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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 email
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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.
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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.
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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
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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 15oC to 25oC

RT Incubators 18oC to 23oC and 18oC to 25oC
Platelet Incubators 20oC to 22oC
QC Incubators 20oC to 25oC and 32oC to 38oC
Blood Fridges/
Cold Rooms 2oC to 6oC
Reagent Fridges 2oC to 8oC
Archive Freezers -20oC or below
-40oC Freezers -30oC or below
-80oC Freezers -70oC or below
Dometic Freezers to reach -30oC 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.
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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.
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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 email monthly to remind all departments to view the Mapping Calendar and
be aware of mappings in their department that month. See email 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
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. 20.0 oC

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 15-25oC
Hottest average 20.27oC, Coldest average 17.49oC

Work out the difference between the coldest average (17.49 oC) and the monitoring probe
average from above (20.0oC), the difference is 2.5oC
Work out the difference between the hottest average (20.27 oC) and the monitoring probe
average (20.0oC), the difference is 0.27oC

To explain; When the monitoring probe is reading 20.0oC, the coldest position will be
16.5oC so that when the monitoring probe is reading 15oC, the coldest spot is actually
12.5oC which is below the acceptable temperature range for that particular area. Whereas
when the monitoring probe is reading 25oC the hottest position is reading 20.27oC which
rounds to 25oC 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 15-25oC to 17.5 – 25oC
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 1.5oC, hottest average 1.8oC different from REES/Comark/Kelsius probe
so if the operating range is 2-6oC it would have to be set at 3.5-4.2oC.
POL:08:VP:003:03:NIBT
APPENDIX 2

Mapping Calendar Monthly reminder email

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