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’ YOPHILIZER PERATOR ANUAL FTS S ™ II YSTEMS TANDARD...
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The information in this document is subject to change without prior notice. Always confirm with SP Scientific that you are using the most current version of this document. SP Scientific is free to modify any of its products and services, in any manner and at any time, notwithstanding the information contained in this document.
Limited Warranty SP Scientific (the “Company”) shall warrant each of its products against defects in material or workmanship for a period of 12 months from the date of installation or 15 months from the date of shipment (whichever comes first) provided that the product is used in a reasonable manner under appropriate conditions and consistent with the applicable operating instructions.
Should damage or loss be discovered, you may make a written request for inspection by the carrier's agent within 15 days of the delivery date. You may then file a claim with the freight carrier or SP Scientific, depending on the terms of your shipment.
Getting Started FTS Systems LyoStar™ II System Checklist After the LyoStar II is in place, and before operation of the equipment, make certain of the following, • The main electrical line cord from the LyoStar II is plugged into the correct power outlet (check serial tag against wall voltage).
Getting Started Heat Transfer Fluid—Initial Set-up The Heat Transfer Fluid reservoir is located in the top rear of the LyoStar II. The fluid circuit is a sealed system that requires no additional fluid to be added to the unit under normal setup or operating conditions.
2-4 gpm. When the system is off, the water flow will stop. This will conserve water if the unit is connected to a municipal water supply. Please do not operate the LyoStar II with cooling water above 86°F (30°C). The unit will add approximately 20,000 BTUs/hour at steady state to your facility water. Peak demand could be as high as 25,000 BTUs/hour.
Condenser drain port is closed. Door Closure The black rubber gasket for the front door of the LyoStar II has been designed so that no vacuum grease is necessary for system operation. Vacuum grease should not be placed on this gasket for any reason. If the gasket shows any signs of cracks or tears replace it immediately.
If this still results in poor test performance SP Scientific Service should be contacted. These baseline specification runs should be performed before any product is processed in the freeze dryer.
Select Leak Rate test from the menu. The Leak Rate Test screen will now be displayed. Enter values to test the performance of the unit. The values SP Scientific uses during QC testing are shown here. Values may be altered but should be run consistently thereafter to accurately compare performance from run to run.
From the Automatic Mode Select screen, select System Test from the menu. The System Test screen will be displayed on the screen. Enter values to test the performance of the unit. The values SP Scientific uses during QC testing are shown here. Values may be altered but should be run consistently thereafter to accurately compare performance from run to run.
When possible, the sample with the thermocouple should be placed in the center of the product tray. SP Scientific also offers a variety of Special Product Sensors, which fit serum bottles with either a 13 mm or 20 mm neck. These product sensors are highly recommended as they are easily fitted to bottles and vials and provide repeatability.
The auto filling liquid nitrogen trap is connected to a LyoStar II when it is important to trap these high vapor pressure solvents. Typically, these solvents come off the product early in the drying cycle.
The SEA is a pivotal option when the operator’s mission is product development or stability studies. Description The SEA is mounted on a modified acrylic door of the LyoStar II. It consists of • Acrylic vacuum antechamber with stoppering ram •...
Shelf latching kits are available for each system. These kits can be used with the LyoStar II shelf assembly to create moveable shelf stacks. The primary use of the shelf-latching system is to facilitate the stoppering of product vials; however, the shelf latching kits may also be used to increase the distance between shelves when processing product in large vials.
Chapter Optional Cleanroom Configuration Overview The following notes the deviations from the standard LyoStar II configuration, and can be applied to any software package in the LyoStar II family. The LyoStar II research and development freeze dryer cleanroom configuration is comprised of four major components.
Check to ensure that the communication cable is connected between the computer and the freeze dryer. Shut down the computer, power off the LyoStar II. Restart the LyoStar II and the computer. Most often caused by low voltage supply to the system. Check the wall voltage and amps Freeze dryer starts "hard".
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Service Department. If the LyoStar II has a capacitance manometer controlling the pressure and the system is having difficulty achieving the primary vacuum start setpoint, the CM may be out of adjustment.
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Call SP Scientific Service. If you do not feel vacuum being pulled through the Vacuum Bleed Valve apply SNOOP or soapy water to the tray chamber door gasket.
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SP Scientific 815 State Route 208 Gardiner, NY 12525 USA 3538 Main Street Stone Ridge, NY 12484 USA www.SPScientific.com (800) 431-8232 (845) 255-5000...
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