STERILITY TESTING OF PHARMACEUTICALS ppt by DR.C.P.PRINCE
Our single use isolators explained
1. Our “Single –Use” Isolators Explained
1.0: Our Containment expertise:
The CEO of Solo Containment was the founding partner of the UK based containment company Extract Technology
(ET) who launched in 1981. ET developed to predecessor to the SMEPAC test in 1989 using HPLC assay methods to
improve the accuracy of containment performance testing. This pioneering work in stainless steel isolation design
created an extensive applications know-how. The Technical Manager at the ET business has been part of the Solo
Containment team since our inception and is responsible for migrating the know-how of stainless steel isolation
technology into our flexible film “single-use” containment systems.
2.0: Flexible Film / Flexible Foil Isolation Systems:
Our flexible film containment systems provide a safe working solution for the handling of HP-API’s toxic agents and
BSL rated compounds. In place of a polished stainless steel isolator body our systems are fully welded flexible foil
that creates a gas tight containment. All the zippers are a gas tight system and when operated at the recommended
negative pressure the containment performance is excellent.
• Low Purchase Cost
• Fast Delivery
• Designed for compact disposal
• Eliminates cleaning validation
• Fast Change over
3.0 Disposable HEPA filtration System:
Solo Containment manufacture their flexible foil
isolators with pre loaded and fully disposable H14
grade HEPA air filtration systems. This keeps the
particle count inside the isolator low whilst assuring no
particle migration is possible into the exhaust system.
Where required a fully disposable “Single-Use” two
stage HEPA system may also be provided.
2. 4.0 Reliable Negative Pressure Airflow:
For enhanced operator safety Solo Containment offer a wide
range of exhaust air fan systems: Ranging from our low cost
manual variable speed system, to our compressed air powered
fan for ATEX applications.
Our fan range includes a fully electronic control package
displaying chamber negative pressure , air change rate and
offering a low pressure alarm signal. This fan is available with
USB output to the BMS (building HVAC control system) and
may be provided with gas tight airflow valves to create an
automated Pressure Decay Test upon operation start up.
5.0 Chemical Attack Resistance:
Resistance to aggressive solvents is a key issue in ADC manufacture. At Solo Containment we are able to upgrade work
gloves to the EPDM or Hyperlon type for added chemical resistance. Where required the complete glove sleeve maybe
upgraded to these materials. To provide additional chemical resistance in the work enclosure we are able to offer fold up
EPDM base trays that can safely contain aggressive materials in the event of an accidental spill.
6.0 Continuous Liner System:
Most Solo Containment HP-API or ADC
manufacturing isolators are available with a fully
disposable Continuous Liner port holding a 40M
cassette of film. This typically provides up to 1 year
of operation and yet is protected from toxin ingress
by a simple zip over door. Available with a high
containment crimping system the Solo continuous
liner system leaves nothing to chance.
7.0 SOP Development:
At Solo we appreciate that our customers need a solution that delivers a safe operating environment day in day out. That is
why the team at Solo are able to develop SOP’s for your applications to ensure that the disposable isolator with all of the
steps and SOP’s needed for maximum safety.
3. We have recently used the Soloflex isolatorin one of our
clinical manufacturing campaigns just a few weeks ago.
We are satisfied with the performance and operability of the
unit so far, and have received a lot of interested looks when
others find out we are using a disposable glove box.
It would not be an understatement to stress how much of
an advantage a system like this provides for us, in a GMP
pharmaceutical environment where we are running multiple
products.
A job well done to you and to all team members at Solo.
8.0: Our Containment performance:
When operated with our recommended SOP’s the Solo flexible film isolation systems deliver an operator protection
performance inline with the most effective rigid stainless steel body isolators. Yet , their low cost , fast delivery and easy
set up make them ideal for short duration manufacturing runs.
9.0: Customer Feedback US based Development Facility
10.0: Other Solo Containment Solutions
Solo Containment offer a wide range of isolation solutions
covering:
Laboratory Bench Top :
http://solocontainment.com/products/sololab/
Small Operations Bench Top :
http://solocontainment.com/products/soloflex/
API Processing :
http://solocontainment.com/products/soloplus/
Low Oxygen Content / Low Humidity:
http://solocontainment.com/products/low-oxygen-low-
humidity/
Solo Containment are represented around the world by engineering professionals with years of
experience in Pharmaceutical and Bio Pharma applications
Contact Solo Containment on: +44 (0)1625 344014
Or visit www.solocontainment.com