Labconco FreeZone Plus Manual de usuario

CHAPTER 1: INTRODUCTION 1

Freeze Dry Process 1

Freeze Dry Rates 2

Freeze Dry Capacity 4

Samples Containing Volatile Substances 5

About This Manual 5

Typographical Conventions 7

YourNextStep 7

CHAPTER 2: PREREQUISITES 9

ElectricalRequirements 10

Location Requirements 10

Vacuum Pump Requirements 10

Chamber or Manifold Requirements 11

Space Requirements 11

YourNextStep 11

CHAPTER 3: GETTING STARTED 13

Unpacking Your Freeze Dryer 14

Freeze Dryer Components 14

Setting Up Your Freeze Dryer 15

Component Orientation & Hose Connections 15

ElectricalConnection 16

Drying Chamber Installation 16

DryingManifoldInstallation 16

Solvent Safety Precautions 17

YourNextStep 18

CHAPTER 4: USING YOUR FREEZE DRYER 19

Freeze Dryer Controls 20

OperationChecklist 21

Operating the Freeze Dryer 22

AutomaticStart-Up 22

ManualStart-Up 23

AddingSample 23

Alarms & Informational Messages 25

ShutDown 26

Defrosting 27

CHAPTER 5: MAINTAINING YOUR FREEZE DRYER 29

CHAPTER 6: MODIFYING YOUR FREEZE DRYER 31

RecorderJack 31

ComputerConnection 32

CHAPTER 7: TROUBLESHOOTING 35

VacuumLeakDetection 36

Refrigeration Module Operation 37

APPENDIX A: FREEZE DRYER COMPONENTS 39

APPENDIX B: FREEZE DRYER DIMENSIONS 43

APPENDIX C: FREEZE DRYER SPECIFICATIONS 45

Wiring Diagram (115V) 47

Wiring Diagram (230V) 48

APPENDIX D: FREEZE DRYER ACCESSORIES 49

DECLARATION OF CONFORMITY 57

Product Service: Domestic 1-800-522-7658, International 816-333-8811

Congratulations on your purchase of a Labconco Freeze

Dry System. Models are available for operation on

115V or 230V.

The Labconco FreeZone® Plus 2.5 Liter Freeze Dry

System is designed for laboratory lyophilization

procedures. It is CFC free so it will not endanger the

environment. The unit is easy to install and maintain.

Proper care and maintenance of this product will result

in many years of dependable service.

Freeze Dry Process

Dehydration is an important process for the

preservation and storage of biologicals, pharmaceuticals

and foods. Of the various methods of dehydration,

freeze drying (lyophilization) is especially suited for

substances that are heat sensitive. Other than food

processing (e.g., coffee, whole dinners), freeze drying

has been extensively used in the development of

pharmaceuticals (e.g., antibiotics) and preservation of

biologicals (e.g., proteins, plasma, viruses and

microorganisms). The nondestructive nature of this

process has been demonstrated by the retention of

viability in freeze dried viruses and microorganisms.

2 Product Service: Domestic 1-800-522-7658, International 816-333-8811

Chapter 1: Introduction

Freeze drying is a process whereby water is removed

from frozen materials by converting the frozen water

directly into its vapor without the intermediate

formation of liquid water. The basis for this

sublimation process involves the absorption of heat by

the frozen sample in order to vaporize the water; the use

of a vacuum pump to enhance the removal of water

vapor from the surface of the sample; the transfer and

deposit of water vapor onto a collector; and the removal

of heat due to ice formation from the collector by

means of a refrigeration system. In essence, the freeze

dry process is a balance between the heat absorbed by

the sample to vaporize the water and the heat removed

from the collector to convert the water vapor into ice.

Freeze Dry Rates

The efficiency of the freeze drying process is dependent

upon the surface area and the thickness of the sample;

the collector temperature and vacuum obtained; the

eutectic point and solute concentration of the sample. It

is important to remember these three factors when

trying to obtain efficient utilization of your freeze dry

system. A listing of selected materials and their

approximate drying times are shown in Table 1 for your

reference.

SAFE TEMPERATURE AND DRYING TIMES

FOR SELECTED MATERIALS

Material

10mm Thick

Safe

Temperature

°C

Collector

Temperature

°C

Hours

(Approx.)

