SCGT- Monitoring of SCTL

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SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

Version
1

A
ctive:

4/8/2011

Page
1

of
9

Documents not printed on
controlled

paper are valid for the print date only

Author: RMakin



CONFIDENTIAL

1

Purpose

To detail the

monitoring

procedure for
SCTL (temperature,
CO
2

etc) and its associated equipment
. The
procedure includes
specifications,

staff
responsibilities
,
recording of data,
handling
of
out
-
of
-
specification
readings
,
g
uidelines for corrective

action and checking of the monitoring systems.

2

Responsibilities


Position

Responsibilities

Production Manager
s BMT,
TCR,
WIT

Ensu
re

that all
SCTL
staff are trained and competent in moni
toring
techniques and practices,
Ensu
re

that all OOS
monitoring
readi
ngs

are investigated and closed
-
out

SCGT

Quality Man
a
ger

Ensure

that all
SCTL

staff are trained and competent in moni
toring
techniques and practices.
Ensur
e

that all OOS monitoring
readings

are investigated and closed
-
out

SCGT

Quality Officer

To
accumula
te, review and implement action to
monitoring data

SCTL Staff

Ensur
e

monitoring of SCTL and associated equipment is performed
according to this SOP

Facility Unit Director
,
Westmead Hospital


To ensure
that
Honeywell

system

alarms are notified to

the

desi
gnated
SCTL staff in a timely fashion.
To provide
the

monitoring data to the
SCGT

Quality Officer

ICPMR Blood Bank

To ensure

alarms
identified out
-
of
-
hours
are notified to

designated
SCTL staff in a timely fashion

3

Equipment & Supplies



IPA Monitoring Sys
tem



Honeywell Monitoring System



GDS 404
Oxygen monitor



GMA 313

CO
2

monitor

(detection)



Gascon
Autochange

PM120 (CO
2

supply)



Vaisala Transmitters (Temperature / Humidity)

4

References

4.1

QS
-
SYS
-
S006 (CAPA)

4.2

RE
-
SCT
-
F006 (SCTL Emergency List)


4.3

RE
-
SCT
-
X002

(SCTL
Facility Warning Sign)

4.4

RE
-
SCT
-
F008
(
F
acility
monitoring form)

4.5

EX
-
SCT
-
X
001

(
GMA 313 Carbon Dioxide Monitor

Operation Instructions
)

4.6

EX
-
SCT
-
X002 (Autochange Manifold Operating Instructions)

4.7

QS
-
SYS
-
P007 (Product Release)

4.8

QS
-
SYS
-
S008 (Product recall procedure)

4.9

QS
-
SYS
-
F003 (SCTL Facility Training Module)

4.10

SCTL Facility Maintenance Schedule

4.11

GDS 404 Series Operating Handbook

4.12

RE
-
WMH
-
S1 IPA System Instructions







SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

Version
1

A
ctive:

4/8/2011

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2

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9

Documents not printed on
controlled

paper are valid for the print date only

Author: RMakin



CONFIDENTIAL

5

Additional information

5.1

Abbreviations:

SCTL

Sydney Cellular Therapy Laboratory

BMT

Bone Marrow Transplant


TCR

T
-
Cell Clinical Research

WIT


W
estmead Islet Transplant

BMC

Building Management Centre

ICPMR

Institute of Clinical Pathology and Medical Research

5.2

Definitions

OOS



Out of Specification

CAPA


Corrective action / preventive action

OFI


Opportunity
for improvement. This is a CAPA in the BMT Network Q
-
Pulse system.

5.3

Monitoring overview

The monitoring of
the
SCTL and associated equipment is performed by
several systems.

The
coverage
and specifications
of
each system

are
detailed below.

Table 1

Monitor
ing
System

Parameter

Equipment /area

Specification

Honeywell

Temperature (°C)


Cryogenics room

BMT Laboratory

Clean room

Compactus

Lower

Upper

14

25

Pressure

(Pa)


Clean room

Anteroom

Changeroom

5

40

CO
2
alarm

Incubator

On

N/A

Nitrogen Exhaus
t F
an

(Cryoroom)

On

GDS 404 (linked
to Honeywell)

Oxygen

(%volume)

Crogenics

Lower limit 19

IPA

Temperature (°C)


Lower

Upper

LN tanks

-
200

-
160

Compactus

Cleanroom

BMT Workroom

19

25

Cleanroom incubator
s

35

39

-
80
°C

BMT Freezer

-
100

-
60

-
20
°C

BMT Freezer

-
30

-
10

BMT refrigerator #3

2

8

BMT refrigerator #4

2

8

Anteroom Refrigerators

2

10*

Anteroom Freezer

N/A

-
5**

CO
2
(%)

