HTM 08-06 Pathology Labortory Gas Systems
HTM 08-06 Pathology Labortory Gas Systems
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ISBN 978-0-11-322781-5
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Description This document covers piped gas systems for pathology laboratory
installations in NHS premises . It deals specifically with the design,
installation, validation and verification (testing and commissioning)
of these systems.
ii
Preface
About Health Technical Memoranda main source of specific healthcare-related guidance for
estates and facilities professionals.
Engineering Health Technical Memoranda (HTMs)
give comprehensive advice and guidance on the design, The core suite of nine subject areas provides access to
installation and operation of specialised building and guidance which:
engineering technology used in the delivery of healthcare. • is more streamlined and accessible;
The focus of Health Technical Memorandum guidance • encapsulates the latest standards and best practice in
remains on healthcare-specific elements of standards, healthcare engineering;
policies and up-to-date established best practice. They are
applicable to new and existing sites, and are for use at • provides a structured reference for healthcare
various stages during the whole building lifecycle. engineering.
DISPOSAL CONCEPT
RE-USE
DESIGN & IDENTIFY
OPERATIONAL OPERATIONAL
MANAGEMENT REQUIREMENTS
Ongoing SPECIFICATIONS
MAINTENANCE TECHNICAL & OUTPUT
Review
PROCUREMENT
COMMISSIONING
CONSTRUCTION
INSTALLATION
Healthcare providers have a duty of care to ensure that Structure of the Health Technical
appropriate engineering governance arrangements are in Memorandum suite
place and are managed effectively. The Engineering
Health Technical Memorandum series provides best The series of engineering-specific guidance contains a
practice engineering standards and policy to enable suite of nine core subjects:
management of this duty of care. Health Technical Memorandum 00
It is not the intention within this suite of documents to Policies and principles (applicable to all Health
unnecessarily repeat international or European standards, Technical Memoranda in this series)
industry standards or UK Government legislation. Where Health Technical Memorandum 01
appropriate, these will be referenced. Decontamination
Healthcare-specific technical engineering guidance is a Health Technical Memorandum 02
vital tool in the safe and efficient operation of healthcare Medical gases
facilities. Health Technical Memorandum guidance is the
iii
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
Health Technical Memorandum 03 Electrical Services – Electrical safety guidance for low
Heating and ventilation systems voltage systems
Health Technical Memorandum 04 In a similar way Health Technical Memorandum 07-02
Water systems will simply represent:
Health Technical Memorandum 05 Environment and Sustainability – EnCO2de.
Fire safety
All Health Technical Memoranda are supported by the
Health Technical Memorandum 06 initial document Health Technical Memorandum 00
Electrical services which embraces the management and operational policies
from previous documents and explores risk management
Health Technical Memorandum 07
issues.
Environment and sustainability
Some variation in style and structure is reflected by the
Health Technical Memorandum 08
topic and approach of the different review working
Specialist services
groups.
Some subject areas may be further developed into topics
DH Estates and Facilities Division wishes to acknowledge
shown as -01, -02 etc and further referenced into Parts A,
the contribution made by professional bodies,
B etc.
engineering consultants, healthcare specialists and
Example: Health Technical Memorandum 06-02 Part A NHS staff who have contributed to the review.
will represent:
S T R Y S TA N D A
DU RD
IN S
& EUROPEAN
NAL ST
HTM 07
IO HTM 02
T
AN
NA
INTER
CUMENTS
Sustainability Gases
RDS
HTM 00
RDS
INTER
Policies and
Principles
DA
NA
AN
IO
ST
T
NA
DO
IC
Y S TA N D Systems
IF
C
EC
D
HTM 05 HTM 04
O
Fire
SP
U Water
C
M Safety Systems H
EN T
TS AL
HE
iv
Executive summary
Introduction Recommendations
Pathology services provide a diagnostic service for
General
clinicians and their patients. They offer high-quality,
timely analysis of specimens to assist in clinical All pathology pressure gases should be piped, but small
diagnosis, preventative medicine (for example screening quantities may be supplied from portable cylinders,
programmes), research and epidemiological studies. connected to specific equipment. Appropriate fire and
safety requirements must be met if cylinders are to be
Pathology laboratory gas systems (PLGSs) are installed
used in this way.
to support these activities by providing a distribution
medium for gases. Laboratory gas cylinders should be stored in a ventilated,
secure external enclosure, similar to, but separated from,
The general provisions of Health Technical
the medical gas storage area.
Memorandum 02-01 – ‘Medical gas pipeline systems’
and the British Compressed Gases Association’s (BCGA) Manifolds and plant should be sited in dedicated plant
Code of Practice 4 (CP4) – ‘Industrial gas cylinder and manifold rooms, generally constructed to the
manifolds & distribution pipework/pipelines (excluding requirements in Chapter 14 of Health Technical
acetylene)’ apply to PLGSs, but certain gases will require Memorandum 02-01 (Part A).
additional safety measures as a result of their toxicity,
flammability etc. Design
When designing PLGSs it is important to allow for
Aim of the guidance repair, maintenance, inspection and extension with
The document aims to provide best practice guidance minimal disruption to the building user.
on the design, installation and testing of pathology Systems should be as simple as possible, with adequate,
laboratory gas systems. It can be applied to fixed gas safe, easy access provided to all parts of the installation.
pipeline systems, discrete plant, compressed gas cylinders
and gas generators in a laboratory environment. Analytical equipment technology and procedures are
continually changing, and consideration should be given
It also aims to improve system management by the to the need to allow for growth and change, irrespective
introduction of defined planned maintenance tasks and a of the scale of work and scientific disciplines involved.
dedicated permit-to-work scheme.
The PLGSs should be readily accessible to modification
and extension. However, plugged-tee outlets (for future
Who should use this guidance change of use frequently fitted to early systems) should
The document is intended to be used by system not be provided.
specifiers, designers, installers, testers, maintainers,
The recommended provision is for service outlets in a
analytical equipment suppliers, laboratory managers and/
regular grid or pattern with service runs in floor ducts,
or their deputies, engineers and quality controllers who
above the ceiling or in vertical ducts, so that any work
have a responsibility for pathology gas systems.
position is able to make use of the full range of services
It will also be of use to those Authorising Engineers provided.
