mari - isolators - pharmtech 2012 - rev05
TRANSCRIPT
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Overview on Isolators Technology
7th International Specialised Forum
PHARMTECHPROM 2012 November 27-28, 2012
Giorgio MARI (Джорджио Мари)
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In the recent years, we assisted to a huge increase in the use of
the isolators. This is due to the continuous growth of the drugs potency but also to a deepened attention to industrial hygiene problems
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QA managerSafety manager
Positive Pressure !Negative
Pressure !
???
Engineer
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“Active” Containment – a fan keeps pressure below the environment:
The negative pressure assists in case of:
- Possible gaskets leaks
- Glove breakage (vel. In 0,4 m/s)
- Accidental door (or connection) opening
Dual filter System (both air inlet and outlet)
In case of fan stop, the “passive” containment is however assured
“Negative Pressure” Concept
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Negative Pressure Isolator
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- EVERYTHING must be inside the room at the beginning (until the room is clean)
- OPERATIONS with the active powder or micro-organism
- EVERYTHING must be cleaned before opening the room
“One Room” Isolators
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“One Room” IsolatorsFirst step
- Everything is inside at the beginning
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- e.g.: weighing; dispensing; powder dissolution
- Everything becomes potentially contaminated
“One Room” Isolatorsoperations
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- COMPLETE cleaning MUST be done before the door is opened
“One Room” IsolatorsFinal Cleaning
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What happens if I forgot to insert something?
- I MUST clean EVERYTHING before opening the door again
What happens if I need to extract something?
- I MUST clean EVERYTHING before opening the door again
- Cleaning the object which has to be extracted is NOT enough
“One Room” IsolatorsRIGIDITY
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PASS-BOX
How to overcome the RIGIDITY of the single room isolator?
Used to insert objects or materials
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Object entry
Cleaning
Unsafe use for object exit(object cannot be handled)
!?!?
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Waste exit continuous plastic tubular film
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IN / OUT room OPERATIONS room
TWO rooms Isolator
VERY “FLEXIBLE” USE FOR MATERILAS IN/OUT
VERY EXPENSIVE
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Systems with many isolators
DISPENSING
REACTOR
CENTRIFUGE DRYER
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Rapid Transport Port (RTP) + ContainerISO 11933 - 3
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Rapid Transport Port (RTP) + Container
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Rapid Transport Port (RTP) + Container
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Rapid Transport Port (RTP) + Container
ISOLATOR INTERIOR
ISOLATOR INTERIOR ISOLATOR
INTERIOR
CONTAINER CONTAINER CONTAINER
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1. approach 2. connection
isolator
glove
container
Rapid Transport Port (RTP) + Container
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3. door opening 4. sample transfer
Rapid Transport Port (RTP) + Container
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CLE
AN
CLE
AN
5. door closing 6. disconnection
Rapid Transport Port (RTP) + Container
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SPLIT – BUTTERFLY (concept)ISOLATOR INTERIOR
CONTAINER
ISOLATOR INTERIOR
CONTAINER
ISOLATOR INTERIOR
CONTAINER
ISOLATOR INTERIOR
CONTAINER
COUPLING
DISCHARGING
CLOSING
DISCONNECTING
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SPLIT – BUTTERFLY (applications)
BUTTERFLY with washing (applications)
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CIP Clean In Place (concept)
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CIP Clean In Place (applications)
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VHP Vaporized Hydrogen Peroxide decontaminationDeep integration with Isolators’ constructor
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VHP Vaporized Hydrogen Peroxide (applications)
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(N2) nitrogen inertization
NITROGEN
Oxygen is reduced < 3%Inside the isolator:Dust explosion problems are avoided
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(F&F) Fill and Finishing applications
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(API) Active Pharmaceutical Ingredients applications