Friability Tester

Operator’s Manual

Agilent Technologies
Notices
© Agilent Technologies, Inc. 2011 Warranty (Technical Data) and 12.212 (Computer
No part of this manual may be reproduced Software) and, for the Department of
The material contained in this doc- Defense, DFARS 252.227-7015 (Techni-
in any form or by any means (including
ument is provided “as is,” and is cal Data - Commercial Items) and DFARS
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agreement and written consent from Agi- notice, in future editions. Further, puter Software or Computer Software
lent Technologies, Inc. as governed by to the maximum extent permitted Documentation).
United States and international copyright by applicable law, Agilent disclaims
laws. all warranties, either express or Safety Notices
implied, with regard to this manual
Manual Part Number and any information contained
herein, including but not limited to CAUTION
70-9068 the implied warranties of mer-
chantability and fitness for a par- A CAUTION notice denotes a
Edition ticular purpose. Agilent shall not be hazard. It calls attention to an
Rev A, July 2011 liable for errors or for incidental or operating procedure, practice, or
consequential damages in connec-
Printed in USA
tion with the furnishing, use, or the like that, if not correctly per-
Agilent Technologies, Inc. performance of this document or of formed or adhered to, could result
3501 Stevens Creek Blvd. any information contained herein. in damage to the product or loss
Santa Clara, CA 95052 USA Should Agilent and the user have a of important data. Do not proceed
separate written agreement with beyond a CAUTION notice until
warranty terms covering the mate-
rial in this document that conflict the indicated conditions are fully
with these terms, the warranty understood and met.
terms in the separate agreement
shall control.

Technology Licenses WA RNING

The hardware and/or software described in A WARNING notice denotes a
this document are furnished under a
license and may be used or copied only in hazard. It calls attention to an
accordance with the terms of such license. operating procedure, practice,
or the like that, if not correctly
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WARNING notice until the
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ary commercial license in Software and understood and met.
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Friability Tester Operator’s Manual

Contents
Figures 5

1 Safety 7
Electrical Hazards 8
Warning 9
Caution 9
Note 9
Information Symbols 10
General 11
WEEE Directive 12

2 Introduction 13
Available Configurations 15
Conventions Used in this Manual 16
USP Suitability Test 17
USP Physical Parameters 17

3 Setting Up the Friability Tester 19

Initial Setup 20
Unpacking Procedure 20
Connecting the Printer 21
Setting the Date and Time 22
Hidden Key Functions 23

Friability Tester Operator’s Manual 3

Contents

4 Operating the Friability Tester 25

Operating the Friability Tester without a Printer 26
Running a Test 26
Stopping a Test 27
Operating the Friability Tester with a Printer 28
Configuring for the Number of Chambers or Drums
Used 28
Running a Test 28
Stopping a Test 31

5 Troubleshooting and Maintenance 33

Maintenance 34
Periodic Maintenance 34
Acrylic Care 35
Fuse Replacement 36
Troubleshooting 37

6 Service and Warranty 39

Service and Warranty Information 40
Exclusions and Limitations 40
Obtaining Warranty Service 40
Warranty Limitations 41
Exclusive Remedies 41

Index 43

4 Friability Tester Operator’s Manual

Figures
Figure 1. Dual-drum Friability Tester 14
Figure 2. Traditional Roche-type USP drum with a
single-chamber design 15
Figure 3. Agilent USP drum with two arched bridges which
saves time by allowing for two tests in one drum. 15
Figure 4. Abrasion drum with internal baffles to agitate the
product inside—for applications requiring a high
degree of mechanical stress. 16

Friability Tester Operator’s Manual 5

Figures

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6 Friability Tester Operator’s Manual

Friability Tester
Operator’s Manual

1
Safety
Electrical Hazards 8
WEEE Directive 12

The Friability Tester has been carefully designed so that when used
properly you have an accurate, fast, flexible, and safe instrument.
If the equipment is used in a manner not specified by the manufacturer,
the protection provided by the equipment may be impaired.
The Friability Tester is operated in conjunction with equipment that uses
aqueous liquids. Unskilled, improper, or careless use of this instrument
can create shock hazards, fire hazards, or other hazards which can cause
death, serious injury to personnel, or severe damage to equipment and
property.
Information on safety practices is provided with your instrument and
operation manuals. Before using your instrument or accessories, you
must thoroughly read these safety practices.
Observe all relevant safety practices at all times.

