Agenda
• Brief Review of Application
• Sales tools / literature overview
• Instrument – What changed/no?
– Consolidated review of the new stuff
• Pharmspec – What changed/no?
– Consolidated review of new stuff
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•
•
•
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Best Practice prior to on-site arrival
Review of Inst install (op manual, gotcha’s)
Review of Pharm install (op manual, gotcha’s)
IQ/OQ – brief review
Support team
Patent Pending
Literature Resources
Sales Literature
• 9703+ Flyer
• HIAC Global & Domestic
Customer lists
• 9703+ Postcard
• 9703+ Sales Training
• 9703+ SOP Migration
Other Resources
• HIAC Instrumentation and
PharmSpec Software
Validation Docs.
• 9703+ User Manual
• PharmSpec User Manual
• 9703+ Quotation Template
What Has Not Changed?
• Syringes
– 1 ml, 10 ml, 25 ml
• Flow rate settings
– 10 – 100 ml
• Sensors
– (MC05 is added)
• Sampling Probes
– (added short-small bore probe)
• Instrument size / shape
– Design allows the laminar flow cabinet to
act upon the sample
– 50%+ of instruments are placed in
laminar flow cabinets.
Some SOP’s reference flow rates, sensor models, syringes and probes
Instrument View
New Sampling Probe
• 3 probes available
– 2 probes have not
changed (1.2 ml tare,
0.172 ml tare volume)
– New small / short
probe has 0.09 ml tare
volume
– Enables the use of 1
ml of product for full
suite of compendial
tests
• Small Vial Clamp
Small Vial Clamp
– Can be removed
– Can be added in the field or ordered
directly
• Use
– Use 1 hand to compress lever arms
– Use other hand to place sample in
central location
– Decompress hand
– Clamp auto-centers and holds sample
container.
• Removal
– Half nut installation
– Standard flat head screw driver required
(not included)
• Docking Module
Docking Module
– Enables removal/disabling of the stir
bar mechanism
– Enables field installation of small vial
clamp outside of the laminar flow
cabinet
• No instrument move forcing a
revalidation
• Future developments to expand 9703
applications
– Auto-sampler docking module in
development
Sampling Safety Switch
• Sampling safety switch
– Ensures the sampling probe does not
crash (and bend or break) into the
docking module
– Ensures the probe does crash and/or tip
the sample container
• This addresses #1 problem revealed
during the face-to-face interviews
Don’t underestimate the importance of this feature during demo
PharmSpec
MC05 Sensor
– Unique calibration curves must be entered for extinction and scatter
– PHA available for both extinction and scatter channels
9703+ MC05
–
Requires unique sensor mounting
–
Field retro-fit kits available
VOC revealed 12% of respondents are seeking particles down to 0.5 um
Back Panel View – New Items
• HRLD cable connector
– Ensures stable sensor connection
during sampling
• USB connection
• Light extinction and light
scattering connections
– Utilized for calibration of either
HRLD or MC05 sensor
– Utilized for on-site field troubleshooting of HRLD or MC05 sensor
• Power connection
• Drain connection
• 15-pin sensor connector
Front Panel User Interface
Changed interface to separate
flushing and syringe change out
buttons, from stir speed and
instrument probe position
• Flushing buttons
– Forward flush (top button)
– Back-flush (bottom button)
• Syringe Open/Close
– Enables syringe change-out
• Stir Speed – RPM
– Precision stir speed in rotations per
minute (RPM)
– Visual indication that the instrument
is still powered
• Sampling probe position
– Move probe upward
– Move probe downward
• Set probe sampling position
– Button used to set the pre-configured probe
test sampling position.
Best Practices
Customer computer (major stumbling block)
• Brand new computer
• Clean Hard-drive
• Recycle
• Communication port problems
Do you have IQ/OQ documents ready (ideally printed and bound)
Brief the customer prior to visit
PharmSpec 3.0
Many of the functions
have not changed
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–
–
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Procedural tests
Run Counter tests
IST tests
Procedure Builder
Historical reporting
Activity Log
Data Storage
Hardware settings
What’s New In PharmSpec 3.0
• Compatibility with the HIAC 9703+ Liquid Particle Counting System
• Compatibility with MC particle counting sensors
• Users are added to PharmSpec using Windows® User Management
• Users log in to PharmSpec using their Windows user account logins and
passwords
• Password expirations and lockout settings are selected using Windows
• USP<789> test procedural standards
• CP test procedural standards
• Procedural standards and user-defined test procedures can be
distributed to other computers by the user
What’s New Con’t
• Partial results are recorded for incomplete tests
• Automatic checks for procedure and software updates can be
scheduled by the user
• Batch printing and exporting of reports
• Alarms for invalid configuration, calibration due, bubbles detected,
concentration limit exceeded, sample probe needs recalibration, sensor
blocked and sensor contaminated
• Number of reviewer signature lines on printed reports is set by the
user
• Company logo can be added to reports by the user
• FDA 21 CFR Part 11 requirement features can be disabled using a
license key (logins, user administration, review and approvals of tests,
and audit trails)
PharmSpec Requirements
*The PC requirements shown
are the minimum requirements
supported.
