Auto-Plus

Operation Manual
60-200-802
Preliminary Release, August 31, 1999

HANSON RESEARCH CORPORATION

9810 VARIEL AVENUE
CHATSWORTH, CA. 91311
(800)821-8165 / (818)882-7266 FAX (818)882-9470
www.hansonresearch.com
 Table of Contents
Page
Section One – Safety Considerations ............................................................................... 1-1
1.1 General................................................................................................................. 1-1
1.2 Warning Signs...................................................................................................... 1-1
1.3 Canadian Emissions Notice................................................................................. 1-3

Section Two - Introduction ................................................................................................. 2-1

2.1 Definitions............................................................................................................. 2-1
2.2 General................................................................................................................. 2-1
2.3 How the System Works (Sampling Steps) .......................................................... 2-2
2.4 Tubing Volume Calculations ................................................................................ 2-2

Section Three - Specifications ........................................................................................... 3-1

Section Four - Installation .................................................................................................. 4-1

4.1 Location................................................................................................................ 4-1
4.2 Space Requirements ........................................................................................... 4-1
4.3 Electrical Requirements....................................................................................... 4-2
4.4 Unpacking and Inspection.................................................................................... 4-3
4.5 Identification ......................................................................................................... 4-4
4.6 Installation and Electrical Connections................................................................ 4-5
4.7 Communication Connections............................................................................... 4-7
4.8 Liquid Connections............................................................................................... 4-9
4.9 Start Up .............................................................................................................. 4-11

Section Five – Operating Instructions, Programming..................................................... 5-1

5.1 Keypad Description.............................................................................................. 5-1
5.2 Indicator Lights ..................................................................................................... 5-3
5.3 General Operating Information ............................................................................ 5-4
5.4 Use of Scrolls ....................................................................................................... 5-4
5.5 Selecting an Input................................................................................................. 5-5
5.6 Input of Alphabetical Characters ......................................................................... 5-6
5.7 Manual Operation................................................................................................. 5-8
5.8 System Options.................................................................................................... 5-9
5.9 System Alarm / Timers ...................................................................................... 5-12
5.10 Repeating an Alarm ........................................................................................... 5-14
5.11 Canceling an Alarm............................................................................................ 5-14
5.12 Acknowledging an Alarm ................................................................................... 5-14
5.13 Print Options ...................................................................................................... 5-15
5.14 Selecting and Viewing Protocol Parameters..................................................... 5-16
5.15 Creating a New Protocol.................................................................................... 5-16
5.16 Editing a Protocol ............................................................................................... 5-18
5.17 Viewing Protocol Parameters ............................................................................ 5-18
5.18 Working with Scripts .......................................................................................... 5-19
5.19 Script Procedures Available............................................................................... 5-20
5.20 Editing Scripts .................................................................................................... 5-21
5.21 Running a Test................................................................................................... 5-21
5.22 Starting a Protocol.............................................................................................. 5-22
5.23 Stand By Mode................................................................................................... 5-24

Table of Contents i
Section Six – Making A Run ............................................................................................... 6-1
6.1 Setting Up............................................................................................................. 6-1
6.2 Starting and Running a Test................................................................................ 6-2
6.3 During the Test..................................................................................................... 6-2
6.4 After the Test........................................................................................................ 6-2

Section Seven – Trouble Shooting.................................................................................... 7-1

7.1 Contacting Hanson Research Corporation for Technical Support...................... 7-1
7.2 Electrical............................................................................................................... 7-1
7.3 Mechanical ........................................................................................................... 7-3
7.4 Printer................................................................................................................... 7-4

Section Eight – Maintenance and Calibration.................................................................. 8-1

8.1 General Cleaning ................................................................................................. 8-1
8.2 Cleaning Method for Tubing, Valves and Syringes ............................................. 8-1
8.3 Fuse Replacement............................................................................................... 8-2
8.4 Syringe Replacement........................................................................................... 8-3
8.5 Volume Calibration............................................................................................... 8-3
8.6 MultiFill Needle Replacement.............................................................................. 8-3

Section Nine – Moving and Storage .................................................................................. 9-1

Section Ten – Parts, Supplies and Accessories............................................................ 10-1

Section Eleven – Sales and Service Offices................................................................... 11-1

Section Twelve - Warranty................................................................................................ 12-1

Table of Contents ii
 Section One - Safety Considerations

1.1 General

1. The Installation Category (Overvoltage Category) for this instrument is Level II. The
Level II category pertains to equipment that receives its electrical power from a local
level, such as an electrical wall outlet.

2. This instrument must be connected to a grounded electrical outlet.

3. Never work on the electrical components in the system while there is power to the
unit. Disconnect power to service instrument.

4. Review all safety and environmental precautions pertaining to any chemicals that are
to be used in conjunction with this equipment.

1.2 Safety checks, warning signs and other symbols

For your own safety, you must observe the following safety checks and warning
signs. These signs indicate a possible source of danger. They also provide
information on what to do to avoid danger.

Sign Location and/or Safety Warning

Reason
Attention: This is a highly sensitive instrument. Read this
• N/A operator’s guide before using the AutoPlus System. When
you use the system, follow generally accepted procedures
for quality control and methods development.
Attention: Changes or modifications to the units that make
• N/A up the Hanson AutoPlus System that are not expressly
approved by the party responsible for compliance could void
the user’s authority to operate the equipment.
Attention: This equipment has been tested and found to
• N/A comply with the limits for a Class A digital device, pursuant
to Part 15 of the FCC rules. These limits are designed to
provide reasonable protection against harmful interference
when the equipment is operated in a commercial
environment. This equipment generates, uses, and can
radiate radio frequency energy, and, if not installed and used
in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of
this equipment in a residential area is likely to cause harmful
interference, in which case you must correct the interference
at your own expense.
Shielded cables must be used with this unit to ensure
compliance with the Class A FCC limits.

Section 1 Safety Considerations 1-1

1.2 Safety checks, warning signs and other symbols (contd.)

Sign Location and/or Safety Warning

Reason
Attention: To meet the regulatory requirements of immunity
• N/A from external electrical disturbances that may affect the
performance of this instrument, do not use cables longer
than 9.8 feet (3 meters) when you make connections to the
terminal strips on the rear panels of the units of the AutoPlus
System. Also, always connect the shield of the cable to
chassis ground at one instrument only.
Caution: To avoid chemical or electrical hazards,
• N/A
always observe safe laboratory practices when
operating the AutoPlus System.
Caution: Supply voltage and supply frequency must
• Power
be of the value specified on the back of the power
Supply
supply. All electrical outlets must be properly
grounded.
Caution: Supply voltage and wattage must be of the
• Rear Panel
value specified for the control unit in the serial number
tag located on the back of the control unit. All
electrical outlets must be properly grounded.
Caution: No operator accessible parts inside. Refer
• Left Side –
servicing to qualified personnel only.
next to screw
Achtung: Es gibt keine vorn Benutzer zo wanenden
Teile. Oberlassen Sie Reparaturen dem qualifizierten
Service-fachmann.

Attention: Aucune pièce remplaçable par l’utilisateur.

Toute réparation doit être effectuée par un technicien
qualifié.

Precaución: No lo abra. Peligro de alto voltaje. El

servicio debe ser implementado por personal
calificado.
Caution: Turn unit off and remove power cord before
• Rear Panel
replacing fuse. Fuse must be replaced with the same
current rating and type described next to the fuse
holder.
Caution: Communication ports must not be
• Rear Main
connected to a telephone line.
Board Panel
Protective conductor terminal.
• Inside
Control

Direct Current.
• Rear Panel

Section 1 Safety Considerations 1-2

1.3 Canadian Emissions Notice

This digital apparatus does not exceed the Class A limits for radio noise emissions
from digital apparatus set forth in the Radio Interference Regulations of the Canadian
Department of Communications.

Le présent appareil numérique n’émet pas de bruits radioélectriques dépassant les

limites applicables aux appareils numériques de la classe A prescrites dans les
réglements sur le brouillage radioélectrique édictés par le Ministére des
Communications du Canada.

