catch the future of containment...
TRANSCRIPT
Catch the future of Containment Technology
Navigation:
Bench top isolators: soloLAB & soloFLEX pages 6-8
API powder dispensing page 10
API granulation containment /milling page 11
Tablet compression / Capsule filling page 12
Molecule Development / Chemistry isolators page 13
Inert Gas negative pressure isolators pages 14-16
ADC compounding isolators (single use) pages 17-18
Aseptic Processing (single use) pages 19-20
Key facts about Solo Containment:• UK based with 24 staff• Solo exports globally with customers in EU, USA, India, Singapore, China, Taiwan, Australia, New Zealand and
Russia• Solo handles around 60 to 80 containment projects each year and is currently manufacturing 200 flex enclosures
each month• ISO 9001 Quality system• ISO 5 Inspection suite• Monthly Bio-Burden testing • IR Spectroscopy testing (film purity) of all film batches entering manufacturing area
Delivering Pharmaceutically Compliant Isolator Systems is in our blood
What do the Solo team deliver?
I need to contain Nano particles
I need to process ADC toxin linkers
My operation needs to be Oxygen free
I need a single use Aseptic isolator
At Solo we deliver all of these containment solutions and more………. Right first time is a given
Trust Solo!
2019 Solo Containment Product Line Up
Laboratory scale
operations
The soloLAB: The pop up bubble isolator that is ideal for small scale operations microscopy and inert gas activities. Equipped with a full size gas tight zip door. Gas line and cable sleeves and a compact HEPA type venting filter. OEB 3* performance*following correct SOP guidelines
soloFLEX: Our high performance bench top containment solution. Capable of nanogram containment performance or equally at home delivering an inert gas or low humidity environment for your processes. The soloFLEX is a standard isolator available in 3 sizes and with a host of options to make this a versatile solution for many activities. Capable of obtaining OEB 4 and OEB 5* Containment levels.*additional upgrade system required
soloFLEX is available in 2 glove , 3 glove and 4 glove operating sizes
soloFLEX Features
and Benefits
StaySeal® Safe HEPA filter drop off system: Enclosure removal without the risk of contamination escape
StaySeal® Safe disposable Continuous liner system
Push Though Safe Change Gloves
To maximise operator safety the soloFLEX isolator range is designed for fast and API exposure free enclosure change overs. Zero cleaning validation as frame and support bench see no API contamination
soloFLEX Features
and Benefits
Size 2 x Glove 3 x Glove 4 x Glove
Work Enclosure Length 953 1453 1953
Work Enclosure Height 900 900 900
Work Enclosure Depth 700 700 700
Airlock Loading (500 wide)(Max Drum height 300mm)
Option LHS or RHS Option LHS or RHS Option LHS or RHS
Continuous Liner System 300mm Dia. x 40M ESD 300mm Dia. x 40M ESD 300mm Dia. x 40M ESD
HEPA Filter system H14 inlet/exhaust(Option 2 x stage exhaust)
H14 inlet/exhaust(Option 2 x stage exhaust)
H14 inlet/exhaust(Option 2 x stage exhaust)
Exhaust Fan options: 1. Manual speed control2. Auto speed control with
alarm3. ATEX compliant Venturi
1. Manual speed control2. Auto speed control with
alarm3. ATEX compliant Venturi
1. Manual speed control2. Auto speed control with
alarm3. ATEX compliant Venturi
All soloFLEX isolators feature a Sieden Crystal high optical clarity front screen, low friction frosted sleeves, push-push safe change glovesContained disposal assured by:StaySeal® Safe HEPA filter drop off system (filter disposed with contaminated enclosure)
StaySeal® Safe disposable Continuous liner system
soloFLEX Features
and Benefits
soloPLUS The versatile component platform for all Pharma containment applications
Buchi RotoVap Isolator
MillRock Lyophiliser IsolatorFrewitt Mill Isolator
R&D Scale double cone blender Isolator 6M long domestic vacuum cleaner performance test Isolator
Campaign Use Isolator for small API sampling & dispensing to Ezi-Dock CSV charge bags
