MARI - Isolators - PharmTech 2012 - rev05

Overview on Isolators Technology

7th International Specialised Forum

PHARMTECHPROM 2012 November 27-28, 2012

Giorgio MARI (Джорджио Мари)

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

QA managerSafety manager

Positive Pressure !Negative

Pressure !

???

Engineer

“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

Negative Pressure Isolator

- 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

“One Room” IsolatorsFirst step

- Everything is inside at the beginning

- e.g.: weighing; dispensing; powder dissolution

- Everything becomes potentially contaminated

“One Room” Isolatorsoperations

- COMPLETE cleaning MUST be done before the door is opened

“One Room” IsolatorsFinal Cleaning

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

PASS-BOX

How to overcome the RIGIDITY of the single room isolator?

Used to insert objects or materials

Object entry

Cleaning

Unsafe use for object exit(object cannot be handled)

!?!?

Waste exit continuous plastic tubular film

IN / OUT room OPERATIONS room

TWO rooms Isolator

VERY “FLEXIBLE” USE FOR MATERILAS IN/OUT

VERY EXPENSIVE

Systems with many isolators

DISPENSING

REACTOR

CENTRIFUGE DRYER

Rapid Transport Port (RTP) + ContainerISO 11933 - 3

Rapid Transport Port (RTP) + Container


ISOLATOR INTERIOR

ISOLATOR INTERIOR ISOLATOR

INTERIOR

CONTAINER CONTAINER CONTAINER

1. approach 2. connection

isolator

glove

container


3. door opening 4. sample transfer


CLE

AN

CLE

AN

5. door closing 6. disconnection


SPLIT – BUTTERFLY (concept)ISOLATOR INTERIOR

CONTAINER

ISOLATOR INTERIOR

CONTAINER

ISOLATOR INTERIOR

CONTAINER

ISOLATOR INTERIOR

CONTAINER

COUPLING

DISCHARGING

CLOSING

DISCONNECTING

SPLIT – BUTTERFLY (applications)

BUTTERFLY with washing (applications)

CIP Clean In Place (concept)

CIP Clean In Place (applications)

VHP Vaporized Hydrogen Peroxide decontaminationDeep integration with Isolators’ constructor

VHP Vaporized Hydrogen Peroxide (applications)

(N2) nitrogen inertization

NITROGEN

Oxygen is reduced < 3%Inside the isolator:Dust explosion problems are avoided

(F&F) Fill and Finishing applications

(API) Active Pharmaceutical Ingredients applications

спасибо за внимание

Giorgio MARI (Джорджио Мари)

[email protected]

MARI - Isolators - PharmTech 2012 - rev05

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