Section 1 Safety Considerations 1-3

 Section Two - Introduction
2.1 Definitions

AutoPlus the basic auto-sampler series (either Maximizer or Dissoscan) with stepper
motor driven syringes.
Maximizer the auto-sampler with 4 two-way solenoid valves per syringe to direct fluid
flow, see Figure 4-1.
Dissoscan the auto-sampler with 1 three-way solenoid valve per syringe to direct fluid
flow, see Figure 4-1.
MultiFill the unit that allows for sample collection, see Figure 4-2.
Load when the syringe plunger is moved down drawing material into the syringe.
Dispense when the syringe plunger is moved up pushing material out of the syringe.
Rack is the vial / test tube holder that fits on the Multi-Fill.
Valve is the flow direction control device.
Prime is to fill an empty tube with selected material
Rinse is to clear out old media from tubing with the target media
Wash is to clear out old media from tubing with blank or wash media
Transfer to move liquid from one tube to another
Dilute to collect two different materials in the same test tube
Protocol are the parameters that are entered into the unit that determine the operation
and steps that are to be accomplished for a given test
Generic is a bath that is not an SR8-Plus or a Validata control.
Auto Probe automatically moving sample probes
Fixed Probe stationary sampling probe
Occurrence dictates when the function is performed

2.2 General

It is recommended to read the entire manual before installing or operating this equipment.

The AutoPlus is a programmable sampler that handles a wide variety of dissolution

applications and requirements.

On command it withdraws (by means of precision stepper motor drive and a syringe),
measures and dispenses an aliquot from a dissolution test station through a UV flow cell
and on into a collection rack that contains vials or test tubes. The Auto-Plus can repeat
this process multiple times.

Most other commercial dissolution sampling systems use peristaltic pump movement of
dissolution fluid into a collector or through a UV flow cell. The AutoPlus was developed
to avoid the volumetric inconsistency and high maintenance of the peristaltic pump and
provide an all inert type environment to minimize drug absorption (see specifications for
the exact wetted materials).

1. Basic auto-samplers (Model MX6 or DS6) will sample from 6 distinct sources.
(Model MX8 or DS8) will sample from 8 distinct sources.

Section 2 Introduction 2-1

 2. If sample collection is needed, using the Hanson Research Corporation MultiFill
allows the operator to program sample volume collection into a variety of test
tube and vial sizes. Note that all septum’s and caps must be pre-cut.

3. The Validation Printer allows the user to utilize the full feature of the AutoPlus
printing capabilities. Protocol parameters, plus the time, speed and temperature
at the start of the test and each time a bath is sampled are also logged when a
Validation Printer is added to the system. Note that bath condition printing can
only be done when the unit is connected with a Hanson Research Corporation
SR8-Plus dissolution system.

2.3 How the System Works

1. A valve at the top of each syringe is opened. The stepper motor turns, driving
the syringe plunger down to the desired volume, loading material into the syringe.

2. The first valve is closed and another valve is opened. The stepper motor
reverses direction to drive the syringe plunger up, pushing the contents out of the
syringe and on to a new location.

3. The Auto-Plus can be connected to a multiple flow cell spectrophotometer for on-
line UV/VIS analysis. It also can be connected to a collector for sample
archiving.

4. The Maximizer can replace media removed from the dissolution vessel. After the
sampling cycle is completed, the unit can automatically replace the media that
was taken from the dissolution vessel.

5. When using only one bath, the AutoPlus can cycle all unused sample back to the
vessel, eliminating any wasted sample.

6. When using more than one bath rinse volume is sent to waste. Baths are
sampled one at a time, usually 3 to 5 minutes apart.

7. Samples may be collected into the MultiFill. Samples may also be diluted while
in the MultiFill.

2.4 Tubing Volume Calculations

1/32” ID (1/16” OD Teflon or stainless tubing) = 0.0126mL per inch.

0.085” ID (1/8” OD stainless tubing) = 0.093mL per inch.

Section 2 Introduction 2-2

 Section Three - Specifications

Weight:
Auto-Plus:....................................................................................................16 kg (36 lb.)
Multi-Fill:.......................................................................................................22 kg (49 lb.)

Size: AutoPlus
Width: .......................................................................................................25 CM (9.5 in.)
Depth:.....................................................................................................50 CM (19.5 in.)
Height: ..................................................................................................37 CM (14.25 in.)

Size: MultiFill
Width: .......................................................................................................25 CM (9.5 in.)
Depth:........................................................................................................66 CM (26 in.)
Height: ....................................................................................................40 CM (15.5 in.)

Electrical: AutoPlus
Voltage:................................................................................. 100 to 240 VAC, Grounded
Frequency: ........................................................................................................ 50/60 Hz
Power Dissipation: ............................................................................................30 Watts
Phase: .................................................................................................................... single
Fused at: ............................................................................................3 amp (“TT” Type)

Electrical: MultiFill
Voltage:..............................................................115 VAC or 230 VAC ± 10%, Grounded
Frequency: ........................................................................................................ 50/60 Hz
Power Dissipation: ............................................................................................20 Watts
Phase: .................................................................................................................... single
Fused at: ......................................................3 amps 115 VAC / 1.6 230 VAC (“F” Type)

Environment:
Ambient temperature Range:............................................................................ 10-40°C
Maximum humidity: ............................................................................................... < 85%

Software Version(s) Applicable:

AutoPlus:..................................................................................................... Version 0.30

Interface Equipment Requirements:

SR8-Plus:........................................................................................Version .98 or grater
Validata.......................................................................................................... Version 2.2
Sampling Probes:..................................................................................... Dual Probe Kit
Printer:....................................... Hanson Research Corporation Validation Printer Only

Section 3 Specifications 3-1

Sample Volume Accuracy:
0.5 to 5.0mL: .................................................................................................... ± 0.05mL
5.1 to 10.0mL: .................................................................................................. ± 0.10mL
10.1 to 15.0mL: ................................................................................................ ± 0.15mL

Materials, Wet: AutoPlus

Syringes: .......................................................................... Borosilicate Glass and Teflon
Sample Tubing: ......................................................................................................Teflon
Ferrules:....................................................................................................Tefzel (ETFE)
Valves and Manifold:..................................... Peek and Ethylene Propylene Elastomers

Materials, Wet: Multi-Fill

Injection Needles:.............................................. Polycarbonate and 304 Stainless Steel
Transfer Valves:............................... Peek, Teflon and Ethylene Propylene Elastomers
Check Valves: ......................................................................Polycarbonate and Silicone

Filtration
10 micron Tip Filter: ......................................................................at Sample Probe Inlet
5 micron, 25mm lure type ..........................................................at Sample Probe Outlet

Sampling:
*Minimum sample interval:................................................................................. 1 Minute
Maximum sample interval: ............................................................ 99 Hours, 59 Minutes
Number of programmable sampling points: .......................................................... 1 - 40
Number of sampling collections before rack change: ..........................................21 / 24
**Maximum sample volume: .......................................90% of Vial / Test Tube Capacity
Rack Type: ..........................................8 x 21 Rows 168 Total 16 x 100mm Test Tubes
Rack Type: ...................................................... 8 x 24 Rows 192 Total 12 x 32mm Vials
Vial / Test Tube Size: ...........................................................12 x 32mm or 16 x 100mm
Septum:..............................................................................................Pre Cut Type Only

* Under specified conditions.

** One sample time point may be collected in multiple rows.

Section 3 Specifications 3-2

 Section Four - Installation
4.1 Location

Environment

The AutoPlus should be placed to the right of the first dissolution bath and between the
first and second bath. The Hanson Research Corporation MultiFill should be placed
under or to one side of the AutoPlus. See section 3 for requirements.

4.2 Space Requirements

150

120
Spectro
SR8-Plus "C" Computer 90

60

Spectro
Computer SR8-Plus "A" SR8-Plus "B" 30
M

P
0
180 150 120 90 60 30 0 30 60 90 120 150 180

Centimeters
u

Typical System Layout

Figure 4-1
l

The AutoPlus is designed to be placed on a standard laboratory bench that is at least 60

cm (24 inches) deep. The system requires clearance above the bench of at least 66 cm
r

(26 inches), see bath, spectrohotometer and computer manufactures specifications for
t

the exact requirements of their components. The laboratory bench should be level and
flat. The laboratory bench must also be capable of supporting the weight, see Section 3.
When using 3 baths, the system layout requires an island layout with a width of about
130-cm (50”). Make sure to have at least this amount of space.
t
i

See section 3 for requirements.

