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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
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)
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 »
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
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
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