Hanson PHASE ONE Manuale utente
PHASE ONE™
DISINTEGRATION TESTER
USER GUIDE
Hanson Research Corporation
40-108-001-Rev. A—14 November 2016
Safety
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 SAF-1
About Hanson Research
Hanson Research is a global technology
company specializing in analytical test
instruments for the pharmaceutical industry.
Founded by the innovator of modern
dissolution test technology, Hanson Research
helps ensure the world’s pharmaceuticals are
pure, safe, and effective by manufacturing
equipment that sets the global standard for
quality, innovation, and long-term value.
Hanson instruments are used by scientists in
over 75 countries worldwide and are
supported by the industry’s top customer
service team. For more information, visit
hansonresearch.com.
Headquarters
Hanson Research Corporation
9810 Variel Avenue
Chatsworth, CA 91311, USA
Main: 818.882.7266
Toll Free: 800.821.8165
Fax: 818.882.9470
hansonresearch.com
Copyright © 2016 Hanson Research Corporation. All
rights reserved. Phase One
™
is a trademark of
Hanson Research Corporation.
Sales and Support
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 SUPPORT
Congratulations on your purchase of the Hanson Phase One™ Disintegration Tester.
While we are certain you will enjoy this new product, we also understand from time to
time you may have a question or technical issue requiring our assistance. Please feel
free to contact us at any time by any of the methods below. We’re happy to help!
Website: www.hansonresearch.com
Tech Support Request Form: www.hansonresearch.com/tsr
E-Mail: [email protected]
Phone: (+1) 818.882.7266
Toll Free: 800.821.8165
Fax: (+1) 818.882.9470
Corporate Headquarters
Hanson Research Corporation
9810 Variel Avenue
Chatsworth, CA 91311, USA
Revision History
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 RH-1
Document Revision History
Revision Date Revised Description of Change
A 14 November 2016 Original issue
To confirm that you have received the latest version of this user
guide, contact Hanson Research Technical Support.
Table of Contents
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 TOC-1
Table of Contents
A. Introduction ……………………………………. A-1
B. Regulatory and Safety ……………………….. B-1
C. Installation ……………………………………… C-1
D. Operation ………………………………………. D-1
E. Disintegration Testing …………………….…. E-1
F. Maintenance ………………………………….. F-1
G. Troubleshooting ………………………..…….. G-1
H. Specifications ………………………..…….….. H-1
I. General Warranty ………………………….….. I-1
A. Introduction
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 A-1
Phase One Disintegration Tester Overview
The Phase One Disintegration Tester is a two-basket system
designed to facilitate testing of tablet disintegration in
conformance with USP Chapters <701> and <2040> and other
harmonized international standards. The unit consists of a
waterbath, two beakers, two basket assemblies, one
heater/circulator, a set of two reciprocating arms driven by a
single electric motor, and other components as shown in the
illustration below.
The tester supports methods requiring two baskets running
simultaneously; the baskets are not independently controlled.
The standard tester configuration comes with two beakers and
two baskets pre-configured for 6-tube (USP Apparatus A) with
plastic disks. 3-tube baskets for Apparatus B are available
separately. The quick-connect basket assemblies snap onto the
basket shaft clips on the ends of the reciprocating arms that
provide the dipping action. The waterbath is easily removed
without tools for periodic cleaning.
A. Introduction
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 A-2
Tester Power Requirements
The internal power supply of the tester automatically switches
to accommodate either 120VAC/60Hz or 240VAC/50Hz. All
testers come with a detachable 120VAC cable with a 3-prong
plug to connect to the power source and a standard female
adapter to connect to the input module on the back of the tester.
Operating the tester on 240VAC requires an appropriate cable
(or adapter) suitable for connecting safely to the power source
and to the back of the tester.
Heater/Circulator
Heating and circulation of bath water is provided by a stand-
alone PolyScience Heater Circulator (H/C) unit featuring a built-
in over-temperature shut-off circuit. The H/C is self-contained
with an easy-to-read LCD display and a touchpad for setting the
temperature.
Heater Power Requirements
Heater/circulator power is dedicated to either 120VAC/60Hz (10
amps) or 240VAC/50Hz (6 amps), depending on which version
was purchased. The H/C has its own power cord configured for
the power supply specified at the time of the order. If the power
source outlet is configured differently than the plug on the H/C
cable as supplied, an appropriate adapter will be required. Note:
the outlet plug for the 240VAC version is IEC Type E.
WARNING! The maximum possible temperature able to be set
for the heater is 98 °C (factory-set limit). However, to avoid
distortion of the waterbath, bath lid, and baskets, and to protect
the tester warranty, the heater should never be allowed to run
higher than 55 °C.
Do not set heater
above 55 °C
A. Introduction
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 A-3
User Interface
The user interface of the Phase One Disintegration Tester
consists of an LCD display and a rotary control knob that allows
the user to select and activate each of the tester’s settings. All
operations are controlled with this knob.
Drip Cups
The low-profile plastic drip cups included with the unit are
designed to be placed under wet baskets for drip containment,
for example when baskets are being removed from the basket
shaft holders. They will also fit on top of the beakers and can be
used to plug the holes in the waterbath lid to reduce
evaporation.
Tester Operation Overview
Once the tester has been unpacked, installed and qualified,
routine operation consists of four steps: tester initialization; test
setup; running the disintegration test; and cleanup. The tester
has the ability to run a timed test or a continuous free run test.
A quick-start overview of the operational procedure is as
follows:
1. Power up tester and heater and initialize the tester.
2. Fill waterbath with DI water to the level indicated on the
label on the front of the bath.
3. Set heater/circulator to desired target temperature. (Do
not exceed 55 °C.)
4. Fill beakers with media to appropriate level.
5. Place tablets in baskets (along with plastic disks if
necessary).
A. Introduction
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 A-4
6. Install baskets on arms by snapping into basket shaft
holder.
7. Highlight the desired test mode—timed or free run.
8. If a timed test, set the time limit.
9. Start the test and monitor at appropriate points.
10. End the test and perform cleanup.
The above steps are described in greater detail in the Operation
section of this user guide.
Recommendations for Using This Manual
Hanson Research recommends the following steps for making
best use of this user guide:
1. Review the Introduction section for an overview of the
instrument.
2. Carefully review and follow all safety instructions.
3. Unpack, inspect, and install the tester according to
instructions in the Installation section.
4. Conduct an initial test of the system using the
procedures outlined in the Operation section.
5. Review the cleaning, maintenance, and troubleshooting
sections to become familiar with keeping the tester in
good working condition.
6. Immediately contact Hanson Technical Support with any
questions on how to properly operate and maintain the
Phase One Disintegration Tester.
B. Regulatory and Safety
Phase One Disintegration Tester User Guide—40-108-001 Rev. A—14 November 2016 B-1
Regulatory Compliance
Hanson Research hereby certifies that this product, including
hardware and firmware, was designed, evaluated, validated,
inspected, and tested to approved specified quality
requirements of Hanson Research Corp. in conformance with
current USP, EP, JP, and other international standards (India &
Korea).
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.
General Safety Considerations
This equipment contains moving parts, which have the
potential to pinch or jam.
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
source such as an electrical wall outlet.
This instrument must be connected to a grounded
electrical outlet.
Never work on the electrical components in the system
while there is power to the unit. DISCONNECT POWER
BEFORE SERVICING THE INSTRUMENT.
Review all safety and environmental precautions pertaining
to any chemicals that are to be used in conjunction with
this equipment.
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