Agilent Technologies 7
1 Safety

Electrical Hazards
The Friability Tester contains electrical circuits, devices, and
components operating at dangerous voltages. Contact with these
circuits, devices, and components can cause death, serious injury, or
painful electric shock.
Panels or covers that are retained by fasteners which require the use of a
tool for removal may be opened only by Agilent-trained,
Agilent-qualified, or Agilent-authorized service engineers. Consult the
manuals or product labels supplied with the Friability Tester to
determine which parts are operator-accessible.
Application of the wrong supply voltage, connection of the instrument
to an incorrectly wired supply outlet, or lack of proper electrical
grounding can create a fire hazard or a potentially serious shock hazard
and could seriously damage the instrument and any attached ancillary
equipment.
Always use a three-wire outlet with ground connection which is
adequately rated for the load. The installation must comply with local,
state, and federal safety regulations.
Do not connect the instrument to the main power supply until you have
made sure that the operating voltage is correctly set for the main power
supply in the specific outlet in your laboratory to which the equipment
will be connected.

8 Friability Tester Operator’s Manual

 Safety 1

Warning
WA RNING

A ‘Warning’ message appears in the manual when failure to observe

instructions or precautions could result in death or injury.
Read all warnings and cautions carefully and observe them at all times.

Caution
CAUTION

A ‘Caution’ message appears in the manual when failure to observe

instructions could result in damage to equipment (Agilent supplied and /
or other associated equipment).

Note
NOT E
A ‘Note’ appears in the manual to give advice or information.

Friability Tester Operator’s Manual 9

1 Safety

Information Symbols
I Switches main power on
0 Switches main power off

Indicates single-phase alternating current

Indicates the product complies with the

requirements of one or more European Union
(EU) directives

Indicates specific equipment meets

consensus-based standards of safety to provide
assurance, required by OSHA, that these
products are safe for use in the workplace for
North America

Indicates that this product must not be disposed

of as unsorted municipal waste

10 Friability Tester Operator’s Manual

 Safety 1

General
CE Compliant Products
The Friability Tester has been designed to comply with the requirements
of the Electro-magnetic Compatibility (EMC) Directive and the Low
Voltage Directive (LVD) of the EU.
Agilent, Inc. has confirmed that each product complies with the relevant
directives by testing a prototype against the prescribed European Norm
(EN) standards.
Proof that a product complies with the directives is indicated by:
• the CE marking appearing on the rear of the product.
• the documentation package that accompanies the product containing
a copy of the declaration of conformity. This declaration is the legal
declaration by Agilent, Inc. that the product complies with the
directives and also shows the EN standards to which the product was
tested to demonstrate compliance. The declaration of conformity is
signed by the representative of the manufacturing plant.

cTUVus - U.S. and Canadian Product Approvals

The Friability Tester has been designed to comply with North American
safety requirements.
This product has been tested and certified for the North American
market by TUV Rheinland of North America, Inc. The TUVus mark
signifies that this product has been tested to U.S. standards and certified
for the U.S. market. The cTUV mark signifies that this product has been
tested to Canadian standards and certified for the Canadian market.
When the two marks are coupled, the cTUVus mark signifies that this
product has been tested to standards and certified for both markets.

Friability Tester Operator’s Manual 11

1 Safety

WEEE Directive
All Agilent products that are subject to the WEEE directive shipped
after August 13, 2005 are compliant with the WEEE marking
requirements. Such products are marked with the “crossed out wheelie
bin” WEEE symbol shown on page 10 in accordance with European
Standard EN 50419.
This symbol on the product or on its packaging indicates that this
product must not be disposed of as unsorted municipal waste. The
separate collection and recycling of your waste equipment at the time of
disposal will help to conserve natural resources and ensure that it is
recycled in a manner that protects human health and the environment.
For more information on collection, reuse, and recycling systems,
please contact your local/regional waste administration, your local
distributor, or Agilent, Inc.

