SP Scientific VIRTIS ADVANTAGE PRO Bedienungsanleitung

FREEZE DRYER OPERATOR’S MANUAL

ANTAGE

LABORATORY

BENCHTOP

FREEZE

DRYER

Rev 002, 01/14 i

All brand or product names mentioned may be trademarks or registered trademarks of their respective

companies.

Part Number 100008577

Rev 002, 01/14

Original Instructions

The U.S. English version of this document is the original instructions.

All other languages are a translation of the original instructions.

SP Scientific

3538 Main Street

Stone Ridge, NY 12484

USA

935 Mearns Road

Warminster, PA 18974

USA

815 State Route 208

Gardiner, NY 12525

USA

The Sovereign Centre,

Farthing Road,

Ipswich IP1 5AP UK

(800) 251-1531

(800) 523-2327

(800) 431-8232

+44 (0)1473 240000

(845) 687-0071

(215) 672-7800

(845) 255-5000

SP Service

(800) 548-4666

SP Service Fax

(845) 687-0024

Website

http://www.spscientific.com

This Freeze Dryer Operator’s Manual contains confidential and proprietary information of SP Scientific and may

be used only by a recipient designated by and for purposes specified by SP Scientific.

Reproduction of, dissemination of, modifications to, or the creation of derivative works from this Freeze Dryer

Operator’s Manual, by any means and in any form or manner, is expressly prohibited, except with the prior

written permission of SP Scientific. Permitted copies of this document must retain all proprietary notices

contained in the original.

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.

THE CONTENTS OF THIS DOCUMENT SHALL NOT CONSTITUTE ANY WARRANTY OF ANY KIND,

EITHER EXPRESSED OR IMPLIED, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF

MERCHANTABILITY AND/OR FITNESS FOR A PARTICULAR PURPOSE OR GIVE RISE TO ANY LIABILITY

OF SP SCIENTIFIC, ITS AFFILIATES OR ITS SUPPLIERS.

The terms and conditions governing the use of this Freeze Dryer Operator’s Manual shall consist of those set

forth in written agreements with SP Scientific.

ii Rev 002, 01/14

Important Symbols

WARNING! INJURY OR EVEN

DEATH MAY RESULT IF A

RECOMMENDATION MARKED WITH

THIS SYMBOL IS NOT HEEDED.

CRUSH HAZARD. KEEP HANDS

CLEAR WHEN OPERATING DOOR.

ELECTRIC SHOCK DANGER! USE

APPROPRIATE CAUTION TO AVOID

INJURY OR DEATH.

CORROSIVE CHEMICAL. WEAR

SUITABLE GLOVES, SAFETY

GLASSES, AND PROTECTIVE

CLOTHING.

BURN DANGER! POTENTIALLY HOT

SURFACE. USE APPROPRIATE

CAUTION.

PROPERTY CAUTION! TO PREVENT

DAMAGE TO CHAMBER EQUIPMENT

AND/OR LOAD, ADHERE TO

PROCEDURES MARKED BY THIS

SYMBOL.

DO NOT STORE FLAMMABLE

MATERIALS IN CHAMBER.

PRACTICAL OPERATING TIP. THESE

RECOMMENDATIONS STREAMLINE

UNIT OPERATION AND PREVENT

COMMON OPERATOR ERRORS.

ALWAYS WEAR APPROPRIATE

PERSONAL PROTECTIVE

EQUIPMENT (PPE) SUITED FOR THE

TASK YOU ARE PERFORMING.

EXPLOSIVE MATERIALS HAZARD!

KEEP OBJECTS AWAY FROM HEAT.

Freeze Dryer Safety Warnings

Do not freeze-dry explosive or highly flammable substances.

Always assume that shelf, condenser and internal parts may be very cold or very hot. Wear protectiveequipment to avoid burns.

Always ensure that only an authorized technician services the refrigeration, heat transfer, vacuum andelectrical systems.

Always ensure that refrigeration air intake is clear and clean.

Always ensure vacuum pump exhaust is properly ventilated and/or contained.

Always practice team lifting when moving heavy equipment.

