Agilent Technologies 100 User manual

Agilent Technologies
100 Automated
Disintegration
Apparatus
Operator’s Manual

100 Operator’s Manual
Notices
© Agilent Technologies, Inc. 2014
No part of this manual may be reproduced
in any form or by any means (including
electronic storage and retrieval or transla-
tion into a foreign language) without prior
agreement and written consent from Agi-
lent Technologies, Inc. as governed by
United States and international copyright
laws.
Manual Part Number
70-9066
Edition
Rev C, March 2014
Printed in USA
Agilent Technologies, Inc.
3501 Stevens Creek Blvd.
Santa Clara, CA 95052 USA
Warranty
The material contained in this doc-
ument is provided “as is,” and is
subject to being changed, without
notice, in future editions. Further,
to the maximum extent permitted
by applicable law, Agilent disclaims
all warranties, either express or
implied, with regard to this manual
and any information contained
herein, including but not limited to
the implied warranties of mer-
chantability and fitness for a par-
ticular purpose. Agilent shall not be
liable for errors or for incidental or
consequential damages in connec-
tion with the furnishing, use, or
performance of this document or of
any information contained herein.
Should Agilent and the user have a
separate written agreement with
warranty terms covering the mate-
rial in this document that conflict
with these terms, the warranty
terms in the separate agreement
shall control.
Technology Licenses
The hardware and/or software described in
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license and may be used or copied only in
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ware and technical data rights granted to
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Safety Notices
CAUTION
A CAUTION notice denotes a
hazard. It calls attention to an
operating procedure, practice, or
the like that, if not correctly per-
formed or adhered to, could result
in damage to the product or loss
of important data. Do not proceed
beyond a CAUTION notice until
the indicated conditions are fully
understood and met.
WARNING
A WARNING notice denotes a
hazard. It calls attention to an
operating procedure, practice,
or the like that, if not correctly
performed or adhered to, could
result in personal injury or
death. Do not proceed beyond a
WARNING notice until the
indicated conditions are fully
understood and met.

100 Operator’s Manual 3
Contents
Figures 7
1Safety 9
Electrical Hazards 9
Warning 11
Caution 11
Note 11
Information Symbols 12
2 Introduction 13
Conventions Used in this Manual 14
Serial Number Format 15
3 Setting Up the 100 17
Unpacking Your 100 18
Environmental Requirements for Installation 19
Setting up the Water Bath 20
Initial Power Up 21
Electrical Connections 21
Installing the Temperature Probe 22
Water Bath Status LEDs 23
Setting the Date / Time Clock 24
Mounting Baskets and Filling Beakers 25
Draining the Water Bath 25

4100 Operator’s Manual
Contents
Hidden Key Functions 26
4 Operating the 100 27
Setting Water Bath Temperature 28
Setting Print Frequency for the Report Center Printer 28
Adjusting Basket Height 29
Placing Dosage Units in the Baskets 30
Selecting Operating Mode 30
Single-basket Operation 30
Multi-basket Operation 31
Three-Basket Operation 34
Printer Operation During Manual or Program Operation
(Optional) 34
5 Troubleshooting and Maintenance 35
Preventive Maintenance 36
Weekly Maintenance 36
Monthly Maintenance 36
Every Six Months Maintenance 37
Yearly Maintenance 37
Disintegration Basket Care 37
Water Bath / Acrylic Care 38
Visual Checks 40
Water Bath Temperature Probe Accuracy Test 41
Report Center Impact Printer 43
Installing the Cartridge Ribbon 43
Replacing the Paper Roll 44
Toggling Your Printer Online 45
Printer Self Test 46
Printer Configuration 47

Contents
100 Operator’s Manual 5
Troubleshooting 49
Obtaining Warranty and Other Services 51
Index 53

6100 Operator’s Manual
Contents
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100 Operator’s Manual 7
Figures
Figure 1. Water Bath Connections 20
Figure 2. 100 Rear Panel 21
Figure 3. 100 Keypad 23
Figure 4. Basket Adjustment 29

8100 Operator’s Manual
Figures
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9
Agilent Technologies
100 Automated Disintegration Apparatus
Operator’s Manual
1
Safety
Electrical Hazards 9
The Agilent 100 has been designed and tested 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 Agilent 100 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.
Electrical Hazards
The Agilent 100 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 100 to determine which
parts are operator-accessible.

10 100 Operator’s Manual
1Safety
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.

Safety 1
100 Operator’s Manual 11
Warning
WARNING
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
NOTE
A ‘Note’ appears in the manual to give advice or information.