Cleanroom incubators

3

7

Humidity (%)

Compactus

Cleanroom

Lower

Upper

30

70

Incubator

80

100







SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

Version
1

A
ctive:

4/8/2011

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9

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controlled

paper are valid for the print date only

Author: RMakin



CONFIDENTIAL

Monitor
ing
System

Parameter

Equipment /area

Specification

GMA 313

CO
2

volume (%)

Cleanroom

Pulsed alarm 1.5%
volume

Continuous 3.0% volume

CO
2
Autochange

System

CO
2

pressure

Gascon

Autochanger
PM120


ICPMR hallway

The HosLab display
-
outside cleanroom
changeroom

500kpa

*
The anteroom refrigerator is a d
omestic refrigerator and is subject to temperature fluctuations greater than the
vaccine refrigerators used in BMT. As such the

alarm
s are set wider. Staff should ensure that the reagents stored
in the refrigerator are not affected by the temperature fluct
uations.

** The anteroom freezer is used for just storing ice bricks. It is only important that the unit is cold enough to keep
the bricks frozen.


5.4

Position of the
SCTL
probes


























5.4.1

I
PA Monitoring System

The IPA Monitoring System is a continuous and centrally monitored system managed via by
a computer terminal located in the BMT Workroom of SCTL.
Any OOS

readings

trigger an
audible alarm in the BMT Workroom
. In addition OOS reading
s

f
or the
-
80
°C

freezer and
the LN tanks in the cryogenics room signal a red alarm in ICPMR Blood Bank. Any OOS
readings for the incubator
s

in the cleanroom signal a blue alarm in Blood Bank.

Key

Honeywell

Temp probe



Alarm panel


Pressure



CO
2
detector



Oxygen



CO
2
Autochange

IPA


LN tanks




Room Temp/ Humidity


-

80°C freezer




Incubator Temp





humidity, CO
2


-

20
°C

freezer





Fridge and Frid
ge Freezer


Refrigerator














BMT Workroom












Change
room



Cleanroom


Anteroom





Compactus







SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

Version
1

A
ctive:

4/8/2011

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9

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paper are valid for the print date only

Author: RMakin



CONFIDENTIAL

5.4.2

Honeywell Monitoring System

The Honeywell Monitoring System is a

continuous and centrally monitored system managed
via BMC of Westmead Hospital. The monitoring
readings

are displayed on LED displays on
control boxes within the BMT Workroom and the Cleanroom.
Alarm

pane
l
s are

also
displayed in the BMT W
orkroom and outsi
de
SCTL in the corridor. The alarm

panel
s
display

power
supply
failure
to the
c
ryo
tanks
, malfunction of the
nitrogen
exhaust fan
,
low
oxygen levels within the
cryogenic

room and low levels of CO
2

within the cleanroom
incubator

(corridor only)
.


Any OOS
re
adings

trigger
s

an alarm in the central control panel

of BMC and produce a local
audible alarm.

Warning:

The temperature readings of the Honeywell System are not completely accurate.
They are designed for adjusting the airconditioning of SCTL. IPA tempera
ture reading
devices (Vaisala Transmitters) which are calibrated have been placed in SCTL for accurate
temperature and humidity readings. The temperature adjustment knobs on the Honeywell
Display Panel outside the anteroom and within the cleanroom may be
used (
in extreme cases
upon approval of the Production Manager) to adjust the temperature. Following adjustment
staff should ensure the temperature remains within specification by reviewing the Vaisala
Transmitters
and/
or the IPA computer.

5.4.3

The CO
2

Autocha
nge

System is used to
supply
continuous CO
2

gas to the incubators in the
cleanroom.
It is reticulated from the ICPMR Hallway to the cleanroom through the
roof.
The Gascon Autochange

PM120
in the CO
2

cage is designed to engage a second gas bottle
when the

first bottle runs out
. The

HosLab unit located outside the cleanroom changeroom
will alarm both audibly and visually
to indicate
that
the gas bottle needs changing over.

6

Procedure

6.1

Monthly

data review

Facility Unit Director

6.1.1

Forward the Honeywell monito
ring da
ta to the
SCGT

Quality Manager and Quality Officer
monthly.

SCGT

Quality Officer

6.1.2

Print off the monitoring data from
the
Honeywell system.

6.1.3

Review the electronic monitoring data
(via Recorder)
on the IPA system

6.1.4

R
eview the
Powerpoint

alarm logs on t
he Alarm Log Folder on the desktop.