Always use a maximum one pound regulator if backfilling from an inert gas source.

Always wear safety glasses when using glass flasks.

Always wear appropriate personal protective equipment (PPE) suited for the task you are performing.

Be sure to carefully read the entire instruction manual before attempting to operate the freeze dryer.

Be sure to verify that the electric service and other utilities match the unit’s requirements before connecting to power.

Never allow hand or body contact with open vacuum ports.

Never clean with solvents. Use mild detergent and water only.

Never operate the unit without all covers in place.

Never pressurize a freeze-drying chamber unless it has been specially designed and coded as a pressurevessel (e.g., displays an ASME-coded certificate).

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 002, 01/14 iii

Warranty Information

VirTis AdVantage Pro 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 Pro and record the information below for future reference. SP Scientific

also recommends that you complete and return your unit’s warranty registration card.

Model Number

Serial Number

Part Number

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. In addition, the Company shall warrant the refrigeration system for a period of 24 months provided the system is

used in a reasonable manner under appropriate conditions and consistent with the applicable operating instructions.

The obligation of the Company shall be, at its option, to repair or replace, without charge any parts that prove to be defective

within the warranty period, if the purchaser notifies the Company promptly in writing of such defect. No product shall be

returned to the Company without prior approval of the Company.

This limited warranty shall cover the costs of parts and labor to repair or replace all defective product(s) at the Seller’s

factory. For all products installed by the Company and located within the Company service travel areas, this warranty shall

cover transportation charges to ship the product to and from the Company’s factory and/or the costs of travel, room and

board if the Company’s employees conduct repair at the Buyer’s location. In lieu of repair or replacement at the Company’s

factory, the Company may, in its discretion, authorize a third party to perform the repair or replacement at the Buyer’s

location, and at the Company’s sole expense.

The Company shall not be responsible for labor charges payable with respect to persons other than Company employees.

Replacement or repair of parts pursuant to this warranty shall not in any way extend the original warranty period. The

Company shall not be responsible for any unauthorized repairs, replacements or product modifications, nor will it be

responsible for any product failures resulting from such unauthorized repairs, replacements or product modifications

negligently or otherwise made by persons other than Company employees or authorized representatives of the Company.

The buyer shall assume transportation charges to ship the product to and from the Company’s factory and the costs of

travel, room and board if the Company’s employees conduct repair at the Buyer’s location within the warranty period if the

product was not installed by the Company’s and/or is not located within the Company’s service travel areas.

THE COMPANY DOES NOT MAKE AND EXPRESSLY DISCLAIMS ANY WARRANTY OF MERCHANTABILITY OR

FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER WARRANTY, EXPRESSED OR IMPLIED, WITH RESPECT

TO THE SALE, INSTALLATION, DESIGN OR USE OF ITS PRODUCTS. ADDITIONALLY, THE COMPANY SHALL NOT BE

LIABLE FOR ANY CONSEQUENTIAL DAMAGES RESULTING FROM THE USE OF OR ANY DEFECTS IN ITS

PRODUCTS.

The Company’s employees are available to provide general advice to customers concerning the use of the Company’s

products; however, oral representations are not warranties with respect to particular products or their uses and may not be

relied upon if they are inconsistent with the relevant product specifications for the items set forth herein.

Notwithstanding the above, the terms and conditions set forth in the Company’s formal sales contracts shall be controlling

and supersede any inconsistent terms contained herein, and any changes to such contracts must be made in writing and

signed by an authorized executive of the Company.

WARNING! THE DISPOSAL AND/OR EMISSION OF SUBSTANCES USED IN CONNECTION

WITH THIS EQUIPMENT MAY BE GOVERNED BY VARIOUS FEDERAL, STATE OR LOCAL

REGULATIONS. ALL USERS OF THIS EQUIPMENT ARE URGED TO BECOME FAMILIAR WITH

ANY REGULATIONS THAT APPLY IN THE USERS AREA CONCERNING THE DUMPING OF

WASTE MATERIALS IN OR UPON WATER, LAND OR AIR AND TO COMPLY WITH SUCH

REGULATIONS.

