P Didier Meyer-bolum 1.pdf · Isolators Containment Aseptic Increasing Reliability of Operation...
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Transcript of P Didier Meyer-bolum 1.pdf · Isolators Containment Aseptic Increasing Reliability of Operation...
© La Calhène 1997P #####
VALIDATION OF BARRIER VALIDATION OF BARRIER VALIDATION OF BARRIER VALIDATION OF BARRIER ISOLATION TECHNOLOGYISOLATION TECHNOLOGYISOLATION TECHNOLOGYISOLATION TECHNOLOGYVALIDATION OF BARRIER VALIDATION OF BARRIER VALIDATION OF BARRIER VALIDATION OF BARRIER ISOLATION TECHNOLOGYISOLATION TECHNOLOGYISOLATION TECHNOLOGYISOLATION TECHNOLOGY
Didier A. Meyer ; www.lacalhene.frIKEV ; ISTANBUL May the 3rd , 2002.Didier A. Meyer ; www.lacalhene.fr
IKEV ; ISTANBUL May the 3rd , 2002.
Michel Chabert
© La Calhène 1997P #####
The Isolation ContinuumThe Isolation Continuum
Asep
tic C
y tot
oxic
Clo
sed
Asep
tic O
pen
Cyt
otox
ic C
los e
d
Barri
er S
yste
m
Barri
er S
yste
m
Bios
afet
y C
abin
et
Lam
inar
Flo
w H
ood
Cla
ssifi
e d R
oom
Cla
ssifi
ed R
oom
Un-
clas
sifie
d R
oom
Un-
clas
sifie
d R
oom
Isolators
ContainmentAseptic
Incr
easi
ng R
elia
bilit
y of
Ope
ratio
n
Positive Pressure Negative Pressure
Increased sterility assurance Increased worker protection
Asep
tic C
lose
d
© La Calhène 1997P #####
© La Calhène 1997P #####
EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND REGULATIONS FOR THE ISOLATORS (1)REGULATIONS FOR THE ISOLATORS (1)REGULATIONS FOR THE ISOLATORS (1)REGULATIONS FOR THE ISOLATORS (1)EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND REGULATIONS FOR THE ISOLATORS (1)REGULATIONS FOR THE ISOLATORS (1)REGULATIONS FOR THE ISOLATORS (1)REGULATIONS FOR THE ISOLATORS (1)
� GMP 1985 & 1992� European Pharmacopea 1998 Edition� US Pharmacopea <1116> «Microbiological
evaluation of clean rooms and otherenvironments »
� USP <1208> « Sterility testing - Validation of isolator systems »
� UK « Isolators for the aseptic preparation of Pharmaceuticals » (yellow book)
� GMP 1985 & 1992� European Pharmacopea 1998 Edition� US Pharmacopea <1116> «Microbiological
evaluation of clean rooms and otherenvironments »
� USP <1208> « Sterility testing - Validation of isolator systems »
� UK « Isolators for the aseptic preparation of Pharmaceuticals » (yellow book)
© La Calhène 1997P #####
EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND REGULATIONS FOR THE ISOLATORS (2)REGULATIONS FOR THE ISOLATORS (2)REGULATIONS FOR THE ISOLATORS (2)REGULATIONS FOR THE ISOLATORS (2)EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND EXISTING RECOMMENDATIONS AND REGULATIONS FOR THE ISOLATORS (2)REGULATIONS FOR THE ISOLATORS (2)REGULATIONS FOR THE ISOLATORS (2)REGULATIONS FOR THE ISOLATORS (2)
� PICS recommendations to the inspectors for «Isolators used for aseptic processing andsterility testing »
� ISO 10648-2 on the classification of leakrates of separative enclosures
� PDA TR 34 on « Design and Validation of Isolator Systems for the manufacturing andtesting of Health care Products »
� A3P « Guide Pratique d ’Utilisation des Isolateurs »
� PICS recommendations to the inspectors for «Isolators used for aseptic processing andsterility testing »
� ISO 10648-2 on the classification of leakrates of separative enclosures