-

Section 4 Installation 4-1

F

o
4.3 Electrical Requirements

The AutoPlus requires a single, grounded electrical outlet, within 2.5 meters (8 feet) of
the location of the system.

The AutoPlus is available in one configuration, 100V through 240V. The voltage is
automatically set when voltage is supplied to the external power supply.

The MultiFill is available in two configurations, 115V and 230V. The voltages are set by
changing the fuse box configuration. This is done at the factory. Check the nameplate
on the back panel to ensure the unit is set to the correct voltage.

The Printer is available in different configurations depending on system set up and

requirements. The printer will be electrically connected to either the SR8-Plus or directly
into a power outlet. Make sure to check the nameplate on the side panel to ensure the
unit is the correct voltage.

Note: Power cords may need to be replaced for some countries power outlet
configuration. Ensure replacement power cord is approved and properly rated for use on
this product, see section 3 for requirements.

Section 4 Installation 4-2

4.4 Unpacking and Inspection

The AutoPlus is shipped in one or more boxes. The shipping boxes were specifically
designed to provide maximum shipping protection and to facilitate unpacking.

1. The AutoPlus, spare parts kits and accessories are packed in individual custom
fit enclosures and then placed into crate size boxes. Carefully unpack your
AutoPlus from its shipping cartons.

2. Check the contents of the carton against the shipping list to be sure that you have
unpacked the entire shipment.

3. Inspect each unit for damage and if any is evident, inform the shipping company
immediately. It is also a good idea to save the shipping cartons in the case of
damage. Hanson Research Corporation insures all shipments through the
shipping company, but is not responsible for shipping damages.

To Unpack

1. Move package close to final destination.

2. Cut and remove any straps.

3. Open box, taking care not to damage box.

4. Remove instrument(s) from box.

5. Reassemble empty box and store for possible future use.

Section 4 Installation 4-3

4.5 Identification

Throughout this manual, reference is made to various components by name. Figures are
provided to assist in the visual identification of these components.

Virtual Instruments

Power
JUL 4 STATUS SET POINT HEADER
A 1999

0:00
ELAPSED
TIME
12:00PM
Diagnostics READY
0:0mL
0:00 SAMPLE
0 OF 0
Timer Alert

f i
c h
ab de g
B
r
l no q
jk m p

x
tu w ()
s v yz

NRTL/C
LIQUID INTERFACE
CONNECTIONS

3A
TT TYPE FUSE

FU
S E F
FUS E

USE

BATH/PRINTER SPECTRO

COLLECTOR
PC 24V DC
1 2 3 4 AUXI/O
MAX. 50W
POWER INPUT
AutoPlus
COMM PORTS MAXIMIZER

Maximizer / Dissoscan
Figure 4-1

Multi-Fill
Ready

MultiFill
Figure 4-2

Section 4 Installation 4-4

4.6 Installation and Electrical Connections

1. After removing the instrument from the box, remove all other shipping materials.

2. Visually inspect the instrument(s) for damage or missing parts. Make note of any
discrepancies and contact Hanson Research Corporation, Customer Support
immediately.

3. Remove any strapping or tape holding the unit for shipping.

4. Clean the unit as necessary to remove any packing debris.

5. Visually inspect all electrical and liquid connections for shipping damage.

6. Review Operation Manual.

Section 4 Installation 4-5

 CAUTION
The unit should not be plugged in until installed per instructions below.

First decide if you are going to place the AutoPlus on top of the MultiFill.

1. MultiFill

MultiFill installation is done by first placing the unit on the bench. With the power
switch in the off position, plug the power cord into a grounded wall outlet. Plug the
other end of the power cord into a the connector on the right side of the unit.

2. Rack

Installing the rack is done by first checking the location pin on the front left of the
MultiFill base. Make sure it is set to the rack size you are using. Set the rack on
the center of the MultiFill while aligning the hole under the rack with the location
pin on the base of the unit.

3. AutoPlus

The AutoPlus installation is done by placing the AutoPlus on top or to the right of
the MultiFill. With the power switch in the off position, connect it’s power supply
cord into the small round connector labeled "power input" on the back of the unit,
slide the cord into the bracket that hangs down under the round connector, this
will ensure that the cord is not pulled out. With the power switch in the off
position, plug the power cord into a grounded wall outlet. Plug one end of the
power cord into the side of the power supply.

4. Printer

The printer may be placed on top of AutoPlus if the AutoPlus is not going to be
placed on top of the MultiFill. Plug the power cord either into a grounded wall
outlet or to a Hanson Bath, see the bath operation manual.

5. Bath(s)

The bath(s) should be placed to each side of the AutoPlus, with the “A” bath to the
left and the “B” bath to the right. See bath manufactures installation instructions
for proper bath installation.

Section 4 Installation 4-6

4.7 Communication Connections

or or
#1 #3 #3 #3
#2 #1 #2 #1
SR8-Plus "A" SR8-Plus "B" SR8-Plus "C"

Computer Printer
or

Multi-Fill Spectro #4 Auto-Plus #2

#3 #1

Communication Connections
Figure 4-3

Each communications cable (gray cable with same type of plug at each end) is inserted
into the corresponding socket by just pushing in. When correctly installed you will hear a
click. To remove, depress the tab and pull straight out.

Section 4 Installation 4-7

All equipment should be in place at this time.

1. AutoPlus to MultiFill

Connect AutoPlus to MultiFill. The MultiFill will use the lower “D” connector type
plug on the left side of the MultiFill along with the communications cable. The
connection is done from the back of the AutoPlus #3 to this connector.

2. AutoPlus to Hanson Bath or Printer

Connect the communications cable from #2 on the back of the AutoPlus to #1 on

the first Hanson Bath. When not using Hanson Bath(s), connect #2 on the back
of the AutoPlus to the bottom of the printer. Note that the first Hanson Bath
connected to the AutoPlus is bath “A”, the second is bath “B” and so on.

3. Hanson Bath to Hanson Bath

For each Hanson Bath connect from #2 to #1 with the last Hanson Bath
connecting to the printer. Note that the first Hanson Bath connected from the
AutoPlus is bath “A”, the second is bath “B” and so on.

4. AutoPlus to Spectrophotometer / Computer

Connect from AutoPlus #4 to the spectrophotometer and AutoPlus #1 to a

computer if using these devices. See other reference and operation manuals
supplied with this system to make final connections to these devices.

5. Other Dissolution Test Station

Install and connect the dissolution instrument per the manufacture’s
recommendations. There is no communications with non Hanson Baths.

Section 4 Installation 4-8

4.8 Liquid Connections

1. Liquid Line Connections

Liquid line connections are done by connecting the six or eight liquid tubes from
the AutoPlus, MultiFill, Spectrophotometer and Sampling Probe. These are
numbered and color coded for identification. They are connected with Nuts,
Unions and Ferrules, as shown in Figure 4-4. Tighten these fittings by hand only
do not use tools.

NUT UNION FERRULE

Liquid Line Connections

Figure 4-4

Position Fitting Color

1 Black
2 Red
3 White
4 Yellow
5 Green
6 Blue
7 (std) Clear
8 (blank) Purple

Liquid Connection Color Codes

Table 4-1

Section 4 Installation 4-9

 or
or

SR8-Plus "A" SR8-Plus "B" SR8-Plus "C"

or or Multiple Media
Waste
Standards Replace

"C"
"B"
Multi-Fill Spectro Auto-Plus
"Return" "A"
In or Out In "D"
or

Overall Liquid Connections

Figure 4-5

There are many ways to connect the dissolution system. Follow the options shown in
Figure 4-5. Make sure to connect number to number. Route tubing in a way to keep it
out of the way and safe from moving parts. Be careful to never set any equipment on top
of the tubing. Tubing harnesses are supplied to make liquid connections. If the tubing is
not long enough to make it to a destination, add another tubing harness to extend the
overall harness length. The shortest length of tubing is always prefered and will reduce
the rinse volume requirement.

Section 4 Installation 4 - 10
4.8 Start Up

CAUTION
The voltage indicated on the control unit must be the same as the power source.
If the incorrect voltage is indicated, do not plug in the instrument and contact HRC.

1. Turn on the power switch located on the front panel of the AutoPlus. The display
will come on and you will hear the stepper motor home itself and then stop.

2. Turn the power off.

3. Verify that the voltage indicated on the back of the MultiFill is the same as the
power source.

4. Turn on the power switch, located on the right side panel of the MultiFill. The
display should come on and you will hear the stepper motor home itself and leave
the needles in the up position. The display will show “MultiFill Ready”.

5. Turn the power off.

Note if any of these steps did not work as described, return to the beginning of the
installation section and check all connections, then refer to trouble shooting section.

Section 4 Installation 4 - 11
 Section Five- Operating Instructions, Programming

5.1 Keypad Description

c f i
ab de gh

r
jk
l no pq
m

u x ()
st vw yz

Figure 5-1

Key Key Name Use

The first press of this key allows user to select a

Run stored protocol. The second press of this key starts
the selected protocol.

f This key gives the user access to syringe functions to

de
Syringe Control perform pre-run priming and post-run cleaning
functions.

i This key gives the user access to functions that deal

gh
Source Control with the sources connected to the AutoPlus for pre-
run and post-run setup tasks.

This key is used to access a series of options. These

include contrast adjustment for the LCD display,
System Options
validation and calibration options, password
protection, diagnostics, and system configuration.

Section 5 Operating Instructions, Programming 5-1

Key Key Name Use

Edit/View Protocol This key is used to select the parameters for a new
protocol. This key is also used to edit/view the
parameters of a stored protocol. Password is required
to change parameters.

This key is used to access print options. These

Print Options include: print status, print protocol, print header,
configure header title.

This key is used to abort a test in progress. Press

twice to abort test. If this key is pressed when there is
Stop
no test in progress, the system is placed in the
standby mode.

This key is used to access the clock and alarm

options. These include setting real time and date,
Clock
display 12HR/24HR clock, sampling alarm, user
alarms, calibration alarm and alarm acknowledgment.

This key is used to access the help screens for the

system. The AutoPlus has context-sensitive help
Help
screens. These include: unit operation tips, calibration
tips and maintenance.

Section 5 Operating Instructions, Programming 5-2

 Navigation Keys These keys are used to move up, down, to the right and to the
left.

Figure 5-2

Esc Key This key is used to backup to the previous screen.

Enter Key This key is used to select an entry.

Clr Key This key is used to erase or delete an entry.

5.2 Indicator Lights

Power On This light indicates power is supplied to the system.

Diagnostics An energized light indicates the system detects a fault, which is fatal to its
use.

Timer Alert An energized light indicates an alarm has been activated. This light turns
off automatically whenever the alarm is acknowledged.

Section 5 Operating Instructions, Programming 5-3

5.3 General Operating Information

Power Up and Main Screen

Whenever the system is powered up, a Title screen is displayed for a few seconds and
then the Main screen is displayed, as shown in Figure 5-3.

DEC 2 3
1 9 9 8
EL APSED
1 2 : 0 0 PM T I ME
READY
0 0 . 0 ML S A MP L E
0 OF 0

Figure 5-3

Notice that there are three tabs on the Main screen: Status, Set Point, and Header.
These are the three screens that comprise the Main screen. In Figure 5-3, the Status
screen is displayed. Press [→] and/or [←] to display the other screens. The Status
screen is normally displayed when the system is operating. In most cases, if one of the
Main screens is not displayed, it can be displayed by pressing [Esc] one or more times.

5.4 Use of Scrolls

The user selects the desired input to operating parameters using a scroll. An example of
a scroll is shown in Figure 5-4.

# S AMP L I NG T I MES : 0
5
1 0
4 0
[ 0 - 4 0 ] 2 5

Figure 5-4

Section 5 Operating Instructions, Programming 5-4

 If the desired input for the parameter is displayed in the scroll, press [↑] and/or [↓] to
highlight it and press [Enter]. The scroll shows up to 5 inputs. Each time an input is
selected, it is placed at the top of the scroll.

If the desired input is not displayed, key in the input and press [Enter]. The input is placed
at the top of the scroll and highlighted. If the scroll had been full with 5 inputs, the input at
the bottom of the scroll is deleted or moved off the edge of the display and the new input
is placed at the top of the scroll. If the input is moved off the edge, simply arrow down to
view the input. Press [Enter] to accept the highlighted input.

Press [Clr] to delete the highlighted input, if necessary.

Some parameters, such as the Sampling Times shown in Figure 5-2, require numeric
input. Other parameters, such as the operator's name, require alphabetic input. Input of
alphabetical characters are described in this section.

5.5 Selecting an Input

An example of a scroll which requires alphabetical characters is shown in Figure 5-5. To
display this screen, with the Status screen displayed, press [→], [→] to display the
Header screen. Then press [1] to display the input screen for "Operator". Highlight the
desired operator name and press [enter].

OP ERA TOR : B I L L
DAVE
S TEVE

( Ma x 2 0 c h a r s )

Figure 5-5

Section 5 Operating Instructions, Programming 5-5

5.6 Input of Alphabetical Characters

1. Note that the operating keys also include the letters of the alphabet. For example,

[Run] has "abc" attached.

2. Successive presses of the key display the letters sequentially. For example,

pressing [Run] one time displays an "A". Pressing it a second time

displays a "B". Pressing it a third time displays a "C".

3. When the desired letter is displayed, press [→] to move to the next character.
Pressing [→] again leaves a space. Pressing [←] allows any character to be
overwritten. Pressing [Esc] or [Clr] deletes the entire input. Pressing [Enter] to
accept the entry.

NOTICE
It is not necessary to press [→] to move to the next
character, unless the next letter uses the same key. This
is more clearly explained in the following example.

4. The third character on [Help] allows a choice of 22 special characters to

be input. These characters are displayed in the pop-up window. Use [→] or [←]
to highlight the desired character, then press [Enter] to place the character in the
input string.

Section 5 Operating Instructions, Programming 5-6

As an example, input the operator's name "BILL SMITH".

1. Press [abc] two times to display a "B".

2. Press [ghi] three times to display a "I".

3. Press [jkl] three times to display a "L".

4. Press [→] to move to the next space.

5. Press [jkl] three times to display a "L".

6. Press [→] twice to leave a space.

7. Press [stu] to display a "S".

8. Press [mno] to display a "M".

9. Press [ghi] three times to display a "I".

10. Press [stu] two times to display a "T".

11. Press [ghi] two times to display a "H".

12. Press [Enter] to place “BILL SMITH” at the top of the scroll.

13. Press [Enter] to accept the highlighted input.

Section 5 Operating Instructions, Programming 5-7

5.7 Manual Operation

The AutoPlus is designed to perform dissolution testing using a series of dissolution

parameters stored in a protocol. Under certain conditions, it is desirable to have manual
control of the syringe and sources.
f
de

Syringe Control Key

Allows the user to perform pre-run priming and post-run cleaning functions.

S Y R I NGE CO N T RO L < ? > H E L P

1 S A M P L E 5 V O L UM E : 0 0 . 0 ML
2 W A S H 6 S O U RC E : A
3 P R I ME 7 T A R GE T : 1
4 D I L U T E 8 R E P EA T : A B CD

< ES C> ME N U < RU N > S T AR T < 9 > MA N U A L

Figure 5-6

Use keys 1-4 to implement syringe control functions.

Use keys 5-8 to select parameters used by the functions.
i
gh
Source Control Key

Gives the user control/access to MultiFill functions.

SO UR C E CO N T RO L

1 H O M E á N E E D L E S U P
2 I N I T I AL I Z E â N E E D L E S DOWN
3 R A C K : 1 6 X 1 0 0 à MO V E F OR WA R D
4 D E V I C E S E T UP ß MO V E B AC K

< ES C > ME N U < 1 - 4 > T A SK < ? > HE L P

Figure 5-7

Section 5 Operating Instructions, Programming 5-8

5.8 System Options

The AutoPlus System has a number of parameters that can be input by the user as part
of the installation procedure.

5.8.1 Contrast on the LCD Display

[1] Adjust Contrast

Press [←] to make the display darker; press [→] to make the display brighter.

5.8.2 Validation

[1] Log Serial Numbers

Allows the user to input system serial numbers. These numbers are stored and
may printed.

[2] Maintenance Log

Is where critical life information is stored. This should only be reset by a qualified
service person.

