PROJECT

INSTALLATION QUALIFICATION
QUALIFICATION
OPERATIONAL QUALIFICATION
AND
AND
CYCLE DEVELOPMENT
DEVELOPMENT
P #####
© La Calhène 1997
MSD - MK 826 PROJECT
STERILE ANTIBIOTIC FILLING
Length
Volume
8m
28 m
8m
27 m3
100 m3
34 m3
(including HVAC)
FREEZE DRYERS
LOADING/UNLOADING
Stoppers
Heating
Tunnel
TV
Inspection
Vials
Filling
Stoppering
Sterilizer
LYO 1
LYO 2
LYO 3
Capping
LYO 4
Frames
Washer
Accumulation
Frames
recycling
Conventional
capping
Transition
P #####
40108
© La Calhène 1997
All isolators are with recirculating laminar flow
VHP sterilization (VHP 1000)
Filling and freeze dryers interface isolators working at RH 15 %
Surrounding room : Grade D
Partners : BOSCH, USIFROID, SEIDENADER, IMA.
P 692/B
LA CALHENE VALIDATION
DATION
VALI
ON
VALIDATI
DEPARTMENT - missions
missions
EXTERNAL SERVICES:
On site qualification of special isolator systems example filling line isolator
On site qualification of “standard “isolator
systems - example sterility test suites
On site qualification of auxiliary equipment
example GLT,TLT, RTD
Technical support for PQ
On site post qualification training
P #####
© La Calhène 1997
LA CALHENE VALIDATION
DATION
VALI
VALIDATION
DEPARTMENT (2)
INTERNAL SERVICES:
Qualification of La Calhène standard equipment
DPTE BETA BAG, GLT, RDT, TLT, sterilizers
sterilizers
Validation support for sterile packaging facility
Validation of sterilization of beta bag systems
Development and qualification of Bis for
confinement systems
P #####
© La Calhène 1997
Q
UALIFICATION
PROTOCOLES
ES
QUALIFICATION
ON PROTOCOL
QUALIFICATI
Protocols are prepared using an “industry
standard”
standard” format
Sent to customer for approval at least 5 weeks
prior to start of qualification
P #####
© La Calhène 1997
INSTALLATION QUALIFICATION
QUALIFICATION
((1)
1)
ETUDES & DEVELOPPEM ENT
V A L ID A T IO N
1 rue d u P e tit C l a m art - B .P . 5 0
78 14 2 V E L IZ Y C E D E X - F R A N C E
T é l. 0 1.4 6.2 9.9 9.60 - F ax . 01.4 6.30.8 7.3 0
C
N S C A 1 6 1 /1 6
1 /4
T E S T S G U ID E
IQ
N°
TESTS
P a ge
R ev. P a ge
8 /4 9
C
L C refer enc e :
37K 53E
C u sto m er referen c e :
4 5 3 8 2 1 3 5/3 9 2
C u sto m er :
M SD
F IC H E S D E C O N T R O L E
IN SP E C T IO N N O T E S
N S C A 1 6 1/3 1
N°
P ag e
REF ERENCE DO CUM ENT
V A L ID A T IO N M A N A G E R
N am e
1 .0
D o c u m e n ta tio n re v ie w
N S C A 1 6 1 /1 6
1 (1 /4 to 4 /4 )
3 to 6
J. N O T T IN G H A M
2 .0
U tility c o n n e c tio n c h e c k
N S C A 1 6 1 /1 6
2 (1 /1)
7
J. N O T T IN G H A M
3 .0
P & ID c h e c k
1.
C om p on e n t a nd id en tifica tion ch e ck
N S C A 1 6 1 /1 6
N /A
N /A
J. N O T T IN G H A M
2.
