SP Scientific VIRTIS ADVANTAGE Operator's Manual

Lyophilizer freeze dryers

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YOPHILIZER

PERATOR

ANUAL

ANTAGE AND

ANTAGE

LUS

REEZE

RYERS

Table of Contents

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Summary of Contents for SP Scientific VIRTIS ADVANTAGE

Page 1 ’ YOPHILIZER PERATOR ANUAL ANTAGE AND ANTAGE REEZE RYERS...
Page 3 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.
Page 4: Important Symbols
Never use acrylic closures if they are cracked or crazed.  Never use with toxic, corrosive, flammable or organic materials unless special precautions are in place to prevent injury to personnel or damage to equipment. Rev 003, 06/11 © SP Scientific 2011...
Page 5: Warranty Information
Warranty Information VirTis AdVantage and AdVantage Plus Lyophilizers are warranted by SP Scientific to be free of defects in material and workmanship when operated under normal conditions as specified in the instructions provided in this manual. Please take this opportunity to locate the serial tag on your new VirTis AdVantage and AdVantage Plus and record the information below for future reference.
Page 7: Table Of Contents
Running a Freeze-Drying Cycle (Automatic Mode) ..................13 Defrost ................................14 Meltback or Collapse ............................15 Options ........................17 Stoppering................................17 Inert Gas Backfill ............................17 Stoppering Procedure ........................... 18 Liquid Nitrogen Trap ............................19 Rev 003, 06/11 © SP Scientific 2011...
Page 8 Contents VirTis AdVantage and AdVantage Plus Filter Trap ................................20 Degassing Filter Trap Cartridges ........................20 Shell Bath................................21 Windmill ................................21 Accessories ................................ 21 General Maintenance ....................23 Overview ................................23 Vacuum System ..............................23 Vacuum Pump ............................... 23 Changing Vacuum Pump Oil .........................
Page 9: Introduction
3.5-liter (AdVantage) or 6-liter (AdVantage Plus) condensing capacity. • Shelf stoppering option with nitrogen gas backfill capability. Note: SP Scientific builds each unit according to the options purchased. Review the standard sections, as well as the relevant optional sections of this manual. Rev 003, 06/11...
Page 11: Getting Started
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.
Page 12: Service Connections
The control panel display will illuminate. Note: SP Scientific ships AdVantage series freeze dryers with standard power connectors based on your voltage and amperage configuration. If your outlet configuration requires a different connector, replace the plug according to local electric codes.
Page 13: Vacuum Pump Installation
AdVantage series freeze dryer. SP Scientific recommends using a vacuum pump with a minimum capacity of 65 liters per minute (Lpm) at 60 Hz, as well as installing an Oil Mist Eliminator (OME) if not venting the pump externally.
Page 14: Oil Mist Eliminators
Plug the vacuum pump into the IEC connectors marked VACUUM PUMP on the back of the unit. Oil Mist Eliminators SP Scientific recommends the installation of an Oil Mist Eliminator (OME) to reduce fumes from the vacuum pump and/or vent the vacuum exhaust externally. Stoppering...
Page 15: Operating Your Lyophilizer
WEAR APPROPRIATE EYE PROTECTION AT ALL TIMES WHEN WORKING WITH OR ANYWHERE NEAR A LYOPHILIZER. The Wizard 2.0 Controller The following instructions assume that you are operating your AdVantage unit using the Wizard 2.0 Control System. Rev 003, 06/11 © SP Scientific 2011...
Page 16: Getting Started
Operating Your Lyophilizer VirTis AdVantage and AdVantage Plus Getting Started Freeze-drying can remove up to 98% of the moisture within the product without compromising the product’s integrity. The process may take approximately 24-72 hours, depending on product characteristics and the recipe programmed.
Page 17: Flask/Manifold Drying
VirTis AdVantage and AdVantage Plus Operating Your Lyophilizer Quickseal Valves Note: AdVantage freeze dryers come equipped with four (4) Quickseal valves. Flask/Manifold Drying Product Preparation AdVantage Series Freeze Dryers include Quickseal valves for processing samples using flasks or other glassware. To prepare samples using glassware: Fill flasks with your product.
Page 18: Running A Freeze-Drying Cycle
Operating Your Lyophilizer VirTis AdVantage and AdVantage Plus Running a Freeze-Drying Cycle Notes: If you are processing samples on the shelf (or shelves) within the product chamber, proceed to the Shelf Drying section. Product must remain frozen at a temperature below its eutectic temperature throughout the drying process.
Page 19: Preventing Glassware Breakage
VirTis AdVantage and AdVantage Plus Operating Your Lyophilizer When the chamber returns to atmospheric pressure, turn the handle and open the door. Defrost the system and remove melted condensate immediately. Note: Refer to the Defrost section of this manual for more information.
Page 20: Running A Freeze-Dry Cycle (Manual Mode)
Operating Your Lyophilizer VirTis AdVantage and AdVantage Plus Running a Freeze-Dry Cycle (Manual Mode) Notes: If you are processing samples using the manifold or in flasks, refer to the Flask / Manifold Drying (Manual Mode) section. Product must remain below its eutectic temperature throughout the drying process.
Page 21: Running A Freeze-Drying Cycle (Automatic Mode)
VirTis AdVantage and AdVantage Plus Operating Your Lyophilizer Running a Freeze-Drying Cycle (Automatic Mode) Press the Recipe button to program a recipe. Up to 16 full-cycle recipes may be programmed. Note: If your unit is equipped with the optional Wizard Workstation, you may program recipes from the workstation.