(MGPS), Authorised Persons (MGPS) and Competent
Persons (MGPS) who have to take on responsibility for Pipeline systems
these systems. The greatest possible care should be taken in construction
of the pipeline systems, for both general and local bench
services. Installation, testing and maintenance should
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
vi
Acknowledgements
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
Contents
Preface
Executive summary
Acknowledgements
Chapter 1 Pathology department functions 1
General
Haematology
Clinical biochemistry
Hospital bacteriology
Hospital virology
Histopathology
Cytopathology
Support laboratories
Cryopreservation room
Immunoassay laboratory
Chromatography laboratory
Cell culture room
Mass spectrometer laboratory
Polymerase chain reaction room
Electrophoresis room
Flow cytometry room
Electron microscopy facilities
Blood grouping and cross-matching
Chapter 2 Safety aspects of PLGS work 5
Hazards
Physical hazards
Infection hazards
Chemical and gaseous hazards
Electrical hazards
Radiation hazards
Gas-leak detection systems
Chapter 3 System design 7
Termination (outlet) points
Allocation of termination points
Equipment workshop
Flow rates and pressures
Pipe sizing
Plant sizing
Chapter 4 Provision of plant and manifolds 10
General
Space required for plant and distribution systems
Flexibility of design
Plant and manifold accommodation – specific requirements
Chapter 5 Manifold systems 12
Chapter 6 Compressed air systems 16
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Contents
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
1 Pathology department functions
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
and nitrogen are used to provide controlled via a piped liquid nitrogen system from an external
atmospheres for the growth of sample cultures. large-capacity tank.
1.17 Some units use freeze-drying equipment, requiring
Hospital virology a dedicated high vacuum source.
1.11 This is concerned with the diagnosis of viral
diseases. While the majority of specimens will Immunoassay laboratory
undergo serological testing (see paragraph 1.9), 1.18 Certain immunoassay tests for haematology and
virus isolation in cell cultures forms an important clinical biochemistry can be carried out in the same
and specialist part of the work. Cell culture work room. They may use low-level radioisotopes and/or
will take place elsewhere. flammable solvents, in which case special facilities
1.12 Inoculated media must be incubated under highly will be required.
controlled temperature and atmospheric conditions 1.19 Immunoassay involves the analysis of body fluids
(for example aerobically in air or oxygen, or to monitor hormone imbalances (associated with
anaerobically in carbon dioxide atmospheres to thyroid and reproductive functions) and cancer and
obtain growth of organisms). other tumour markers. Other applications include
screening for drugs of abuse and infectious diseases.
Histopathology 1.20 Vacuum is employed generally in separation of
1.13 This is the morphological study of cells arranged in compounds, usually by filtration. Specially
tissues that have been removed from the human constructed vacuum pumps (for example
body. containing Teflon-coated internal parts) maintain
performance while evacuating highly corrosive
Cytopathology chemicals. In some instances, vacuum is generated
by the use of water-driven ejector units.
1.14 This is the morphological study of dissociated cells.
Cytopathology involves collecting cells by scraping Chromatography laboratory
the surface of an organ, from a secretion or
excretion, or by needle aspiration from an organ or 1.21 Chromatography is a way of separating molecules
body cavity. It comprises two main areas: based on differences in their structure and/or
composition. It involves moving a preparation
a. gynaecological cytopathology, which screens of the materials to be separated – the “test
cells from the female genital tract (for example preparation” – over a stationary support.
cervical smears);
1.22 Test molecules that display tighter interactions with
b. non-gynaecological cytopathology, which the support will tend to move more slowly through
examines cells from other sites in the body for the support than those molecules with weaker
the diagnosis of malignancy, infectious or interactions. In this way, different types of molecule
inflammatory diseases. can be separated from each other as they move over
the support material.
Support laboratories
1.23 Highly toxic and, in some instances, carcinogenic
1.15 Support laboratories include all areas that chemicals may be used in the process, and these
accommodate functions directly supporting both may be evacuated via dedicated vacuum pumps.
routine and specialised testing laboratories. No
testing is carried out in these spaces, which 1.24 Gas liquid chromatography (GLC) involving
comprise facilities such as equipment rooms, passage of a gas (for example argon, nitrogen or
instrument rooms and preparation rooms. hydrogen) through the substrate is also carried out
to achieve similar objectives.
Cryopreservation room 1.25 Compressed air is also used for substrate gel
1.16 This may be required for accommodating liquid preparation and drying.
nitrogen freezers for the cryopreservation of
biological specimens. The freezers come in a range Cell culture room
of sizes and are refilled either via portable dewars or 1.26 Cell culture facilities may be required for the
cultivation of tissues. Class II safety cabinets will be
1 Pathology department functions
1.32 Gel electrophoresis is one of the most common 1.41 The prepared specimen is placed inside the
analytical methods in biochemistry and molecular microscope’s vacuum column through an airtight
biology and is being increasingly applied to door. The air is pumped out of the column. An
pathology. electron gun then emits a stream of high-energy
electrons via a series of magnetic lenses onto the
1.33 Electrophoresis is the separation of molecules specimen.
according to how fast they move in an electric
field. This is carried out in a gel (polymer matrix). 1.42 The beam is moved across the specimen by a series
Samples are put in at one end of a slab of polymer of scanning coils. As the electrons hit each spot,
gel. An electric field across the gel pulls the secondary electrons are knocked loose and counted
molecules through it; smaller molecules move faster by a detector. The results are sent to an amplifier
through the gel than larger; thus, molecules are from which the final image is built up.
separated according to size. 1.43 Again, the equipment uses a dedicated, very high
1.34 Carcinogenic compounds may be used in this vacuum source.
process.