C om p on e n t con form ity ch e ck
N S C A 1 6 1 /1 6
3 (1 /15 to 1 5/1 5)
8 to 2 2
J. N O T T IN G H A M
LA CALHENE
IN S P E C T IO N S / T E S T S
NAM E
E x ecu ted b y
V erified b y
P #####
© La Calhène 1997
D A T E & V IS A
D a te & V isa
CUSTO M ER
NAM E
D A T E & V IS A
INSTALLATION
INSTALLATION QUALIFICATION
QUALIFICATION
((2)
2)
ETUDES & DEVELOPPEM ENT
V A L ID A T IO N
1 ru e d u P e tit C l a m a r t - B .P . 5 0
78 14 2 V E L IZ Y C E D E X - F R A N C E
T é l. 0 1 .4 6 . 2 9 .9 9 . 6 0 - F a x . 0 1 . 4 6 . 3 0 . 8 7 .3 0
C
N S C A 1 6 1 /1 6
2 /4
T E S T S G U ID E
IQ
N°
TESTS
4 .0
H A Z O P a n d S o co tec ch ec k
5 .0
E le c tr ic a l in s ta lla t io n c h e c k
6 .0
P age
R ev. P age
9 /4 9
C
L C refer enc e :
37K 53E
C u s to m er refere n c e :
4 5 3 8 2 1 3 5 /3 9 2
C u s to m er :
M SD
F IC H E S D E C O N T R O L E
IN S P E C T IO N N O T E S
N S C A 1 6 1 /3 1
N°
P age
REFERENCE DO CUM ENT
V A L ID A T IO N M A N A G E R
N am e
N S C A 1 6 1 /1 6
N /A
N /A
J . N O T T IN G H A M
5 .1
E le c tric a l c a b in e t c o m p o n e n t c h e c k
E le c t r i c a l fi le
N /A
N /A
J . N O T T IN G H A M
5 .2
C a b li n g c h e c k
E le c t r i c a l fi le
N /A
N /A
J . N O T T IN G H A M
5 .3
V a l v e a n d b l o w e r o p e ra ti o n
N T A 3 0 1 4 /2
4 (1 / 2 t o 2 /2 )
2 3 to 2 4
J . N O T T IN G H A M
5 .4
M u n ters
N S C A 1 6 1 /1 6
N /A
N /A
J . N O T T IN G H A M
N T A 3 0 1 4 /2
5 (1 /1 )
25
J . N O T T IN G H A M
N S C A 1 6 1 /1 6
N /A
N /A
J . N O T T IN G H A M
D a te & V isa
M e c h a n i c a l i n s t a ll a tio n c h e c k
6 .1
Is o l a t o r t r a n s f e r s y s t e m s
6 .2
A cce ss w in d o w s a n d d o o rs
LA CALHENE
IN S P E C T IO N S / T E S T S
NAM E
E x ecu ted b y
V e rifie d b y
P #####
© La Calhène 1997
D A T E & V IS A
CUSTO M ER
NAM E
D A T E & V IS A
INSTALLATION
INSTALLATION QUALIFICATION
QUALIFICATION
((3)
3)
ETU D ES & D EV ELO PPEM EN T
V A L ID A T IO N
1 r u e d u P e ti t C l a m a r t - B .P . 5 0
78 14 2 V E L IZ Y C E D E X - F R A N C E
T é l. 0 1 .4 6 . 2 9 .9 9 . 6 0 - F a x . 0 1 . 4 6 . 3 0 . 8 7 .3 0
C
N S C A 1 6 1 /1 6
3 /4
T E S T S G U ID E
IQ
N °
7 .0
TESTS
Page
R ev. P age
1 0 /4 9
C
L C reference :
37K 53E
C u s to m er refere n c e :
4 5 3 8 2 1 3 5 /3 9 2
C u s to m er :
M SD
F IC H E S D E C O N T R O L E
IN S P E C T IO N N O T E S
N S C A 1 6 1 /3 1
N°
P age
REFERENCE DO C UM ENT
V A L ID A T IO N M A N A G E R
N am e
D a te & V isa
C a lib r a t i o n c h e c k
7 .1
R e l a t i v e h u m i d it y s e n s o r s
N S C A 1 6 1 /1 6
6
26
J . N O T T IN G H A M
7 .2
D if f e r e n t i a l p r e s s u r e s w i t c h e s
N S C A 1 6 1 /1 6
7
27
J . N O T T IN G H A M
7 .3
D if f e r e n t i a l p r e s s u r e s e n s o r s
N S C A 1 6 1 /1 6
8
28
J . N O T T IN G H A M
7 .4
A ir v e l o c it y s e n s o r
N S C A 1 6 1 /1 6
9
29
J . N O T T IN G H A M
7 .5
T e m p e r a tu r e s e n s o rs
N S C A 1 6 1 /1 6
10
30
J . N O T T IN G H A M
7 .6
T h e rm o m e te rs
N S C A 1 6 1 /1 6
11
31
J . N O T T IN G H A M
7 .7
T e m p e r a t u r e s w itc h e s ( h e a t t a p e c o n t r o l )
N S C A 1 6 1 /1 6
12
32
J . N O T T IN G H A M
7 .8
C on v e rte rs
N S C A 1 6 1 /1 6
13
33
J . N O T T IN G H A M
7 .9
L o o p te s t
N S C A 1 6 1 /1 6
14
34
J . N O T T IN G H A M
N S C A 1 6 1 /1 6
15
35
J . N O T T IN G H A M
