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System U (Universal) Dissoette II Autosampler

Automated Dissolution System

Hanson Research

Rev. 11/92

Packaging — Processing

Bid on Equipment 1-847-683-7720

www.bid-on-equipment.com

System U (Universal) Versatility

The modern dissolution lab typically handles numerous dissolution protocols, often requiring different setup parameters and analytical technique. Quality control labs require high volume workload with trouble-free operation; R&D labs require versatile systems with easy change-over programming. The Hanson Research "System U", featuring the new "Dissoette II" autosampler, is engineered to meet these demands, providing high performance and complete versatility in one cost-effective package.

Typical automated UV dissolution system using Hanson "SR" high performance bath, Dissoette II autosampler, and UV spectrophotometer interfaced to PC computer for data handling.

Hanson Research "System U" Capabilities:

• Complete versatility; one system handles both UV and HPLC n Microprocessor control with non-volatile memory n Easy keypad program entry with user prompts n Automatic, unattended sampling from 6 or 12 flasks n Hanson Auto-Probes for USP sampling position nAutomatic media replace n Built-in collection station for UV and/or HPLC n Puncture septums in HPLC collection vials ° n Automatic interface with most modern spectrophotometers • UV Auto-detect program includes standard and wash n Complete RS-232 interface for in-house computer n Use popular Lotus 1-2-3 for dissolution data handling n Direct inject to Waters 712D WISP for automatic HPLC nA truly "universal" dissolution sampling system!

Packaging - Processing



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System U (Universal) Concept & Design

Hanson Research introduced the first 6-flask dissolution test station in 1969, and the first complete autosampling system in 1975. Our equipment is in use in pharmaceutical, university and government laboratories worldwide. We are not just equipment manufacturers, we are dissolution test specialists.

Hanson dissolution systems for the 1990's are based on over twenty years of worldwide dissolution test expertise. From extensive contact with industry, academia and government regulatory agencies, we know the problems that dissolution labs face. "System U" is designed to offer the ultimate in performance, versatility and trouble-free operation.

The diagram above illustrates the exclusive vacuum-pressure flow system engineered into the Hanson Research System U. We use no peristaltic pumps (with their inherent drift in flow rates and bubble problems.) System U incorporates state-of-the-art design in vacuum-pressure fluid flow, pneumatics, interface to baths and detector, and microprocessor control with user-friendly prompts. •

— PacKaging - Processing



3—way Sample valve V

3—way valve

—V

Media Replace

Sample Measure

Tubes GS (6)

Media Replace Measure Tubes (6)

27—R Media Replace Source

Bath 1 6 Flasks

with Auto—Probes

)

Bath 2 6 FLasks

with Auto—Probes

27—W Direct — Inject HPLC

injection block

Auto —Collect

"System U" Dissoette II Autosampler

Flow Schematic V ---+— Vacuum

P Pressure

to Waters 7121 WISP

27— D "Robo—Sip" UV Auto—Detect

Evaporation Control Caps available

Samples in Collection Carousel

UV Test Tubes or HPLC Vials

UV F ow Ce l in Spectrophotometer

Standard (plus Wash)

P

NL

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System U (Universal) Block Diagram

The Hanson "System U" offers easy change-over to several analytical methods. The block diagram below illustrates the wide choice of options. From automatic sampling of 6 or 12 flasks, to collection for either UV or HPLC sample analysis, to fully automated detection with computer data handling, the System U is a workhorse easily adapted to any dissolution requirement.

SR6 AUTO— AUTO— SR6 6—FLASK PROBE PROBE 6—FLASK BATH BATH

BASIC 27-6A

27-12A

DISSOETTE 6 SAMPLES 12 SAMPLES

DISSOETTE II 27—R MEDIA REPLACE

27—T ALL

TEFLON

— COLLECTION OPTIONS —

96 144 144 96 48 27—W TEST TEST HPLC WISP WISP DIRECT TUBES TUBES VIALS HPLC HPLC INJECT 12 ML 7 ML 1 ML VIALS VIALS 712D

•

27—D AUTO—

DETECT

— METHOD OF UV OR UV ANY WATERS OTHER SPECTRO HPLC HPLC DETECTION TESTS SYSTEM SYSTEM AND DATA

HANDLING

VALIDATA PRINTER

IBM PC W/LOTUS

HANSON RESEARCH "SYSTEM U" SOLID LINE AUTOMATED DOTTED LINE MANUAL




Media Replace - Measure Tubes

Sample Measure Tubes _• for 6 or 12 samples

All-Teflon Flow - system available

Direct-Inject to Waters 712D HPLC

Volume adjustable 500p,1 to 12m1 —)

Exclusive "Robo-Sip" Automatic UV Detection —

with standard & wash

Rugged vacuum-pressure Pump system included

(not shown)

Built-in Collection Station with Carousels

- for both UV & HPLC (96 WISP shown)

Automatic Sampling Probes to Baths (not shown)

Microprocessor Control with program memory

Easy Keypad operation with User Prompts

Complete RS-232 Computer interface

The New Dissoette II

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The new "Dissoette II" autosampler is the centerpiece of the Hanson Research System U. The Dissoette II incorporates state-of-the-art design in microprocessor control and fluid handling capability. Whether you are in quality control or research & development, the Dissoette II can be configured to handle all of your dissolution test requirements.

The following pages detail the many options available with the Dissoette II "System U" dissolution test system.

— Packaging - Processing



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Dissoette II Basic Model Options The Dissoette II may be ordered for either 6 or 12-flask sampling capability. Both models are complete systems including microprocessor control, sampling station with built-in collector, and vacuum-pressure air system. nModel 27-6A 6-flask autosampler nModel 27-12A 12-flask autosampler

Collection Options The Dissoette II includes an array of collection options for automatic, unattended sampling and collection. Each Dissoette includes your choice of carousel for either UV test tubes or HPLC vials. Additional carousels and special Waters WISP carousels are ordered extra. (All carousels are easily retrofitted in the lab.)

Auto-Collect in test tubes for UV and other tests n96-position carousel for 16x125mm test tubes (12m1 max.) n144-position carousel for 13x100mm test tubes (7m1 max.) (use 144 for UV Auto-Detect system P/N 27-D)

Auto-Collect in standard-size HPLC vials ▪144-position carousel for 8x43mm HPLC vials (700/11 max.) n144-position carousel for 12x32mm HPLC vials (1m1 typ.)

Auto-Collect in Waters HPLC "WISP" Carousel n48-position WISP carousel with needle injection n96-position WISP carousel with needle injection

Performance Options The following performance options may also be ordered with your Dissoette II autosampler.

Automatic Media Replace P/N 27-R Provides automatic return of clean media to flasks each time samples are withdrawn. Media is returned through sample lines, "self-cleaning" the tubing and input filters. Media replace volume is adjustable 5004Ito 12ml. Recommended for UV work where numerous large-volume samples are collected.

All-Teflon Flow System P/N 27-T The standard Dissoette II system is 97% Teflon tubing with 3% lab-grade Tygon tubing in roller-valve. The "All-Teflon" system includes precision Teflon valves. Recommended for problem drugs that sorb on plastic tubing.




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Auto-Detect Options for UV

The Dissoette II offers additional capability in interfacing with a spectrophotometer for automatic UV analysis. Order these options for complete automation of your UV dissolution test procedures.

UV Auto-Detect with new "Robo-Sip" P/N 27-D The exclusive Hanson "Bobo-Sip" robotic sampling arm (shown) automatically transfers samples from the Dissoette collection station into a flow cell for UV analysis (and then returns them to collection carousel.) This option also includes a reference standard and wash for each sample group.

UV Spectrophotometer The Dissoette II system is designed for easy interface to most modern spectrophotometers (e.g. Beckman, Milton Roy, Shimadzu, etc.) The Milton Roy Spectronic 601 (shown) may be ordered directly from Hansbn Research.

Print sample readings & bath conditions Connect the Hanson "ValiData" Printer (shown) to your Dissoette II and automatically print raw absorbance readings from your detector. Use Hanson SR6 dissolution baths and also print bath RPM and temperature!

Data-PakTM Software for popular Lotus 1-2-3 The Dissoette II "27-D" (above) includes complete RS-232 computer interface. Connect to your in-house PC computer, and use the Hanson "Data-Pak" with internationally popular Lotus 1-2-3 for complete versatility in statistical analysis and dissolution test report documentation.