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
Blood grouping and cross-matching 1.45 The size and nature of pathology facilities may
range from a large facility within an acute general
1.44 Blood for transfusion is usually grouped by the
hospital to a small satellite laboratory within a
time it is received from regional blood transfusion
community healthcare building providing basic
centres. It is tested in the hospital laboratory for
phlebotomy services and support for anti-
compatibility with the blood of the patient
coagulation, diabetes management and sickle-cell
undergoing the transfusion (whose blood group
screening clinics.
will also need to be determined).
2 Safety aspects of PLGS work
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
2.11 Extinguishers (for both electrical and chemical- 2.14 Gas-leak detection systems are generally expensive
based fires) should be strategically placed near to compared with oxygen depletion monitors.
solvent stores, fume cupboards and at other key However, recent concerns over the ability of the
points throughout the laboratory. Fire blankets may latter to accurately indicate oxygen levels in carbon
also be necessary. Reference should be made to dioxide atmospheres have led to increased interest
Health Technical Memorandum 05-03 Part G – in the former.
‘Laboratories on healthcare premises’.
2.15 A risk assessment – based on the agents used and
2.12 The British Compressed Gas Association (BCGA) the volume and ventilation facilities of the area in
Code of Practice 23 (CP23) – ‘Application of the which they are to be used – should be carried out.
Pressure Systems Safety Regulations 2000 to
2.16 “Second man” working has proved ineffectual
industrial and medical pressure systems installed
in at least one case of oxygen depletion, and it is
at user premises’ – gives detailed requirements
recommended that in areas where liquid nitrogen
imposed by the Pressure Systems Safety Regulations
is being handled in a confined space, an oxygen
2000 on gas systems, containers and mobile
depletion monitor be fitted.
systems installed at users’ premises.
2.17 The primary alarm level of this unit should not be
Gas-leak detection systems less than 19% oxygen.
2.13 Concerns over the safety of personnel exposed to 2.18 The area should also be subject to a strict,
various toxic agents, or fire risks associated with documented operating procedure, especially for
leakage of PLGS or attached equipment, have filling and decanting processes, and all staff
led to a rise in the number of gas-leak detection working with the liquid should be trained and
systems fitted in laboratories. These usually employ issued with appropriate PPE.
either a chemical detection type of sensor, which
monitors the actual concentration of the hazardous
agent, or oxygen concentration monitoring,
intended to warn of oxygen depletion in a confined
space.
3 System design
3 System design
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
SPECIAL
GASES
BENCH MOUNTED
SPECIAL
GASES
WALL MOUNTED
3 System design
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
10
4 Provision of plant and manifolds
lighting access and noise reduction given in c. some gases may be fed directly to equipment
Chapter 14 of Health Technical Memorandum from a discrete local cylinder/regulator
02-01 (Part A), taking into account the following combination within the laboratory. In these
requirements: cases, the laboratory safety officer, or other
authority having jurisdiction, must confirm
a. plant and manifolds should be housed
that the volume and nature of the gas do not
separately from each other, and separately from
constitute a hazard. All cylinders must be
MGPS plant and manifolds;
secured in position;
b. when a laboratory is intended to be routinely
d. rooms housing flammable gases should have a
and frequently operated with flammable gases
roof of lightweight construction or be provided
supplied from a manifold system, the manifold
with other means of explosion relief;
should be sited either:
(i) in a separate manifold room with at least BCGA Guidance Note 7 (GN7) – ‘The safe use of
one wall fitted with a door having a fire- individual portable or mobile cylinder gas supply
resistance classification of at least one hour, equipment’ provides guidance on the safe use,
opening to the outside, and be ventilated inspection and maintenance of individual cylinder gas
in accordance with Chapter 14 of Health supplies, the gas being controlled by a single cylinder-
Technical Memorandum 02-01 (Part A); mounted regulator, which is used to deliver industrial
or cylinder gases to gas-using equipment. It does not
cover toxic or corrosive gases.
(ii) outside of the building and connected
to the laboratory equipment by a e. specialist advice should be sought for the
permanently installed pipework system; installation of electrical systems installed in
manifold rooms containing flammable gases
Note (see paragraphs 11.42–11.46).
Pipework carrying flammable gases from source to
point of use should be run outside buildings wherever
possible. Where this is not possible, care must be taken
to ensure that pipework can be easily accessed for the
purposes of inspection and maintenance.
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
5 Manifold systems
5.1 Manifolds for PLGS are generally smaller and less manifolds, and associated distribution pipework up
complex than those used for MGPS. to 54 mm nominal bore. The manifold pressure is
up to 300 bar, while the distribution pressure is
5.2 Typical arrangements for single- and multiple-
limited to 40 bar.
cylinder manual and auto-changeover manifolds are
shown in Figures 2–8. 5.7 BCGA Code of Practice 5 (CP5) – ‘The design and
construction of manifolds using acetylene gas from
5.3 Fitting gas manifolds inside the laboratory is not
1.5 bar to a maximum working pressure of 25 bar
advised but, if carried out, manifold size should not
(362 lbf/in²)’ covers the design and construction of
exceed 2 × 3 cylinders.
acetylene gas manifolds, working at pressures from
5.4 Care should be taken to ensure that all cylinders are 1.5 bar up to 25 bar. The statutory requirements
well secured. of such systems are detailed. Also applicable is
5.5 It is important that specialist suppliers and BCGA Code of Practice 6 (CP6) – ‘The safe use of
installers are used to ensure compatibility of acetylene in the pressure range 0–1.5 bar (0–22 lbf/
equipment with the gases used (see Chapter 12). in2)’.
5.6 BCGA Code of Practice 4 (CP4) – ‘Industrial gas 5.8 Internal and external leakage of manifold
cylinder manifolds and distribution pipework/ components, which can lead to higher static
pipelines (excluding acetylene)’ gives minimum pressures or depletion of cylinders and low line
safety standards for the design, installation, pressures, is addressed in BS EN 29090:1992/
operation and maintenance of industrial gas supply ISO 9090:1989 and BS EN 738-2:1998.