7 .1 0 P re s s u r e g a u g e s
LA C A LH EN E
IN S P E C T IO N S / T E S T S
N A M E
D A T E & V IS A
C U STO M ER
N A M E
E x ecu ted b y
V e rifie d b y
1 r u e d u P e ti t C l a m a r t - B .P . 5 0
78 14 2 V E L IZ Y C E D E X - F R A N C E
T é l. 0 1 .4 6 . 2 9 .9 9 . 6 0 - F a x . 0 1 . 4 6 . 3 0 . 8 7 .3 0
P #####
© La Calhène 1997
ETU D ES & D EV ELO PPEM EN T
V A L ID A T IO N
D A T E & V IS A
INSTALLATION
INSTALLATION QUALIFICATION
QUALIFICATION
((4)
4)
ETUDES & DEVELO PPEM ENT
V A L ID A T IO N
1 ru e d u P e tit C la m art - B .P . 5 0
78142 V E LIZY C E D E X - F R AN C E
T é l. 0 1.4 6. 2 9 .9 9 .60 - F ax . 01 .4 6 .30 .8 7 .3 0
C
N S C A 1 6 1 /1 6
4 /4
T E S T S G U ID E
IQ
N°
8 .0
TESTS
R e v. P a g e
1 1 /4 9
C
37K 53E
C u s to m er r ef er e n c e :
4 5 3 8 2 1 3 5/3 9 2
C u s to m er :
M SD
F IC H E S D E C O N T R O L E
I N S P E C T IO N N O T E S
N S C A 1 6 1/3 1
N°
P age
REFERENCE DO CUM ENT
V A L ID A T IO N M A N A G E R
N am e
D a t e & V is a
F u n c tio n a l te s ti n g o f c o n tr o l h a r d w a r e a n d s o ft w a r e
8 .1
H a r d w ar e ch e ck
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
8 .2
B a ck u p an d r es to re tes t
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
8 .3
L oa d e r a n d a p p lica tio n ve rifica tio n
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
8 .4
In p u t/o u tp u t tes ts
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
8 .5
U n ita r y te sts (fu n ctio n al b lo ck )
N S C A 1 6 1 /2 5
8 .6
T ra n s itio n t es ts
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
8 .7
S e q u en cin g te sts
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
8 .8
P ha se tes ts
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
8 .9
D e fa u lt tes tin g – s e co n d a ry n etw o r k
N S C A 1 6 1 /2 5
J . N O T T IN G H A M
N /A
J . N O T T IN G H A M
8 .1 0 P ha se v ie w te sts
NAM E
E x e c u te d b y
V e ri fie d b y
© La Calhène 1997
N /A
N /A
J . N O T T IN G H A M
LA CALHENE
IN S P E C T IO N S / T E S T S
P #####
P age
L C r ef er e n c e :
D A T E & V IS A
CUSTO M ER
NAM E
D A T E & V ISA
OPERATIONAL QUALIFICATION
(1)
ETUD ES & DEVELO PPEM ENT
V A L ID A T IO N
1 rue d u P e tit C lam art - B .P . 5 0
78 14 2 V E LIZY C E D E X - F R AN C E
T él. 0 1.4 6.2 9.9 9.60 - F ax . 01.4 6.30.8 7.3 0
C
1/2
TE STS G U ID E
OQ
N°
TEST
P RO C E D U R E
T E ST S
D oc N ° : N S C A 161/17
P age
R ev. P age
L C refer ence :
37K 53 E
C ustom er reference :
453 8213 5/3 92
7/28
C ustom er :
M SD
B
F IC H E S D E C O N T RO L E
IN SP E C T IO N NO T E S
N SC A 16 1/32
N°
P ag e
V A L ID A T IO N M A N AG E R
Nam e
1.0
C h ec k o f IQ p rio r ity 1 p u n ch list c o m p letio n
N SC A 1 61 /17
N /A
N /A
J. N O T T IN G H AM
2.0
F ilter in t eg r ity te stin g
N T A 3 01 4/10
1 (1/13 to 1 3/1 3)
3 to 15
J. N O T T IN G H AM
3.0
L ea k test in g
N T A 30 14 /6
2 (1/1)
16
J. N O T T IN G H AM
4.0
V H P  1001 fu n ction al ch ec k
N T A 30 18 /1
3 (1/2 to 2 /2)
17 to 1 8
J. N O T T IN G H AM
5.0
S te riliza tio n p h a se te s t
N SC A 1 61 /21
4 (1/4 to 4 /4)
19 to 2 2
J. N O T T IN G H AM
6.0
A ir d istrib u tio n

Pressure differen tial in production ph ase
N SC A 1 61 /10
5 (1/2 to 2 /2)
23 to 2 4
J. N O T T IN G H AM
R ecircu lation rate in prod uction p hase
N SC A 1 61 /10
6 (1/14 to 1 4/1 4)
25 to 3 8
J. N O T T IN G H AM
1.3.