Auto-Detect Option for HPLC

Direct Inject to WATERS 712D WISP P/N 27-W Connect your Dissoette II directly to Waters 712D WISP HPLC system (shown) for complete automation of dissolution sampling and HPLC analysis. Easily retrofitted in the lab. (Please consult Waters/Millipore for details on Waters HPLC systems.) Photo courtesy Waters




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Interface to Dissolution Baths

Built-in Auto-Probe with Hanson baths Exclusive built-in "Auto-Probes" on Hanson SR6 baths automatically sample from USP prescribed position and withdraw from media after sampling. Rugged and easy to use. Auto-Probes include 104 input filters. In-line filters (shown) may be added.

Snake and Uni-Probe for other commercial baths The "Snake" and "Uni-Probe" Auto-Probes include six sample probe assemblies which may connect to 3+3, 4+2 or straight-6 bath configurations. (Note: Other dissolution baths offer limitations when connecting autosampling equipment. For optimum performance satisfaction we recommend using Hanson SR6 dissolution baths with built-in Auto-Probes.)

A Note on Dissoette II Programming...

The new "SIP" Control (System Interface Program) offers easy programming control for all sampling, collection and auto-detect options. The SIP Control includes factory-written operating software installed in permanent memory. Simply follow easy menu commands with user-friendly prompts for all keypad inputs. (Or write and save your own test protocols!)

Once an operation program is initiated, the Dissoette II may be left to run unattended, automatically shutting down when the dissolution test is complete.

On program initiation, the Dissoette II will automatically:

n Sample from 6 or 12 dissolution flasks with Auto-Probes; n Precisely measure each sample aliquot; n Volumetrically dispense samples into collection carousel; n If 27-R Media Replace is included, return clean media replacement aliquot to

each flask; n Continue sampling & collection for each time point. n If 27-D UV Auto-Detect is included, collected samples will be transferred to flow

cell for automatic UV analysis (either after each sample group is collected, or under separate program at the end of the test.)

n If 27-W HPLC Auto-Detect is included, measured samples will be transferred directly to working Waters WISP 712D for automatic HPLC analysis.




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Dissoette II Performance Specifications

"Power Requirements: 115V 50/60Hz 10A or 230V 50/60Hz 5A. SIP Control uses standard RS-232 interface. (A clean power source suitable for computers is recommended.)

nSample/Collection Flow System: Standard flow system is 97% Teflon tubing with 3% lab-grade Tygon tubing, plus glass/stainless wetted parts. Auto-Probe sampling probes include 104 sintered polyethylene input filters. P/N 27-T replaces Tygon with 100% Teflon valves. Carry-over is minimal with automatic back-flush of system (standard.) Special "rinse" cycles may also be programmed. Note: If intended samples are viscous or contain surfactants, flow problems may occur. Consult Hanson Research for details.

"Sample Aliquot Size: Volume adjustable 500A Ito 12m1. Volume repeatability is ± 1% for volumes over 2m1.

"Sampling Intervals: Up to 40 maximum. Each sampling "time point" interval is programmable up to 99 hours (each interval must be greater than sampling time duration.)

"Sampling Time Duration: Minimum 21/2 minutes for 6 samples; minimum 5 minutes for 12 samples. UV Auto-Detect time is determined by "read" time, wavelength scanning, etc.

"Samples Per Interval: Model 27-6A; one group of 6 samples with simultaneous collection. Model 27-12A; 12 samples with two groups of 6 samples collected back-to-back.

• Total Samples: 48, 96 or 144, depending on carousel used. (Carousels when full may be manually replaced during test to expand sample collection capability.)

"27-D UV Auto-Detect: Collected samples are sequentially transferred into flow cell (and returned to carousel after reading); each sample group (6 or 12) includes a reference standard & wash; SIP sends "read" contact closure (& RS-232) each time flow cell is full and stabilized.

"Evaporation Control: Available for test tubes and HPLC vials (see ordering information.)

"Pump System: Vacuum-pressure air system with diaphram pump. Settings are pre-set at factory and are adjustable on regulators; nominal 20" vacuum & 30 PSI.