5.8.3 Calibration

[1] Volume Offset

Alows the user to increase or decrease the volume pumped by the syringes. This
should only be changed after doing volumetric tests.

5.8.4 Password

When password protection is activated the user is not allowed to erase a

protocol, edit protocol parameters, edit serial number log entries or implement
any of the calibration routines. To activate or disable password protection option:

1. With the System Options screen displayed, press [4] to display the System
Password Menu screen.
2. To activate, Input a password up to 20 characters long, followed by [Enter].
3. To disable, Input previous password, followed by [Enter].
4. An icon in the shape of a lock appears next to the functions which are password
protected.

NOTICE
If the password is lost or forgotten, you must contact the factory
to regain access to the system.

Section 5 Operating Instructions, Programming 5-9

5.8.5 Diagnostics

When [5] Diagnostics key is pressed, the control will go through and check the system
for faults or failures.

5.8.6 System Configuration

[1] Device Setup

Press the number for each of the devices to display the installation status of
each. The system checks for these devices when the Diagnostic tests are
performed. A failure is indicated if any if the indicated accessories are not found.

[2] System ID

This ID is printed with the status information. It can be used to identify which
system is being used, if the laboratory has more than one system. This is also
used for identification when the system is operated remotely.

[3] External Signals

This information that is sent out the RS232 when directed the protocol directs it to
do so. Normally used for communicating with a spectrophotometer.

[4] Language
NOTICE
English is the default language, consult the factory for a list of currently available
language choices.

Section 5 Operating Instructions, Programming 5 - 10

[5] RS232 Setup

1. Port- Select the port to configure.

2. Baud Rate- Determines the transmission/reception speed of data between the

AutoPlus and the external device. The available baud rates are 1200, 2400, 4800,
9600I and 19200.

3. Data Bits- Is an integer indicating the number of data bits to be used in

transmitting each single character. The available options are 7 or 8I characters.

4. Parity- Indicates the type of parity checking that is used during communications.
The available options are ODD, EVEN and NONE I .

5. Command Echo- When this parameter is ONI , the AutoPlus returns (or echoes
back) the System ID of the unit (truncated to 6 characters) followed by the
command number once it is successfully implemented. When the parameter is
OFF, no response is sent back to the external device whether command
implementation was successful or not.

NOTICE
I = Factory Default Settings

Section 5 Operating Instructions, Programming 5 - 11

5.9 System Alarm / Timers

With the Main screen displayed, press [Clock] to display the System

Alarm/Timers screen.

[1] Sampling Alarm

This alarm is used to alert the user when a sampling is to be taken from the
flasks, as determined by the sampling interval set in the protocol. To set the
parameters for the sampling alarm:

1. Press [1] to select "SAMPLING ALARM". The Sampling Alarm screen is

displayed.

2. Press [←] or [→] to turn the alarm on or off. The alarm is both audible and is
indicated by the "Timer Alert" status light on the display.

3. Set the prenotification time. This sets the amount of time that the user is alerted,
before the sample needs to be taken. The range is 0-9:59 (Hours:Minutes)

4. Press [Enter] to display the System Alarm/Timers screen.

5. Press [Esc] to display the Main menu.

[2] User Alarms

The system includes three undesignated alarms that the user can set to be
alerted for an important event. Examples of user alarms include change the bath
water, add algaecide, change the pH, or change the media. To set the user
alarms:

1. Press [3] to select "USER ALARMS". The User Alarm screen is displayed.

2. Press [↑] or [↓] to display the desired alarm number.

3. Input the date, time, and a reminder of what the alarm is. Follow each input with
[Enter].

4. Press [Esc] to display the System Alarm/Timers screen.

5. Press [Esc] to display the Main menu.

When the date and time are reached, the user is alerted of the alarm by an
audible sound, a pop-up window on the screen and illumination of the "Timer
Alert" status light on the display.

Section 5 Operating Instructions, Programming 5 - 12

[3] Calibration Alarm

The calibration alarm is used to alert the user when the calibrators must be run to
validate the system. To set the calibration alarm:

1. Press [3] to select "CALIBRATION ALARM". The Calibration Alarm screen is

displayed.

2. Input the date and time for the next calibration. Follow each input with [Enter].

3. Use the arrow keys to select the recurrence.

4. Press [Esc] to display the Main menu.

When the date and time are reached, the user is alerted of the alarm by an
audible sound, a pop-up window on the screen and illumination of the "Timer
Alert" status light on the display.

[4] To Set the System Time and Date:

1. Press [4] to select "SET TIME & DATE". The Set Date and Time screen is
displayed.

2. Input the current date and press [Enter]. Input the current time and press [Enter].
If the displayed date or time is correct, press [Enter] to input the other.

3. Press [esc] and [enter] to accept the entry.

[5] Displaying 12 / 24 Hour Clock:

Press [5] to change the clock format from one to the other format.

Section 5 Operating Instructions, Programming 5 - 13

5.10 Repeating an Alarm (Recurrence)

After setting alarms as previously described, the user may incorporate a recurrence for
that alarm. Follow the instructions on the display to disable (which will only do the alarm
once), or Mon-Fri, Mon-Sat, Everyday, or with Everyday showing the user can program
the number of days for the recurrence to take place.

5.11 Canceling an Alarm

An alarm that has been set, but has not become due, can be canceled by displaying the
input screen and pressing [Clr].

5.12 Acknowledging an Alarm

When an alarm is triggered, the "Timer Alert" status light is illuminated and a pop-up
warning window is displayed momentarily. The window is displayed again every few
seconds and the audible beep is sounded until the alarm is acknowledged. To
acknowledge the alarm:

1. Press [Clock]. The alarm pop-up window is displayed one last time.

2. Press any key to acknowledge the alarm and turn the "Timer Alert" light off.

3. Press [Esc] to return to the Main screen.

Section 5 Operating Instructions, Programming 5 - 14

5.13 Print Options

With the Main screen displayed, press [Print Options] to display the Print

Options screen.

[1] Print Status:

Press [1] to print the current status of the AutoPlus.

[2] Print Protocol:

Press [2] to select and print a protocol.

[3] Print Header:

Press [3] to print the header.

[4] Configure Title:

The title includes five lines of information which are printed at the start of each
test. To configure the title:

1. Press [4] to select "CONFIGURE TITLE". The Title Configuration screen is

displayed.

2. Select the number and input the information. Note that 3,4 and 5 change the first
three header screen prompts.

3. Press [esc] to display Print Options screen.

Section 5 Operating Instructions, Programming 5 - 15

5.14 Selecting and Viewing Protocol Parameters

With the Main screen displayed, press [Edit/View Protocol] to display the Edit

Protocol screen as shown in figure 5-9.

S E L E CT P R OT OC OL :
( 1 - 2 5 ) 1 3 0 MI N T E S T
2 CA L I B T ES T
3 R& D ST UDI E S
D R U G N AME HE R E 4 PT CL I D3
DOS AGE HE RE

Figure 5-9

5.15 Creating a New Protocol

NOTICE
Password access is required to modify protocol parameters.

Input a protocol number, which is not displayed on the scroll, otherwise you would start
editing the highlighted protocol. The Operation Parameters screen is displayed. A series
of input screens are displayed. Input the desired parameters on each screen and move
to the next screen by pressing [Enter].

NOTICE
You can move between parameter input screens by pressing [→] and [←].

Operation Parameters:

1. Operation Mode: Collect Only; Collect & Detect; Detect Only.

2. Rack Type: 12x32 and 16x100.

Sampling Parameters:

1. Sample Rinse Volume: Input volume required to rinse sample lines.

2. Sample Collect Volume: Input volume to be collected.
3. Replace Media: Yes or No to replace media.

Detection:

1. Detect Volume: Input volume required for detection.

2. Read Delay: Input time required to analyze all cells used.

Section 5 Operating Instructions, Programming 5 - 16

Drug Name: Input in a 20 character field.

Dosage Name: Input in a 20 character field.

Protocol ID: Input in a 20 character field.

Auto Print Interval:

This allows the status conditions (elapsed time, system I.D., speed, and
temperature) to be printed at the designated interval during the test.
Range: 0- 99:59 (Hours: Minutes)

Test Length:

Input the total time for the test, but not including the optional infinity test.
Range: 0- 999: 59 (Hours: Minutes)

# Sampling times:

This sets the number of times that the system will run the programmed sampling
protocol.
Range: 0- 40 sampling points.