Milk -5 -40 10

Urea -7 -40 10

Blood Plasma -10 to -25 -40 16

Serum -25 -40 18

Vaccinia -30 to -40 -50 22

Influenza Vaccine -30 -50 24

Human Tissue -30 to -40 -50 48

Vegetable Tissue -50 -80 60

*Total sample quantities are contingent on various freeze dryer capacities.

Table 1

Product Service: Domestic 1-800-522-7658, International 816-333-8811

Chapter 1: Introduction

Up to the point of overloading the system, the greater

the surface area of the sample, the greater the rate of

freeze drying. By contrast, for a given surface area, the

thicker the sample the slower the rate of freeze drying.

This is based on the fact that the heat of sublimation is

usually absorbed on one side of the frozen sample and

must travel through the frozen layer to vaporize water

at the other surface. In addition, as the sample is freeze

dried, the water vapor must travel through the layer of

dried material. The thicker the sample, the greater the

chance that the dried layer may collapse which would

cause an additional decrease in the rate of freeze drying.

The surface area and thickness of the sample can

usually be ignored when each sample contains only a

few milliliters. However, for larger volumes, the

samples should be shell frozen to maximize the surface

area and minimize the thickness of the sample. The

volume of the freeze dry flask should be two to three

times the volume of the sample.

In order for lyophilization to occur, ice must be

removed from the frozen sample via sublimation. This

is accomplished by the collector and the vacuum pump.

The collector, which should be at least 10 to 15°C

colder than the eutectic temperature (melting

temperature) of the sample, traps vapor as ice. Since

the vapor pressure at the collector is less than that of the

sample, the flow of water vapor is from the sample to

the collector. Since this vapor diffusion process occurs

very slowly under normal atmospheric conditions, a

good vacuum is essential to maintain an efficient rate.

In most applications, the maintenance of a vacuum of

133 x 10-3 mBar or less is required for freeze drying to

occur.

The rate of freeze drying is directly proportional to the

vapor pressure and the vapor pressure is dependent

upon both eutectic temperature and solute concentration

of the sample. For example, a solution of sodium

chloride would freeze dry at a slower rate than pure

water. The eutectic temperature of a sodium chloride

solution is about –21°C and at this temperature the

vapor pressure is about 1/16 that at 0°C. Although the

eutectic temperature is not dependent upon the

4 Product Service: Domestic 1-800-522-7658, International 816-333-8811

Chapter 1: Introduction

concentration of sodium chloride, the vapor pressure of

the water would decrease as the concentration of

sodium chloride increased. This is due to the fact that

as the solute concentration increases, less of the surface

area of the frozen sample is occupied by water. In

general, most solutions or biological samples will have

a eutectic temperature of –10 to –25°C. However, if

there is a simple sugar such as a glucose or if the

sample is animal or plant tissue, the eutectic

temperature may be as low as –30 to –50°C.

Freeze Dry Capacity

The volume of a sample that can be freeze dried at one

time is related to factors discussed previously and the

size and design of the freeze dry system. With any

given instrument, the capacity is based on the surface

area of the sample; the eutectic temperature and

concentration of the sample; and the rate and amount of

heat transferred to the frozen sample. Of these factors,

the eutectic temperature is the most important factor in

determining the amount of sample that can be freeze

dried at one time, particularly when flasks are used.

This is because as the eutectic temperature decreases,

the vapor pressure decreases but the rate of heat

absorption by the sample does not change. This tends

to promote melting of the sample which leads to a

marked increase in vapor pressure and ultimately

overloads the collector and vacuum pump. Samples

that have eutectic temperatures of –20°C or lower

should be placed on the freeze dry system one flask at a

time so that the vacuum in the system may recover

before adding another sample to the system. If the

vacuum does not recover to less than 133 x 10-3 mBar

the capacity of the freeze dry system has been exceeded

and the sample should be removed.

If there is a problem with a particular type of sample

melting when placed on the freeze dry system, dilution

of the sample with more water or providing some

insulation around the flask to decrease the rate of heat

absorption by the sample may help. If the eutectic

temperature of the sample is –40 to –60°C, the freeze

dry system selected for use must be equipped with

Product Service: Domestic 1-800-522-7658, International 816-333-8811

Chapter 1: Introduction

cascade type refrigeration so that the collector

temperature can be cooled to below –75°C, or a dry

ice/solvent trap can be used between the collector and

the vacuum pump.

