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Dissolution Copley

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Pharmaceutical Testing

Dissolution: DISi Series


Expertly engineered systems for everyday dissolution testing
Meeting the latest specifications as laid down in the European, United
States and associated Pharmacopoeias, the DISi Series from Copley is a
range of reliable and cost-efficient dissolution tester systems designed
with the highest standards of solid dosage testing performance in mind.
Ideal for use in both R&D and QC environments, the DISi Series is equipped with precision
ground shafts that will accept any of the baskets, paddles or rotating cylinders described
in the Ph. Eur., USP and associated Pharmacopoeias.
Designed to minimise user training and reduce the burden of routine equipment
maintenance, the DISi Series simplifies the dissolution testing process, without
compromising on data quality.

Ph. Eur. and USP Integrated, precision


compliant temperature control
and measurement

Intuitive touchscreen
Single-point electronic
control to simplify
temperature calibration
operation

Six and eight test station unit Extensive data


configurations available output options

Wide speed range to Option to automate


accommodate broad and remotely control
scope of methods DISi Systems

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Dissolution

DISi Series: Key Features


Easy-clean Viton® Intuitive touchscreen control Robust metal case with
membrane-sealed with icon-based menu advanced corrosion
zero-evaporation lids structure simplifies operation protective coating
included as standard

PT100 temperature probe


monitors bath and vessel
temperature with electronic
calibration feature

Independent digital
heater/circulator maintains
a constant temperature and
minimises vibration

Note:
Easily removable leak-proof All vessels are Maximum fill Full automation-compatible
water bath with convenient serial-numbered line indicator
to support high-throughput
drain tap eases bath as standard
water emptying workflows

Convenient screw-in ‘Easy-Centre’ centring


basket/paddles enable system for precise
easy method change vessel positioning
in seconds

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Pharmaceutical Testing

DISi Series: Touchscreen User Interface

A C
B

D E F

G H

Key Features:
• Intuitive menu structure enables users to locate • Resistive touchscreen interface can be operated
features quickly and easily with gloves on
• Easy-set user-configurable test parameters: • Hygienic wipe-clean screen
Speed (revolutions per minute)
• Passcode-protected temperature calibration
Temperature (°C)
Test duration (HH:MM:SS) • High productivity - easy system set-up and
operation minimises training burden
• Status of ‘Actual’ v ‘Set’ test parameters clearly
displayed throughout testing
• Test progress bar provides clear and constant
indication of run status

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Dissolution

Reporting

Extensive data output options are available as standard,


including direct reporting to a printer or PC.

Reported parameters
• Speed (revolutions per minute)
A Setting a test parameter Set
Average RS 232
Maximum
Set v Actual test parameters Minimum
B
(before test run)
• Temperature (°C)
USB A
Set
Set v Actual test parameters (during
C Average
test run, with test progress bar)
Maximum
Minimum
USB B
D Settings menu
• Test Duration (HH:MM:SS)
Set
Actual
Passcode-protected temperature
E
calibration process • Calibration Data
Calibration date
Temperature calibrated at (°C)
F Temperature calibration

Compliance & Maintenance


G Report output settings menu

DISI Serie
tification s Certific
DISI SeriesPh.Cer Of Complia ation
H Motor speed (RPM) verification Eur./USP nce to Ph.
Of Compliance
to Eur./USP

✓ Certificate of compliance to Ph. Eur./USP


provided as standard

✓ Comprehensive IQ/OQ/PQ documentation


packages and toolkits available

✓ Passcode-protected single-point electronic


temperature calibration

✓ Latest temperature calibration information


stored and available to export/print

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Pharmaceutical Testing

Choose your DISi Dissolution System

DIS 600i DIS 800i


With bench space a premium in many laboratories, the Maximising visibility and access to the critical sampling
DIS 600i is one of the most compact dissolution testers area above the bath, the DIS 800i represents the very
available on the market today. latest in tablet dissolution testing technology.

Cat. Number Cat. Number


1336 1338

No. Stirred Vessels No. Stirred Vessels


6 8

Ph. Eur. and USP Test Methods Supported Ph. Eur. and USP Test Methods Supported
1, 2, 5, 6 1, 2, 5, 6

Heater Heater
Low vibration integrated digital heater/circulator Low vibration independent external digital
heater/circulator

Unit Dimensions (w x d x h) Unit Dimensions (w x d x h)


728 x 495 x 689 mm 728 x 495 x 689 mm (unit)
260 x 330 x 150 mm (heater)

30
Dissolution

DISi Series: Technical Specifications


Pharmacopoeial Compliance Ph. Eur. Chapters: 2.9.3, 2.9.4
USP Chapters: <711> <724>

User Interface Resistive touchscreen

Speed Range 20 - 220 rpm +/- 2%

Heater Accuracy ± 0.1°C

Heater Temperature Range Ambient - 50 °C

Vibration Elimination Low vibration heaters

Test Run Time Up to 99 hours, 59 minutes, 59 seconds

Alarm(s) 1. End of testing (audible) 2. Low bath water level warning on-screen indicator

Data Output RS 232


USB A (for connection with a USB printer)
USB B (for connection with a PC)

Temperature Calibration
Single-point electronic temperature calibration. designed to guide users through the process
Calibration of the DISi Series temperature probe is without fuss. The latest temperature probe
simple, through the use of an electronic calibration calibration information is stored and available
key and passcode-protected calibration menu to print/export when convenient to the user.