iv Rev 002, 01/14

Rev 002, 01/14 v

Contents

Important Symbols...............................................................................................................................................ii

Freeze Dryer Safety Warnings............................................................................................................................. ii

Warranty Information .......................................................................................................................................... iii

Introduction .................................................................................................................1

Overview..............................................................................................................................................................1

Key Features........................................................................................................................................................1

AdVantage Pro Series Freeze Dryer....................................................................................................................2

AdVantage Pro (Front View)............................................................................................................................2

AdVantage Pro (Side Views)...........................................................................................................................2

AdVantage Pro (Rear View)............................................................................................................................3

Getting Started............................................................................................................5

Initial Inspection...................................................................................................................................................5

Lifting the AdVantage Pro Freeze Dryer ..............................................................................................................6

AdVantage Pro Setup..........................................................................................................................................6

Service Connections............................................................................................................................................6

Vacuum Pump Installation ...................................................................................................................................7

Installing the Vacuum Pump............................................................................................................................7

Product Preparation: Shelf Drying........................................................................................................................8

Stoppering...................................................................................................................9

Inert Gas Backfill..................................................................................................................................................9

To Backfill with Inert Gas:..............................................................................................................................10

Stoppering Operation.........................................................................................................................................11

To Operate the Stoppering System:..............................................................................................................11

Quickseal Valves.......................................................................................................13

Quickseal Valves ...............................................................................................................................................13

Product Preparation: Flask / Manifold Drying.....................................................................................................14

Using Quickseal Valves During a Freeze-Drying Cycle.................................................................................15

Meltback........................................................................................................................................................16

Additional Options.....................................................................................................17

Bulk 316 Stainless Steel Trays ..........................................................................................................................17

Removable Bottom Stainless Steel Trays..........................................................................................................17

Stoppering Rod Extension .................................................................................................................................17

Contents

VirTis AdVantage Pro

vi Rev 002, 01/14

Vacuum Break Solenoid (VBS) Valve................................................................................................................17

Shelf Latching Kit...............................................................................................................................................18

Solvent Resistant Door......................................................................................................................................18

Liquid Nitrogen Trap ..........................................................................................................................................19

To Operate a Liquid Nitrogen Trap:...............................................................................................................19

Filter Trap...........................................................................................................................................................20

Degassing Filter Trap Cartridges...................................................................................................................20

Lab Cart.............................................................................................................................................................21

Condenser Drain Tray........................................................................................................................................21

Replacement Door Gasket.................................................................................................................................21

General Maintenance................................................................................................23

Overview............................................................................................................................................................23

Vacuum System.................................................................................................................................................23

Vacuum Pump...............................................................................................................................................23

Changing Vacuum Pump Oil.........................................................................................................................24

Scheduling Oil Changes................................................................................................................................24

Clearing the Vacuum Pump Maintenance Alarm...........................................................................................24

Optional Secondary Traps.............................................................................................................................25

Gas Ballast Valve on the Vacuum Pump.......................................................................................................25

Vacuum Tubing and Gaskets........................................................................................................................25

Quickseal Valves...........................................................................................................................................27

Refrigeration System .........................................................................................................................................27

Air-Cooled Condenser...................................................................................................................................27

Compressor(s)...............................................................................................................................................28

Appendix A: Troubleshooting....................................................................................29

Vacuum Problems..............................................................................................................................................29

Product Melting..................................................................................................................................................30

Appendix B: Cover Removal.....................................................................................31

Appendix C: Shelf Latching.......................................................................................37

Shelf Latching Instructions.................................................................................................................................37

Appendix D: Serum Vial Capacities ..........................................................................39

Serum Vial Capacities Chart..............................................................................................................................39

Appendix E: Stainless Steel Cleaners.......................................................................41

Appendix F: Chemical Resistance Charts.................................................................43

Acrylic Parts.......................................................................................................................................................43

AdVantage Pro Bezel.........................................................................................................................................44

AdVantage Pro Front Panel...............................................................................................................................48

AdVantage Pro: Miscellaneous Parts.................................................................................................................50

AdVantage Pro Top ...........................................................................................................................................62