Air change rate in aeration step of sterilization
p hase
N SC A 1 61 /10
7 (1/3 to 3 /3)
39 to 4 1
J. N O T T IN G H AM
1.4.
Air speed m ap, u niform ity of airflow
sm oke test in prod uction p hase
N T A 3 01 4/11
8 (1/8 to 8 /8)
42 to 4 9
J. N O T T IN G H AM
1.1.
1.2.
an d
LA CALHENE
IN S P E C T IO N S / T E S T S
NAM E
V erified b y
P #####
© La Calhène 1997
D A T E & V ISA
D a te & Visa
CUSTOM ER
NAM E
D A T E & V ISA
OPERATIONAL QUALIFICATION
(2)
ETUDES & DEVELOPPEM ENT
V A L ID A T IO N
1 rue d u P etit C lam art - B .P . 5 0
78 14 2 V E LIZY C E D E X - F R AN C E
T é l. 0 1.4 6.2 9.9 9.60 - F ax . 01. 4 6. 30.8 7.3 0
C
2 /2
T E S T S G U ID E
OQ
N°
T E ST S
T E ST
P RO C ED URE
D oc N ° : N S C A 1 6 1 /1 7
P a ge
R ev. P a ge
L C refer enc e :
37 K 53 E
C u sto m er referen c e :
45 38 21 3 5/39 2
8 /2 8
C u sto m er :
M SD
B
F IC H E S D E C O N T R O L E
IN SP E C T IO N N O T E S
N S C A 1 6 1/32
N°
P ag e
V A L ID A T IO N M A N A G E R
Nam e
7 .0
P a rtic le c o u n t
N T A 3 0 1 4 /12
9 (1 /7 to 7 /7 )
5 0 to 5 6
J. N O T T IN G H A M
8 .0
N o is e le v e l c h e c k
N T A 3 0 1 4 /17
1 0 (1 /2 to 2/2 )
5 7 to 5 8
J. N O T T IN G H A M
9 .0
L ig h t le v e l c h e c k
N T A 3 0 1 4 /13
1 1 (1 /2 to 2/2 )
5 9 to 6 0
J. N O T T IN G H A M
1 0 .0
M a n u a l p h a s e te s t
N S C A 1 6 1 /2 5
N /A
N /A
J. N O T T IN G H A M
1 1 .0
E m e r g e n c y p h a s e te s t
N S C A 1 6 1 /2 5
N /A
N /A
J. N O T T IN G H A M
1 2 .0
C le a n in g p h a s e te s t
N S C A 1 6 1 /2 5
N /A
N /A
J. N O T T IN G H A M
1 3 .0
T e s tin g p h a s e t e s t
N S C A 1 6 1 /2 5
N /A
N /A
J. N O T T IN G H A M
1 4 .0
P r o d u c tio n p h a s e te s t
N S C A 1 6 1 /2 5
N /A
N /A
J. N O T T IN G H A M
LA CALHENE
IN S P E C T IO N S / T E S T S
NAM E
V erified b y
P #####
© La Calhène 1997
D A T E & V IS A
D a te & V isa
CU STOM ER
NAM E
D A T E & V IS A
CYCLE DEVELOPME
DEVELOPMENT
NT
DEVELOPMENT
PROGRAMME (1)
(1)
ETUDES & DEVELOPPEMENT
VALIDATION
1 rue du Petit Clamart - B.P. 50
78142 VELIZY CEDEX - FRANCE
Tél. 01.46.29.99.60 - Fax. 01.46.30.87.30
Doc N° : NSCA 161/37
C
TEST GUIDE
CD
CONTROLS
TESTS
N°
Page
8/30
Rev. Page
B
INSPECTION NOTES
NSCA 161/38
N°
Page
TEST
PROCEDURE
37 K 53 E
MSD
VALIDATION MANAGER LA CALHENE
Nom
Date & Visa
1.0
Prerequisites check
N/A
N/A
N/A
