FLEXIBLE CONTAINMENT SYSTEMS

March 2016

1 Copyright and Intellectual Property notice: All designs, knowhow and concepts shown in this presentation are the property of Solo Containment Ltd and may

not be shared to any third party without written permission © Solo Containment 2015

See the video: https://www.youtube.com/watch?feature=player_embedded&v=Ac9zDQPKe4Y

Our Background in Containment Technology: • Founded containment company Extract Technology in 1981

• Developed “Downflow Powder Handling booth” in 1984

• Detailed surrogate API challenge to downflow booth 1989

• Carried out “Containment Hierarchy” testing of booth technology – then booths +

work stations – then barrier isolation system 1991

• Established Containment Strategy Pyramid based on risk & hazard in 1996

• Solo Containment founded 2011 – Objective: Develop Superior Flexible Film Containment Technology

Solo is based in the UK – 14 employees – ISO9001 – Produce 50 to 60 flexible enclosures every month

We were instrumental in ISPE

SMEPAC

We are a small dedicated team

Solo Ship weekly to the USA – Asia and

Europe

3

Flexible Film Containment Technology…. Does it work?

soloFLEX Isolator challenge: 10Kg API transfer x 3 runs

Isolator + HEPA exhaust + Installation + IQ/OQ €14,000

Isolator + HEPA exhaust + Installation + IQ/OQ €23,000

As with any containment system – SOP’s and maintenance are key to long term safe operation.

As we review this test data it is clear that a well designed flexible film isolator will operate at the same performance standard as a classic stainless steel isolator. The system Solo Containment offer is a flexible film isolator – engineered to rigid stainless steel isolator standards • Negative pressure cascade in API handling chambers • Multi stage HEPA filtration • Consideration to contamination free HEPA filter service and enclosure change over

Comparison between classic stainless steel & Flexible Film Isolators

Stainless Steel Flexible Film

Cost

€150,000? €20, to 30,000?

Operating Cycle 10-15 years Frame 10-15Yr Enclosure 1- 4Yrs (campaign Use?)

Containment Performance Effected by transfer coupling or

RTP performance

sub 1.0µg/M³ sub 1.0µg/M³

Ergonomics OK if mock-up tested Easy to change

Chemical Resistance High resistance Reasonable resistance

Cleaning validation Anticipate high cost for CIP system validation

Disposable

Delivery to Site

24 weeks

6 to 8 weeks

10

Solo Containment Safety Features: Your guarantee of right first time performance

Aseptic -Lab Anerobic –Lab OEB3 (50-10µg/M³) OEB4 (10-1.0µg/M³) OEB5 (1.0- 0.01µg/M³)

Heavy Duty PVC Enclosure

FDA rated PU Film

Gas Tight fully welded access zips Single Chamber isolator Bi/Bo container entry

Two Chamber isolator

+ SOP

Gas tight acrylic pass box : Compression Gasket Inflatable gasket

Multi-Chamber with pressure cascade

+SOP

3 step continuous liner operation

+SOP

6 step continuous liner operation

Cuff mounted 3 groove safe change gloves

Cuff mounted Push-push safe change gloves

Contained Coupling Powder Transfer

Contained Coupling Powder Transfer with secondary containment chamber

+SOP

RTP contained transfer bagged materials

Manual variable speed fan

Automatic speed control fan

ATEX Fan option

Filter condition / Leak test alarm

99.95% Effy P3 Breather filter

Screw Mount HEPA

Push-Push safe change HEPA

Nitrogen inertion via PALL filter

Grade A environment in fill chamber

Gamma Irradiated Enclosure

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These “Hardware” Selections are backed up with a complete

range of validation options:

• Ergonomic Validation with full scale mock-up review on clients site

• Detailed equipment specifications and / or URS

• FAT at Solo facility

• Surrogate API challenge during Solo FAT

• Development of SOP’s

• SAT

• IQ/OQ

• Site Surrogate API challenge

Specification: The Key to reliable Containment Performance:

Flexible Film Containment and ATEX Classifications

Flexible Film Containment and ATEX Classifications

Polyurethane Film FPU 80 AS is considered suitable for ATEX zone 21

13

Specification: Let’s look at some examples:

Negative Pressure Enclosure around Granulator OEB 3

Aseptic -Lab Anerobic –Lab OEB3 (50-

10µg/M³)