Sampling times:

This screen is used to specify the time when each of the samplings is to be
taken. The input is different on this screen. Notice that the screen displays all
sample times with the current sample time highlighted. Input the time for the first
reading and press [Enter]. Repeat for each time point.
Range: 00:00 to 99:59 (Hours: Minutes)

Protocol Comments: Input up to a 20-character comment about the protocol.

When the last parameter (Protocol Comments) is input, the protocol is stored.
Protocol set up is complete.

Section 5 Operating Instructions, Programming 5 - 17

5.16 Editing a Protocol

NOTICE
Password access is required to modify protocol parameters.

1. With the Main screen displayed, press [Edit/View Protocol] to display the

Edit Protocol screen.

2. Use [↑] and/or [↓] to highlight the desired protocol and press [Enter].

3. As each of the parameter selection screens is displayed, the selected parameter

is highlighted at the top of the scroll. Any of the parameters can be changed
using the same procedure used to initially input the parameters.

4. When the desired parameter(s) have been changed, press [Esc] twice to return
to the Main screen.

5.17 Viewing Protocol Parameters

1. With the Main screen displayed, press [Edit/View Protocol] to display the

Edit Protocol screen.

2. Use [↑] and/or [↓] to highlight the desired protocol and press [Enter].

3. The Operation Parameters screen is displayed. Notice that the selected protocol
number is displayed in the folder on the lower left-hand corner of the screen.

4. Press [Enter] to display the selected input for each parameter.

To print the parameters of an existing protocol:

1. With the Main screen displayed, press [Print Options] to display the Print

Options screen.

2. Press [2] to select "Print Protocol". The Select Protocol screen is displayed.

3. Highlight the desired protocol and press [Enter]. The protocol parameters are
printed.

4. When printing is complete, press [Esc] to return to the Main screen.

Section 5 Operating Instructions, Programming 5 - 18

5.18 Working with Scripts

Script definitions: From the parameters entered by the user, the software generates a
script or a list of procedures that it will follow to implement the user requests. Since the
script is generated automatically, most users will not need to concern themselves with it.

Press while in a protocol to move to the scripting screen.

However, advanced users will want to edit the script by inserting functions into the
template or initial script generated.

Examples:

• If the user selects the Collect Only mode, 5ml sample rinse volume, 7 ml sample
collect volume and media replace on an AutoPlus with Uni-Probes, the software
will generate the following script:

1— Sample Rinse (5 ml)

2— Sample Collect (7 ml)
3— Replace Volume (12 ml)

If the advanced user wants to print status every time a sample is taken and
clean the flowcell line with media at the end of the test, he edits the script as
follows:

1— Sample Rinse (5 ml)

2— Print (Bath Status, Always)
3— Sample Collect (7 ml)
4— Replace Volume (12 ml)
5— Pump (C, D,20 ml, End of Test)

If the user has an AutoPlus with Dual-Probes and selects the Detect Only Mode,
5ml sample rinse (he is not prompted for collect volume or media replace), the
software will generate the following script:

1— Sample Rinse (5 ml)

2— Detect Only (1 ml, 1 sec, RS232, Always)

• If the user selects the Collect & Detect mode, 7ml sample rinse volume, 5 ml
sample collect volume and media replace on an AutoPlus with Dual-Probes, the
software will generate the following script:

1— Sample Rinse (7 ml)

2— Collect & Detect (5 ml, 1 ml, 1 sec, RS232)
3— Replace Volume ( 5 ml)

If the advanced user wants to wash the lines with media after detection, he
would edit the script as follows:

Section 5 Operating Instructions, Programming 5 - 19

 1— Sample Rinse (7 ml)
2— Collect & Detect (5 ml, 1 ml, 1 sec, RS232)
3— Pump (C, D,5 ml, Always)
3— Replace Volume ( 5 ml)

Advanced users can use the transfer and detect functions to take multiple readings of the
standards and to load multiple standards. The transfer function allows the user to move
a programmed volume of fluid from a source to a target location at a selected time during
or after the test so that a wash cycle can be implemented at any time or a reagent or pH
volume can be placed in the bath at a given time point.

5.19 Script procedures available:

1. Sample Rinse (Sample Rinse Volume, Sample Rinse Ratio)

2. Collect & Detect (Sample Collect Volume, Detect Volume, Read Delay, Signal
Type)
3. Collect Only (Sample Collect Volume)
4. Detect Only (Detect Volume, Read Delay, Signal Type, Implement)
5. Replace Media (Sample Collect Volume, Sample Rinse Volume)
6. Transfer (Source, Target, Volume, Implement)
7. Print (Data, Implement)
8. Delay (Time, Implement)
9. Prompt (Message, Time, Implement)

Other script procedures worth considering could be a wash procedure which would be
an advanced version of the pump procedure that would wash all sampling lines with a
single line of script. Procedures to implement I/O functions for more advanced interfacing
with external devices. A pause procedure that would not only delay the test but actually
pause it.

Section 5 Operating Instructions, Programming 5 - 20

5.20 Editing Scripts

The user is allowed to edit the script that is generated for each protocol as a result of the
parameters entered.

The user is able to view and print the current script. He can also insert and delete
functions from the script body. He can also edit the properties (volume, valve, etc) of an
existing script procedure.

5.21 Running a Test

The user may run a test by simply starting a protocol stored in memory. The first option
is an automated approach that should be used to start frequently used procedures.
Starting a protocol has the following advantages:

1. Ensures that the critical test parameters are selected correctly every time and
cannot be changed by the operator;
2. Enables the user to monitor USP tolerances during the test;
3. Automatically prints pertinent test data at the beginning of the test;
4. Allows the user to program sampling alarms;
5. The system may be easily programmed to allow for staggered sampling; perform
an infinity test and automatically shut down the heater after the test ends.

Section 5 Operating Instructions, Programming 5 - 21

5.22 Starting a Protocol

The AutoPlus is designed to perform dissolution test using a set of parameters stored in
a protocol. Information on setting these parameters is provided in section 5.6. Before
starting a test, verify that there is sufficient water in the bath, and that the flasks are
prepared with the correct dissolution media.

1. Press [Run]. The Select Protocol screen is displayed.

SE L E CT P R OT OC OL :
( 0 - 9 ) 0 3 0 MI N T E S T
1 CA L I B T ES T
2 R& D ST UDI E S
D R U G N AME 3 PT CL I D3
DOS AGE

Figure 5-10

2. Highlight the desired protocol and press [Enter]. The Select Target screen is
displayed. Press the corresponding number to accept the displayed unit or
method for testing. Press [enter] when done. Press the file key to view and or
change the bath offset time and which row the MultiFill is to start at.

The system is now in the set up mode. The system will check and diagnose that
the setup and equipment specified are ready. Note that this process is not
completely foolproof. Equipment that cannot communicate and that does not
have feedback, should be physically checked to ensure they are ready and set up
properly.

DEC 2 3
1 9 9 8
EL APSED
1 2 : 0 0 PM T I ME
READY
0 0 . 0 ML S A MP L E
0 OF 0

Figure 5-11

Section 5 Operating Instructions, Programming 5 - 22

3. Press [→] to display the Set Point screen, as shown in Figure 5-12.

AUG 1 2
1 9 9 9
S PE CT RO A UT O ¤CA L
1 2 : 0 0 PM ONL I NE 0 0 : 0 0 ¡US E R
¤SA M P
MUL T I F I L L T EST
ONL I NE L ENGT H 0 00 : 0 0

Figure 5-12

The Set Point screen displays the timing interval for Auto Print, and the time for
the test length and if the MultiFill and Spectrophotometer are online. The Set
Point screen also indicates which of the alarms have been set.

If any parameter is incorrect, press [Stop] twice to abort test.

4. Press [→] to display the Header screen, as shown in Figure 5-13.

AUG 1 2
1 9 9 9

1 2 : 0 0 PM 1 OP ERA TOR :
2 T EST NO. :
3 L OT N O. :
4 C O MM E NT S :

Figure 5-13

Input the operator's name, test number, lot number, and comments. This header
information, along with the two lines input for "Configure Title", is printed with the
protocol parameters at the start of the test.

