Agilent Technologies 100 User manual

100 Automated Disintegration Apparatus
Operator’s Manual

Notices
Manual Part Number
SD-29001863 Rev. E
Edition: 03/2022
Copyright
© Agilent Technologies, Inc. 2020, 2022
No partof this manual may be
reproduced in any form or by any means
(including electronic storage and retrieval
or translation into a foreign language)
without prior agreement and written
consent from Agilent Technologies, Inc.
as governed by United States and
international copyright laws.
Agilent Technologies, Inc.
3501 Stevens Creek Blvd.
Santa Clara, CA 95052 USA
Warranty
The material contained in this document
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 merchantability and fitness
for a particular purpose. Agilent shall not
be liable for errors or for incidental or
consequential damages in connection
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
material 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 this document are furnished under a
license and may be used or copied only in
accordance with the terms of such
license.
Restricted Rights Legend
U.S. Government Restricted Rights.
Software and technical data rights
granted to the federal government
include only those rights customarily
provided to end user customers. Agilent
provides this customary commercial
license in Software and technical data
pursuant to FAR 12.211 (Technical Data)
and 12.212 (Computer Software) and, for
the Department of Defense, DFARS
252.227-7015 (Technical Data -
Commercial Items) and DFARS
227.7202-3 (Rights in Commercial
Computer Software or Computer
Software Documentation).
Safety Notices
CAUTION
A CAUTION 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 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
Content
This manual covers the following modules:
•Agilent 100 Automated Disintegration Apparatus (G7962A)
1Safety 6
Electrical Hazards 7
Warning 8
Caution 8
Note 8
Information Symbols 9
2Introduction 10
Introduction 11
Conventions Used in this Manual 12
Serial Number Format 12
3 Setting Up the 100 13
Unpacking Your 100 14
Environmental Requirements for Installation 15
Setting up the Water Bath 16
Initial Power Up 17
Electrical Connections 17

Content
4100 Operator’s Manual
Installing the Temperature Probe 19
Water Bath Status LEDs 20
Setting the Date / Time Clock 21
Mounting Baskets and Filling Beakers 22
Draining the Water Bath 22
Hidden Key Functions 23
4 Operating the 100 24
Setting Water Bath Temperature 25
Setting Print Frequency for the Report Center Printer 25
Adjusting Basket Height 26
Placing Dosage Units in the Baskets 27
Selecting Operating Mode 27
Single-basket Operation 27
Multi-basket Operation 28
Three-Basket Operation 31
Printer Operation During Manual or Program Operation (Optional) 31
5 Troubleshooting and Maintenance 32
Preventive Maintenance 33
Weekly Maintenance 33
Monthly Maintenance 33
Every Six Months Maintenance 34
Yearly Maintenance 34
Disintegration Basket Care 35
Water Bath / Acrylic Care 36
Visual Checks 37
Water Bath Temperature Probe Accuracy Test 38

Content
100 Operator’s Manual 5
Report Center Impact Printer 40
Installing the Cartridge Ribbon 40
Replacing the Paper Roll 41
Toggling Your Printer Online 42
Printer Self Test 43
Printer Configuration 44
Troubleshooting 46
Obtaining Warranty and Other Services 47

6100 Operator’s Manual
1Safety
Electrical Hazards 7
The Agilent 100 (G7962A) 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 (G7962A) 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.

1Safety
100 Operator’s Manual 7
Electrical Hazards
The Agilent 100 (G7962A) 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.
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.

1Safety
8100 Operator’s Manual
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.

1Safety
100 Operator’s Manual 9
Information Symbols
I Switches main power on
0 Switches main power off
Indicates single-phase alternating current
The apparatus is marked with this symbol when the user shall
refer to the instruction manual in order to protect risk of harm to
the operator and to protect the apparatus against damage.
Confirms that a manufactured product complies with all
applicable European Community directives. The European
Declaration of Conformity is available at:
http://regulations.corporate.agilent.com/DoC/search.htm
Confirms that a manufactured product complies with all
applicable UK Regulation.
The UK Declaration of Conformity is available at:
http://regulations.corporate.agilent.com/DoC/search.htm
Indicates specific equipment meets standards of safety. These
products are safe for use in the workplace for North America.
This product complies with the European WEEE Directive
marking requirements. The affixed label indicates that you must
not discard this electrical/electronic product in domestic
household waste.
NOTE
Do not dispose of in domestic household waste!
To return unwanted products, contact your local Agilent office, or
see http://www.agilent.com for more information.
Indicates the product complies with regulatory compliance
requirements of New Zealand and Australia.
ISM1-A ISM classification according to CISPR11/EN55011: ISM Group 1
Class A
CAN ICES-001(A)
NMB-001(A)
This ISM device complies with Canadian ICES-001. Cet appareil
ISM est conforme à la norme NMB-001 du Canada

10 100 Operator’s Manual
2Introduction
Introduction 11
Conventions Used in this Manual 12
Serial Number Format 12

2Introduction
100 Operator’s Manual 11
Introduction
The 100 (G7962A) 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 apparatus is fully programmable by simply entering the time duration of the
test. Baskets automatically lift from the beaker at the end of the test in the pass /
fail mode. The 100 also has individual digital time displays for each basket and
the water bath temperature is displayed continuously on the front panel.
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. See “Obtaining Warranty and Other
Services” on page 47..