6.1.5

Check RE
-
BMT
-
F007 Equipment Action log to see if there
have been any issues

with O
2
.

6.1.6

Check

the

monitoring chart
s against the
specified

limits
in
Table 1.

6.1.7

Complete the RE
-
SYS
-
F
008

(
F
acility monitoring form).

6.2

Out of range
readings

noted during review

Quality Officer

6.2.1

I
nvestigate

any OOS
readings

and establis
h

the root cause
of the issue.

6.2.2

If the
reading

is due to a known event which has
no potential

to

impact on product
s

(e.g.
alarm test) record this on
RE
-
SYS
-
F
008

(F
acility

monitoring form).

6.2.3

I
f the OO
S
reading

cannot be linked to a

known
event

raise
a CAPA
following QS
-
SYS
-
S006

(CAPA).
T
he reason for an alarm not being

raised
or notified at the specified time
must
also
be established
.

6.2.4

Discuss
what action to take with the

rel
evant Production
Manager

(s)
and Quality Manager
.

Quality Manager

6.2.5

Inform all
relevant users of the facility of the issue if there was a potential that product was
effected.








SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

Version
1

A
ctive:

4/8/2011

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of
9

Documents not printed on
controlled

paper are valid for the print date only

Author: RMakin



CONFIDENTIAL



Production Managers

6.2.6

R
eview
all products released
s
ince the time of the OOS
rea
ding
.

6.2.7

Initiate the
QS
-
SYS
-
S
00
8
(
P
roduct recall

procedure
)
, if required.

6.3

Alarm

6.3.1

General
alarm
s

All ICPMR and Security Staff

a)

Report all audible

and visual alarms to BMC on Ext 56111

b)

If the alarm cannot be identified and/or resolved call
the designated staff

f
ollowing

RE
-
SCT
-
X002

(SCTL Facility Warning Sign)
which is posted on the SCTL front
door.

6.3.2

Honeywell

monitoring system

BMC

a)

Investigate any alarms
and correct the issue, where possible.

b)

Record the date and time of the alarm as well as any action taken.

c)

If t
he alarm cannot be resolved or has a potential t
o affect the work performed in
SCTL

(e.g. room temperature above 30
°C
)

call

the
staff listed on the BMC computer.

Designated SCTL contacts

a)

Discuss with BMC if the issue is due to known event.

b)

Where relevant,
i
nform all rele
van
t user
s

of the SCTL

following
RE
-
SCT
-
F006
(SCTL Emergency List).

As a minimum a message
must

be left with the Production
Manager
(
s
)

or delegate

of which their work may be affected.


c)

During normal working hours, place a sign on the front d
oor of SCTL detailing the
issue and warning staff not to use the rooms that are affected for production purposes.

d)


Raise a CAPA i
n Q
-
Pulse following QS
-
SYS
-
S006 (CAPA).

Production Managers TCR, BMT, WIT

a)

Investigate the impact of the
non
-
conformance on prod
ucts.

b)

Record a
ny

action in the
relevant
CAPA.

c)

Record the issue in the non
-
conformance section of the Product Release form and
follow

the clinical release section of QS
-
SYS
-
P007 (Product Release).

WARNING: When an alarm is due to
out of
specification

O
2

le
vels and/ or room
pressure processing MUST NOT occur until the issue has been completely resolved.

Processing when temperatures are OOS is not recommended. In urgent cases processing
may occur bu
t this must be recorded in the n
on
-
conformance section of the

Product
Release form
.

6.3.3

IPA

Monitoring System

SCTL Staff

(normal
working hours)

a)

Establish the location of the alarm.

b)

Investigate the cause of the issue and correct immediately
.


c)

N
otify your Production Manager and the Quality Manager.

Note: the system may be

muted, however, it must be ensured that the Production Manager
and Quality Manager are notified in a timely fashion.

See Appendix 8.3.

d)

Raise a CAPA in Q
-
Pulse f
ollowing QS
-
SYS
-
S006 (CAPA)


Designated SCTL staff (out of hours)

a)

When called by

an ICPMR st
aff member, BMC or S
ecurity e
stablish if the alarm is
due to a known event.







SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

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1

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ctive:

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Author: RMakin



CONFIDENTIAL

b)

If necessary, c
all

other parties (following
RE
-
SCT
-
F006 (SCTL Emergency List)
)

which may h
ave more information e.g. BMC, S
ecurity.

c)

Call Blood Bank and explain the situation. Ask i
f they can check the laboratory and
IPA system.

d)

If the issue is due to a known event and has been corrected record as a CAPA
following QS
-
SYS
-
S006 (CAPA)
on the next working day.

e)

If no known issue can be identified, the issue cannot be resolved by BMC,

Sec
urity or
Blood Bank or the issue has the potential to affect product
s come to work (or arrange
for
a staff member to come in to work).