12 Friability Tester Operator’s Manual

 Friability Tester
Operator’s Manual

2
Introduction
Available Configurations 15
Conventions Used in this Manual 16
USP Suitability Test 17
USP Physical Parameters 17

Your Friability Tester provides a standardized, reproducible method for

measuring the tendency of a tablet or its coating to chip or powder when
subjected to the mechanical stresses of the coating as well as the
shipping and handling processes. The Friability Tester drums turn at a
constant 25 RPM with precision and accuracy ensured by the use of a
synchronous motor. Speed is linked to the AC line frequency, usually
either 50 or 60 Hz, depending on your geographic location. As the
product in the drum tumbles against the drum’s internal vane, its loss
due to breakage or chipping can be measured. The Friability Tester is
available in a single-drum and dual-drum model.
An optional printer provides documentation of instrument operation
including test start time, operating mode, and set duration in either
number of rotations or elapsed time. On units equipped with the printer,
you can enter the starting and ending weights of the tablets and the
percentage loss is calculated per USP.

The Friability Tester contains electrical circuits, devices, and

WA RNING
components operating at dangerous voltages. Contact with these
circuits, devices and components can cause death, serious injury,
or painful electric shock.

Agilent Technologies 13
2 Introduction

Figure 1 Dual-drum Friability Tester

Panels or covers that are retained by fasteners which require the use
CAUTION
of a tool for removal may be opened only by Agilent-trained,
Agilent-qualified, or Agilent-authorized service engineers.

14 Friability Tester Operator’s Manual

 Introduction 2

Available Configurations
The Friability Tester is available in a single-drum or dual-drum
configuration. The dual-drum configuration turns synchronously on
opposite ends of the same shaft. This option allows two tests to run
simultaneously.
Three types of drums are available:.

Figure 2 Traditional Roche-type USP drum with a single-chamber

design

Figure 3 Agilent USP drum with two arched bridges which saves
time by allowing for two tests in one drum.

Friability Tester Operator’s Manual 15

2 Introduction

Figure 4 Abrasion drum with internal baffles to agitate the product

inside—for applications requiring a high degree of me-
chanical stress.

Contact the Dissolution Systems Service Department for any special

drum needs you may have.

Conventions Used in this Manual

• Items you are asked to press are in bold. For example, “press H on
the keypad”.

16 Friability Tester Operator’s Manual

 Introduction 2

USP Suitability Test

Before initial use of any dissolution instrument, and periodically
thereafter, the USP requires that you run an Performance Verification
Test with USP Dissolution Calibrators. These calibrator tablets are
available from the USP at the following address:
USP-NF Reference Standards
12601 Twinbrook Parkway
Rockville, MD 20852
301.881.0666
Complete instructions come with the calibrator tablets. Calibration tests
can be very sensitive to factors such as paddle or vessel misalignment,
vessel shape, vibration of the system, age of the calibrator tablets and
reference standards, and many other factors.

USP Physical Parameters

In addition to the Apparatus Suitability Test, several physical
parameters must be monitored, such as shaft wobble, centering, speed,
and shaft verticality. A Certificate of Inspection is included with all
dissolution apparatus. Contact the Dissolution Systems Service
Department for more information on USP Physical Parameters.

Friability Tester Operator’s Manual 17

2 Introduction

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18 Friability Tester Operator’s Manual

Friability Tester
Operator’s Manual

3
Setting Up the Friability Tester
Initial Setup 20
Setting the Date and Time 22
Hidden Key Functions 23

Agilent Technologies 19
3 Setting Up the Friability Tester

Initial Setup
Complete the following sections to initially set up the Friability Tester
and all other system components.

Unpacking Procedure
Complete these steps to safely unpack and set up your equipment:
1 Open each carton and check the contents for damage which may
have occurred during shipping. Shipping damage rarely occurs, but if
it does contact both the carrier who delivered the instruments and the
Dissolution Systems Service Department. Though claims for damage
should be filed with the carrier, we can help you file a claim.
2 Carefully remove the Friability Tester base unit from the shipping
carton. Place it on a clean, dry, level area of your benchtop within
four feet (122 cm) of a grounded electrical outlet.

The electrical connection at the back of the tester is the primary

WA RNING
disconnect for the instrument. The tester should be positioned to
allow accessibility to the power cords for easy disconnection.

