2. 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
3. We are a small
dedicated team
Solo Ship weekly to the USA – Asia and
Europe
3
4. Flexible Film Containment Technology….
Does it work?
soloFLEXIsolator challenge: 10Kg API transfer x 3 runs
8. 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
9. 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. 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
SoloHardwareSelection
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: