Fresh Thinking in Flexible Film API Containment
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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
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