� PDA TR 34 on « Design and Validation of Isolator Systems for the manufacturing andtesting of Health care Products »
� A3P « Guide Pratique d ’Utilisation des Isolateurs »
© La Calhène 1997P #####
Texts to come …Texts to come …Texts to come …Texts to come …Texts to come …Texts to come …Texts to come …Texts to come …
�ISO 209 working group 7, in 2002 where isolators are one of the (separative enclosures)
�PIC/PICS on gassed isolators�ASPEC “ Guide Isolateurs -
Qualifications “
�ISO 209 working group 7, in 2002 where isolators are one of the (separative enclosures)
�PIC/PICS on gassed isolators�ASPEC “ Guide Isolateurs -
Qualifications “
© La Calhène 1997P #####
REQUESTS FROM ISO 10648REQUESTS FROM ISO 10648REQUESTS FROM ISO 10648REQUESTS FROM ISO 10648----2...2...2...2...REQUESTS FROM ISO 10648REQUESTS FROM ISO 10648REQUESTS FROM ISO 10648REQUESTS FROM ISO 10648----2...2...2...2...
� Classification of enclosures according to theirleaktightness
� Intended for « sensitive products requiring a special atmosphere and/or a sterile medium » i.e. applicable for the isolators
� When to be done:� Factory Acceptance Test�Site Acceptance Test�Operational Qualification Test�Monitoring Test
� Classification of enclosures according to theirleaktightness
� Intended for « sensitive products requiring a special atmosphere and/or a sterile medium » i.e. applicable for the isolators
� When to be done:� Factory Acceptance Test�Site Acceptance Test�Operational Qualification Test�Monitoring Test
© La Calhène 1997P #####
© La Calhène 1997P #####
Isolator,The Panacea for Sterile Process?Isolator,The Panacea for Sterile Process?
� Not replacing terminal sterilization processes
� Not avoiding the aseptic techniques
� Not allowing parametric release
� Not replacing terminal sterilization processes
� Not avoiding the aseptic techniques
� Not allowing parametric release
© La Calhène 1997P #####
© La Calhène 1997P #####
© La Calhène 1997P #####
© La Calhène 1997P #####
ManipulationManipulationManipulationManipulationManipulationManipulationManipulationManipulation
© La Calhène 1997P #####
Gloves: Choice and User GuidelinesGloves: Choice and User GuidelinesGloves: Choice and User GuidelinesGloves: Choice and User GuidelinesGloves: Choice and User GuidelinesGloves: Choice and User GuidelinesGloves: Choice and User GuidelinesGloves: Choice and User Guidelines
© La Calhène 1997P #####
THE GLOVE : THE WEAKEST POINT OF THE THE GLOVE : THE WEAKEST POINT OF THE THE GLOVE : THE WEAKEST POINT OF THE THE GLOVE : THE WEAKEST POINT OF THE ISOLATORSISOLATORSISOLATORSISOLATORS
THE GLOVE : THE WEAKEST POINT OF THE THE GLOVE : THE WEAKEST POINT OF THE THE GLOVE : THE WEAKEST POINT OF THE THE GLOVE : THE WEAKEST POINT OF THE ISOLATORSISOLATORSISOLATORSISOLATORS
� Material must transmit the sensitivity� Important mechanical constraint : hole, cutting, tear� Difficult to see its integrity� Fragile barrier between the hand of the operator and
the contaminated and/or sterile environment� Degradation of the materials with the sterilising
agents (H2O2, PAA)
� Material must transmit the sensitivity� Important mechanical constraint : hole, cutting, tear� Difficult to see its integrity� Fragile barrier between the hand of the operator and
the contaminated and/or sterile environment� Degradation of the materials with the sterilising
agents (H2O2, PAA)