found in mapping. 1 STATEMENT This document defines the policy for Temperature and Relative Humidity Mapping within NIBTS to ensure compliance with the Blood Safety & Quality Regulations (BSQR). The policy outlines the approach adopted by NIBTS to provide assurance that all storage areas are operating within the required temperature range and where applicable the specified range for humidity. Specifically NIBTS aim to ensure that:, The equipment used for storing blood and blood products is adequate to ensure the blood components remain within specified temperature limits during storage. The temperature within specified storage areas including Room Temperature Incubators is satisfactory, to ensure that critical items that are GMP sensitive remain within set temperature limits during storage. The Relative Humidity within specified storage areas is suitable to ensure that the blood pack labels remain within a specified relative humidity limit during long term storage. POL:LP:004 NIBTS Policy Storage and Transportation of Blood Components states the temperatures and conditions required for storage and transportation of blood components and how non-compliance is handled. In addition to regular mapping of those areas used for storage NIBTS use continuous temperature monitoring systems to ensure continued compliance with specified temperature ranges. The location of these continuous temperature monitoring points will be agreed during the mapping process to ensure consideration of hot and cold spots. 2 OVERVIEW 2.1 The Blood Safety and Quality Regulations 2005 and Amendments to these, the EU GMP Guidelines and the Guidelines for the BTS in the UK (Red Book) 7th Ed. 2005, advise on the conditions for storage and transport of blood components and on temperature mapping and monitoring. Recommendations on Good Practice compliant with regulatory requirements are available from the MHRA.

3 POL: 08:VP:003:03:NIBT PAGE: 3 of 7 Temperature mapping is considered to be the documented verification of the temperature found throughout the area (and duration of storage) to ascertain whether it is uniform with no localised hot or cold spots. The temperature mapping process is also to ensure the on-going monitoring position(s) represent the performance of the unit. 3 RESPONSIBILITY 3.1 Mapping within the NIBTS will be performed by the Validation Officer and RA&C Compliance Officers as required. However, the main responsibility to ensure that mapping is carried out rests with the manager of the relevant area (Equipment Owner).or in their absence, their deputy. The NIBTS Validation Officer has the responsibility for ensuring that standardised procedures are in place and for providing advice and guidance on the mapping reports where required. The Regulatory Affairs & Compliance Department has a role to facilitate this process and to review and approve the following documentation generated during the process Mapping Reports Change Control requests All mapping documentation must be archived carefully for future reference and regulatory inspection. This is the responsibility of Department Managers or in their absence, their deputy. Responsibility for scheduling remapping of that equipment/area on the mapping lists lies with NIBTS Department Managers or in their absence, deputies. Only trained and competent personnel are expected to carry out mapping studies and this training should be reflected in their training records. Each mapping procedure will be formally approved prior to use. NIBTS will undertake an approach to mapping which complies with the current regulatory requirements and industry guidance. 4 POLICY All equipment storing blood components and specified storage areas which control temperature and store GMP critical items will be temperature mapped when new in the empty and full state and thereafter under operational conditions, usually annually for equipment with summer and winter mappings for stores areas. Remapping will be carried out after significant repair or alteration.

4 POL: 08:VP:003:03:NIBT PAGE: 4 of 7 Empty and full is used to establish the worst case mapping results and the fill level during use should not exceed this level without performing a new mapping. When necessary to map a new area in the full state, NIBTS will load the area with other materials to simulate the presence and thermal characteristics of blood components, for example using bags of saline. Where it is clearly impractical to simulate in the "full" state, the equipment owner must complete a risk assessment on the exclusion of a "full state" mapping before routine use. It must be noted NIBTS do not permit the storage of blood components in unvalidated areas and that decisions on mapping will be risk assessed and science based. NIBTS General Store, Omagh store and any other location identified as necessary will be temperature mapped twice a year, summer and winter for a minimum of 1 week s duration with a sampling time of no more than 15 minutes. The NIBTS General Store mappings will include Relative Humidity in the area where blood pack labels are stored. The Dometic freezers in the Process Laboratory are temperature mapped annually using the Single Flexible Teflon Sensors over the duration of a run with a sample time of one minute. Other mappings will usually be annual and have a duration of 24 hours with a sample time of no more than 5 minutes and will, for the smallest of storage equipment, include a minimum of 3 points which will normally be at least the centre chamber, top and bottom. The number of probes will be sufficient to comprehensively cover the area being mapped. In the case of large equipment, it is expected that mapping locations will normally be at least the centre chamber, and the 4 corners top and bottom of the parts of the cabinet used for storage. Mapping exercises will include correlation between the routine probe readings and the mapping probes. Where a correlation is not possible a comparison will be made. Areas being routinely remapped can be used during the mapping period. Times and duration when doors are opened during the test will be documented where appropriate. The amount of product in the cabinet during the test will be recorded with the test results. Minimum mapping probe calibration tolerance is ± 0.5 C of a National Standard. Mapping equipment is calibrated by the supplier annually and after repair. Any changes to the equipment/area that is temperature mapped will be documented through the NIBTS Change Control process during which the need for re-mapping will be assessed and documented. Mapping will be carried out within 2 weeks of its due date as recorded in the SharePoint Mapping Calendar on the NIBTS Intranet. Date creep is not permitted and mappings are recorded as due on the same date year on year. In the event a mapping