Samples Containing Volatile

Substances

In certain cases the solvent in a sample to be freeze

dried may contain volatile components such as acetic

acid, formic acid or pyridine. In addition to these

substances having an effect on the eutectic temperature,

they may enhance the vapor pressure at the surface of

the sample. Also, compared to water, they will require

the absorption of less heat for sublimation to occur.

Hence, freeze drying samples that contain volatile

substances will have a greater tendency to melt,

particularly when placed in flasks or exposed to room

temperature. If a sample containing a volatile

substance tends to melt when placed on a freeze dry

system, dilution of the sample with more water will

help keep the sample frozen. For example, a 0.2M

solution of acetic acid is much easier to freeze dry than

a 0.5M solution.

About This Manual

This manual is designed to help you learn how to

install, use, and maintain your Freeze Dryer.

Instructions for performing routine maintenance and

making minor modifications to your Freeze Dryer are

also included.

Chapter 1: Introduction provides a brief overview of

the Freeze Dryer, explains the organization of the

manual, and defines the typographical conventions used

in the manual.

Chapter 2: Prerequisites explains what you need to do

to prepare your site before you install your Freeze

Dryer. Electrical requirements are discussed.

6 Product Service: Domestic 1-800-522-7658, International 816-333-8811

Chapter 1: Introduction

Chapter 3: Getting Started contains the information

you need to properly unpack, inspect and install your

Freeze Dryer.

Chapter 4: Using Your Freeze Dryer discusses the

basic operation of your Freeze Dryer. Information on

how to attach samples and run the Freeze Dryer is

included.

Chapter 5: Maintaining Your Freeze Dryer explains

how to perform routine maintenance on your Freeze

Dryer.

Chapter 6: Modifying Your Freeze Dryer describes how

to attach a recorder or computer for monitoring the

operation.

Chapter 7: Troubleshooting contains a table of

problems you may encounter while using your Freeze

Dryer, including the probable causes of the problems,

and suggested corrective actions.

Appendix A: Freeze Dryer Components contains

labeled diagrams of the components of the Freeze

Dryer.

Appendix B: Freeze Dryer Dimensions contains

comprehensive diagrams showing the dimensions for

the Freeze Dryer.

Appendix C: Freeze Dryer Specifications contains

product specifications. Wiring diagrams for both the

115V and 230V Freeze Dryer are also included.

Appendix D: Freeze Dryer Accessories lists the part

numbers and descriptions of all of the accessories

available for your Freeze Dryer.

Product Service: Domestic 1-800-522-7658, International 816-333-8811

Chapter 1: Introduction

Typographical Conventions

Recognizing the following typographical conventions

will help you understand and use this manual:

• Book, chapter, and section titles are shown in italic

type (e.g., Chapter 3: Getting Started).

• Steps required to perform a task are presented in a

numbered format.

• Comments located in the margins provide

suggestions, reminders, and references.

• Critical information is presented in boldface type in

paragraphs that are preceded by the exclamation

icon. Failure to comply with the information

following an exclamation icon may result in injury

to the user or permanent damage to your Freeze

Dryer.

• Important information is presented in capitalized

type in paragraphs that are preceded by the pointer

icon. It is imperative that the information contained

in these paragraphs be thoroughly read and

understood by the user.

Your Next Step

If your Freeze Dryer needs to be installed, proceed to

Chapter 2: Prerequisites to ensure your installation site

meets all of the requirements. Then, go to Chapter 3:

Getting Started for instructions on how to install your

Freeze Dryer and make all of the necessary

connections.

For information on the operational characteristics of

your Freeze Dryer, go to Chapter 4: Using Your Freeze

Dryer.

If your Freeze Dryer is installed and you need to

perform routine maintenance on the Freeze Dryer,

proceed to Chapter 5: Maintaining Your Freeze Dryer.

☞

8 Product Service: Domestic 1-800-522-7658, International 816-333-8811

Chapter 1: Introduction

For information on making modifications to the

configuration of your Freeze Dryer go to Chapter 6:

Modifying Your Freeze Dryer.

Refer to Chapter 7: Troubleshooting if you are

experiencing problems with your Freeze Dryer.

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