Inform all rele
van
t user
s

of the SCTL

following
RE
-
SCT
-
F006. As a minimum a
message must be left with the Production Mana
ger(s) that their work may be affected.

d)

Investigate the cause of the issue and correct immediately.

e)

If the issue can’t be corrected place a sign on the equipment or facility specifying ‘Out
of Order

Equipment /facility and products contained must not be u
sed.’

f)

Investigate the impact of the non
-
conformance on products.

g)

Record all action taken in the relevant CAPA.

h)

Record the issue in the non
-
conformance section of the Product Release form and
follow the clinical release section of QS
-
SYS
-
P007 (Product Relea
se).

6.3.4

GMA 313 Carbon Dioxide Leak Detector

(Cleanroom)

The visual alarm displays are located in the changeroom and cleanroom.

The alarm
system has two modes 1
) Pulsed
and 2
) Continuous.

1)
Pulsed alarm indicates that CO
2

gas
has exceed
ed

1.5% volume but le
ss than 3%.

2) Continuous
alarm indicates

DANGER
-

CO
2

gas leak has exceeded 3.0% volume.

In the case of either alarm:

a)

Evacuate the affected area.

b)

Seal the affected area to prevent entry
.

c)

Place a sign on the front door of SCTL detailing the issue and war
ning staff not to use
the rooms that are affected.

d)

Dial ‘111’ Emergency.

e)

Contact the Quality Manager and Production Managers

following RE
-
SCT
-
F006
(SCTL Emergency List)

WARNING: If the alarm is in 2) continuous mode

contact

HOSLAB on 9816 3555
.

NO Person

should enter the room unless it can be verified by a personal CO
2

monitoring d
evice that it is safe to do so.

6.3.5

GDS 404

Oxygen Monitor

a)

The oxygen monitor is located just inside the BMT Workroom door on the left hand
side. The oxygen level should normally b
e approximately 21%.

b)

If the oxygen monitor reads 17


19%, look from the BMT Workroom to see if the
Cryotanks are frosted on the outside, or if there are clouds of cold air anywhere. Also
listen for hissing from the
LN
2

cylinders. These signs indicate l
eakage of liquid
nitrogen
.

c)

Dial ‘111’ emergency.

d)

C
ontact BMT Laboratory Staff following RE
-
W
MH
-
X4 (BMT Lab Alarm Sign).

e)

Do not enter the

cryoroom

if the monitor displays less than 17% oxygen, as
asphyxiation can occur. Close the door and contact BMT Labo
rat
ory Staff following
RE
-
WMH
-
X4

f)

If the Oxygen monitor is alarming audibly but the Oxygen levels are normal, then
there may have been
a
power disruption. Call BMC on Ext 56111.







SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

Version
1

A
ctive:

4/8/2011

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of
9

Documents not printed on
controlled

paper are valid for the print date only

Author: RMakin



CONFIDENTIAL

6.3.6

CO
2
Autochange

System

WIT and TCR Staff

a)

When the alarm requires the gas bottle

change get the keys from the BMT key box
(number 12).

b)

Go to the CO
2

cage located in the ICPMR Hallway.

c)

Follow the gas bottle changeover procedure located in the CO
2

cage.

(See EX
-
SCT
-
X002 Autochange Manifold Operating Instructions)

Note: Staff should a
lso

routinely check the HosLab u
nit display upon entry into the
cleanroom to see if a gas bottle requires replacing.

6.4

P
eriodic T
esting of the
Monitoring

Systems.

6.4.1

Honeywell

a)

The
alarm systems are

calibrated

and function

checked

six monthly by Honeywell.

The re
sults are recorded on RE
-
SCT
-
F009 BMC Monitoring Form.

6.4.2

IPA

a)

Perform the simulated

alarm test weekly for each probe.

b)

Notify Blood Bank that the alarm checks are being performed.

c)

Click
on the ‘password’ tab

on the IPA system
, enter SCTL, click on each indiv
idual
equipment / room and simulat
e

an out
-
of
-
range result.

d)

Check that the alarms activate, including relevant lights in Blood Bank.

e)

For each simulated alarm click on ‘Switch to alarm list’ and ‘Exit’. This will keep a
record of the alarms.

f)

Cut and paste

th
e alarm list into PowerPoint. See Appendix 8.4.

