© PharmOut 20161

IMA SpA

Containment Solutions

Marco Preus, 11-12 July 2016

© PharmOut 20162

A little bit of history and market trends

Initially, isolators

were mainly used

for compounding

toxic API

© 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…..

© 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

© 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

© PharmOut 20166

Advantages of the “6 walls design”

• No gaskets between Isolator and Machine base

• Applied on all IMA Isolated machines

© PharmOut 20167

Advantages of the “6 walls design”

6 WALL DESIGN:

- Perfect cleaning

- Lifetime resistant

- No maintenance

- No risks

© PharmOut 20168

Advantages of the “6 walls design”

Video “6 walls design”

© 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

© PharmOut 201610

Isolated vials filling lines

• All sections can be isolated: Filling, Stoppering, FD

loading/unloading, capper, vial external washer.

© PharmOut 201611

Tableting and Capsule fillers

© PharmOut 201612

Blistering machines: Giants

GIANT blister line with “6-walls” housing fully integrated on the machine and SOMBRERO

feeding system

© PharmOut 201613

ANY QUESTIONS?

Marco Preus

Isolation technology

Product manager

preusm@ima.it

Shane Sipthorp

Selpak

shane@selpak.com.au