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n EVERYTHING YOU NEED FOR CELL AND GENE THERAPY PRODUCTS AT YOUR HAND Producing advanced therapy medicinal products (ATMPs) for therapeutic purposes is a complex task, for which aseptic conditions are only one part of the requirement. Apart from the clean room zone itself, you need trained operators and strict procedures to prepare the room and the people involved to be ready for the process. This requires huge efforts in terms of infrastructures, personnel training and compliance. This approach is required by a wide range of advanced therapeutical approaches, including: • Production of ATMPs...

Euroclone, with its ISOCell PRO Cell Therapy Isolator, can be the answer to your needs by providing a streamlined workflow environment reducing the set up and running costs of cell therapy products preparation while still operating within the restrictive confines of various regulatory bodies (FDA, EUP, USP) and industry guidelines (GMP, PDA). • The sterility is maintained with the positive pressure of HEPA-filtered air. The outlet HEPA prevents against any return of non-sterile air. • System is designed to be used in validated GMP processes • Simplicity of the ISO 5 location and easy gowning...

Infrastructural cost reduction: Only Class D surrounding environment required Reduction of the central air conditioning system No need for specific consumables Time reduction: Faster Qualification/Validation Decrease in process time (no need for operator to progressively pass from a class D to a class A, no need for specific clothes) Decrease of decontamination time (H2O2 vapour) Safest: Smaller environment allowing easier monitoring and control Increase of the stability of the environmental parameters in the working area Possibility to install different units in a same room (independent alternative...

UNIDIRECTIONAL AIRFLOW The main working area is classified as class A according to GMP/EU, the aeraulics are designed to provide a unidirectional flow within both the main working area and the transfer hatch. The airflow in the transfer hatch is designed to increase during the opening of the product inlet in order to keep the internal environment clean and allow for a fast recovery of the class A environment. INTEGRATED CO2/O2 INCUBATOR The incubator is a custom device designed to fit into an isolator environment and connected to the SCADA system in order to monitor all the controlled parameters....

In several processes producing advanced therapy medications, using a centrifuge is essential. The centrifuge, over the counter or refrigerated, will be selected based on your production needs and placed under the working space thus keeping the class A manipulation area free. As for the incubator, it is fundamental that the centrifuge is used in compliance with the GMP rules that require to work in a controlled and monitored environment. Euroclone proposes the ISOCell PRO centrifuge to meet this need. ISOCELLPRO | ADVANCED THERAPY ISOLATOR

Producing a wide range or advanced therapy medications requests large production spaces, particularly for the medications dedicated to expanding cells in incubator. The two incubators equipped with CO2 and N2 allow to work also in hypoxia. The disinfection of the working area using hydrogen peroxide is effected without removing the cell coltures inside each incubator. These and other features make the incubator extremely flexible and able to meet a great number of processes’ needs complying with the GMP. ISOCELLPRO | ADVANCED THERAPY ISOLATOR

ISOCell PRO The manipulation incubator for the preparation of cell/genic therapy includes two stations, a microscope for the evaluation of the cell coltures status and an incubator for the storage and growth of the cell coltures. Furthermore, the ISOCell PRO can work in positive or negative pressure based on the processes of production to be implemented. ISOCell PRO is the unique one on the market already installed, validated and currently used in a laboratory credited for productions in GMP of injectable cells (CPC-CHUV Lausanne, Switwerland). ISOCELLPRO | ADVANCED THERAPY ISOLATOR

YOUR PROJECT, OUR SOLUTIONS Euroclone and its partners can provide a complete support for your project and requirements. We believe that assisting the customer from the planning phase through the realization of mock-ups, the identification of technical solutions to meet process requirements, the installation and training, until the final steps of validation and follow-up, is the key for a successful project. We have established a network of professionals who can help you integrate your process with the ISOCell PRO technology via customization and support, in order to achieve the best results...

TECHNICAL SPECIFICATIONS ISOCell PRO is realised in compliance with the Rules Governing Medicinal Products in the European Union (EudraLex) – Volume 4 EU Guidelines of Good Manufacturing Practice – Annex 1 Manufacture of Sterile Medicinal Products – 2008 revision. In particular it is designed in accordance with the requirement for Isolator Technology (paragraph 21 – 25). ISOCell PRO complies with the following European Directives and is designed according to the following European Norms: • Machinery Directive 2006/42/CE • EMC Directive 2004/108/CE • ISO14644.1 – Cleanroom and associated controlled...

Weight of the entire module (kg) External dimensions of the module (mm): Total noise level of the module (in dB) Material used for the exterior construction of the module Material used for interior construction of the module Air cleanliness class inside the module Working area average luminosity Air tightness of isolator Power consumption (in watt) for the entire module User interface type Electrical feed line Compressed air Laboratory gas lines (depending on process) Vacuum line for particle counter Interface 1500 Depth: 1500 - Width: 2900 - Height: 2350 <55 dbA Stainless steel AISI 304 Stainless...