2Introduction
12 100 Operator’s Manual
Conventions Used in this Manual
•Items you are asked to press are in bold. For example, “press Hon the
keypad”.
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

100 Operator’s Manual 13
3 Setting Up the 100
Unpacking Your 100 14
Setting up the Water Bath 16
Initial Power Up 17
Installing the Temperature Probe 19
Water Bath Status LEDs 20
Setting the Date / Time Clock 21
Mounting Baskets and Filling Beakers 22
Draining the Water Bath 22
Hidden Key Functions 23

3SettingUpthe100
14 100 Operator’s Manual
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.

3SettingUpthe100
100 Operator’s Manual 15
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
•Overvoltage Category: II
•Altitude: 2000m
•Temperature: 5 ºC to 40 ºC
•Power: 115 V, 50/60 Hz, 10 A or 230 V 50/60 Hz, 5 A
Main supply voltage fluctuations are not to exceed ± 10% of the nominal
supply voltage

3SettingUpthe100
16 100 Operator’s Manual
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 19.
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.

3SettingUpthe100
100 Operator’s Manual 17
Initial Power Up
Electrical Connections
See Figure 2, “100 Rear Panel,” on page 17to complete the steps that follow.
Figure 2. 100 Rear Panel
1Ensure the power is off.
2Connect the power cord between the AC power connector and an AC power
receptacle of the appropriate voltage.
WARNING
Before plugging the 100 into any power outlet, ensure the instrument is
configured for the voltage provided. Check the serial number tag on the rear
panel to confirm the voltage requirement.
The electrical connection at the back of the apparatus is the primary
disconnect for the instrument.

3SettingUpthe100
18 100 Operator’s Manual
3Turn on the 100. The three position screens and the temperature screen on
the front panel illuminates immediately. You will hear the circulator working as
it begins to pump the bath water through the system. Bubbles may appear at
the water bath inlet as air is expelled from the system.
4Place the disintegration beaker(s) through the holes in the top cover of the
water bath.
5As the water circulates, there may be a slight drop in the water bath level as
the internal tubing fills. Wait until the beakers are in place before adding
additional water as required to bring the level back to within no more than 2.5
inches of the top of the water bath. Replace the cover, if removed.
NOTE
Check for leaks. Allow the circulator to run for five minutes, then check the bath,
tubing, connectors and the bench area immediately surrounding the apparatus. If
any water leaks are seen, turn off the power immediately and remove the power
cord. Locate and fix the source of the leak before proceeding.

3SettingUpthe100
100 Operator’s Manual 19
Installing the Temperature Probe
The 100 is shipped with a factory-installed temperature probe inside the
heater /circulator tank and an external probe to be placed directly in the water
bath. Both probes are necessary and the temperature readings must remain
within 5 °C of each other or the 100 will not operate. If either probe is not
functioning or not installed, the alarm sounds and the keypad is inactive.
To install the external temperature probe, complete the following steps:
1Plug the temperature probe into the jack labelled TEMP. PROBE on the rear
panel.
2Insert the metal tip of the probe into the small hole in the water bath cover.
3Ensure the small hole and temperature probe are toward the front of the water
bath.
4Press INT/EXT to view the temperature readings for each probe. When the
external probe reading displays, the Ext Temp Probe LED illuminates.
NOTE
No installation or positioning is necessary for the internal temperature probe.

3SettingUpthe100
20 100 Operator’s Manual
Water Bath Status LEDs
Figure 3. 100 Keypad
The Heater On LED flashes to indicate heater activity. When the heater is on
continuously, as will occur when the water bath is cold, the LED remains
illuminated. As the target temperature is approached, the LED flashes indicating
the heater is cycling on and off.
The Over Temp LED illuminates
•if the temperature of the water of the water bath exceeds 65 °C. Check for
obstructions and low water if this condition occurs. The over temp
condition clears automatically when the temperature cools below 55 °C.
Press CLEAR to reset if the temperature is between 55 and 65 °C.
•if the external temperature probe is not in the water bath or is not
connected.
•if the temperature probe readings are more than 5 °C higher than the set
temperature.
water bath
status LEDs