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Production Lyophilizers Brochure - 20 Pages

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Production Lyophilizers Brochure

Catalog excerpts

ELEGANT CAKE EVERY TIME FTS Systems Genevae Hull Hotpaok vims YOUR TIME • YOUR INVESTMENT • YOUR RESULTS

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ACCELERATE YOUR TIME TO MARKET PROCESS DEVELOPMENT TIME, CYCLE TIME, TURNAROUND TIME ‘Time is money’ and a single delay from broken vials or other inefficiencies in your freeze drying production can cost millions of dollars. Choosing a freeze drying partner who understands your unique application, facility requirements and project goals is the first step to maximizing your return on investment. At SP Scientific we like to say “There are companies that can build freeze dryers, but only SP Scientific has the science, technology and engineering expertise to design and build systems that...

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FROM OUR INITIAL MEETING, THROUGH THE LIFE OF YOUR FREEZE DRYER - OFTEN 40 YEARS OR MORE - YOU HAVE A PARTNER IN SP SCIENTIFIC. J productionlyo@spscientific.com ■■"■■J www.spscientific.com 3

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TURNING SCIENCE INTO TECHNOLOGY SP Scientific's strength in pilot-scale freeze drying and methods development, as well as our collaboration with highly regarded lyophilization experts put SP in a unique position to offer state-of-the-art process technologies scalable to new or retrofit production freeze dryer projects. WHAT CONTROLYO™ NUCLEATION TECHNOLOGY CAN DO FOR YOU: • Shorter primary drying times; ControLyo™ controls the degree of supercooling to optimize • Less aggregation and better stability of protein formulations • Technology conforms to the regulatory framework by controlling...

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DETERMINE DRYING PHASE END POINT UTILIZING TDLAS LYOFLUX l Non-invasive tunable diode laser absorption spectroscopy (TDLAS) measures the molecular flow of water molecules from chamber to condenser which enables continuous determination of water vapor mass flow rate Accurately pinpoints the completion of primary, and most importantly, secondary drying phases Software provides key process parameters effecting end product quality such as vial heat transfer coefficient (kv), batch average product temperature, product dry layer thickness, and product drying resistance ACCURATELY MEASURE PRODUCT...

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MAXIMIZE PRODUCT YIELD WITH BUILT-IN EFFICIENCY MINIMIZE DOWNTIME WITH HY-PRO VAPOR FLOW CONDENSER l Cyclonic vapor flow condenser directs vapor and deposits it evenly on the entire condensing plate surface area Results in even ice build-up for more efficient vapor removal Full condenser access door allows complete inspection of Clean-In-Place process for full confidence and quick turnaround time SIMPLE DESIGN LN2 REFRIGERATION SYSTEM SAVES OPERATING AND MAINTENANCE COSTS l l l High-efficiency heat exchangers Easy to maintain with fewer moving parts Eliminates the need for major electrical...

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CUSTOM BUILT TO YOUR REQUIREMENTS LISTEN, LOOK, SOLVE, IMPLEMENT - FROM UNDERSTANDING NEEDS TO FULLY OPERATIONAL SYSTEMS At SP Scientific we do something very unique and unusual: we listen. We make certain we understand all the intricacies of your operation and everything that may impact your freeze drying process. After we listen, we look for ourselves. We conduct a thorough analysis of your facility often uncovering and solving potential problems before they turn into costly delays. Attention to detail at the outset of your project, coupled with our proprietary technologies allows our...

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FLEXIBLE CONFIGURATION AND DESIGN TO MEET YOUR SPECIFICATIONS 13 1. CHAMBER SIZE AND SHELF AREA Shelf areas up to 100 m2 are tailored to suit a wide range of applications and processes. Chamber size and shelf area are the first critical calculation in assuring proper dryer size. The Shelf Area/Vial Capacity chart gives an initial overview of dryer size. Shelf configuration depends upon product configuration as well as integration of the unit into your facility. Thorough cleaning performed quickly and safely optimizes productivity. SP freeze dryers can be fitted with a variety of options...

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Many factors including energy use and ease of maintenance impact operational economy. Within the dryer, accurate, efficient control of the freeze drying process and thorough design of a robust cycle will assure highest product quality while positively impacting operational economy. SP’s leadership in process development freeze dryers have advanced the introduction of many technologies and best practices which can be incorporated into your production unit. Those using SP’s LyoStar 3 for cycle development can count on matchless accuracy and unique ease-of-use features and technologies that...

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COUNT ON IT Over six decades of experience, innovation and development of best practices go into every freeze dryer that carries our name and is deemed a trustworthy environment for your product. ENGINEERING CONSIDERATIONS High quality engineering, materials and workmanship enable long life and easy maintenance. SP SOP result in superior validation documentation that has been used by all major pharmaceutical companies and helps ensure your fastest route to validation. When needed, our teams have and will work successfully with your preferred and validated international suppliers to utilize...

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INTEGRATION AND INSTALLATION PREPARATION Effective project management and pre-planning mean your standard unit is generally ready for factory acceptance testing pending current plant loading. Typical installation takes two to six weeks depending upon size of the unit and readiness of the facility. Contact productionlyo@spscientific.com for details. Our team has in-depth experience, routinely working with your partners or ours, to ensure seamless operation of the entire line including: l l l l l l Sterile filtration and filling Capping and crimping Manual or auto loading systems Isolators...

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SERVICES & SUPPORT Our customer service begins when we review your process requirements, discuss your needs and answer all your questions. It continues throughout the entire design, manufacturing and testing process. But, building your freeze dryer is simply where our partnership begins. SP customers have a 100% success record on installation and validation of SP Lyophilizers. Being able to support your investment is what sets us apart. INSTALLATION SERVICES l l l l Set-up and configuration Rigging, air caster moving, precision laser leveling, floor protection, safety monitoring Utility...

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