Section 5 Operating Instructions, Programming 5 - 23

 5. Press [→] to display the Status screen. When parameters are within tolerance, a
pop-up screen appears displaying “DROP DOSAGE AND PRESS [Run] “ to start
test.

6. Press [run] to start test.

If Auto Print was selected, the status conditions are printed at the interval
specified in the protocol.

The number of samplings, and the remaining time until the next sampling is
displayed on the Status screen. If the sampling alarm is turned on, when each
sampling interval is reached, an audible alarm will sound, a warning window is
displayed momentarily, the "Timer Alert" illuminates.

7. When the protocol is complete, the display will show

“Test Complete Press Any Key”

5.23 Stand By Mode

1. When not running a protocol, press [stop] to put the unit in the stand by mode.
Press any key to wake the unit up.

Section 5 Operating Instructions, Programming 5 - 24

 Section Six – Making A Run
6.1 Setting Up

1. Auto-Plus

Verify that all liquid and communications connections are connected per the
installation requirements, see section 4. Turn power on and select protocol to
run, see section 5. Verify media and waste sources are available.

2. Multi-Fill

Verify that all liquid and communications connections are connected per the
installation requirements, see section 4. Turn power on. The display should
read “Multi-Fill Ready”. Install test tubes or vials into rack and place rack on unit.

3. Hanson Bath(s)

Verify that all liquid and communications connections are connected per the
installation requirements, see section 4. Verify that the dissolution unit(s) are
ready and are within the required specifications. Extra solution may be added to
each vessel to accommodate any priming requirement.

4. Other Dissolution Bath(s)

Verify that all liquid connections are connected per the installation requirements,
see section 4. Verify that the dissolution unit(s) are ready and within the required
specifications.

5. Sampling Probes

Verify that all liquid connections are connected per the installation requirements,
see section 4. Verify that the probes are adjusted to the correct sampling depth
and that the correct number is placed in the correct position. Verify that the
specified filter is correctly installed.

6. Printer

Verify that the communications connections are connected per the installation
requirements, see section 4. Verify there is adequate paper supply and that the
power is on. Both lights should be on and not blinking.

7. Solutions

Verify that there is an adequate amount of media replace and standard and blank
material available. Prime all appropriate materials before starting the test, see
section 5.

Section 6 Operating Instructions 6-1

6.2 Starting and Running a Test

1. Note; see section 5 for programming and operational capabilities. Press start on
the Auto-Plus and select a pre-programmed protocol and press enter. Then
select target baths, bath offset, row position and press enter.

2. Drop dosage into dissolution vessels in bath “A”.

3. Press start again on AutoPlus to set time zero.

4. Drop tablets into the dissolution vessels of subsequent bath(s) when directed.

6.3 During the Test

1. The Auto-Plus will count down to the sampling time point and load and dispense
the programmed rinse volume to rinse the sampling lines.

2. Then the Auto-Plus will draw and dispense the programmed sample volume and
send a signal to the spectrophotoment to read the samples and or collect the
programmed sample volume.

3. Replace the volume removed with fresh media, if programmed to do so.

4. The Auto-Plus will also send important information to the Validation Printer for a
hard-copy test report of the process.

6.4 After the Test

After each test insure that a wash cycle is implemented. The wash cycle may be
programmed into the protocol to start at the end of the test for unattended system
washing.

Section 6 Operating Instructions 6-2

 Section Seven - Trouble Shooting
7.1 Contacting Hanson Research Corporation for Technical Support.

To expedite your request for technical support, please supply or have the following
information available:

1. Model and serial numbers of the instrument(s).

2. System configuration.
3. How long the equipment had worked before the problem occurred and how old
the equipment is.
4. Any background information, recent repairs, or parts replaced to date.
5. How the system is being used, what the application is.
6. Detailed information about the problem (what is working and what is not).
7. Detailed troubleshooting steps that have been taken to date.

7.2 Electrical

No Power Light on Front Panel

Possible Cause Action

Power switch off. Turn power switch to the on position.

Power disconnected. Check and connect power.

Bad fuse. Check or replace fuse, see section 8.

Power supply defective (no light on power Check or replace power supply.
supply)

Display Will Not Come On

Possible Cause Action

Auto-Plus is in stand-by. Press any key.

Display back-light out. Check and replace back-light.

Section 7 Trouble Shooting 7-1

Display Not Clear

Possible Cause Action

Contrast not set correctly. Adjust contrast, see section 5.

Loss of Programmed Information

Possible Cause Action

Battery Failure. Replace Main Board Smart Block Module.

Section 7 Trouble Shooting 7-2

7.3 Mechanical

Sample Volumes Inconsistent

Possible Cause Action

Not using vial caps. Use recommended vial caps.

Leaking syringe. Check and replace syringe.

Sample Volumes Incorrect

Possible Cause Action

Offset volume set incorrectly Check and set offset volume.

Offset volume not set Check and set offset volume.

Excessive Carry-Over

Possible Cause Action

Inadequate rinse volume. Increase rinse volume.

Used sample filters. Replace sample filters.

Drug Loss

Possible Cause Action

Sample adsorbing to filters or other parts of Evaluate filters, sample may be absorbing to
the liquid flow path. them. See section 3 for wetted parts.

Section 7 Trouble Shooting 7-3

7.4 Printer Problems

Light Always Blinks

Possible Cause Action

No paper. Replace paper roll.

Paper incorrectly installed. Check paper to see that is installed

correctly, and that the paper indicator button
is not stuck. Consult Printer Operation
Manual.

Prints A Little and Then Light Blinks

Possible Cause Action

Paper incorrectly installed. Check paper to see that is installed

correctly, and that the paper indicator button
is not stuck. Consult Printer Operation
Manual.

Will Not Print

Possible Cause Action

No paper. Replace paper roll.

Paper incorrectly installed. Check paper to see that is installed

correctly, and that the paper indicator button
is not stuck. Consult Printer Operation
Manual.

Printer not connected. Connect printer, see section 4.

Printer Self Test, turn power off, hold down both buttons SEL and LF, turn power back on.
When unit begins to print, release buttons. Printer should print;
DP614
POWER ON SELECT
CR = CR
France
DRAWER
SERIAL INTERFACE
8 BIT
NON PARITY
9600
NATIVE

Section 7 Trouble Shooting 7-4

 Section Eight - Maintenance
8.1 General Cleaning

The AutoPlus and MultiFill have been designed to be a low maintenance instrument. In
general, the instruments are maintained by wiping cleaning after each use, as well as
running HPLC grade water through the units after each test.

The exterior of the instrument should be periodically wiped down with a damp cloth.
Frequency of cleaning depends on instrument usage and operating environment. If there
is spillage on the unit, clean it up as soon as possible.

8.2 Cleaning Method for Tubing, Valves and Syringes

Supply HPLC grade water at each sampling input (sampling probes) or at media replace
source. Program AutoPlus to pump at least 20mL of solution through, see section 5.
This method should be done after each test.

Section 8 Maintenance 8-1

8.3 Fuse Replacement

CAUTION
For continued protection against risk of fire,
replace the fuse(s) with same type and current rating.
Disconnect power cord before changing fuses.

To check the fuse and replace a defective fuse in the AutoPlus,

1. The fuses are located on the back of the control. The system has one fuse. The
amperage is labeled next to the fuse. The fuse holder has a finger grip knob,
push in and slightly turn counter-clockwise then pull knob with fuse straight out.

2. Check the fuse with an ohm meter. If you are not sure or if you do not have an
ohm meter, replace the fuse.

3. If the fuse is defective, remove the fuse from the holder by pulling it straight out.
Replace with a fuse of the same type and rating, see section 3.

4. Push the fuse back into the control. Secure the fuse holder by pressing in and
slightly turning clockwise.

To check the fuse(s) and replace a defective fuse in the MultiFill,

1. The fuses are located on the side of the control where the power cord is
connected to the unit. The system has one or two fuses. With a small bladed
screwdriver, gently pry the cover/fuse block away from the power entry port
housing and remove.

2. Check the fuse with an ohm meter. If you are not sure or if you do not have an
ohm meter, replace the fuse.

3. If the fuse is defective, remove the fuse from the holder by pushing it out towards
the side. Replace with a fuse of the same type and rating, see section 3.

4. Slide the cover/fuse block back into the power entry port housing the same way
that it came out. Snap the cover/fuse block assembly securely into place.