Figure 2 Manual-change manifold (with pressure reduction package) (for key see page 15)
Reproduced by kind permission of the Gas-Arc Group Ltd
1
6 5
6
2 4
12
5 Manifold systems
Figure 3 Single cylinder coupler (with pressure reduction package) (for key see page 15)
Reproduced by kind permission of the Gas-Arc Group Ltd
4
6
5 3
1
6 5
7 6
2 4
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
Figure 5 Auto-changeover manifold (with pressure reduction package) (for key see page 15)
Reproduced by kind permission of the Gas-Arc Group Ltd
6 5
8 11
6
10
2
12
6 5
8 11
6
10
7
2
12
14
5 Manifold systems
14
1 13
16
15
Figure 8 Acetylene manual-change manifold – multi-cylinder bank (for key see below)
Reproduced by kind permission of the Gas-Arc Group Ltd
14
13
19 15
17
7
18
5
3 3
15
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
6.1 Simplex plant is generally sufficient to meet the 6.5 Frequently, this basic level of oil removal and
needs of the laboratory. air filtration is the only treatment given for air
delivered to most equipment quoted as requiring
6.2 Any type of plant able to produce output to the
dry air.
laboratory design specification can be used, but
care must be taken to ensure that the quality of the 6.6 Dry air is generally specified without recourse to
air delivered is able to satisfy the requirements of all dew-point specifications (although an atmospheric
types of equipment likely to be connected to the dew-point of –20°C has been quoted as sufficiently
system. dry for most equipment).
6.3 Equipment manufacturers often state “oil-free” air 6.7 Given that adding a desiccant dryer will easily
as an essential, but non-quantitative, requirement. produce the medical air atmospheric dew-point of
If this is the case, the minimum requirement for –46°C, there is little to be gained by specifying the
compressed air treatment is the fitting of: lower value.
• automatic drains on the compressor receiver; 6.8 Therefore, some installers are fitting small simplex
units delivering medical air quality in the interests
• an oil trap (also with automatic drain);
of good practice. Using air of this quality is
• an oil mist filter; and recommended in this Health Technical
• a bacteria filter with charcoal element to Memorandum and has the added advantage of
medical air standards (see Chapter 7 of Health extending the life of equipment and control
Technical Memorandum 02-01 (Part A)). systems by reducing the likelihood of condensation
within the pipeline and equipment.
6.4 A suitable alternative would be an oil-free
compressor of suitable capacity and fitted with
bacteria and charcoal filtration as above.
16
7 Central vacuum plant
7.1 The fitting of centrally provided laboratory vacuum 7.4 The bacteria filters should have an efficiency (when
is rare owing to possible damage to the plant from tested by the sodium flame test in accordance with
chemicals passing through the system. Separate BS 3928:1969) of greater than 99.995% at the
pumps, dedicated to individual equipment items, system design flow (see Chapter 7 of Health
are recommended. Technical Memorandum 02-01 (Part A)).
7.2 Hazardous agents vented via these pumps should 7.5 Exhaust terminations of central plant should be
be disposed of to safe areas via terminations above roof level, and constructed and signed in
carrying appropriate warning signs. Any pump type accordance with Health Building Note 15 –
capable of meeting the disposal requirements of ‘Accommodation for pathology services’.
hazardous agents may be used.
7.6 Internally-sited plant must be fitted with exhausts
7.3 In some circumstances, scrubbing or washing constructed and ducted in accordance with the
systems may have to be installed between health and safety requirements of the specific
equipment and terminal points. A duplex bacteria processes serviced.
filtration system of at least the standard used for
medical vacuum plant should be fitted before the
receiver. Condensation traps should be fitted where
required.
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
8 Gas generators
8.1 Gas generators provide a simple and reliable 8.10 Drying of the gas to an atmospheric dew-point of
alternative to piped cylinder gas supplies and are –40°C is typical, and some of the units are designed
available as both bench-top generators and high- to produce clean air in addition to the nitrogen.
capacity systems, replacing gas cylinders as a source
of calibration standard. Air and zero air
8.2 Such generators generally have low electricity 8.11 Air generators produce laboratory-grade purified air
consumption and, in the case of those using air as a for the most demanding techniques (for example
source gas, low driving-medium consumption. for gas analysers and other types of analytical
8.3 Gas generators are easy to install and require only instrument such as gas chromatography with a
minimal annual maintenance. They are commonly flame ionisation detector (GC-FID) etc).
available for: 8.12 The units either purify an existing compressed air
• nitrogen and zero nitrogen, supply or may use an integral compressor.
• air and zero air, and 8.13 First-stage purification removes oil, water and
dirt particles using a 1–10 μm coalescing filter
• hydrogen, (depending on the manufacturer).
although other units are available to special order 8.14 A further membrane dryer may be used to remove
for less frequently used gases. moisture. A portion of the air produced may be
8.4 Bench-top units produce flow rates in the typical used as purge for the dryer.
range of 10–30 L/min. 8.15 Hydrocarbons, including methane, are then
removed by passing the air over a heated catalyst,
Nitrogen and zero nitrogen or activated carbon filter, leaving a typical residual
8.5 Using a compressed air supply, which may be total hydrocarbon level of <0.1 ppm.
provided from an integral oil-free compressor, 8.16 Catalysts are also used to convert any carbon
nitrogen is produced using a pressure-swing monoxide (CO) into carbon dioxide (CO2) and
adsorption system (zeolite molecular sieve). remove any oxides of nitrogen.
8.6 The purity of the nitrogen produced is usually 8.17 A 0.01–0.1 μm particle removal filter (depending
described in terms of its residual oxygen content, on manufacturer) completes the purification
which varies with the application. A range of process.
10 ppm to 3% oxygen content is typical of these
8.18 As part of the process, some units are fitted with
generators.
an integral ultraviolet sterilization chamber. The
8.7 Oxygen produced by the unit is usually exhausted ultraviolet light also oxidises any nitric oxide (NO)
to its surroundings. into nitrogen dioxide (NO2).