Electronic Temperature
DISi Series Calibration Key

Cat. No. Description


1336 Dissolution Tester DIS 600i (incl. 6 Drive Shafts)
1338 Dissolution Tester DIS 800i (incl. 8 Drive Shafts)
1209 Electronic Temperature Calibration Key
1309 IQ/OQ/PQ Documentation Pack
1307 Printer (including USB cable)

31
Pharmaceutical Testing

Choose your
DISi System Accessories
All DISi Series are equipped with precision-ground shafts
that will accept any of the baskets, paddles or rotating
cylinders described in the Pharmacopoeias. Each clutch
can be raised, lowered or engaged independently of the
drive head, ensuring users have maximum accessibility to
the vessels, whilst also making the systems suitable for
staggered starts.
Each element can be supplied with a Teflon coating for
additional protection against aggressive media,
if required and can be laser numbered
and certified upon request.

Baskets, Paddles & Rotating Cylinders


Basket Stirring Elements (Ph. Eur. /USP Method 1)
Cat. No. Description
1302B Set of 6 Baskets (Ph.Eur./USP Method 1)
1302A Set of 8 Baskets (Ph.Eur./USP Method 1)
1302 Basket only in 316 Stainless Steel (40 mesh)
1317 Basket Holder in 316 Stainless Steel
1331 3-Prong Retention Spring in Hardened 17-7 Steel
1333 Basket Stirring Element complete with Drive Shaft

Paddle Stirring Elements (Ph. Eur. /USP Method 2)


Cat. No. Description
1304B Set of 6 Paddles (Ph.Eur./USP Method 2)
1304A Set of 8 Paddles (Ph.Eur./USP Method 2)
1304 Paddle only in 316 Stainless Steel
1341 Paddle Stirring Element complete with Drive Shaft
1343 Paddle Stirring Element complete – Teflon Coated

Dissolution Drive Shaft


Cat. No. Description
1329 316 Stainless Steel Drive Shaft only

Capsule Sinkers & Weights

Cat. No. Description


1356 Set of 6 316 Stainless Steel Sinkers
1356A Set of 8 316 Stainless Steel Sinkers
1345 Set of 6 USP/Ph.Eur. Alternative Sinkers
1345A Set of 8 USP/Ph.Eur. Alternative Sinkers
1348 Wire, 316 Stainless Steel (50 ft length)
1357 Set of 6 3-Prong Plastic Sinkers

32 Disintegration
02
Dissolution

Vessels
Compliant with Ph. Eur. and USP specifications, all DISi Series
vessels feature unique Easy-Centre systems ensuring perfect
positioning every time. Locking the vessel into the correct
position relative to the drive shaft, the fixture ensures that
the vessels will not become loose or float, even when empty.
UV-resistant vessels are also available for products sensitive
to UV.

Easy-clean Viton® membrane-sealed low evaporation lids


are included as standard with each vessel.

Vessels
Cat. No. Description
1344 Vessel, 1000 mL
1346 Vessel, 1000 mL, with “Easy-Centre”
1352 Amber Vessel, 1000 mL
1349 Amber Vessel, 1000 mL, with “Easy-Centre”
1366 “Easy-Centre” Vessel Ring

EMC Ultra-Precision Dissolution Vessels


With dimensional tolerances a factor of 2 higher than those specified in the FDA Enhanced Mechanical
Calibration, the EMC Ultra-Precision Dissolution Vessel brings even higher levels of accuracy to
dissolution testing.
All relevant parts are individually serialised as standard.
4
1. Inside Diameter 101.19 +/- 0.13 mm 5
1
2. Inside Spherical Radius 50.59 +/- 0.13 mm Radius

3. Height 154.75 +/- 0.50 mm


6
(Inside Spherical Radius to top)

4. Flange OD 120.00 +/- 0.50 mm


3
5. Flange Thickness 3.50 +/- 0.50 mm

6. Perpendicularity 0.50° Max 2


(Inside Vessel Dia.
to Flange Underside)

Cat. No. Description


1398 EMC Dissolution Vessel, 1000 mL, with “Easy-Centre”

Vessel Covers
Cat. No. Description
1354 Vessel Cover for DIS 600i/800i
1393 Automatic Tablet Drop Vessel Cover (Set of 6 for DIS 600i)
1394 Automatic Tablet Drop Vessel Cover (Set of 8 for DIS 800i)
Vessel Cover for DIS 600i/800i Automatic Tablet Drop Vessel Cover 1355 Plug for Vessel Cover
for DIS 600i/800i

Dissolution 33
03
Pharmaceutical Testing

Automatic Tablet Drop


Eliminate the need for time-lag correction factor
calculations with the Automatic Tablet Drop system.
Guaranteeing simultaneous tablet ejection at the start
of the test run, synchronised sampling is simplified.

Automatic Tablet Drop


Cat. No. Description
1393 Automatic Tablet Drop Vessel Cover (set of 6 for DIS 600i)
1394 Automatic Tablet Drop Vessel Cover (Set of 8 for DIS 800i)

Sampling Probes
Choose from a range of dissolution sampling probe systems,
optimised for different user requirements:

1. Manual sampling cannula: with a Luer fitting to accept a 20


mL syringe, bent at the top to enable easy positioning within the
dissolution vessel.
2. Resident probe: designed to be left in-situ in the dissolution
vessel for the duration of the test and is height adjustable,
in accordance with differing methods described in the
pharmacopoeias. 3 different types are available: a. b. c.

a. For automated systems: fitted with Omnifit fittings


used in conjunction with the return line inserts
b. For automated systems: fitted with Omnifit fittings
c. For manual sampling (with Luer fittings)

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