6.4.3

GDS 404

a)

The O
2

system is c
alibrated
by WS Biomedical every six month
s

as per
SCTL Facility
Maintenance Schedule
.

BMT Staff

b)

Check the Oxygen levels on each day of laboratory operation and record on RE
-
BMT
-
F31 (Oxygen Monitor Log).

c)

Perform a monthly alarm check of the oxygen monitor by blowing into the unit.
Record that the alarm has sounded on RE
-
BMT
-
F31 (Oxygen Monitor Log).

d)

Record any actions taken in the comments box. If more room is required to detail t
he
action complete RE
-
BMT
-
F007 (Equipment Action Log).

e)

Notify BMC and your Production Manager if the issue cannot be resolved.

f)

Complete an OFI and notify the SCGT Quality Manager.

6.4.4

GMA 313

a)

The GMA 313

CO
2

monitoring system is calibrated

by
HosLab six monthl
y as per
SCTL Facility Maintenance Schedule.

WIT and TCR Staff

b)

Upon entry into the cleanroom staff should ensure the green light on the monitor is lit.
This indicates the monitor has power supply.





SCGT

Quality Officer

c)

Once a week

perform a fun
ction test on the system following
EX
-
SCT
-
X001
(
GMA
313 Carbon Dioxide Monitor Operation Instructions
)
.

The audible warning (pulsed)
and visual alarm should activate.

d)

Record that the test has been performed on
RE
-
SCT
-
F008 (Facility monitoring form)
.

6.4.5

CO
2
Au
tochange

System

WIT and TCR Staff







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-

Monitoring of SCTL


RE
-
SCT
-
S004

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CONFIDENTIAL

a)

Upon entry into the cleanroom check the reading and lights display to see if a gas
bottle requires replacing.


SCGT

Quality Officer

b)

Check the electronic
function test monthly by pressing the ‘test’ button on the HosLab
uni
t.


6.4.6

BMT and cleanroom equipment

a)

All equipment attached to the monitoring systems are checked and calibrated
following the SCTL Facility Maintenance Sche
dule or relevant equipment SOPs.

6.4.7

Generator test

a)

Each month a generator test is performed across Westmead

Hospital by BMC to
ensure that critical equipment move from essential power to emergency power. The
essential power is turned off and after 5
-
10 sec the emergency power will activate.
Once the test is complete the system is switched back to essential powe
r. A log of the
generator tests is kept at BMC.

7

Changes to previous version



N/A

8

Appendices

8.1

Instructions for
out
-
of
-
hours
Blood Bank Staff
.

Following the below action to each alarm.

8.1.1

Red alarm

in Blood Bank



LN tanks and
-
80
°C

freezer


a)

C
ontact the Producti
on Manager BMT or delegate following
RE
-
SCT
-
F006 (SCTL
Emergency List).

8.1.2


Blue Alarm

in Blood Bank
-

CO
2

incubator
s


a)

Out
-
of
-
hours contact the Production Manager TCR or delegate following

RE
-
WMH
-
X5 Emergency contact list (CO2 incubator)
.

8.2

General c
orrective a
ction guide

8.2.1

Discuss with BMC or other users of the SCTL any issues which may have generated the
alarm (
e.g.
generator check).

8.2.2

Check all equipment

8.2.3

Check all power suppl
y

8.2.4

Check all cables.

8.3

Muting the IPA Alarm

8.3.1

Click on ‘Switch to alarm list’ on the IPA com
puter. This is important as a record of the
alarm is maintained on this list.

8.3.2

Click on ‘Exit’

8.3.3

Click on the password tab. Enter ‘SCTL’ (upper case)

8.3.4

Click on mute.

Note: By clicking on ‘Stop Siren’ the lights flashing in Blood Bank for a cryotank,
-
80
°C

free
zer and
cleanroom incubator alarm are stopped. This should only be done following the appropriate staff
being notified.

8.4

Cutting and pasting the alarm list into PowerPoint.

8.4.1

Click on ‘mimic’

8.4.2

Select ‘Current alarm’

8.4.3

Select ‘fn’ and ‘Print Screen’

8.4.4

Open PowerPo
int
via the start menu







SCGT
-

Monitoring of SCTL


RE
-
SCT
-
S004

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1

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ctive:

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Author: RMakin



CONFIDENTIAL

8.4.5

Select ‘Ctrl’ and ‘v’ to paste.

8.4.6

Crop the image.

8.4.7

Add text box and write in

‘……. alarms recorded on Microscan'
. Record your initials.

8.4.8

Save under the date.

8.4.9

Clear the alarm log.


9

End of document