J. NOTTINGHAM
2.0
Isolators / VHP® generators OQ completion check
N/A
N/A
N/A
J. NOTTINGHAM
3.0
Check of IQ priority 1 punchlist for equipment completion
N/A
N/A
N/A
J. NOTTINGHAM
4.0
Isolator preparation
N/A
N/A
N/A
J. NOTTINGHAM
4.2. VHP inlet flow, uni-directional flow air speed and
distribution fan flow checks
NSCA 161/10, NTA 3014/9
1 (1/2 to 2/2)
3 to 4
J. NOTTINGHAM
4.3. Pre sterilization checks
NTA 3022/1, NTA 3022/4,
NTA 3022/6, NTA 3022/7
2 (1/1)
5
J. NOTTINGHAM
N/A
3 (1/1)
6
J. NOTTINGHAM
N/A
4 (5/14 to 6/14)
10 to 12
J. NOTTINGHAM
NTA 3014/18
4 (1/14 to
14/14)
7 to 20
J. NOTTINGHAM
4.1. Initial positioning of temporary distribution fans
4.4. VHP programming and isolators sterilization recipe
checks
5.0
Verification of data acquisition system and calibration of
thermocouples
6.0
Temperature mapping and gaz distribution using chemical
indicators
LA CALHENE
INSPECTIONS / TESTS
Verified by
P #####
MK 0826
Project :
Reference LC :
Client :
© La Calhène 1997
NAME
DATE & VISA
CLIENT
NAME
DATE & VISA
CYCLE DEVELOP
DEVELOPMENT
MENT
NT
DEVELOPME
PROGRAMME (2)
(2)
ETUDES & DEVELOPPEMENT
VALIDATION
1 rue du Petit Clamart - B.P. 50
78142 VELIZY CEDEX - FRANCE
Tél. 01.46.29.99.60 - Fax. 01.46.30.87.30
Doc N° : NSCA 161/37
C
TEST GUIDE
CD
CONTROLS
TESTS
N°
Page
9/30
INSPECTION NOTES
NSCA 161/38
N°
Page
TEST
PROCEDURE
7.0
Base cycle verification and isolator reconfiguration
8.0
Verification of biological indicators
37 K 53 E
MSD
VALIDATION MANAGER LA CALHENE
Nom
Date & Visa
N/A
5 (1/2 to 2/2)
21 to 22
J. NOTTINGHAM
NTA 3022/6
6 (1/1)
23
J. NOTTINGHAM
9.0
Bio-decontamination capability using Bis
NSCA 161/08
7 (1/24 to
24/24)
24 to 47
J. NOTTINGHAM
10.0
Aeration testing
NSCA 161/08
8 (1/1)
48
J. NOTTINGHAM
11.0
Final cycle parameters
N/A
9 (1/1)
49
J. NOTTINGHAM
12.0
Definition of final distribution fan positioning
N/A
N/A
N/A
J. NOTTINGHAM
LA CALHENE
INSPECTIONS / TESTS
Verified by
P #####
MK 0826
Project :
Reference LC :
Client :
Rev. Page
A
© La Calhène 1997
NAME
DATE & VISA
CLIENT
NAME
DATE & VISA
E
XAMPLE OF A RECE
RECENT
NT
EXAMPLE
PROJECT (1) - Pre sterilisation checks
Do’s - Prepare the isolator and the room,
Limit access to test personnel only,
Check that other project activities will not interfere,
Hold daily progress meetings to keep all parties informed.
