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Our single use isolators explained

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a short insight into the systems available from Solo Containment

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Our single use isolators explained

  1. 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. 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. 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

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