5 POL: 08:VP:003:03:NIBT PAGE: 5 of 7 has not been performed within 2 weeks of date due an incident is to be raised with the exception of situations where the fridge is not in operational use at the time. Where an area needs repair or settings changes a mapping of routine fill level is used. 4.1 ACCEPTANCE CRITERIA FOR TEMPERATURE MAPPING Stores RT Incubators Platelet Incubators QC Incubators Blood Fridges/ Cold Rooms Reagent Fridges Archive Freezers 15 o C to 25 o C 18 o C to 23 o C and 18 o C to 25 o C 20 o C to 22 o C 20 o C to 25 o C and 32 o C to 38 o C 2 o C to 6 o C 2 o C to 8 o C -20 o C or below -40 o C Freezers -30 o C or below -80 o C Freezers -70 o C or below Dometic Freezers to reach -30 o C or below within 60 minutes Component Processing Labs as specified by Hospital Services Manager 4.2 ACCEPTANCE CRITERIA FOR RH MAPPING Blood Pack label storage 30% to 70% 4.3 APPROVED USERS Only those individuals authorised by the Regulatory Affairs & Compliance Manager to use the Ellab equipment may do so. 4.4 SENSOR CALIBRATION AND LOGGER MAINTENANCE Equipment used for mapping will be calibrated annually. Calibration Certificates will be maintained and be available for inspection. Ellab loggers will be serviced annually. 4.5 SENSOR SELECTION Equipment for mapping will be selected as appropriate for the area being mapped. Ellab Single rigid temperature sensors used to temperature map any area that has been identified as requiring temperature mapping with the exception of the Dometic Freezers in the Components Laboratory.

6 POL: 08:VP:003:03:NIBT PAGE: 6 of 7 The Ellab Single Flexible Teflon Sensors used in the Dometic Freezers. Ellab Dual Temperature / Relative Humidity Sensors (±2%) are used to measure relative humidity in specific Store areas. Various procedures are available to detail the operation of the temperature monitoring equipment and software and are listed in the cross reference section at the beginning of this policy. Comark EV Diligence Calibrated Data loggers are available for use in temperature mapping if required however their use must be approved by the RA&C Manager. For instructions for use of Comark loggers refer to SOP:ST:010 Use of Comark N2011 Loggers. 4.6 MAPPING DOCUMENTATION The results for mapping will be documented in a Mapping Report FORM:DD:1193. as detailed in SOP VL:023 Preparing a Mapping Report. The report will require the user department prior to approval for the mapping, to comment, sign and date the following sections, Section 3 detailing the acceptability of the mapping results. Section 4 where there are deviations from the acceptance criteria to record deviation outcomes and actions where relevant. If there are no deviations write none and date and sign to acknowledge. Section 5 the Head of Department or deputy will confirm the position of the continuous temperature monitoring probe is appropriate for the current mapping. This justification is to include the rationale for the probe positioning with consideration to the hottest and coldest positions, the nature of the GMP product stored and its requirements with reference to any restrictions on probe positioning.. Where probe positioning cannot meet the requirements for continuous temperature monitoring consideration should be given to alteration of the the temperature range for the continuous temperature monitoring probe to take into account the offset from this probe and the max or min mapping temperature position as appropriate. Guidance on probe positioning and determining temperature ranges is provided in Appendix 1. Individuals who carried out the mapping, wrote the Mapping Report and checked it will sign and date Section 6 Mapping Approval will be indicated by completion of Section 7 of the report which is completed and approved by the user department and then passed to the Validation Officer to be approved and finally by the Regulatory Affairs & Compliance Manager or Quality Manager as deputy.