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Dissoette II Ordering Information

Dissoette II Basic Model Options Basic models are complete systems including microprocessor control, sampling/collection station with choice of carousel (below), and vacuum-pressure air system with pump. Auto-Probes (below) are required. Additional options and accessories are available as listed herein. n6-Sample Basic Dissoette II Model 27-6A n12-Sample Basic Dissoette II Model 27-12A

Collection Options Each basic model above includes choice of one carousel for either UV test tubes or HPLC vials: nUV 96-position carousel (for 16x125mm test tubes 12m1 max.) nUV 144-position carousel (for 13x100mm test tubes 7m1 max.)

(UV 144 carousel required for UV Auto-Detect P/N 27-D) nHPLC 144-position carousel (for 8x43mm vials 700A1 max.) nHPLC 144-position carousel (for 12x32mm vials 1m1 typ.)

Additional carousel kits are ordered extra (kits include carousel and injection block): n96-position carousel (for 16x125mm UV tubes) P/N 27-210-002 n144-position carousel (for 13x100mm UV tubes) P/N 27-210-006 n144-position carousel (for 8x43mm HPLC vials) P/N 27-210-005 n144-position carousel (for 12x32mm HPLC vials) P/N 27-210-004

Special Waters WISP HPLC carousel kits are ordered extra (kits include WISP carousel and needle injection block): n48-position WISP carousel kit P/N 27-210-050 n96-position WISP carousel kit P/N 27-210-051

Auto-Probe Interface to Dissolution Baths (required) nBuilt-in Auto-Probe for Hanson SR2 bath P/N 72-300-260 n Snake Auto-Probe for other commercial bath P/N 27-707-105 n Uni-Probe Auto-Probe for other commercial bath P/N 27-700-201

Performance Options nAutomatic Media Replace Accessory P/N 27-R

(Recommended for UV when large-volume samples are collected) m All-Teflon Flow System & Valves P/N 27-T

(Recommended for problem drugs that sorb on plastic tubing)

Auto-Detect Option for HPLC a Direct Inject to Waters 712D WISP P/N 27-W

(Please consult Waters for details on Waters HPLC systems)




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Ordering Information continued

Auto-Detect Option for UV Includes interface cables to UV detector and computer; please consult Hanson for listing of approved UV detectors and specify detector to be used when ordering.

n UV Auto-Detect with Robo-Sip P/N 27-D

UV Spectrophotometer & Flow Cells n Milton Roy Spectronic 601 UV Spectrophotometer P/N 49-515 n 10mm light path UV cell (1:1 standard) P/N 91-450-005 n 5mm light path UV cell (1:2) P/N 91-450-027 n 2mm light path UV cell (1:5) P/N 91-450-026 ▪ mm light path UV cell (1:10) P/N 91-450-004

Printer for UV Sample Readings n ValiData Printer P/N 47-200-720

,'Use with SRS baths and also print bath RPM & temperature)

"Data-Pak" Software for Computer Data Handling Hanson Data-Pak Software requires Dissoette II P/N 27-D (above), plus Lotus 1-2-3 and Measure software (below.)

• Data-Pak Dissolution Software P/N 81-DP n Data-Pak Software Extra "Network" Copy P/N 81-DP-NET • Lotus 1-2-3 for 3 1/2" Disks P/N 81-100-010 n Lotus 1-2-3 for 5 1/4" Disks P/N 81-100-011 n Measure Software for 3 1/2" Disks P/N 81-100-000 n Measure Software for 5 1/4" Disks P/N 81-100-001

Dissoette II Accessories and Spares n Extra sample filters 104 (50/bag) P/N 27-101-074 n Dissoette II spare parts kit P/N 27-000-702 n Electro-mechanical lab tool kit P/N 91-902-020 n 13x100mm test tubes (250/box) P/N 27-800-633 n 16x125mm test tubes (250/box) P/N 27-800-605 n Evaporation caps for 13x100 tubes (150/pk) P/N 27-800-715 n Evaporation caps for 16x125mm tubes (50/pk) P/N 27-800-714 Please consult Hanson for specifications on HPLC vials and evaporation control caps for HPLC vials.

Note (Nov. 1992): The Dissoette ll is also available for 7-flask sampling, on special order only. Please consult Hanson Research for details.

See also Hanson SR6 high performance dissolution test stations and Media-Mate automatic media prep system!




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