8.8 So-called zero nitrogen is produced when the high-
purity nitrogen is passed over a heated catalyst (also Hydrogen
integral to the unit), reducing the hydrocarbon 8.19 These units are often used with gas analysers, as a
content to less than 1 ppm. fuel gas.
8.9 Other gaseous contaminants such as carbon 8.20 Hydrogen generators generally use membrane
monoxide and oxides of nitrogen, as well as technology for electrolytic production of pure
particulates, are also removed during this process. hydrogen gas.
18
8 Gas generators
8.21 Electrolytic membrane technology is clean and 8.23 Some units are fitted with an automatic shut-off
requires less maintenance than, for example, if gas quality specifications are not met, and
generators using caustic solutions. adjustable alarms allow the user to be warned
whenever operating conditions vary from the set
8.22 Distilled or deionised water is required for
point.
operation, and there is no need to store and use
other chemicals.
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
9.1 The general guidelines given in Chapter 8 of Cylinders stored within the laboratory
Health Technical Memorandum 02-01 (Part B)
for “ready use”
should be followed for pathology gas cylinder
storage and management. 9.7 Cylinders should be in racks or secured in an
upright position in designated “parking” areas
9.2 It is important to maintain separation between
known to all staff.
medical and pathology gas cylinders and oxidising
and flammable gases when stored. 9.8 The aggregate accumulation of cylinders at any one
bench position/workstation should not exceed one
9.3 Ventilation and electrical installation requirements
extra cylinder for each cylinder actually connected
for flammable gas storage areas are also important.
for use.
9.4 Staff handling the cylinders must be trained in
9.9 BCGA Guidance Note 2 (GN2) – ‘Guidance
manual handling techniques and be made aware
for the storage of transportable gas cylinders for
of the properties and hazards of the compounds
industrial use’ defines the principles of safe practice
contained within. In particular, training should
for the storage of gases in cylinders, or liquid
be given in procedures for dealing with defective
containers less than 1000 L, on industrial premises.
cylinders and emergency situations (for example
It is relevant to the use of these gases in pathology
rapid release of flammable gases).
laboratories.
9.5 BCGA Guidance Note 3 (GN3) – ‘Safe cylinder
9.10 BCGA Code of Practice 30 (CP30) – ‘The safe
handling and the application of the Manual
use of liquid nitrogen dewars up to 50 litres’ and
Handling Operations Regulations to gas cylinders’
BCGA Technical Information Sheet 6 (TIS6) –
defines the principles of safe practice for the
‘Cylinder identification, colour-coding and
handling of compressed and liquefied gas cylinders.
labelling requirements’ are also applicable. In
It explains how compliance with the Manual
particular, CP30 contains valuable information on
Handling Operations Regulations 1992 may be
the safe transport of small dewars on healthcare
achieved.
premises.
9.6 Personal protective equipment must be provided
and used where appropriate. This is particularly
relevant to the decanting process for cryogenic
gases (for example liquid nitrogen) where
additional precautions against liquid spillage and
consequent oxygen depletion must be taken.
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10 Alarm systems
10 Alarm systems
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
11 Installation practice
22
11 Installation practice
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
11.33 Some manifolds are supplied with valved-off purge For this reason, acetylene systems must not be installed
points, and these offer an acceptable alternative to using copper or silver-containing components.
fitting a specific test point.
Mild or stainless steel can be used for acetylene
Jointing techniques pipeline installations, the latter being the preferred
material.
11.34 Copper pipelines should be joined, where
applicable, using the inert brazing technique Jointing methods must be appropriate to the material
described in Chapter 13 of Health Technical (for example tungsten inert gas (TIG) welding for
Memorandum 02-01 (Part A). stainless steel). Mechanical jointing methods must
produce joints exhibiting characteristics of a welded
11.35 Oxygen-free nitrogen should be used as the inert joint (for example by the use of twin-ferrule
gas shield. mechanical couplings).
11.36 For very small systems, it will not be practicable If acetylene or other flammable gases are to be passed
to cut out sample joints, but the technique can be through a mixing device, together with an oxidising
applied to larger systems at the discretion of the gas (for example oxygen), it is normal practice to fit a
Authorised Person (MGPS) and/or laboratory combined non-return valve and flame arrestor to both
manager. flammable and oxidising gases. However, it will be
11.37 Degreased mechanical couplings can be used as necessary to consult with specialist installers and
an alternative to brazed joints, but the fire integrity equipment manufacturers on exact requirements for
and material compatibility of such joints should be fitting non-return valves and flame arrestors/automatic
appropriate to the gas service and installation quick-acting shut-off valves.
environment. BCGA Code of Practice 6 (CP6) gives guidance on
11.38 It is recommended that any mechanical joints used the safe distribution of acetylene at pressures between
should have a fire integrity equivalent to that of a 0 and 1.5 bar.
copper-to-copper brazed joint. Both fixed and mobile systems are included, as are the
11.39 Couplings at terminal points and valves will statutory requirements.
usually be of the compression type, depending
on the design of the terminal/valve. Safety note: liquid nitrogen pipeline
installations
Safety note: terminal point Liquid nitrogen is usually supplied to a laboratory
connections in small dewars, refilled by decanting from a larger,
In some instances, terminal points have been static cryogenic storage vessel. There are also some
connected to rigid pipework using flexible connecting installations where liquid nitrogen is piped from the
hoses (for example nylon). This method of connection main vessel to terminations in the laboratory. Specialist
is not recommended, particularly where such material contractors must be used for this type of installation,
could lead to gas escape in the event of failure during a as it may well involve the use of vacuum-insulated
fire. pipework, which is not only expensive but also
difficult to install without damage to the vacuum seals.