3 Ensure the Friability Tester is turned off.

Before plugging the Friability Tester into any power outlet,

WA RNING
ensure the instrument is properly configured for the voltage
provided. Check the serial number tag on the rear panel of the
instrument to confirm the voltage requirement.

4 Connect the power cord (found in the instrument accessory kit)

between the receptacle on the rear panel and an electrical outlet of
the appropriate voltage.
5 Turn on the Friability Tester. The LED screen on the front panel
illuminates. If not, ensure the unit is securely plugged in and there is
power at the outlet. If the unit still fails to respond, see

20 Friability Tester Operator’s Manual

 Setting Up the Friability Tester 3

“Troubleshooting” on page 37 or call the Dissolution Systems

Service Department.

Connecting the Printer

If your tester is equipped with an optional printer, complete the
following steps:
1 Remove the printer from the shipping carton.
2 Place it on a clean, dry, level area of your benchtop to the right of
your Friability Tester.
3 Connect the printer cable between the rear of the printer and the port
on the right side panel of the Friability Tester.
4 Connect the AC power adapter between the jack on the rear of the
printer and an electrical outlet of the appropriate voltage.
5 Toggle the printer online.

Friability Tester Operator’s Manual 21

3 Setting Up the Friability Tester

Setting the Date and Time

The Friability Tester comes equipped with a battery-backed up clock
which stores the date and time. If your unit is equipped with a printer,
the date and starting time print on the report. If applicable, complete the
following steps to set the date and time:
• Press SET CLOCK. The current date (in mm/dd/yy format) and
time (in 24-hour format) display alternately.
• To accept the current date and time, press CLEAR. The test duration
displays and no further action is required.
• To change the date and time, press SET CLOCK again. The date
displays in mm/dd/yy format.
• To accept the date as it displays, press ENTER. The time displays in
24-hour format.
• To change the date, enter the new value and press ENTER. The time
displays in 24-hour format.
• To accept the time as it displays, press ENTER. The test duration
displays.
• To change the time, enter the new value and press ENTER. The test
duration displays.

22 Friability Tester Operator’s Manual

 Setting Up the Friability Tester 3

Hidden Key Functions

Hidden keys can be accessed only when the Printer On LED is not
illuminated, indicating that the printer is disabled, and the motor is
running. Press PRINT to enable or disable the printer. To enable the
PRINT key, press CLEAR > 9. In the following table, CLEAR >
(function) indicates you should press CLEAR and then the function
key.

Table 1 Hidden Key Functions

Key Sequence Function

CLEAR > 1 Use this key sequence to indicate one chamber.

CLEAR > 2 Use this key sequence to indicate two chambers.

CLEAR > 3 Use this key sequence to indicate three chambers.

CLEAR > 4 Use this key sequence to indicate four chambers.

CLEAR > 6 Use this key sequence to enable the PCB display.

CLEAR > 8 Use this key sequence to indicate the Friability Tester.

CLEAR > 9 Use this key sequence to enable the PRINT key.

CLEAR > 0 Use this key sequence to disable PRINT key.

Friability Tester Operator’s Manual 23

3 Setting Up the Friability Tester

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24 Friability Tester Operator’s Manual

Friability Tester
Operator’s Manual

4
Operating the Friability Tester
Operating the Friability Tester without a Printer 26
Operating the Friability Tester with a Printer 28

Agilent Technologies 25
4 Operating the Friability Tester

Operating the Friability Tester without a Printer

If your unit is equipped with a printer, see “Operating the Friability
Tester with a Printer” on page 28.

Running a Test
Complete the following steps to run a test using a Friability Tester not
equipped with a printer:
1 Ensure the PRINT key is disabled. See “Hidden Key Functions” on
page 23 for instructions on how to disable the PRINT key.
2 Select the mode of operation, either timer or counter, by pressing
TIME COUNT. This key toggles the unit between the two operating
modes. The Timer LED illuminates to indicate the timer option is
selected. The Counter LED illuminates to indicate the counter option
is selected.
3 Enter either the number of rotations (up to 999,999) or the time
duration (in hh:mm:ss format) as applicable and press ENTER.
Once entered, the test duration is saved by the unit and does not need
to be reset unless you want to change it. To change the duration, enter
the new value and press ENTER.
4 Locate the drums supplied with your unit. Hold the drums firmly so
the covers do not fall off. Place the drums on the benchtop and
carefully remove the covers and set them aside.