Section 8 Maintenance 8-2

8.4 Syringe Replacement

Replace syringe plungers when maintenance log indicates 100,000 cycles. After
replacing syringe plungers, Volume Calibration should be performed.

1. Remove shoulder screw at bottom of syringe.

2. Grasp barrel with finger and turn to unscrew the syringe end from the manifold.

3. Install the new syringe into the manifold finger tight and replace the shoulder
screw.

8.5 Volume Calibration

Use HPLC grade water at room temperature.

1. Weigh empty sample collection vials with caps and record. Do at least three sets.

2. Program AutoPlus to collect the required sample volume.

3. Weigh full sample collection vials and subtract the empty value from the full. Make
any calculations required for water density.

4. To make fine adjustments to the collected volume, use the volume offset function,
see section 5.

8.6 MultiFill Needle Replacement

Visually inspect monthly. Replace as necessary, or every 12 months.

1. Remove rack, from the keypad move the dispensing needles out a few rows.

2. Grasp the plastic top of the needle and twist to unscrew. The needle will come
away from the connector.

3. Insert new needle and twist until tight. Repeat for each needle.

4. Run a few test cycles to insure proper operation of the needles and that there are
no leaks.

Section 8 Maintenance 8-3

 Section Nine - Moving and Storage

Storage

If the unit will not be used for a short period of time (3 days or more), the unit
should be cleaned and the power should be turned off. If the unit will not be used
for an extended period of time (30 days or more), the instrument should be
cleaned, covered and unplugged from the power source.

Moving

The unit is heavy and great care should be taken when moving it. If the unit is
moved to a new location, revalidation should be considered.

AutoPlus

1. Remove all liquid sources and program the AutoPlus to pump 20mL of air to clear
as much liquid from the system as possible.

2. Turn the power off. Disconnect all tubing, communication and electrical
connections from the unit.

MultiFill

1. Turn the power off. Remove rack and secure needle arm.

2. Disconnect all tubing, communication and electrical connections from the unit.

Section 9 Moving and Storage 9-1

 Section Ten - Parts, Supplies and Accessories
Spare Parts

60-200-805 Q-Pak IQ/OQ/PQ for Auto-Plus

73-100-116 Validation Printer 115 VAC (for 115 and 230V SR8-Plus)
60-200-101 Validation Printer 115VAC (for 115V AutoPlus)
60-200-102 Validation Printer 230 VAC (for 230V AutoPlus)
47-200-701 Printer Paper 1 Roll (for above printers)
47-200-702 Printer Ribbon 1 (for above printers)
47-200-759 Communication / Printer Cable 9’ Long
60-200-300 Communication Plug for MultiFill
91-110-019 AutoPlus external power supply

60-200-550 Syringe
60-200-555 Syringe Plunger
91-418-055 Shoulder Screw (Syringe)
60-200-425 Valve Assy (4 valves on top of syringe, Maximizer)
60-200-449 Valve Assy (single valve on top of syringe, Dissoscan)

60-200-315 Main Board

60-200-314 Back Plane Board (vertical board)

91-030-053 Rack for 16 x 100 Test Tubes

91-030-051 16mm Test Tube (box of 250)
27-800-714 16mm Test Tube Cap (bag of 50)
91-030-063 Rack for 12 x 32 HPLC Vials
91-030-150 12 x 32 HPLC Vials with pre-slit septum (pack of 100)

60-200-517 O-Ring 1/16 ID MultiFill Home

91-601-248 Check Valve MultiFill Home
60-200-703 Stainless Probe 1/8 x 13 long (for 1 tubing channel)
27-101-074 Sample Filter, 10 micron (for tip of 1/8 tube) (pack of 50)
91-450-062 Sample Filter, 5 micron (for in-line lure connection) (pack of 75)

91-212-065 Fuse 3 Amp (Auto-Plus)

91-212-071 Fuse 3 Amp (Multi-Fill 115V)
91-212-072 Fuse 1.6 Amp (Multi-Fill 230V)

Section 10 Parts, Supplies and Accessories 10 - 1

Fittings and Tubing

91-601-130 1/16 Ferrule, Blue (used for 1/16 tubing)

91-601-131 ¼-28 x 1/16 Nut, Black
91-601-132 ¼-28 x 1/16 Nut, Red
91-601-133 ¼-28 x 1/16 Nut, White
91-601-134 ¼-28 x 1/16 Nut, Yellow
91-601-135 ¼-28 x 1/16 Nut, Green
91-601-136 ¼-28 x 1/16 Nut, Blue
91-601-137 ¼-28 x 1/16 Nut, Clear
91-601-139 ¼-28 x 1/16 Nut, Purple

91-601-140 1/8 Ferrule, Yellow (used for 1/8 tubing)

91-601-141 ¼-28 x 1/8 Nut, Black
91-601-142 ¼-28 x 1/8 Nut, Red
91-601-143 ¼-28 x 1/8 Nut, White
91-601-144 ¼-28 x 1/8 Nut, Yellow
91-601-145 ¼-28 x 1/8 Nut, Green
91-601-146 ¼-28 x 1/8 Nut, Blue
91-601-147 ¼-28 x 1/8 Nut, Clear
91-601-149 ¼-28 x 1/8 Nut, Purple

91-601-138 ¼-28 Union White

91-601-036 ¼-28 Union Clear
91-601-181 ¼-28 x Female Lure
91-601-180 ¼-28 x Male Lure

91-600-006 Teflon Tubing 1/32 x 1/16

60-200-706 Tubing Harness 6 conductor 3’
60-200-708 Tubing Harness 8 conductor 3’

Tools and Accessories

10-000-025 Tool to Hold Teflon Tubing

91-902-020 Electro-Mechanical Tool Kit

Section 10 Parts, Supplies and Accessories 10 - 2

 Section Eleven - Sales and Service Offices

The Auto-Plus is sold and serviced by a worldwide network of dealers and distributors. If
you need additional accessories, replacement parts, or require service information, you
can either contact your local agent, or you can contact Hanson Research Corporation at
their worldwide headquarters:

Hanson Research Corporation

9810 Variel Avenue
Chatsworth, CA 91311 USA

Phone: (818) 882-7266

Toll free in USA, Canada and Puerto Rico: (800) 821-8165

FAX: (818) 882-9470

WEB Site: http://www.hansonresearch.com

Section 11 Sales and Service Offices 11 - 1

 Section Twelve - Warranty

GENERAL WARRANTY: Hanson Research Corporation products are warranted for one
full year including parts and labor. An extended three-year warranty is available to USA
domestic customers at time of purchase. International dealer warranties may vary.
Optional service contracts may be available after warranty period expires. Hanson
Research Corporation makes no warranty, expressed or implied, for glassware,
consumables, or products not manufactured by Hanson Research Corporation, as
evidenced by nameplate on the item or other designation. We will give responsible
assistance to buyer in obtaining from the respective manufacturer whatever adjustments is
reasonable in light of manufacturer’s own warranty. Hanson Research Corporation shall
be released form any and all obligations under any warranty, either expressed or implied,
if the product covered is repaired or modified by other than its own personnel, or made
without written authorization of Hanson Research Corporation. There are no other
warranties, expressed or implied, and Hanson Research Corporation shall not be liable
under any circumstances for consequential damages.

Section 12 Warranty 12 - 1
 Section Thirteen - Accessories, Auto-Probe
13.1 Installation

If your system is to be connected to an HRC Auto-Probe, connect the tubing lines

together, see figure 13-1. There is also a chart to show the color and number code.
Connect number to number, color to color. See section 4 for more information.

13.2 Operation

Adjusting the sample probe is done by;

1. putting the "drive head" to it's operating position
2. moving the Auto-Probe Coupler, item 4, to its lowest position
3. adjust the sample probe by loosening the screw, item 3 and raising or lowering the
sample probe to achieve the proper sampling position.

THE SAMPLE PROBE END POSITION IS TO BE MIDWAY BETWEEN THE

SURFACE OF THE MEDIUM AND THE TOP OF THE PADDLE OR BASKET.

It is important that when using sample tip filters, item 1, that they are always
completely submerged while sampling.

Section 13 Auto-Probe 13 - 1
 Auto-Probe
Figure 13-1

Section 13 Auto-Probe 13 - 2