For this reason, all terminal points should be
connected directly to the rigid pipework. Where the use of vacuum-insulated pipework is
envisaged, the design layout of the installation should
Safety note: acetylene pipeline ensure that the distance from the storage vessel to the
termination point is kept to a minimum in order to
installations avoid excessive gassing-off on start up of laboratory
Acetylene gas, in the presence of moisture, will react processes.
with copper and silver compounds to produce
See also BCGA Code of Practice 30 (CP30).
mechanically unstable compounds known as
acetylides. If these compounds have formed within the
system, physical impact on, or dismantling of, system Removal of pipework
components can cause explosive decomposition of the
11.40 Because of the nature of the agents carried,
acetylides, with potentially fatal results.
removal and cutting out of redundant PLGS
24
11 Installation practice
pipelines and equipment can present significant The standard also gives details of the protective
hazards. measures that need to be applied to reduce the risk
of explosions.
11.41 All such work – including inert gas purging before
cutting into existing pipelines, capping off, and 11.44 BS EN 60079-10:2003 supports the Dangerous
removal of redundant equipment and pipework – Substances and Explosive Atmospheres Regulations
should only be carried out by specialist PLGS 2002 and provides information on obligations
contractors. It should not be carried out by with respect to hazardous zones within
demolition contractors. establishments.
11.45 The separation between flammable-gas carrying
Electrical installations pipework and electrical equipment that is not
11.42 Appropriate protection against ignition must be classified as “gas-proof ” (for example laboratory
provided for all electrical apparatus in contact with ring main and lighting circuits) must not be less
the gas stream (for example pressure switches and than 25 cm.
contact gauges). 11.46 For hydrogen pipelines, care should be taken to
11.43 BS EN 60079-10:2003 and BS EN 60079-14: ensure that the pipeline is sited above electrical
2003 cover the classification of hazardous areas equipment and sockets, and that the separation
where flammable gas or vapour risks may arise. distance is greater than 50 cm.
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
12.1 The extent of testing of pathology gas systems is Use of helium as a leak-proving medium
considerably less than that of MGPS. Nevertheless,
12.8 For most systems, oxygen-free nitrogen is
because of the hazardous nature of some of the
acceptable as a test gas during pressure and other
gases carried, all tests should be carried out in a
testing. However, there are (infrequent) occasions
conscientious manner to ensure installation of a
when helium has been requested as a leak-proving
safe working system.
medium, because of its small atomic size and hence
12.2 Carcass and complete systems will not generally its superior ability to permeate very small leaks. It is
be tested separately; rather, testing of pipework perfectly acceptable to employ helium as the test
sections between plant/manifolds and terminal gas, but detection equipment is expensive and
points, with the latter fitted, will be expected. requires careful calibration if any advantage is to be
gained by its use.
Engineering tests 12.9 However, helium should always be used as the test
gas for hydrogen systems, as both gases can pass
Pressure (leak) testing of systems through joints that have proved leak-tight with
12.3 Using oxygen-free nitrogen, each system (with all nitrogen.
termination points fitted and isolated) must be
tested at a pressure of at least 1.5 times its working Annual leak test
pressure. By implication, a maximum test pressure 12.10 Laboratory managers may request annual leak-
of 6 bar will be required, and it is common practice testing of some (usually flammable) gas systems.
to test all systems, including those such as propane For this test to take place, the system must be
(which will run at 2 bar), at this pressure. If depressurised by venting off gas in a safe manner,
terminal control devices would be compromised and purged of the working gas by the use of
by this pressure, they should be removed for the oxygen-free nitrogen. The latter is then used as the
duration of the test. The pipeline would then be test gas.
plugged at the terminal.
12.4 The test gas should be applied at the manifold Cross-connection test
connection in the case of cylinder sources and at 12.11 PLGSs are generally smaller in extent than
the plant connection in the case of compressed air. MGPSs, and any cross-connection is usually
12.5 Plant and manifolds should be disconnected for the revealed during installation. However, it is essential
duration of the test. that there is no cross-connection between oxidising
and flammable gas systems.
12.6 Using suitable measuring equipment, no leaks
should be detected during a two-hour test period. 12.12 It is also important that acetylene is not allowed
to contaminate copper pipework, although the
12.7 Vacuum system pipework is also tested to this chance of this is small as differences in pipeline
standard. No additional testing under vacuum is material should be self-evident.
performed other than the functional test of the
plant. 12.13 A cross-connection test must be performed using
the test gas.
Note 12.14 The test method in the format below has been
Plant and manifolds will be leak-tested by suppliers, used successfully to confirm absence of cross-
but may also be tested for leaks by installers during connection between systems, and follows guidance
functional tests. previously issued in Health Technical
26
12 Validation and verification
Memorandum 2022 – ‘Medical gas pipeline Design flow and pressure-drop tests
systems’ (1997).
12.16 A formal flow and pressure-drop test as for MGPSs
is not normally required, unless requested by the
Note laboratory manager, although it should be
Health Technical Memorandum 02-01 (2006), the confirmed that all terminal points operate
revised edition of Health Technical Memorandum correctly.
2022 (1997), describes an alternative method of test in
Chapter 15 of Part A, whereby two systems – starting Functional tests
with oxygen and vacuum – are tested simultaneously. 12.17 Each system should be tested to ensure that all
Subsequent tests are carried out without the need to plant, manifold and alarm and indicating systems
return each system to atmospheric pressure. For those are functioning as specified in the contract.
installers familiar with the requirements of Health
Technical Memorandum 02-01 (2006), either method Performance testing of modified systems
of testing for cross-connection may be used.
12.18 Formal flow and pressure drop tests are not
a. Using the test gas at working pressure, the required, as it is unlikely that addition of extra
oxygen (or other defined pressure gas) system terminal points will significantly affect the
is pressurised first. performance of the system.
b. All other systems are at atmospheric pressure, 12.19 However, consideration must be given to
with line valves etc open. additional and significant demands created by
connection of high flow equipment such as drying
c. A check is made to ensure that there is a flow cabinets. Such additions could warrant a change,
at every oxygen (or other defined gas) terminal for example, from cylinder- to compressor-
point: there must be no flow at any other supplied air.
terminal point on other gas systems.