The right- and left-side drums are not interchangeable. The vanes curve
NOT E in opposite directions. Be sure to identify them properly before
mounting. Drums supplied with dual-drum units have right- and
left-side configurations. Check the label on the cover of each to identify
them. Left-side drums mount on the left side of the unit as viewed from
the front. Right-side drums mount on the right side as viewed from the
front.

26 Friability Tester Operator’s Manual

 Operating the Friability Tester 4

5 Brush away any loose dust from the tablets to be tested.

Follow USP guidelines or applicable test procedures to determine the

NOT E number of tablets to be tested. Generally, a minimum of 20 tablets
should be used in testing. For tablets weighing over 650 mg each, 10
tablets are usually sufficient.

6 Accurately weigh the tablets.

7 Load the tablets to be tested into the drums and replace the covers.
8 For each drum, hold the cover firmly in place and slide the drum
body onto the shaft. There are two pins at the end of the shaft which
hold the drum while the shaft turns. Match the pins with the slots in
the hub.
9 For each drum, place the locking nut on the end of the shaft and
tighten. Do not overtighten or damage to the drum may result.
10 Press START STOP to begin. The time duration or number of
rotations count down on the display screen and the test stops
automatically when 0 is reached. The display automatically resets to
the original set value preparing the instrument for the next test.
11 At the conclusion of the test, remove the drums.
12 Remove the tablets and brush away any loose dust. Per the USP, if
obviously cracked, cleaved, or broken tablets are present in the tablet
sample after tumbling, the sample fails the test.
13 Re-weigh the tablets. Calculate the percentage of weight loss using
the following formula:

Stopping a Test
When running a test on a Friability Tester without a printer, you can stop
the test by pressing START STOP. The drums stop immediately and the
display returns to the original test length setting.

Friability Tester Operator’s Manual 27

4 Operating the Friability Tester

Operating the Friability Tester with a Printer

If your unit is not equipped with a printer, see “Operating the Friability
Tester without a Printer” on page 26.

Configuring for the Number of Chambers or Drums Used

Complete the following steps to configure your printer-equipped
Friability Tester for the number of chambers or drums in use:
1 Ensure the Printer On LED is not illuminated. If the LED is
illuminated, press PRINT to disable the printer.
2 Press START STOP. The drums rotate.
3 Press the following keystroke combinations depending on the
number of chambers you wish to specify:
• CLEAR > 1 - one chamber
• CLEAR > 2 - two chambers
• CLEAR > 3 - three chambers
• CLEAR > 4 - four chambers
4 Press START STOP. The drums stop rotating.
5 Press PRINT to enable the printer. The Printer On LED illuminates.
The next time you press START STOP, with the printer enabled, the
appropriate number of initial and final weights are requested based
on the number of chambers specified.

Running a Test
If your unit is equipped with the optional printer, you can print a report
at the end of each test to document the date, starting time, mode
selected, and the set duration. If the Printer On LED is illuminated, the
printer is enabled. Press PRINT to enable or disable the printer.

28 Friability Tester Operator’s Manual

 Operating the Friability Tester 4

Complete the following steps to operate your Friability Tester with

printer:
1 Ensure the printer is enabled. When enabled, the Printer On LED
illuminates.
2 Toggle the printer online.
3 Select the mode of operation, either timer or counter, by pressing
TIME COUNT. This key toggles the unit between the two operating
modes. The Timer LED illuminates to indicate the timer option is
selected. The Counter LED illuminates to indicate the counter option
is selected.
4 Enter either the number of rotations (up to 999,999) or the time
duration (in hh:mm:ss format) as applicable and press ENTER.
Once entered, the test duration is saved by the unit and does not need
to be reset unless you want to change it. To change the duration, enter
the new value and press ENTER.
5 Locate the drums supplied with your unit. Hold the drums firmly so
the covers do not fall off. Place the drums on the benchtop and
carefully remove the covers and set them aside.