This advanced design provides OEB 5 standards of API containment with zero cleaning validation. One flex enclosure can be used for each API material Change over of the flex enclosure is completed in minutes and all contaminated items such as HEPA filters and the continuous liner port are lifted from the support frame
API Dispensing
API Granulation & Powder processingsoloPLUS is the perfect solution for containment around granulators, milling, roller compactors and fluid bed dryers:
Containment performance levels of OEB 4 & OEB 5
Solo work frequently with the Ezi-Dock system
API Containment – Compression & Capsule Filling
Half suit system available for long reach activities
Xcelodose 600 Isolator with vibration resistant granite bed
API molecule / Process development
Small Filter Dryer Isolator Under assembly: PSL Glass Filter Dryer product harvesting Isolator
Small scale chemistry processing
in Solo barrier Isolator
ProCepT Spray Dryer
Isolator
Floor Tray Isolator
Inert Gas / Humidity Control SystemsSolo’s versatile gas delivery system can protect sensitive material during lyophilisation and filling activities
Rapid gas saturation pass box with single use aseptic filling enclosure
Nitrogen gas saturated Lyo and Quadro Comil Enclosure (rear view)
Telstar LyoBeta with special mounting flange
Nitrogen Saturated Comil U5 Isolator with RTP loading
Inert Gas / Humidity Control Systems
PLC driven humidity control isolator on Xcelodose 600
Containment of Xcelodose capsule filler with humidity control
Inert Gas / Humidity Control Systems
Large Jet Mill enclosure operating at negative pressure under compressed dry air environment
Rohrer 570 Blister Line with Solo’s Zero Humidity system
Multi Chamber Inert Gas API Dispensing into AVAX bag system
Advanced Single Use Isolators for ADC manufacture
High Potency API Applications / ADC CompoundingsoloPLUS is available as a single use fully disposable enclosure system where all contaminated parts are removed on a campaign basis. Zero cleaning validation required. Special safety features:
• EPDM high chemical resistivity gauntlets• EPDM base tray to protect film from solvent
spills• Multi stage H14 HEPA filter exhaust system• Automatic pressure decay test on every start
cycle• Automatic fan collapse of contaminated
enclosure• Magnetic Stirrer interface
StaySeal® Safe HEPA filter drop off system(filter disposed with contaminated enclosure)StaySeal® Safe disposable Continuous liner system
See the data from the 5 day containment test in accordance with EN689 (2018)
Single Use Aseptic Fill System
Solo Aseptic Processing System
Creating the worlds first Clinical Batch in a disposable isolator: https://labiotech.eu/fight-contamination-single-use-systems/
Solo Aseptic Processing System:The key Components…..
Triple wrapped GI treated enclosure is opened and placed onto stainless frame system
H14 HEPA filters hook into fan array module and drop into work deck recess
Add media/ ATMP solution container and connect to pre irradiated connectors
Hand fill vials and exit Grade A chamber via heat seal 15M continuous liner
Start Grade A airflowUnidirectional at
0.45M/Sec
Solo Aseptic Processing System:The Set Up
Solo Aseptic Processing SystemTypical Lyophiliser fill line with single use Isolator:
Our reputation depends on getting you the results you need….Our expertise with containment testing dates back to 1989 with the precursors to what became the ISPE smepac test system
Each year we conduct tests on our systems to ensure that we fully meet the required containment levels our customers require
We develop safe enclosure change out systems
We work with your operational team to develop effective SOP’s to maximise safety
See the Solo Hazard/Risk selection tool – New for 2019
Pharmaceutical Clients using Solo Containment Isolators
Global Clients: Oncology Specific Clients:
Filtration & Drying HP-API
Quadro-Comil Isolator
Drug Re-Pack Isolator
Lyophilised HP-API
ADC Compounding Isolator
Kilo-Lab Glassware IsolatorDr Reddy’s & Glenmark now customers
When you need containment solutions
Invest in the future
www.solocontainment.com+44 (0)1625 344014
Contact Solo Containment