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© PharmOut 20161
IMA SpA
Containment Solutions
Marco Preus, 11-12 July 2016
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© PharmOut 20162
A little bit of history and market trends
Initially, isolators
were mainly used
for compounding
toxic API
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© PharmOut 20163
A little bit of history and market trends
Later, the industry saw the need to isolate
primary packaging machinery…….including filling
lines for aseptic products…tablet press…capsule
fillers….blisters machines…..
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© PharmOut 20164
Advantages of a contained process
• Better personnel protection, then:
• Lower costs:
• Less PPE (Personal protective equipment)
• Less time to spend to wear PPE
• Lower training costs
• Less risks for operators, then it will be easier to
find operators
• …ethics
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© PharmOut 20165
Advantages of a contained process
• Better quality of the products :
• Separation operator-product
• Minor risks of cross-contamination:
• No room contamination
• Possibility of WIP (Wash In Place) cycles
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© PharmOut 20166
Advantages of the “6 walls design”
• No gaskets between Isolator and Machine base
• Applied on all IMA Isolated machines
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© PharmOut 20167
Advantages of the “6 walls design”
6 WALL DESIGN:
- Perfect cleaning
- Lifetime resistant
- No maintenance
- No risks
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© PharmOut 20168
Advantages of the “6 walls design”
Video “6 walls design”
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© PharmOut 20169
Advantages of WIP (Wash In Place)
• At the end of a process with high potent products
a WIP cycle is available in almost all type of
machines
Video Washing Video Drying
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© PharmOut 201610
Isolated vials filling lines
• All sections can be isolated: Filling, Stoppering, FD
loading/unloading, capper, vial external washer.
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© PharmOut 201611
Tableting and Capsule fillers
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© PharmOut 201612
Blistering machines: Giants
GIANT blister line with “6-walls” housing fully integrated on the machine and SOMBRERO
feeding system
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© PharmOut 201613
ANY QUESTIONS?
Marco Preus
Isolation technology
Product manager
Shane Sipthorp
Selpak