Agilent Technologies BIO-DIS Apparatus 3/7 User manual

Agilent BIO-DIS Apparatus 3 / 7
Operator’s Manual

Notices
Manual Part Number
70-9057 Rev D
November 2018
Copyright
© Agilent Technologies, Inc. 2018
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or translation into a foreign language)
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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
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.

Apparatus 3 / 7 Operator’s Manual 3
Content
1Safety 7
Electrical Hazards 8
Warning 9
Caution 9
Note 9
Information Symbols 10
2 Introduction 11
Conventions Used in this Manual 15
Serial Number Format 15
USP Suitability Test 16
USP Physical Parameters 16
3 Setting Up the Apparatus 3 / 7 17
Unpacking Your Equipment 18
Environmental Requirements for Installation 19
Setting up the Apparatus 3 / 7 19
Installing the Heater / Circulator 20
Filling the Water Bath 23
Installing Outer Media Tubes 24
Installing the Sample Tubes (Apparatus 3) 24
Installing the Sample Holders (6-row Apparatus 7) 24
Installing the Sample Holders (12-row Apparatus 7) 25
Installing the Evaporation Curtains 25
Tightening the Evaporation Curtains 26
Powering Up the Apparatus 3 / 7 27
Hidden Key Functions 28
Configuring the Apparatus 3 / 7 29

Content
4 Apparatus 3 / 7 Operator’s Manual
4 Operating the Apparatus 3 / 7 31
Keypad Options 32
Main Menu 34
Setting Alarms 35
Heater / Circulator Control 36
Print 37
Start Dip / Stop Dip 38
Programing the Apparatus 3 / 7 39
Starting a Program 41
5 Conversion Procedures 43
300 mL to 100 mL Conversion 44
300 mL to 1L Conversion 46
1L to 300 mL Conversion 48
300 mL to Double Row Dip 1L Conversion 50
Alignment Procedure 54
Alignment Option 1 54
Alignment Option 2 54
General Conversion Procedures 55
Removing Bridge Assembly Panels 55
Replacing Bridge Assembly Panels 56
Installing the Evaporation Cover 56
Removing the Agitator Shaft 56
Installing the Agitator Shaft 57
Cannula Removal 57
Cannula Installation 58
6 Maintenance and Troubleshooting 59
Preventive Maintenance 60
Daily Maintenance 60

Content
Apparatus 3 / 7 Operator’s Manual 5
Weekly Maintenance 60
Monthly Maintenance 61
Holder Care 61
Water Bath / Acrylic Care 62
Visual Checks 64
Report Center Impact Printer 65
Installing the Cartridge Ribbon 65
Replacing the Paper Roll 66
Toggling Your Printer Online 67
Printer Self Test 68
Printer Configuration 68
Fuse Replacement 70
Obtaining Warranty and Other Services 71

Content
6 Apparatus 3 / 7 Operator’s Manual
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Apparatus 3 / 7 Operator’s Manual 7
1Safety
Electrical Hazards 8
The Apparatus 3 / 7 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.
Operation of an Apparatus 3 / 7 involves the use of solid dosage forms and
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
8 Apparatus 3 / 7 Operator’s Manual
Electrical Hazards
The Apparatus 3 / 7 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 8020 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
Apparatus 3 / 7 Operator’s Manual 9
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
10 Apparatus 3 / 7 Operator’s Manual
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.

Apparatus 3 / 7 Operator’s Manual 11
2Introduction
Conventions Used in this Manual 15
Serial Number Format 15
USP Suitability Test 16
USP Physical Parameters 16

2Introduction
12 Apparatus 3 / 7 Operator’s Manual
The patented Apparatus 3 / 7 is ideal for extended-release products or any
dosage form requiring release profiling at multiple pH levels. Capable of running
unattended for periods of up to six days, the unit can store up to 15 programs
and allows almost any aspect of a test to be programmed including dip speed,
time in each row, hold dip time, and drain time. The seven test samples traverse
the six rows of corresponding outer media tubes filled with different media. The
Apparatus 3 / 7 transports each sample from one medium to the next,
automatically, without operator intervention. Virtually any solid dosage form can
be accommodated including pellets, tablets, and capsules.
Custom Apparatus 3 / 7 are available. Depending on the Apparatus 3
configuration, media volume of the outer media tube can vary from 100 mL, 300
mL (USP), or 1000 mL. This manual covers the operation of the standard 7-tube,
6-row systems as well as the modified 12-tube, 12-row Apparatus 7 system (see
Figure 1, “Standard 6-row Apparatus,” and Figure 2, “Apparatus 7, Modified 12 x
12,” on page 13).
Figure 1. Standard 6-row Apparatus

2Introduction
Apparatus 3 / 7 Operator’s Manual 13
Figure 2. Apparatus 7, Modified 12 x 12
A built-in Report Center Printer provides hard-copy documentation of testing
progress and conditions. A four-line digital display provides constantly updated
operation information as a test proceeds.
The temperature is maintained by the heater / circulator. All parameters are
controlled via the Apparatus 3 / 7 keypad. Automated sampling can be
performed using the 8000. This unit can be pre-programmed to withdraw
samples at designated time points. Samples can be collected into either test
tubes or pre-capped HPLC vials for direct transfer to an HPLC system. Septa are
pierced using the exclusive needle manifold, which lowers and raises at each
sample time point. Sample trays are available in a variety of sizes to
accommodate almost any size vial or test tube.
There are various types of Apparatus 7 sample holders. Reciprocating disks with
O-rings (see Figure 3, “Reciprocating Disk,” on page 14) hold the transdermal
systems in place as they move through the medium. The 12-row system uses
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.