12.20 In addition, when gas generators are installed, care
d. The oxygen (or other defined gas) system is should be taken to ensure that they are rated to
then brought down to atmospheric pressure, cope with any additional load.
and all valves/terminal points are left open and
the test gas is applied to another system. 12.21 Discussion with end-users, manufacturers and
installers should take place to determine the service
12.15 This process is repeated for other systems in turn. requirements of specialist equipment.
In all cases there must be no gas flow from any
system, other than the one under test. 12.22 Infection control issues will require detailed
discussion with other professionals (for example
Notes microbiologists).
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
12.26 However, if requested by the laboratory manager, test equipment and its associated sampling and
the test can be performed on all systems when disposal tubing with gases that may be highly
filled with the inert shield gas. flammable or corrosive.
12.27 The test must not be performed on any working
Quality-control testing routines
systems other than oxygen and compressed air.
12.37 For reasons given in paragraph 12.35,
Filling with the working gases comprehensive pharmaceutical quality-control
testing of PLGS is rare.
12.28 The small volumes associated with PLGSs mean
that purging the test gas from the system can be 12.38 Frequently, no quality-control testing of PLGS
completed efficiently and quickly. takes place and, hence, many Quality Controllers
have no experience of such systems.
12.29 Each terminal point should be purged to allow
exhaustion of the test gas. On most systems, this 12.39 Users should be encouraged to ensure that
can be achieved easily with a two-minute purge. adequate testing of systems has taken place before
use, as the consequences of using contaminated
12.30 Great care must be taken to ensure safety when
gases can be serious in terms of equipment damage
disposing of the purging gases, particularly those
and/or performance.
that are flammable.
12.40 Employing a Quality Controller with experience
Pipelines left before filling with the working gas of MGPS testing is essential, and the Quality
12.31 Time may elapse between initial construction and Controller chosen should be on the MGPS
filling with the working gas. National QC Register as recommended in
Chapter 15 of Health Technical Memorandum
12.32 During this period, systems should be left filled 02-01 (Part A).
with the inert shield gas at working pressure.
12.33 Repurging with the shield gas before filling with Particulates and oil
the working gas will be necessary if there is any 12.41 The particulate and oil tests described above may
doubt that a system has been depressurised in the have been carried out by the installer before a
interim. Quality Controller is invited to test the system.
12.34 This is especially important in the case of Repetition of these tests is therefore at the
flammable gases, where ingress of air could lead to discretion of the Quality Controller.
the formation of explosive mixtures.
Water
Pharmaceutical tests 12.42 Leaving pipework open to the elements can lead to
water vapour ingress. In extreme cases, liquid water
Important safety information will collect in unprotected pipework. If at all
possible, a moisture test carried out before filling
12.35 Quality-control testing of systems carrying
with working gases will ultimately save time and
flammable agents such as pure acetylene, hydrogen
cut down on wastage of expensive gases.
and propane is not recommended.
12.36 Some anaerobic mixtures contain small quantities Other tests
of hydrogen gas and, if these are to be tested, 12.43 The laboratory manager may request additional
attention should be given to the following: tests, and the Quality Controller will be able to
a. disposal of flammable, toxic etc gases requires give advice on relevant tests when required. These
particular care if hazards to personnel are to be tests will include:
avoided. Disposal routes and methods should a. Compressed air system:
be examined before testing is attempted, to Air quality can be tested to European
ensure total safety; Pharmacopoeia (Ph. Eur.) specifications if a
b. if there is any doubt as to the compatibility suitable dryer system is fitted. Otherwise, a test
of test equipment with the gases to be tested, to ensure oil levels are below 0.1 mg/m3 will
testing should not be carried out. This applies ensure protection of the system against oil
particularly to the use of electrically powered contamination. Dew-point levels of an “oil
28
12 Validation and verification
separator plus filter” only system are difficult to Requirements before a PLGS is taken
predict, but values can be recorded in order to
into use
aid detection of trends in plant performance.
Users should be made aware of potential General
damage to expensive equipment that can result
from condensation of water vapour. 12.44 Before a system is used, the appropriate persons
must certify in writing that all tests have been
b. Vacuum system: completed and that all systems comply with the
Presence of suction only, although actual requirements. This must include certification that
vacuum may be recorded if desired. all drawings and manuals required by the contract
c. Other gases: have been supplied and as-fitted drawings are
Tests are usually based on: correct.
(i) proving the absence of inert shield purge 12.45 All certificates must be dated and signed by the
gas (although this will be difficult when appropriate witnesses, by the contract supervising
analysing gas mixtures containing officer, and by the representative of the contractor.
nitrogen); 12.46 All construction labels and signage should be
(ii) proving the absence of excessive amounts removed from the system.
of moisture (as described above).
Operational policy
Mixtures of oxygen, carbon dioxide, nitrogen
and hydrogen in varying proportions can be 12.47 If the Authorised Person (MGPS) is to assume
tested for presence of water vapour, oxygen, responsibility for the PLGS, the MGPS
carbon dioxide and monoxide, nitrous oxide, operational policy can be amended to include
nitric oxide, nitrogen dioxide and sulphur operational requirements for the PLGS.
dioxide, as appropriate to the mixture and 12.48 If the Authorised Person (MGPS) has no
in accordance with the gas suppliers’ responsibility for the PLGS, the laboratory
specifications. manager, or delegated representative, will assume
Gases of very high purity may also warrant responsibility for the PLGS.
initial testing of pipelines for specific 12.49 It will then be the responsibility of the laboratory
contaminants in very low concentrations. manager or his/her delegated representative to
In such instances, the advice of the laboratory prepare, or arrange for preparation of, a separate
manager, and the specialist gas and equipment operational policy for the PLGS.
suppliers, should be sought.
12.50 Arrangements for policy implementation and
monitoring should be documented and a regular
review carried out.
12.51 Guidance on operational policy content and
preparation is given in Chapter 5 and Appendices
A and B of Health Technical Memorandum 02-01
(Part B).
