Extract Technology Ltd

Brand & Trade Names

• Cell Therapy Isolators Extract Technology produce a range of Cellular therapy Isolators to suit clients individual requirements. Ergonomic design generated by the use of sloping operator interface panels, large oval PharmaPort gloveports (safe change), all proven with the aid of full scale mock-ups. Multiple chamber arrangements providing defined barriers between process steps, enhancing aseptic performance Fully welded fabrications of 316L stainless steel, providing crevice free construction with internally radiused corners. On-board recirculation laminar flow air flow system guaranteeing ISO 5 classification. Closed loop fan control systems maintaining operational settings. GAMP 5 compliant. Integration of proprietary devices e.g. RTP’s. incubators, centrifuge and decontamination system etc. Controlled environments such as temperature, humidity and oxygen content. The Main advantages of using Cell therapy Isolators compared to the traditional cleanroom operation are as follows: EU GMP compliant design Increased safety by reducing contamination risks (increased patient safety) Full process equipment integration within grade A environment Easier process separation Different pressure regimes available within each chamber Energy efficiency Routine Hydrogen Peroxide Decontamination Gowning not required
• FlexiPharm Isolator Extract Technology are a leading worldwide supplier of rigid and flexible containment systems for the pharmaceutical healthcare, biotech and chemical markets. Providing operator protection to <1μg/m³ , Flexipharm is a new innovative product forming part of our initiative to offer a low cost containment solution while maintaining the high standards required within the Pharmaceutical Industry. Available with 2,3,or 4 glove ports and an entry zip it becomes the ideal solution for small scale weighing and dispensing operations handling highly potent API’s. Drawing on our extensive market experience with flexible and rigid isolator projects the Flexipharm has been designed with Operator ergonomics, ease of use and the “off the shelf” supply chain/ low cost pricing structure at the heart of the design. The controls consist of a simple fan speed controller with green and red zoned visual indicators showing correct pressure within the enclosure and exhaust filter condition. Design Advantages: To provide operator protection to <1μg/m³ Negative operating pressure to – 25pa in the chamber Low noise levels Single chamber design complete with bag out port 3 off connections for mechanical services Isolator frame and optional table made from 304 stainless steel Large zip on the main chamber for the loading of process equipment Open loop control and green/red visual indication of isolator pressure and exhaust filter condition Safe change H14 “push- push” exhaust HEPA filters within a stainless steel housing
• IsoPharm standard containment isolator Providing operator protection to <1 μg/m³, IsoPharm is a new innovative product forming part of our initiative to offer a cost effective containment solution while maintaining the high standards required within the Pharmaceutical Industry. Available with 2, 3 or 4 gloveports and entry / exit airlock, IsoPharm is the ideal solution for small scale weighing and dispensing operations handling highly potent API’s. Drawing on our extensive experience with Isolator projects the IsoPharm Isolator has been designed with Operator ergonomics and ease of use at the centre of our design process. The control philosophy provides essential operations, all accessible through the easy to use operator HMI. Design Advantages To provide operator protection to <1 μg/m³ Negative operating pressure in the Airlock (50Pa) and Main Chamber (75Pa) Lighting Levels in the Main Chamber >500Lux Noise circa 65dBa Single chamber design complete with interlocked entry / exit airlock Isolator chamber manufactured from 3mm thick 316L stainless steel. 0.6Ra internal finish Internal radius corners Hinge open front access door for equipment / process set up Closed loop control and glove breach protection Safe change double hepa filter
• Restricted Access Barrier Systems RABS Extract Technology Restricted-Access Barrier Systems or RABS, provides product protection superior to traditional systems and offers a viable alternative to Isolators and cleanrooms. Our bespoke systems are designed to meet all existing requirements for Aseptic processing. RABS provide protection by delivering a physical and aerodynamic barrier over a critical process zone with easier access to the process in the event when intervention is required and can be used for many applications in a fill-finish area. Extract Technology has developed over many years a diverse engineered RABs port folio to include: Open Passive RABs which utilise existing cleanroom overhead air supply systems to deliver HEPA filtered air over a critical process before returning air back into the clean room without the need for additional fans or filters. Open Active RABS which have an on board fan /filtration units to supply HEPA Filtered air over a critical process before returning air back into the clean room Closed RABS is a positive pressure system which has on board fan /filtration units to supply HEPA Filtered air over a critical process which then passes through exhaust filters before being recirculated. Closed RABS can also utilise ETL’s on board VPHP bio decontamination system or alternatively OEM’s stand alone bio decontamination units can be connected directly into the closed RABS
• Sterile Isolators Extract Technology’s Sterility Test Isolators are designed to allow operators to perform sterility testing in an aseptic environment providing assurance of process integrity. They also provide a controlled means of loading and removing the processed product and waste materials from the Isolator enclosure. This system provides a cost-effective alternative to the “multi-isolator” approach to sterility testing and is ideal for those customers with limited laboratory space whilst benefiting from the ability to provide rapid decontamination. Benefits include: Ergonomic design generated by the use of sloping operator interface panels, large oval PharmaPort gloveports (safe change) EU GMP compliant design Full process equipment integration within grade ISO 5 environment Integrated Millipore Steritest® Unit or Sartorius Sterisart®NF Easier process separation Different pressure regimes available within each chamber Energy efficiency Integrated Hydrogen Peroxide Decontamination Bespoke racking and storage to suit the application Space saving design Recirculation laminar flow airflow system or turbulent airflow systems available providing ISO 5 classification
• SteriPharm Standard Aseptic Isolator As part of the standardised product range, SteriPharm is a user and maintenance friendly system providing a cost effective alternative for sterility testing Available with 4 size standard options, SteriPharm is designed to offer increased protection and quality assurance of process integrity by utilising single pass turbulent airflow achieving a grade A environment. Configured with 2 or 4 glove product handling chambers and the option of entry / exit airlocks complete with rapid gassing facility to enable operators to handle products in a highly controlled process flow. The SteriPharm Bio-decontamination process ensures a 6 log reduction in bacterial spore population with inclusive safety features to guarantee operator and plant safety. Increased protection from contamination is achieved by reducing human interventions, physical barrier technology, pressure differential and routine Vapour Phase hydrogen peroxide decontamination. Design Advantages Ergonomic design generated by the use of sloping operator interface panels, large oval PharmaPort gloveports (safe change) EU GMP compliant design Increased safety by reducing contamination risks (ensuring product compliance) Full process equipment integration within grade A IS05 environment Easier process separation Different pressure regimes available within each chamber Energy efficient Integrated Hydrogen Peroxide Decontamination Vapour Phase (VPHP) Bespoke racking and storage to suit the application Space saving design Integrated waste port for primary packaging

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