The right- and left-side drums are not interchangeable. The vanes curve
NOT E in opposite directions. Be sure to identify them properly before
mounting. Drums supplied with dual-drum units have right- and
left-side configurations. Check the label on the cover of each to identify
them. Left-side drums mount on the left side of the unit as viewed from
the front. Right-side drums mount on the right side as viewed from the
front.

6 Brush away any loose dust from the tablets to be tested.

Follow USP guidelines or applicable test procedures to determine the

NOT E number of tablets to be tested. Generally, a minimum of 20 tablets
should be used in testing. For tablets weighing over 650 mg each, 10
tablets are usually sufficient.

7 Accurately weigh the tablets.

8 Load the tablets to be tested into the drums and replace the covers.

Friability Tester Operator’s Manual 29

4 Operating the Friability Tester

9 For each drum, hold the cover firmly in place and slide the drum
body onto the shaft. There are two pins at the end of the shaft which
hold the drum while the shaft turns. Match the pins with the slots in
the hub.
10 For each drum, place the locking nut on the end of the shaft and
tighten. Do not overtighten or damage to the drum may result.
11 Press START STOP. You are prompted to enter the initial weight (in
grams) of the product in the drum. Up to four weights can be entered
depending on the number of chambers or drums used (see
“Configuring for the Number of Chambers or Drums Used” on
page 28). The following is a summary of what displays after pressing
START STOP but before the drums begin to turn:
• The number 1 displays on the display screen alternating with the
last initial weight entered for the product in chamber or drum 1.
Press ENTER to accept the displayed value or enter the new
initial weight and press ENTER. If configured for one chamber
or drum, the drum begins to turn.
• If configured for two chambers or drums, the number 2 flashes on
the display screen alternating with the last initial weight entered
for the product in chamber or drum 2. Press ENTER to accept the
displayed value or enter the new initial weight and press ENTER.
If configured for two chambers or drums, the drums begin to turn.
• If configured for three chambers, the number 3 flashes on the
display screen alternating with the last initial weight entered for
the product in chamber 3. Press ENTER to accept the displayed
value or enter the new initial weight and press ENTER. If
configured for three chambers, the drums begin to turn.
• If configured for four chambers, the number 4 flashes on the
display screen alternating with the last initial weight entered for
the product in chamber 4. Press ENTER to accept the displayed
value or enter the new initial weight and press ENTER. If
configured for four chambers, the drums begin to turn.

When the drums have stopped turning at the conclusion of the test, the
NOT E screen prompts you to enter ending weights for the products in each
chamber or drum as it did for starting weights.

12 At the conclusion of the test, remove the drums.

30 Friability Tester Operator’s Manual

 Operating the Friability Tester 4

13 Remove the tablets and brush away any loose dust. Per the USP, if
obviously cracked, cleaved, or broken tablets are present in the tablet
sample after tumbling, the sample fails the test.
14 Re-weigh the tablets and enter the requested values.
15 After the ending weight for the last chamber or drum has been
entered, the printer prints a test report including the calculated
percentage of weight loss for all samples.

Stopping a Test
1 When running a test on a Friability Tester equipped with a printer,
you can stop the test by pressing START STOP. The drums stop
immediately and the display prompts you to enter the ending weights
for the products as described above.
2 Enter the ending weights and press ENTER for each chamber as
applicable. The printer prints a test report and calculates the
percentage of weight loss for the products even though the test was
stopped prematurely.

Friability Tester Operator’s Manual 31

4 Operating the Friability Tester

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32 Friability Tester Operator’s Manual

Friability Tester
Operator’s Manual

5
Troubleshooting and Maintenance
Maintenance 34
Fuse Replacement 36
Troubleshooting 37

Agilent Technologies 33
5 Troubleshooting and Maintenance

Maintenance
The Friability Tester contains electrical circuits, devices, and
WA RNING
components operating at dangerous voltages. Contact with these
circuits, devices, and components can cause death, serious
injury, or painful electric shock.

Periodic Maintenance
Periodic maintenance needs may vary depending on frequency of
instrument usage.
• Immediately wipe all spills or errant materials from the exterior of
the instrument or any exposed part using a clean cloth and plain
water.
• Do not use cleaners containing ammonia or organic solvents, such
as alcohol, on the acrylic drums. These compounds can attack the
plastic, causing cracks and fractures which will not be covered by
the warranty.
• Store all Friability Tester drums properly.