OEB4 (10-

1.0µg/M³)

OEB5 (1.0-

0.01µg/M³) Heavy Duty PVC

Enclosure

FDA rated PU Film

Gas Tight fully welded

access zips

Single Chamber isolator

Bi/Bo container entry

Two Chamber isolator

Gas tight acrylic pass box

:

Compression Gasket

Inflatable gasket

Multi-Chamber with

pressure cascade

3 step continuous liner

operation

6 step continuous liner

operation

Cuff mounted 3 groove

safe change gloves

Cuff mounted Push-push

safe change gloves

Contained Coupling

Powder Transfer

Contained Coupling

Powder Transfer with

secondary containment

chamber

RTP contained transfer

bagged materials

Manual variable speed

fan

Automatic speed control

fan

ATEX Fan option

Filter condition / Leak

test alarm

99.95% Effy P3 Breather

filter

Screw Mount HEPA

Push-Push safe change

HEPA

Nitrogen inertion via

PALL filter

Grade A environment in

fill chamber

Gamma Irradiated

Enclosure

14

Specification: Let’s look at some examples:

Drum to Ezi-Dock Isolator OEB 3

Aseptic -Lab Anerobic –Lab OEB3 (50-

10µg/M³)

OEB4 (10-

1.0µg/M³)

OEB5 (1.0-

0.01µg/M³) Heavy Duty PVC

Enclosure

FDA rated PU Film

Gas Tight fully welded

access zips

Single Chamber isolator

Bi/Bo container entry

Two Chamber isolator

Gas tight acrylic pass box

:

Compression Gasket

Inflatable gasket

Multi-Chamber with

pressure cascade

3 step continuous liner

operation

6 step continuous liner

operation

Cuff mounted 3 groove

safe change gloves

Cuff mounted Push-push

safe change gloves

Contained Coupling

Powder Transfer

Contained Coupling

Powder Transfer with

secondary containment

chamber

RTP contained transfer

bagged materials

Manual variable speed

fan

Automatic speed control

fan

ATEX Fan option

Filter condition / Leak

test alarm

99.95% Effy P3 Breather

filter

Screw Mount HEPA

Push-Push safe change

HEPA

Nitrogen inertion via

PALL filter

Grade A environment in

fill chamber

Gamma Irradiated

Enclosure

15

Specification: Let’s look at some examples:

Clinical Trials Dispensing Isolator OEB4

Aseptic -Lab Anerobic –Lab OEB3 (50-

10µg/M³)

OEB4 (10-

1.0µg/M³)

OEB5 (1.0-

0.01µg/M³) Heavy Duty PVC

Enclosure

FDA rated PU Film

Gas Tight fully welded

access zips

Single Chamber isolator

Bi/Bo container entry

Two Chamber isolator

Gas tight acrylic pass box

:

Compression Gasket

Inflatable gasket

Multi-Chamber with

pressure cascade

3 step continuous liner

operation

6 step continuous liner

operation

Cuff mounted 3 groove

safe change gloves

Cuff mounted Push-push

safe change gloves

Contained Coupling

Powder Transfer

Contained Coupling

Powder Transfer with

secondary containment

chamber

RTP contained transfer

bagged materials

Manual variable speed

fan

Automatic speed control

fan

ATEX Fan option

Filter condition / Leak

test alarm

99.95% Effy P3 Breather

filter

Screw Mount HEPA

Push-Push safe change

HEPA

Nitrogen inertion via

PALL filter

Grade A environment in

fill chamber

Gamma Irradiated

Enclosure

16

Specification: Let’s look at some examples:

Oncology Product Re-Pack Isolator OEB5

Aseptic -Lab Anerobic –Lab OEB3 (50-

10µg/M³)

OEB4 (10-

1.0µg/M³)

OEB5 (1.0-

0.01µg/M³) Heavy Duty PVC

Enclosure

FDA rated PU Film

Gas Tight fully welded

access zips

Single Chamber isolator

Bi/Bo container entry

Two Chamber isolator

Gas tight acrylic pass box

:

Compression Gasket

Inflatable gasket

Multi-Chamber with

pressure cascade

3 step continuous liner

operation

6 step continuous liner

operation

Cuff mounted 3 groove

safe change gloves

Cuff mounted Push-push

safe change gloves

Contained Coupling

Powder Transfer

Contained Coupling

Powder Transfer with

secondary containment

chamber

RTP contained transfer

bagged materials

Manual variable speed

fan

Automatic speed control

fan

ATEX Fan option

Filter condition / Leak

test alarm

99.95% Effy P3 Breather

filter

Screw Mount HEPA

Push-Push safe change

HEPA

Nitrogen inertion via

PALL filter

Grade A environment in

fill chamber

Gamma Irradiated

Enclosure

17

Specification: Let’s look at some examples:

Enzyme Research Process Train Isolator OEB5

Aseptic -Lab Anerobic –Lab OEB3 (50-

10µg/M³)

OEB4 (10-

1.0µg/M³)

OEB5 (1.0-

0.01µg/M³) Heavy Duty PVC

Enclosure

FDA rated PU Film

Gas Tight fully welded

access zips

Single Chamber isolator

Bi/Bo container entry

Two Chamber isolator

Gas tight acrylic pass box

:

Compression Gasket

Inflatable gasket

Multi-Chamber with

pressure cascade

3 step continuous liner

operation

6 step continuous liner

operation

Cuff mounted 3 groove

safe change gloves

Cuff mounted Push-push

safe change gloves

Contained Coupling

Powder Transfer

Contained Coupling

Powder Transfer with

secondary containment

chamber

RTP contained transfer

bagged materials

Manual variable speed

fan

Automatic speed control

fan

ATEX Fan option

Filter condition / Leak

test alarm

99.95% Effy P3 Breather

filter

Screw Mount HEPA

Push-Push safe change

HEPA

Nitrogen inertion via

PALL filter

Grade A environment in

fill chamber

Gamma Irradiated

Enclosure

18

Specification: Let’s look at some examples:

High Potency Tablet Blister Line Isolator OEB5

Aseptic -Lab Anerobic –Lab OEB3 (50-

10µg/M³)

OEB4 (10-

1.0µg/M³)

OEB5 (1.0-

0.01µg/M³) Heavy Duty PVC

Enclosure

FDA rated PU Film

Gas Tight fully welded

access zips

Single Chamber isolator

Bi/Bo container entry

Two Chamber isolator

Gas tight acrylic pass box

:

Compression Gasket

Inflatable gasket

Multi-Chamber with

pressure cascade

3 step continuous liner

operation

6 step continuous liner

operation

Cuff mounted 3 groove

safe change gloves

Cuff mounted Push-push

safe change gloves

Contained Coupling

Powder Transfer

Contained Coupling

Powder Transfer with

secondary containment

chamber

RTP contained transfer

bagged materials

Manual variable speed

fan

Automatic speed control

fan

ATEX Fan option

Filter condition / Leak

test alarm

99.95% Effy P3 Breather

filter

Screw Mount HEPA

Push-Push safe change

HEPA

Nitrogen inertion via

PALL filter

Grade A environment in

fill chamber

Gamma Irradiated

Enclosure

Acrylic

Ezi-Dock

19

Specification: Let’s look at some examples:

Disposable Aseptic Small Run Vial Filling

Aseptic -Lab Anerobic –Lab OEB3 (50-

10µg/M³)

OEB4 (10-

1.0µg/M³)

OEB5 (1.0-

0.01µg/M³) Heavy Duty PVC

Enclosure

FDA rated PU Film

Gas Tight fully welded

access zips

Single Chamber isolator

Bi/Bo container entry

Two Chamber isolator

Gas tight acrylic pass box

:

Compression Gasket

Inflatable gasket

Multi-Chamber with

pressure cascade

3 step continuous liner

operation

6 step continuous liner

operation

Cuff mounted 3 groove

safe change gloves

Cuff mounted Push-push

safe change gloves

Contained Coupling

Powder Transfer

Contained Coupling

Powder Transfer with

secondary containment

chamber

RTP contained transfer

bagged materials

Manual variable speed

fan

Automatic speed control

fan

ATEX Fan option

Filter condition / Leak

test alarm

99.95% Effy P3 Breather

filter

Screw Mount HEPA

Push-Push safe change

HEPA

Nitrogen inertion via

PALL filter

Grade A environment in

fill chamber

Gamma Irradiated

Enclosure

Solving Containment Issues with Alternative Methods