Page 22: Defrost
Operating Your Lyophilizer VirTis AdVantage and AdVantage Plus Defrost CAUTION: DO NOT CHIP AWAY AT ICE WITHIN THE CONDENSER AS DAMAGE TO THE CONDENSER MAY RESULT. CORROSIVE CHEMICAL CAUTION: IF CONDENSATE CONTAINS CORROSIVE OR ORGANIC SOLVENT RESIDUE, FLUSH ALL CONTACT AREAS TO REMOVE IT AND COMPLETELY DRAIN THE CONDENSER.
Page 23: Meltback Or Collapse
VirTis AdVantage and AdVantage Plus Operating Your Lyophilizer Meltback or Collapse Meltback is a process defect commonly associated with freeze-drying that describes the condition of a product when it melts or defrosts before subliming. Products that have low freezing points are more prone to meltback during the freeze-drying process.
Page 25: Options
The heat shelf control is disabled The product chamber has been backfilled with an inert gas, if applicable. Notes: SP Scientific recommends performing a test run to ensure familiarity with the stoppering process before adding your product. AdVantage Plus units with the stoppering option require a constant supply of compressed air regulated at 60 psig;...
Page 26: Stoppering Procedure
Options VirTis AdVantage and AdVantage Plus To backfill with inert gas: Connect the gas source to the Inert Gas Backfill port on the back of your AdVantage series freeze dryer. If in Manual Mode, set the pressure regulator on the inert gas bottle to provide a slight positive pressure.
Page 27: Liquid Nitrogen Trap
VirTis AdVantage and AdVantage Plus Options Return the stoppering mechanism to the original position by returning the stoppering lever to the up position. Ensure that all function indicator lights are off and that no automatic cycles are currently running. Press Vacuum Release to release any pressure from the system.
Page 28: Filter Trap
Check center well often and refill with liquid nitrogen as needed. Filter Trap SP Scientific filter traps protect your vacuum pump from damaging and corrosive vapors released during freeze-drying. If purchased, the filter trap is typically located between your freeze dryer and the vacuum pump.
Page 29: Shell Bath
Flask lift devices elevate flask caps, forming a conical coating inside the flasks as they rotate. This prevents fouling of the lid, filter or stoppering plug. Contact your SP Scientific representative for more information. Windmill The Windmill option can be an excellent indicator of the rate of water vapor transfer and assist in determining the end of the drying phase.
Page 31: General Maintenance
When visually checking the oil, use the following guidelines: • Pale yellow or clear vacuum pump oil indicates good condition. • Dark vacuum pump oil indicates acid contamination. • Cloudy gray vacuum pump oil indicates water contamination. Rev 003, 06/11 © SP Scientific 2011...
Page 32: Changing Vacuum Pump Oil
General Maintenance VirTis AdVantage and AdVantage Plus Changing Vacuum Pump Oil Change the oil immediately after shutting down the pump while the oil is still hot. Protect your hands from the hot oil. Make sure vacuum is released from the system.
Page 33: Gas Ballast Valve On The Vacuum Pump
This will distribute the grease evenly on the inside of the tubing. If the tubing needs to be replaced, contact SP Scientific. The required length is approximately two feet. Reattach tubing to the unit.
Page 34 General Maintenance VirTis AdVantage and AdVantage Plus Door Gasket The door gasket should be routinely inspected for cracks. To inspect the door gasket: Remove the door gasket. Grasp the gasket in both hands and turn it inside out. Inspect the inside of the gasket. This is where you are most likely to find a potential problem.
Page 35: Refrigeration System
If the line is warm or just slightly cool to the touch, it usually means that a loss of refrigerant has occurred, and that the condenser and shelf are experiencing cooling problems. Contact SP Scientific for more information. Rev 003, 06/11...
Page 36: Acrylic Parts
General Maintenance VirTis AdVantage and AdVantage Plus Acrylic Parts Clean acrylic parts with a mild detergent. Use a soft cloth or Kimwipes® to avoid scratching the acrylic. The following table may be used as a general guide to acrylic’s chemical resistance.
Page 37: Appendix A: Troubleshooting
Replace the vacuum probe tube and retest. Note: If following this checklist does not resolve the vacuum problem, contact SP Scientific Service and a trained technician will assist you. Rev 003, 06/11 © SP Scientific 2011...
Page 38: Product Melting
Appendix A: Troubleshooting VirTis AdVantage and AdVantage Plus Product Melting The most common reason for product melting is insufficiently low vacuum pressure. Adequate vacuum is required to keep products in a frozen state. Check for a vacuum leak or possible restrictions in the vacuum hose as described above.
Page 39: Appendix B: Serum Vial Capacities
Capacity (ml) Qty per Tray 179077 179275 179101 179085 179143 179135 178855 178830 178897 178921 178954 178988 Add 8mm for partially inserted stopper. Thin Wall. Special Stoppering Ampoule (add 10mm for partially inserted stopper). Rev 003, 06/11 © SP Scientific 2011...
Page 41: Appendix C: Shelf Latching For Advantage Plus Units
To return to a two-shelf arrangement, repeat the process and remove the latching rod extensions (Item A). Ensure that the shoulder screws are secured before raising the shelf stack. Rev 003, 06/11 © SP Scientific 2011...
Page 42 Appendix C: Shelf Latching for Advantage Plus VirTis AdVantage and AdVantage Plus Units Configuration B Ensure that all shelves are empty. Turn the stoppering valve to the Down position to allow the Pneumatic Cylinder Rod to extend fully. Remove the eight (8) upper shoulder screws (Item C) and install latching rod extensions (Item A).
Page 44 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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