oxygen methodchoice of the control - İkev didier meyer-bolum 2.pdf · choice of the control :...

© La Calhène 1997P #####

CHOICE OF THE CONTROL : CHOICE OF THE CONTROL : CHOICE OF THE CONTROL : CHOICE OF THE CONTROL : OXYGEN METHODOXYGEN METHODOXYGEN METHODOXYGEN METHOD

CHOICE OF THE CONTROL : CHOICE OF THE CONTROL : CHOICE OF THE CONTROL : CHOICE OF THE CONTROL : OXYGEN METHODOXYGEN METHODOXYGEN METHODOXYGEN METHOD

� Allow to do a control with the isolator at work

� Very few effect of the changes of temperature and humidity

� Normalised method : ISO 10648-2

� Low detection threshold: Allow to detect a non visible hole

� User ’s friendly

� Allow to do a control with the isolator at work

� Very few effect of the changes of temperature and humidity

� Normalised method : ISO 10648-2

� Low detection threshold: Allow to detect a non visible hole

� User ’s friendly


Ingress and Egress of sterile components...Ingress and Egress of sterile components...Ingress and Egress of sterile components...Ingress and Egress of sterile components...Ingress and Egress of sterile components...Ingress and Egress of sterile components...Ingress and Egress of sterile components...Ingress and Egress of sterile components...

� To keep their qualification for sterile process all the circulation of components, materials and equipments must be done a sterile way

� There are two types of transfer: batch or continuous

� To keep their qualification for sterile process all the circulation of components, materials and equipments must be done a sterile way

� There are two types of transfer: batch or continuous


Ingress and Egress of sterile components: Ingress and Egress of sterile components: Ingress and Egress of sterile components: Ingress and Egress of sterile components: A useful tool for batch transfer ; the DPTE® A useful tool for batch transfer ; the DPTE® A useful tool for batch transfer ; the DPTE® A useful tool for batch transfer ; the DPTE® Ingress and Egress of sterile components: Ingress and Egress of sterile components: Ingress and Egress of sterile components: Ingress and Egress of sterile components: A useful tool for batch transfer ; the DPTE® A useful tool for batch transfer ; the DPTE® A useful tool for batch transfer ; the DPTE® A useful tool for batch transfer ; the DPTE®

� Benefits of the DPTE® double door transfer systems:�Validated system with various diameters�Allows transfers of various nature� Let the access of the Alpha part free between

transfers�Bidirectional (protected unloading)�Worldwide compatible unmatched system�Compatible with DPTE® Bêta type container of any

material

� Benefits of the DPTE® double door transfer systems:�Validated system with various diameters�Allows transfers of various nature� Let the access of the Alpha part free between

transfers�Bidirectional (protected unloading)�Worldwide compatible unmatched system�Compatible with DPTE® Bêta type container of any

material


DPTE® a validated system...DPTE® a validated system...DPTE® a validated system...DPTE® a validated system...DPTE® a validated system...DPTE® a validated system...DPTE® a validated system...DPTE® a validated system...

� Microbiological performances: Ability of a germ free transfer within a highly contaminated environment�DPTE®, Jon M. Nottingham PDA Basel Feb. 1998

� Particulate performances: No contamination release�DPTE®,Jean-Pierre Brossard ISPE Amsterdam 1997

� Leaktightness integrity performances: Ability of having a leakrate 1000 times lower than the one of the isolator�Routine Integrity Testing of Isolators, Jean-Michel

Rivière PDA Basel Feb. 2000

� Microbiological performances: Ability of a germ free transfer within a highly contaminated environment�DPTE®, Jon M. Nottingham PDA Basel Feb. 1998

� Particulate performances: No contamination release�DPTE®,Jean-Pierre Brossard ISPE Amsterdam 1997

� Leaktightness integrity performances: Ability of having a leakrate 1000 times lower than the one of the isolator�Routine Integrity Testing of Isolators, Jean-Michel

Rivière PDA Basel Feb. 2000


AutoclavableAutoclavableAutoclavableAutoclavable DPTEBêtaBagDPTEBêtaBagDPTEBêtaBagDPTEBêtaBag®®®®AutoclavableAutoclavableAutoclavableAutoclavable DPTEBêtaBagDPTEBêtaBagDPTEBêtaBagDPTEBêtaBag®®®®


The sterile waste The sterile waste The sterile waste The sterile waste DPTEBêtaBagDPTEBêtaBagDPTEBêtaBagDPTEBêtaBag®®®®The sterile waste The sterile waste The sterile waste The sterile waste DPTEBêtaBagDPTEBêtaBagDPTEBêtaBagDPTEBêtaBag®®®®

oxygen methodchoice of the control - İkev didier meyer-bolum 2.pdf · choice of the control :...

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