Extract Technology Ltd, worldwide leaders in containment Downflow Booths, Isolators and aseptic Isolator systems has successfully launched a range of standard Isolators for companies seeking affordable systems whilst maintaining the high standard required for the pharmaceutical, healthcare, biotech and chemical markets.
Known for their bespoke range of containment solutions, the new low cost, high containment standard range named SteriPharm, IsoPharm and FlexiPharm offer a variety of manufacturing advantages, delivering the same optimum protection for the operator and product as conceptual designs have been based upon proven solutions.
“Following the success of the standardisation programme for our Downflow Booth systems, we as a business recognised the advantages of modular, innovative standardisation” said Technical Director, Paul Hudson. “The natural progression was to move forward with our standard strategy to include containment and aseptic isolators. Based on the voice of the customer, coupled with in-house design and manufacturing capabilities has led to the introduction of our cost effective containment and aseptic range that maintains our brand identity without devaluing the product which in turn offers added value to our clients”.
SteriPharm – Adding to their advanced aseptic systems, Extract Technology Ltd has introduced SteriPharm, a low cost standard aseptic isolator that is suitable for operators to perform Sterility testing in an aseptic environment.
SteriPharm is a user and maintenance friendly system that provides a cost effective alternative for sterility testing and is ideal for customers with limited laboratory space whilst benefiting from the ability to provide rapid Bio-decontamination.
Operator and product protection is at the heart of the design process as the SteriPharm is designed to offer increased protection and achieves this by physical barrier technology, pressure differential and routine Vapour Phase Hydrogen Peroxide (VPHP) decontamination, reducing the possibility of any contamination risks and at the same time ensuring product compliance.
Available with 4 size options, the SteriPharm Isolator provides assurance of process integrity utilising single pass turbulent flow achieving a Grade A environment.
The range of SteriPharm Isolators can be configured with 2, or 4 gloveport product handling chambers and the option entry/exit airlocks complete with rapid gassing facility enabling operators to transfer, handle and manipulate products in a highly controlled process flow.
The SteriPharm Bio-decontamination process ensures a 6 log reduction in bacterial spore population. As the Bio-decontamination process requires the use of potentially toxic gases, with the OEL typically less than 1ppm, the SteriPharm includes safety features to constantly monitor H202 leak detection to ensure operator and plant safety at all times.
For easy processing suitably designed racks are available as part of the SteriPharm package. With its many design advantages and inclusive features as standard for easy operation, further ancillary equipment options are available to meet operator requirements. Whether it is bespoke racking, non viable/ viable particle monitoring, Rapid Transfer Port (RTP) or a Steritest Equinox transfer pump or whatever specifications are required by the user in an aseptic solution, the SteriPharm Isolator will deliver all these wants and more.
IsoPharm – As part of the standard range, IsoPharm is the new innovative containment isolator which has successfully been launched to optimise cost, efficiency and simplify every day running procedures for small scale weighing and dispensing operations during handling high potent API’s.
Drawing on their extensive experience with containment Isolator technology has enabled the manufacturing process be minimised providing client assurance, a cost effective solution and shorter lead times.
The containment Isolator runs at negative pressure in the Airlock (50Pa) and Chamber (75pa) providing operator protection to <1ug/m3, thus maintaining the high standards required within the pharmaceutical industry and achieving the ISO 5 classified environment within the Isolator.
Developed with operator ergonomics the IsoPharm Isolator is available with 2, 3 or 4 gloveport plus airlock entry / exit and presents a state of the art user friendly controls system for essential operations, all accessible through the easy to use colour HMI with IECS (Integrated Electrical Controls System). Pre-defined to incorporate Extract Technology’ key safety features the HMI has 3 access levels as standard via an alpha/numerical keypad providing a high quality controls system.
The containment solution includes a product handling chamber complete with interlocked airlock manufactured from 3mm thick 316L stainless steel complete with a large area of acrylic glazing providing maximum viewing of all process operations and an inclined front face to aid operator ergonomics and access.
“In process” safe change gauntlets via the PharmaPort, Safe change double H14 HEPA exhaust filtration (push-push type), closed loop control and glove breach protection >0.5m/s are all attributes to the IsoPharm containment Isolator.
The IsoPharm also comes with the flexibility to adapt the system by integrating further controls / ancillary equipment options such as a Rapid Transfer Port, Glove port test kit, cleaning system or environmental control monitoring should the clients requirements change.
FLEXIPHARM – Benefiting from shorter lead times and lower costs than that of a Rigid Stainless Steel Isolator system, Extract Technology Ldt are due to launch FlexiPharm, a low cost flexible containment isolator suited for R&D projects, small batching and trial campaigns for the pharmaceutical, biotech and hospital sector.
With extensive market experience in flexible and rigid isolator projects, FlexiPharm has derived from the company’s bespoke range of flexible containment systems and has been designed with a ease of use and “off the shelf” supply chain/ low cost pricing structure and will be available by the end of the first quarter.
Design advantages will include a flexible single chamber complete with bag out port with the option of a gas type zip for loading of process equipment, supported by an Isolator frame and optional table made from 304 stainless steel. The controls consist of a simple fan speed controller with green/ red visual indicators to show correct pressure within the enclosure to ensure operator protection is maintained to <1up/m3.
The light weight frame and portability makes the FlexiPharm the ideal solution for laboratories with limited test space and is easy to dispose of following the end of a batching campaign. The availability of replacement enclosures, supply and safe change H14 ‘push-push’ exhaust HEPA filters positions the FlexiPharm as one the most cost effective flexible containment solutions in the market place.
The Control Strategy Pyramid © – Designed to satisfy both current and projected industry standards the Extract Pyramid © provides pharmaceutical companies with a clear guide to assessing the level of containment required to safely handle differing hazardous materials. The Pyramid recognises that hazards posed by any specific process are a result of several interrelated factors, all of which require assessment to define the most appropriate containment strategy.
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