Monthly Maintenance
• Check the drums for cracks or chips.
• Wipe the shaft clean.
• Ensure the pins which hold the drums while the shaft turns are not
bent.
• Clean the outside of the tester with a damp cloth.

34 Friability Tester Operator’s Manual

 Troubleshooting and Maintenance 5

Annual Maintenance
The Friability Tester contains electrical circuits, devices, and
WA RNING
components operating at dangerous voltages. Contact with these
circuits, devices, and components can cause death, serious
injury, or painful electric shock.
Panels or covers that are retained by fasteners which require the
use of a tool for removal may be opened only by Agilent-trained,
Agilent-qualified, or Agilent-authorized service engineers.

• Inspect all electrical connections for corrosion and damage.

• Clean the inside and outside of the tester with a damp cloth.
• Check belt tension—total deflection should not exceed 1/2 inch
(1.3 cm).

Acrylic Care
Do not use cleaning compounds containing ammonia or abrasive
CAUTION
cleaners on your drums.

• The Friability Tester drums are fabricated of commercial grade

acrylic. Be sure to rinse them thoroughly with deionized water
after each use, and dry thoroughly with a soft towel or cloth.
• Do not clean with abrasive cleansers or cloths. Use deionized
water whenever possible. If you must use a cleanser or solvent, be
sure that it is as mild as possible, non-abrasive, and fully
compatible with PETG and acrylic before use. If in doubt, call the
service department for advice before proceeding.
• Do not use ammonia, window-cleaning sprays, kitchen scouring
compounds, or solvents such as acetone, gasoline, benzene,
alcohol, carbon tetrachloride, or lacquer thinner. These can
scratch the material’s surface and / or weaken it causing small
surface cracks called “crazing”.

Friability Tester Operator’s Manual 35

5 Troubleshooting and Maintenance

• Our recommendations include but are not limited to the

following:
• Hot water:< 150 °F
• Vinegar (5% Glacial Acetic Acid)
• Ethyl alcohol: maximum 10%
• Isopropyl alcohol: maximum 25%

Fuse Replacement
The Friability Tester contains electrical circuits, devices, and
WA RNING
components operating at dangerous voltages. Contact with these
circuits, devices, and components can cause death, serious
injury, or painful electric shock.
Panels or covers that are retained by fasteners which require the
use of a tool for removal may be opened only by Agilent-trained,
Agilent-qualified, or Agilent-authorized service engineers.

Follow these steps to replace the main power fuse:

1 Before checking or attempting to replace a fuse, unplug the Friability
Tester and remove the power cord from the unit.
2 Press the release tab on the fuse holder located in the power entry
module with the blade of a small screwdriver or equivalent.
3 Upon release, slide the holder out of the power entry module.
4 Remove the old fuse and insert the new fuse.
5 Slide the holder back into the power entry module and push until it
locks into place.
6 Replace the power cord.

Never replace a fuse with one of a higher amperage rating.

WA RNING
Doing so may compromise the safety margin and could result in
damage to the instrument or personal injury.

36 Friability Tester Operator’s Manual

 Troubleshooting and Maintenance 5

Troubleshooting
The Dissolution Systems Service Department can assist you if you
experience problems or have questions concerning your Friability
Tester. Many problems can be traced to simple sources and are easily
solved.
Following is a troubleshooting guide which may help you. The
Dissolution Systems Service Department can be reached at
800.229.1108 (within the USA) or 919.677.1108 (outside the USA).
Optionally, you can send a fax to 919.677.1138. You can also e-mail the
Dissolution Systems Service Department at
[email protected].

Table 2 Troubleshooting

Problem Possible Cause Suggested Solution

The LED on the front panel There is no power at the outlet. Ensure the outlet has power going to it.
display screen does not
illuminate. The unit is not plugged in. Ensure the unit is securely connected to
an electrical outlet.

The fuse is blown (open). Replace the fuse. See “Fuse

Replacement” on page 36.

The drums do not turn. Program was not started. Press START STOP.