7 POL: 08:VP:003:03:NIBT PAGE: 7 of 7 Hard copies of the signed mapping report will be retained by equipment owners. Q Pulse will be used to as an electronic repository for scanned signed copies of the mapping report. Approval of the scanned copy on Q Pulse is required. 4.7 MAPPING CALENDAR Mapping schedule will be recorded as an electronic SharePoint calendar as found on the NIBTS Home page as Mapping Calendar. This may be printed out as required. Access to edit the calendar will be restricted to the Validation Officer and RA& C Compliance Officer with other users provided with read only access. The SOP s for use of the Mapping Calendar are listed in the cross reference section of this document. The Validation Officer or in their absence the Compliance Officer will send out an monthly to remind all departments to view the Mapping Calendar and be aware of mappings in their department that month. See in Appendix 2 5 EQUALITY SCREENING OUTCOME This policy has been drawn up and reviewed in light of the statutory obligations contained within Section 75 of the Northern Ireland Act (1998). In line with the statutory duty of equality this policy has been screened against particular criteria. If at any stage of the life of the policy there are any issues within the policy which are perceived by any party as creating adverse impacts on any of the groups under Section 75 that party should bring these to the attention of the Head of HR & Corporate Services 6 TRAINING REQUIREMENTS All staff with responsibility for ensuring maintenance of areas used for storage of temperature dependant goods must read and understand this policy. This will include: Validation Officer, RA&C Compliance Officers RA&C Manager, Quality Manager, Laboratory Manager, Donor Service General Manager, HR & Corporate Services Manager, Chief Executive, Medical Director Laboratory Heads of Department and Deputies Facilities Manager, Stores Supervisor, Stores Assistant Senior Nurse Unit Leaders, Donor Recruitment & Organisation Manager, Specialty Doctor Apheresis

8 POL:08:VP:003:03:NIBT APPENDIX 1 How to interpret mapping results in relation to Continuous temperature monitoring probe results (referred to as monitoring probe ) Regardless of the device used, Ellab, REES, Comark, Kelsius, the interpretation is the same Note the average for the monitoring probe for the period of the mapping, e.g o C From the mapping results raw data note any deviations and how long they were out of spec, was it for 5 mins on a couple of occasions, or for 12hours, was it in one position or several positions, was there a reason in the event log for the out of spec results, look at the statistics in the report and decide if they represent the usual actual temperature in each position if you think they don t then note down your thoughts for discussion. In the mapping statistics look at the average for each position. Note the hottest average and the coldest average; Example using an acceptance range of o C Hottest average o C, Coldest average o C Work out the difference between the coldest average (17.49 o C) and the monitoring probe average from above (20.0 o C), the difference is 2.5 o C Work out the difference between the hottest average (20.27 o C) and the monitoring probe average (20.0 o C), the difference is 0.27 o C To explain; When the monitoring probe is reading 20.0 o C, the coldest position will be 16.5 o C so that when the monitoring probe is reading 15 o C, the coldest spot is actually 12.5 o C which is below the acceptable temperature range for that particular area. Whereas when the monitoring probe is reading 25 o C the hottest position is reading o C which rounds to 25 o C and is not a concern. So now there are 2 courses of action you can take, you can move the monitoring probe or you can change the range of the monitoring probe. In this example the Comark logger can be moved to the coldest position or the operating temperature range in the area can be changed from the current o C to o C which takes the mapping results into consideration. Had the hottest average been sufficiently different from the monitoring probe then the upper level of the operating temperature would have to have been lowered to take the offset from the hottest average off the upper temperature range. Examples Coldest average 1.5 o C, hottest average 1.8 o C different from REES/Comark/Kelsius probe so if the operating range is 2-6 o C it would have to be set at o C.

9 POL:08:VP:003:03:NIBT APPENDIX 2 Mapping Calendar Monthly reminder Information Storage areas and equipment holding GMP critical items for NIBTS are required to be Temperature/RH mapped either annually, or summer and winter or as required according to regulatory and maintenance requirements. These mappings must be repeated within 2 weeks of the annual date of mapping. It is essential that there is no use creep and that the date of mapping remains the same year on year. To help maintain accurate records of the mappings required each month, they have been recorded electronically on a SharePoint Calendar. A SharePoint Calendar allows events to be added with recurrences so mappings will appear on that date each year or as required. Please, 1. Check the Mapping Calendar on the NIBTS Intranet for the month ahead. 2. Note the mappings on the calendar to be done for your department. If you wish you can print the calendar for that month or print a list of mappings and dates. SOP:VL:020 SharePoint Mapping Calendar, explains how to do this. 3. Notify the Validation Officer, in the first instance, if there are any reasons why a listed mapping should not be done, or if the date needs to be altered such as, if disposed of, not in use, under repair, adjustments are planned, or maintenance is due, so that the mapping date can be altered accordingly to prevent a remap being necessary. If the Validation Officer is not available within the time required, please contact the RA & C Manager, Angela Macauley. 4. Please contact the Validation Officer if further training on how to use the Mapping Calendar is required. We will continue to carry out temperature mappings according to the Mapping Calendar until advised otherwise. Eileen Taylor Validation Officer ext 4564