12 100 Operator’s Manual
1Safety
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 standards of
safety. 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.
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 in
accordance with European Standard EN 50419.
For more information on collection, reuse, and
recycling systems, please contact your
local/regional waste administration, your local
distributor, or Agilent.
Indicates the product complies with regulatory
compliance requirements of New Zealand and
Australia.

13
Agilent Technologies
100 Automated Disintegration Apparatus
Operator’s Manual
2
Introduction
Conventions Used in this Manual 14
Serial Number Format 15

14 100 Operator’s Manual
2 Introduction
The 100 is designed to provide versatility and reliability, while meeting
all current USP testing requirements. Its three basket positions can be
programmed to dip together or independently, allowing up to three
different tests to be run at the same time. In addition to the standard
six-tube USP-approved basket rack, a variety of optional basket racks
are available for large and bolus tablets. The 100 is used for
disintegration testing in accordance with current USP requirements. The
optional built-in Report Center Printer provides hard-copy
documentation of the instrument operation for the highest degree of
confidence.
The 100 is available in two models: single basket and three basket. The
three-basket apparatus is fully programmable by simply entering the
time duration of the test. The baskets automatically lift from the beaker
at the end of the test in the pass / fail mode. The three-basket model has
individual digital time displays for each basket. The water bath
temperature is displayed continuously on the front panel. Both models
include accessories.
Conventions Used in this Manual
•Items you are asked to press are in bold. For example, “press H on
the keypad”.
CAUTION
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.

Introduction 2
100 Operator’s Manual 15
Serial Number Format
The serial number contains 10 characters and follows this syntax:
CC1234xxxx
Syntax Code Meaning Description
CC Country of origin 2 alpha characters matching the required trade designation for
the country of origin
12 Year of manufacture ‘09’ for 2009, ‘10’ for 2010, etc.
34 Week of manufacture ‘01’ for week 1 to ‘52’ for week 52

16 100 Operator’s Manual
2 Introduction
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17
Agilent Technologies
100 Automated Disintegration Apparatus
Operator’s Manual
3
Setting Up the 100
Unpacking Your 100 18
Setting up the Water Bath 20
Initial Power Up 21
Installing the Temperature Probe 22
Water Bath Status LEDs 23
Setting the Date / Time Clock 24
Mounting Baskets and Filling Beakers 25
Draining the Water Bath 25
Hidden Key Functions 26

18 100 Operator’s Manual
3 Setting Up the 100
Unpacking Your 100
1Open 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.
2Carefully remove the 100 from its shipping carton. Hold the unit
firmly to prevent it from dropping.
3Check for items which may have come loose during shipping. Be
sure to remove all parts before discarding or storing the packaging.
4Place the unit on a clean, dry, level section of the bench top or table.
At least four inches of space should be open for the rear panel power
connections and for access to the rear panel power switch.
WARNING
Hold the unit only by the base. Do not hold by the reciprocating
shafts to avoid damage.
WARNING
The electrical connection at the back of the apparatus is the
primary disconnect for the instrument. The apparatus should be
positioned to allow accessibility to the power cords for easy
disconnection.

Setting Up the 100 3
100 Operator’s Manual 19
Environmental Requirements for Installation
•Humidity: max relative humidity 80% for temperatures up to 31 ºC
decreasing linearly to 50% relative humidity at 40ºC
•Indoor use only
•Pollution Degree: 2
•Installation Category: II
•Altitude: 2000m
•Temperature: 5 ºC to 40 ºC
•Power: 115 V/60 Hz, 230 V/50 Hz, 10 A
Main supply voltage fluctuations are not to exceed ± 10% of the
nominal supply voltage

20 100 Operator’s Manual
3 Setting Up the 100
Setting up the Water Bath
1Ensure the 100 is not plugged in.
2Place the water bath on the 100 with the lower quick-connect fitting
positioned on the left side of the apparatus. Use the locator holes on
the water bath and the locator pins on the 100 to ensure proper
placement.
3Locate the two tubes with quick-connect fittings and insert them into
the appropriate quick-connect fittings on the 100 water bath (see
Figure 1, “Water Bath Connections,” below).
Figure 1 Water Bath Connections
4Ensure the cover is in place on the water bath with the small hole
toward the front. Ensure the disintegration beakers are not in place in
the cover.
5Fill the water bath through any one of the three beaker holes in the
cover.
6Check the water bath and all connecting tubing for leaks. When
satisfied that no leaks are present, proceed to “Installing the
Temperature Probe” on page 22.
NOTE
Initially fill the water bath no higher than 2.5 inches (6.4 cm) from the
top, to allow for displacement by the beakers when they are inserted.