The drive belt is broken. Replace the drive belt.

The test length is incorrect. The wrong operating mode is Set the proper mode (counter or timer).
selected. See “Running a Test” on page 26 and
page 28.

Friability Tester Operator’s Manual 37

5 Troubleshooting and Maintenance

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38 Friability Tester Operator’s Manual

Friability Tester
Operator’s Manual

6
Service and Warranty
Service and Warranty Information 40

The warranty is provided by Agilent Technologies, Inc. or one of its

authorized representatives.

Agilent Technologies 39
6 Service and Warranty

Service and Warranty Information

Agilent dissolution products carry a one-year warranty on parts and
labor. The Dissolution Systems Service Department (or one of its
representatives) will, at its option, either repair or replace any
mechanical and electrical components in your instrument which prove
to be defective. During the first year of warranty coverage, there is no
charge for the labor to repair your unit. The Dissolution Systems Service
Department (or one of its representatives) will determine the best site to
repair the unit, either onsite or returned to Agilent Technologies, Inc.
Any onsite warranty services are provided only at the initial installation
point. Installation and onsite warranty services are available only in
Dissolution Systems service travel areas.

Exclusions and Limitations

Excluded from this warranty are expendable or consumable items such
as, but not limited to, paddles, baskets, vessels, and acrylic water baths.
Also excluded are defects from improper or inadequate maintenance by
the customer, user-induced chemical action or contamination,
unauthorized modification or misuse, and improper site preparation and
maintenance.
Operation of software is not warranted to be uninterrupted or error-free.

Obtaining Warranty Service

To obtain warranty service in the United States, contact the Dissolution
Systems Service Department at 800.229.1108 to obtain authorization to
return units for repair. At the option of the customer, onsite warranty
service is available, but travel charges may be incurred. The customer
should prepay all shipping charges for products returned to the
Dissolution Systems Service Department (unless otherwise authorized),
and Agilent Technologies, Inc. will pay all charges for return to the
customer.

40 Friability Tester Operator’s Manual

 Service and Warranty 6

Warranty Limitations
Agilent Technologies, Inc. makes no other warranty, either express or
implied, with respect to this product. Specifically disclaimed are any
implied warranties of merchantability and fitness for a particular use. In
no event will Agilent Technologies, Inc. be liable for any indirect,
incidental, or consequential damages arising from the use of this
product. This warranty gives you specific legal rights which may vary
from state to state or province to province, so you may have other rights
and some of these exclusions may not apply to you.

Exclusive Remedies
The remedies provided herein are the customer’s sole and exclusive
remedies. In no event shall Agilent Technologies, Inc. or its
representatives be liable for any direct, indirect, special, incidental, or
consequential damages, whether based on contract, tort, or any other
legal theory. Some states or provinces do not allow the exclusion or
limitation of incidental or consequential damages, so the above
limitation or exclusion may not apply to you.

Friability Tester Operator’s Manual 41

6 Service and Warranty

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42 Friability Tester Operator’s Manual

Index
A L USP Suitability Test, 17

Acrylic care, 35 Limitations, 40

W
C M Warranty, 40
Warranty Limitations, 41
calculating percentage of weight Maintenance, 34
loss, 27 Periodic, 34
configurations, available, 15 Monthly Maintenance, 34
Configuring for chambers/drums, 28
Connecting the Printer, 21 O
Conventions, 16
Obtaining Warranty Service, 40
operating Friability Tester with a
D printer, 28
drum Operating Friability Tester without a
Abrasion, 16 Printer, 26
Agilent-type, 15
Roche-type, 15 P
percentage weight lost formula, 27
E Periodic Maintenance, 34
Exclusions, 40
Exclusive Remedies, 41 R
running a test, 26, 28
F
Friability tester with a Printer, S
operating, 28
Service, 40
Friability Tester without a Printer,
operating, 26 stopping a test, 27, 31
Fuse Replacement, 36
T
H Troubleshooting, 37
hidden key functions, 23
U
I Unpacking Procedure, 20
Initial Setup, 20 unpacking your equipment, 20
USP Physical Parameters, 17

Friability Tester Operator’s Manual 43

Index

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44 Friability Tester Operator’s Manual