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
13.1 In the absence of a formal permit-to-work system 13.4 Copies of the permit should be retained by the
for PLGSs, some Authorised Persons (MGPS) have Authorised Person (MGPS) and/or the laboratory
amended MGPS permit forms to manage PLGS manager.
work. However, as the MGPS permit is intended
13.5 If pharmaceutical testing has taken place, a copy of
for use with patient-connected systems, its use on a
the quality control test results should be signed by
PLGS is not appropriate.
the Quality Controller and appended to the
13.2 An alternative permit form is reproduced in completed permit.
Figure 9 and should be used for work on the PLGS.
13.6 The Quality Controller may retain a copy of the
13.3 There may be other permits applicable to work on permit by request.
a PLGS, for example “confined spaces” and “hot
work”. These should be referenced on the PLGS
permit document.
30
13 PLGS permit-to-work system
I understand and accept responsibility for the work described above. I have been informed of and understand all relevant safety
hazards and procedures. No other work will be carried out under this authorisation.
Name (print) __________________________ Company _ ___________________________________________________
Signature _________________________________ Date _ _______________ Time __________________
Other Permits in use for this work N
o ________________
No ________________
It has been necessary to extend the work beyond the allotted time. The system(s) remain safe to work on and all hazards and
precautions have been explained to the person taking over.
The expected time of completion of the work is now _ ______ hours on _________________ (date)
Name (print) __________________________ Company _ ___________________________________________________
Signature _________________________________ Date _ _______________ Time __________________
All work described has been completed and tested in accordance with Health Technical Memorandum 08-06 Chapter 13.
A copy of the test results/service report attached to this Permit has/have been left with the Authorised Person (MGPS)/
Laboratory Manager.
Name (print) __________________________ Company _ ___________________________________________________
Signature _________________________________ Date _ _______________ Time __________________
Following successful test results, I accept the above system(s) back into use.
Name (print) _______________________________ Title _ ___________________________________________________
Signature _________________________________ Date _ ____________________
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Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
14 PLGS maintenance
c. clearly visible at all times; • obtain permit-to-work to carry out all work,
including leak tests if necessary;
d. accessible to facilities staff.
• inform customer/client of alarm conditions to
14.5 It is important to ensure that engineering services be expected during maintenance work.
are readily maintainable. Within the pathology
facility, services should be arranged so that they 14.14 On all single-cylinder-served pipelines:
are secure; yet maintenance access should not be • carry out full flow test through regulator at
impeded. working pressure to ensure continued capability
14.6 As a general principle, with the exception of of multi-stage regulator;
drainage, only those services which serve the facility • test regulator against closed outlet valve to
should be located above false ceilings and, wherever check for creep;
possible, they should be installed over corridors and
• carry out leak test using recognised leak
other circulation spaces.
detector (Snoop/Teepol etc);
14.7 In clean areas and other areas requiring non-
• inspect all tailpipes/non-return valves for
accessible ceiling voids, the design of engineering
leakage/damage;
services should ensure that access for terminal point
filters etc is from below. • inspect all signage/labelling for permanence
and legibility.
32
14 PLGS maintenance
14.15 On all auto-changeover manifolds: • check all equipment for signs of five-year
replacement with reference to the guidelines
• check both inlet valves for full shut-off;
given in BCGA Code of Practice 7 (CP7) –
• re-balance both left- and right-hand primary ‘The safe use of oxy-fuel gas equipment
regulators to manufacturer’s recommended (individual portable or mobile cylinder supply)’
settings and carry out full flow test through and BCGA Guidance Note 7 (GN7) – ‘The
integral line regulator; safe use of individual portable or mobile
• test regulator against closed outlet valve (where cylinder gas supply equipment’;
fitted) to check for creep; • upon completion of all works, inform
• carry out leak test using recognised leak customer/client of alarm reinstatement to
detector (Snoop/Teepol etc); normal conditions and sign off any permit-to-
work issued.
• inspect all tailpipes/non-return valves for
leakage/damage; Recommended service intervals
Single regulator systems Once per annum
• if an annual pressure drop is to be carried out,
ensure all safety relief valves are removed and Auto-changeover manifolds Twice per annum
blanked unless testing at statutory 1.2 times the Leak tests (if required) Once per annum
working pressure;
33
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
Zone 2
Zone 3
34
Pathology Vacuum
35
Specialist services – Health Technical Memorandum 08-06 Pathology laboratory gas systems
References
36
References
maximum working pressure of 25 bar (362 lbf/in2). Technical Information Sheet 6 (TIS6) – Cylinder
Revision 1, 1998. identification colour-coding and labelling
requirements. Revision 1, 2005.
Code of Practice 6 (CP6) – The safe distribution of
acetylene in the pressure range 0–1.5 bar (0–22 lbf/
in2). Revision 1, 1998. Building Services Research &
Information Association (BSRIA)
Code of Practice 7 (CP7) – The safe use of oxy-fuel
gas equipment (individual portable or mobile cylinder guidance
supply). Revision 4, 2004. Technical Note TN 17/95 – Rules of thumb.
Code of Practice 23 (CP23) – Application of the 4th Edition, 2003.
Pressure Systems Safety Regulations 2000 to Technical Note TN 10/92 – Space allowances for
industrial and medical pressure systems installed at building services distribution systems: detailed design
user premises. Revision 1, 2002. stage. 1992.
Code of Practice 30 (CP30) – The safe use of liquid Technical Note TN 9/92 – Space and weight
nitrogen dewars up to 50 litres, 2000. allowances for building services plant: inception stage
Guidance Note 2 (GN2) – Guidance for the storage of design. 1992.
transportable gas cylinders for industrial use. Revision
3, 2005. Other publications
Guidance Note 3 (GN3) – Safe cylinder handling and European Pharmacopoeia (Ph. Eur.) 2005 (5th
the application of the manual handling operations edition). European Directorate for the Quality of
regulations to gas cylinders. Revision 1, 2005. Medicines, 2005.
http://www.pheur.org
Guidance Note 7 (GN7) – The safe use of individual
portable or mobile cylinder gas supply equipment.
Revision 1, 2004.
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38