P #####
© La Calhène 1997
Don’ts -Start with an element
missing or faulty - compromises
can bite back later on
EXAMPLE OF A RECE
RECENT
NT
PROJECT (2) -VHP generator qualification
Calibration - do before
starting cycle
development tests
Supply pipe work don ’t forget the risk
of condensation
Pressure reference
point - don ’t forget
possibility of
pressure variations
P #####
© La Calhène 1997
EXAMPLE OF A RECE
RECENT
NT
PROJECT (3) - verification of data
collection system and thermocouples
Do’s -Calibrate thermocouples in advance,
Make accurate and detailed records of the
cable routings,
Synchronise clocks on all test equipment,
the VHP and isolator PLC
P #####
© La Calhène 1997
Don’ts - Don ’ts forget to check that thermocouples
will not catch in moving parts
EXAMPLE OF A RECE
RECENT
NT
PROJECT (4) - initial positioning of
distribution fans
Do’s - Define N° of fans during design
Check for interference with other elements
Check where supply cable will pass
P #####
© La Calhène 1997
Don’ts - Forget to accurately record
position in three dimensions before
and after testing,
EXAMPLE OF A RECE
RECENT
NT
PROJECT (5) - Gas distribution studies
Do’s -Prepare a « CI team ». It is best to have
3 people per team - 2 to read CIs and one to
record the results,
Train each member to recognise the same
colour change,
Split the isolator into sections,
Use a gas concentration monitor (UOP).
P #####
© La Calhène 1997
Don’ts - Don’t ask someone to read CIs unless
they are perfectly familiar with each location looking for the CIs affects the results,
Do not carry out test without a « map » for each
tester
EXAMPLE OF A RECE
RECENT
NT
PROJECT (6) - BI tests
Do’s - Work under controlled conditions and
use « aseptic » techniques,
Know the D value,
Record any handling errors,
Place BIs in « representative » areas only.
P #####
© La Calhène 1997
Don’ts - Use too many locations,
Use BIs without removing the packaging (some
are supplied in paper/tyvek bags).
NOTES
STERILISATION
NOTES ON STERILISATION
CYCLE TESTING
TESTING (1)
GOOD
GOOD PREPARATION AND GOOD CONTROL ARE
OF UPMOST IMPORTANCE
CYCLE
CYCLE DEVELOPMENT FOR A SPECIAL
PRODUCT SUCH AS A FILLING LINE SHOULD BE
REGARDED AS A SEPERATE STAGE IN THE
VALIDATION PROCESS POSITIONED BETWEEN
OQ AND PQ
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© La Calhène 1997
E
XAMPLE OF A RECE
RECENT
NT
EXAMPLE
PROJECT (7) - Sterility test suite
PLC controlled transfer
and workstation isolators
VHP gas generator
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© La Calhène 1997
EXAMPLE OF A RECE
RECENT
NT
PROJECT (8) - Sterility test suite
qualification
Operational
Qualification
ends with
sterilisation
tests using Bis
3 types of test:
temperature
mapping, CI
tests and BI
tests
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© La Calhène 1997
EXAMPLE OF A RECE
RECENT
NT
PROJECT (9) - gas concentration transfer
isolator using Polytron HC sensor
Target concentration
1400 ppm
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© La Calhène 1997
EXAMPLE
RECENT
CENT
EXAMPLE OF A RE
NT
RECE
PROJECT (10)
(10) - Technical support for PQ
Sterilisation tests
at end of OQ with
islolator load
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© La Calhène 1997
A typical
isolator load must be
evenly
distributed for
good gas
distribution
E
XAMPLE OF A RECE
RECENT
NT
EXAMPLE
RECENT
PROJECT (11) - Technical support for PQ
Advice on the use
and positioning of
environmental
monitoring
equipment
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© La Calhène 1997
Advice on
isolator
cleaning
procedures
and material
compatibility
Conclusion
Isolator technology is one solution to perform aseptic
processing
The validation and the periodic re-validation is one important
part to assure the profile of quality of the production
The time dedicated to the validation and re-validation has to be
taken in account for the production planning
The reproducibility in the use of Isolation Technology brings an
important safety factor when compared with manned Aseptic
Processing Area
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© La Calhène 1997