2Introduction
14 Apparatus 3 / 7 Operator’s Manual
custom sample holders. The inverted basket is a modified version of the
Japanese sinker basket and can be used with many types of solid dosage forms.
Figure 3. Reciprocating Disk
NOTE
The sample holders used with the standard 6-row system cannot
be used with the 12-row system.
WARNING
The apparatus 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.

2Introduction
Apparatus 3 / 7 Operator’s Manual 15
Conventions Used in this Manual
•Items you are asked to press are in bold. For example, “press Hon the
keypad”.
•Key sequences you are asked to press appear like this: MENU > 0> 8.
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

2Introduction
16 Apparatus 3 / 7 Operator’s Manual
USP Suitability Test
Before the first use of an Apparatus 3, run an apparatus suitability test with USP
Chlorpheniramine Maleate extended-release calibrator tablets. Calibrator tablets
are available from the USP at the following address:
USP
12601 Twinbrook Parkway
Rockville, MD 20852
[phone] or [phone]
Complete instructions come with the calibrators. Apparatus suitability tests can
be very sensitive to factors such as shaft misalignment, vessel shape, vibration
of the system, age of the calibrators, reference standards, and many other
factors. Contact the Dissolution Systems Service Department if you have any
questions regarding these procedures.
USP Physical Parameters
In addition to the apparatus suitability test, you must monitor several physical
parameters, such as stroke distance, dip speed, and temperature. A Certificate of
Compliance is included with your Apparatus 3 / 7. Contact the Laboratory
Services Department for more information on USP physical parameters.
NOTE
There is no USP apparatus suitability test for the Apparatus 7.

Apparatus 3 / 7 Operator’s Manual 17
3 Setting Up the Apparatus 3 / 7
Unpacking Your Equipment 18
Setting up the Apparatus 3 / 7 19
Powering Up the Apparatus 3 / 7 27
Hidden Key Functions 28

3 Setting Up the Apparatus 3 / 7
18 Apparatus 3 / 7 Operator’s Manual
Unpacking Your Equipment
Complete the following steps to safely unpack your apparatus and accessories:
1Open each carton carefully and check the contents for any damages which
may have occurred during 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 are filed with the
carrier, we can help you file a claim and get up and running as quickly as
possible.
2Carefully remove the Apparatus 3 / 7 from its shipping carton.
3Remove all cushioning material and tape.
4Place the instrument on a clean, dry, level section of bench top with the drive
unit front panel facing you.
5Place the heater / circulator next to the unit.
WARNING
The Apparatus 3 / 7 is heavy and the track on the left side is
sharp. Do not lift it alone. Also, do not lift the instrument by the
drive unit. Lift by holding the water bath frame.
WARNING
The electrical connection at the back of the instrument is the
primary disconnect. The instrument should be positioned to
allow accessibility to the power cords for easy disconnection.

3 Setting Up the Apparatus 3 / 7
Apparatus 3 / 7 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: 2000 m
•Temperature: 5 ºC to 40ºC
•Power: 115/230 V ac, 50/60 Hz, 2 A
Main supply voltage fluctuations are not to exceed ± 10% of the nominal
supply voltage
Setting up the Apparatus 3 / 7
1Level the Apparatus 3 / 7 by placing the circular level on the appropriate
vessel carrier. Check for level in the front and rear center and the left and right
sides. Turn the adjustable rubber feet on the bottom of the water bath frame
until the bubble in the level is in the center circle at all four check points.
2Ensure the power switch on the rear panel is in the OFF position.
3Connect the power cord to the power receptacle on the Apparatus 3 / 7 rear
panel.
4Plug the power cord into an electrical outlet of the appropriate voltage.
WARNING
Ensure the Apparatus 3 / 7 is configured for the voltage available
in your laboratory.

3 Setting Up the Apparatus 3 / 7
20 Apparatus 3 / 7 Operator’s Manual
Installing the Heater / Circulator
The Apparatus 3 / 7 uses a single water bath connected directly to the inlet and
outlet of the heater / circulator. Complete the following steps to install the heater
/ circulator:
1Locate the heater / circulator tubing kit containing two lengths of 1/2-inch
plastic tubing (one long, one short) and four tubing clamps.
2Locate the tubing clamps in the tubing kit. Place a clamp over one end of the
shorter of the two lengths of tubing supplied. Carefully place this end of the
tubing over the connector labeled IN on the heater / circulator. Slide the tubing
on until it meets the panel.
3Slide the tubing clamp over the connector and tighten securely.
4Place a tubing clamp over the opposite end of the same piece of tubing.
Attach the tubing to the open end of the Y connector coming from the
barbed-angle tubing adapter on the right side of the water bath (see Figure 4,
“Tubing Connection,” below).
5Slide the tubing clamp over the connector and tighten securely.
NOTE
These instructions assume the heater / circulator is placed to the
right of the Apparatus 3 / 7 when looking at the front of the
equipment. If your heater / circulator is placed to the left of the
Apparatus 3 / Apparatus 7, use the longer tubing when the
instructions call for the shorter tubing and the shorter tubing when
the instructions call for the longer tubing.
CAUTION
Do not overtighten the clamp as damage may occur.
CAUTION
•Do not overtighten the clamp as damage may occur.