SP Scientific VIRTIS 2K Manuel utilisateur

FREEZE DRYER OPERATOR’S MANUAL

VIRTIS BENCHTOP 2K, 4K AND 6K

FREEZE DRYERS

Rev 007, 10/11 i

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

companies.

Part Number 414258

Rev 007, 10/11

SP Scientific 815 State Route 208 3538 Main Street

Gardiner, NY 12525 USA Stone Ridge, NY 12484 USA

(800) 431-8232

(845) 255-5000

SP Service (800) 722-7721

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 007, 10/11

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.

WEAR SAFETY GLASSES. EXPLOSIVE MATERIALS

HAZARD! KEEP OBJECTS

AWAY FROM HEAT.

Freeze Dryer Safety Warnings

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.

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

Do 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 chambers. Laboratory freeze-drying systems are designed for vacuum only.

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 007, 10/11 iii

Warranty Information (VirTis Lyophilizers)

VirTis BenchTop 2K, 4K and 6K 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 BenchTop

2K, 4K and 6K 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”) warrants each of its products against any defects in material or

workmanship, provided that the product is used in a reasonable manner under appropriate conditions and

consistent with the applicable operating instructions, for a period of 12 months from the date of installation

or 15 months from the date of shipment (whichever comes first).

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. 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 will 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 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.

iv Rev 007, 10/11

Rev 007, 10/11 v

Contents

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

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

Warranty Information (VirTis Lyophilizers) .......................................................................................................... iii

Introduction .................................................................................................................1

Features...............................................................................................................................................................1

BenchTop Usage .................................................................................................................................................1

Cold Trap Condenser Module ..............................................................................................................................1

Available Configurations ......................................................................................................................................2

Installation and Startup ............................................................................................... 3

Initial Inspection ...................................................................................................................................................3

Service Connections ............................................................................................................................................3

Vacuum Pump Installation ...................................................................................................................................4

Installing the Vacuum Pump............................................................................................................................4

Oil Mist Eliminators..........................................................................................................................................5

BenchTop Setup ..................................................................................................................................................5

Vacuum Baffle Plate ............................................................................................................................................6

Freeze-Drying Concepts ............................................................................................. 7

Overview..............................................................................................................................................................7

Elements of Freeze-Drying ..................................................................................................................................7

Freeze .............................................................................................................................................................7

Vacuum ...........................................................................................................................................................7

Heat.................................................................................................................................................................8

Condenser.......................................................................................................................................................8

Product Dependencies.........................................................................................................................................8

Sentry 2.0 Controls ..................................................................................................... 9

LED Wave Display (Qualitative Reference) .........................................................................................................9

Button Functions ................................................................................................................................................10

Up/Down (+/-) Buttons...................................................................................................................................10

MENU Button ................................................................................................................................................10

COND Button ................................................................................................................................................10

VAC Button....................................................................................................................................................10

AUTO Button .................................................................................................................................................10

DEFR Button .................................................................................................................................................10

LCD Display Functions ......................................................................................................................................11

Main Menu .........................................................................................................................................................11

Vacuum Control.............................................................................................................................................12

Purge.............................................................................................................................................................12

Bath...............................................................................................................................................................12

Heat (Optional) ..............................................................................................................................................12

User Options Menu ............................................................................................................................................12

Vacuum Control.............................................................................................................................................12

Contents

irTis BenchTop 2K, 4K and 6

vi Rev 007, 10/11

Temperature Units.........................................................................................................................................12

Vacuum Units ................................................................................................................................................13

Relay Test .....................................................................................................................................................13

Vacuum Pump Maintenance .........................................................................................................................13

Alarms Menu......................................................................................................................................................14

Setpoints Menu ..................................................................................................................................................14

Condenser Temperature ...............................................................................................................................14

Vacuum OK ...................................................................................................................................................14

Power Save Deadband .................................................................................................................................14

Maintenance Menu and Factory Options ...........................................................................................................15

Factory Options .............................................................................................................................................15

Interstage Control..........................................................................................................................................16

Calibration .....................................................................................................................................................16

Basic Operation......................................................................................................... 19

Getting Started...................................................................................................................................................19

Product Preparation: Flask/Manifold Drying.......................................................................................................19

Product Preparation: Drum Manifold Shelf Drying .............................................................................................19

Product Preparation: Chamber Drying ...............................................................................................................20

Quickseal Valves ...............................................................................................................................................20

Operation Instructions........................................................................................................................................21

Meltback.............................................................................................................................................................22

Preventing Glassware Breakage........................................................................................................................23

Product Dryness End Point ................................................................................................................................23

Stoppering (Optional) .........................................................................................................................................23

Cold Trap Condenser................................................................................................ 25

Overview............................................................................................................................................................25

Product Requirements .......................................................................................................................................25

Cold Trap Setup.................................................................................................................................................26

Optional Components ............................................................................................... 27

Manifolds............................................................................................................................................................27

Shelf Racks........................................................................................................................................................28

Liquid Nitrogen Trap ..........................................................................................................................................29

Filter Trap...........................................................................................................................................................30

Degassing Filter Trap Cartridges...................................................................................................................30

BenchTop Cold Plate .........................................................................................................................................31

Initial Setup of the BenchTop Cold Plate .......................................................................................................31

Cold Plate Operation .....................................................................................................................................31

General Maintenance................................................................................................ 33

Vacuum System.................................................................................................................................................33

Vacuum Pump...............................................................................................................................................33

Changing Vacuum Pump Oil .........................................................................................................................33

Vacuum Tubing and Gaskets ........................................................................................................................34

Condenser Gasket ........................................................................................................................................34

Vacuum Pump Gas Ballast Valve..................................................................................................................35

Quickseal Valves...........................................................................................................................................36

Refrigeration System .........................................................................................................................................36

The Air-Cooled Condenser............................................................................................................................36

Condenser Chamber .....................................................................................................................................36

Acrylic Parts .......................................................................................................................................................37

Appendix A: Troubleshooting .................................................................................... 39

irTis BenchTop 2K, 4K and 6

Contents

Rev 007, 10/11 vii

Vacuum Problems..............................................................................................................................................39

Product Melting ..................................................................................................................................................40

Appendix B: Serum Vial Capacities........................................................................... 41

Appendix C: Stainless Steel Cleaners....................................................................... 43