*The user may benefit by using
a faster processor and/or
additional memory.
*Windows Vista and Windows
7 users may have higher
requirements.
Bubble Detection Alarm
1) Clear description of alarm
2) Recommended actions
3) Potential cause and where
to go for help
Ships disabled as standard.
Adding A User
-Right click on “My Computer”
-Click “Manage”
-Double click “Users”
-Next to the “Users” folder, Right
click and select “New User”
-The following fields must be filled
in: User name, Full name and
Password fields. Complete the
other fields as needed.
-The following fields must be filled
in: User name, Full name and
Password fields. Complete the
other fields as needed.
Add A User To A Group
-Click “Groups”
-Double click on the Group you wish to add the
User to. The four groups from which you can
choose to add a User to are:
1)PharmSpecAdmins
2) PharmSpecCalTechs
3) PharmSpecOperators
4) PharmSpecSupervisors
- Click Add
-Enter the “User Name” in the dialogue box and
click “Check Names”
**If you are working in a Domain and wish to add
a Local User click on “Locations” and select your
computer.
-Once the User is found select “OK” and the User
is added to the selected Group
9703+ w/ HRLD
HRLD components
1 HIAC 9703+ liquid particle counter
2 Sensor, HRLD
3 Cable, sensor
Included Accesories
Shipping kit
1 Nut 7 Probe, small bore
2 Hex Key, 1.5 mm 8 Cable, USB
3 Syringe, 10 ml 9 Power supply, 24V
4 Power cord, AC 10 O-rings
5 Stir Bar, Teflon 11 Tubing
6 Probe, large bore 12 Power cord, European
HRLD Sensor Install
1
2
3
4
HRLD Sensor Install Con’t
5
6
7
Instrument Install Guidance
Connect the drain line
The sample waste from the instrument must be collected in a compatible
waste container. Monitor the liquid level in the waste container to prevent
overflow. Dispose of waste in accordance with local, state and national
environmental regulations.
Install or remove the docking module
Docking modules are available for single or multiple-container sampling
Install the small-vial clamp
The optional small-vial clamp connects to the docking module with 2
screws.
Connect the power cord
A power supply unit is used to supply power to the instrument
Install Guidance con’t
Remove the magnetic stirrer
The magnetic stirrer in the docking module can be removed if
necessary
1. Pull the tab on the docking module away from the
instrument to remove the module.
2. Remove the four screws on the bottom plate of the
module. Separate the bottom plate from the module
enclosure.
3. Pull to remove the stirrer plug from the circuit board.
4. Remove the two holding screws from the stirrer motor
flange and remove the magnetic stirrer assembly.
5. Put the bottom plate on the module enclosure and install
the four screws.
User interface:
The buttons on the front panel allow the user to operate the
syringe, sample probe and stirrer.
1 Syringe controls
2 Stirrer speed (RPM)
controls
3 Power switch
indicators
4 Stop button
5 Sample probe
6 LED status
Button Descriptions
Button
Name
Description
Stop
Stops the movement of the syringe and
probe. Sampling is stopped. The stirrer
continues to operate.
Set
Moves the sample probe up or down.
Hold to increase speed.
Lift/Lower
Sends the sample probe to the top or
bottom
IQ/OQ -Validation Support
Documentation
Purpose of the Tests
The validation project is a set of tests that are used to make sure that the computer-related
system is operating to the specifications that have been identified. Before a full operational
qualification (OQ) is done, an installation qualification (IQ) is done.
•
•
On-site IQ/OQ service is available.
IQ/OQ documentation offered to customers as an option
Customer Upgrade - Awareness
•
We are unable to support PharmSpec 1.X historical database report viewing
– This can be done in PharmSpec versions 1.X and 2.X but not 3.X
– PharmSpec 1.X did not migrate to Windows XP, which is the minimum operating system
for PharmSpec 3.0
•
All current HRLD sensors in the field must be fitted with the new 9703+ cable
when used with new instrument
– Due to speed and sensitivity enhancements, the old HRLD cabling is not optimized for
the 9703+
– All new HRLD part #’s with new cable have been developed for quotes on 9703+
– Retrofitting the new cable on an old sensor is an acceptable solution
•
We no longer user PharmSpec application security, we utilize Windows security for
login access
– Be sure to add your user’s to one of the PharmSpec User groups, clearly outlined in the
operator manual
Hach Internal 9703+ Support Team
•
This is an internal list to be used when normal channels of support have not
provided an adequate solution.
Software: Tim Rivas x 6535
Software: Guy Wood x 6532
Tech Support: John Moir x 6545
General Questions: Paul Yates x 6528
General Questions: Dave Dunham x 6548
….and when all else fails
Bill Bars x 6551
Gary Minnick x 6552