Hanson. The Hanson Data-Pakrm Complete Dissolution Data-Handling Software. Dissolution Data Handling. Packaging Processing Bid on Equipment

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1 Hanson Hanson Research Corporation 9810 Variel Avenue Chatsworth, CA USA Toll-free Inside Calif FAX August 1992 The Hanson Data-Pakrm Complete Dissolution Data-Handling Software Dissolution Data Handling The requirement for computer-generated "dissolution data handling" has grown exponentially as dissolution testing of pharmaceutical formulations has been applied to QC/QA of manufactured product, as well as research of new pharmaceutical formulations. Several commercial software products are now available to the pharmaceutical scientist, and they all suffer the same shortcoming: rigidity. That is, although they may (at best) offer a good statistical package and "sexy" graphics, they are typically static products that do not allow the scientist the ability to customize statistical parameters, formatting or presentation. As well, the expense of in-house software development is often cost-prohibitive. Hanson Research has addressed this shortcoming by adapting the use of worldfamous Lotus for the application of dissolution test data handling. The strength of Lotus is its ability to offer the pharmaceutical scientist complete versatility in configuring dissolution test reports, including statistical data handling and test report documentation that any given dissolution protocol may require. With over ten million users, Lotus is the number one spreadsheet program in the world, and its worksheet, database, and graphics capabilities provide an ideal environment to achieve state-of-the-art statistics and report validation. Hanson Data-Pak Dissolution Software, using the Hanson Dissoette H autosampling system, provides a complete UV dissolution test report with (a) detailed title page, (b) data page with raw ABS sample readings and sample group statistics, and (c) time-release profile graphics. The Data-Pak includes Lotus file management, password protection, and "starter kit" for set-up of all instrument communications. Packaging Processing

2 Data-Pak Dissolution Software...Easy to Use as "1-2-3" -2 Hanson Data-Pak dissolution software is designed for ease of use and maximum performance in statistics, graphics, and validation. Working within the Lotus environment, all the power of is in your hands. Dissolution test reports are easily customized by the pharmaceutical scientist for data collection, data reduction, and data presentation. The Data-Pak includes complete Lotus file management capability, password protection programmed by the lab manager, and a convenient "starter kit" for set-up of all instrument communications parameters. Data-Pak test report validation provides: (a) detailed title page with product/test header information (b) raw sample ABS readings (6 or 12 flasks) for each sampling interval c) in-house standard reading with each sample group d) sample group statistics (mean, high, low, standard deviation and RSD) e) bath RPM and temperature report (f) graphics report of time release profile (g) easy file save and data base validation (h) FDA recommended password protection All report parameters and statistics are easily customized using Lotus, and up to 24 sampling time intervals may be documented. By using a PC computer with suitable printer, a hard copy test report is produced for final test validation. Complete Automated Dissolution Test System (L to R) SRI2 Dissolution Test Station with ValiData Controls, Dissoette II Autosampler with UV Auto-Detect, UV spectrophotometer, & IBM PC compatible computer with printer. The Data-Pak provides complete instrument interface. Hanson Research provides a complete dissolution package. The Hanson Dissoette II autosampler is the centerpiece of the system, providing automatic sampling, collection, auto-sip to UV flow cell, and complete RS-232 interface to UV spectrophotometer and IBM PC compatible computer. The ValiData, standard with all Hanson SRII dissolution baths, provides test report validation of operating RPM and temperature. Choose from a wide variety of popular UV spectrophotometers (Beckman, Milton Roy, Shimadzu, CamSpec, etc.), and use your in-house IBM PC compatible computer (or network to mainframe.) Hanson Data-Pak dissolution software puts it all together with complete interface and documented validation of each dissolution test run.

3 3 Specifications Software requirements: The Hanson Data-Pak is MS-DOS based, 100% IBM PC compatible software. The Data-Pak requires Lotus version 2.3 or higher, plus Measure Software version 2.2, both available from Hanson Research (see ordering information below.) A working knowledge of Lotus is highly recommended. Dissolution Hardware requirements: The Hanson Dissoette II with P/N 27-D UV Auto-Detect is required for full autosampling interface. The Hanson SRII with ValiData is required for additional report of test station RPM and bath temperature. The Data-Pak works with either one or two dissolution test stations (either 6 or 12 sample flasks.) Spectrophotometer requirements: The Data-Pak version 3.1 (Aug/92) includes complete communications set-up for: (a) Beckman DU Series 60 & DU Series 600 (b) Milton Roy Spectronic 601 (c) Shimadzu UV160U (d) CamSpec M330 Quality UV flow cell with input/output fittings required (available from Hanson.) Other spectrophotometers with RS-232 interface may* be used, but communications and software installation for other models and manufacturers must be provided by own "in-house" personnel. (* Please consult HRC for details.) Computer requirements: (Same specifications as required by Lotus 1-2-3) IBM PC or 100% compatible computer; hard disk drive; minimum 512K of RAM operating under DOS 2.0 or above; two standard communications ports; VGA monitor; suitable dot matrix or laser printer. Specifications may change without prior notice. Data-Pak up-grades available to all users at nominal charge. Trademarks herein: Data-Pak, SRII, ValiData, Dissoette II 'TM Hanson Research Corp. / Lotus TM Lotus Development Corp. / Measure TM National Instruments Corp. / IBM PC TM International Business Machines Inc. Ordering Information P/N 81-DP P/N 81-DP-NET P/N P/N P/N P/N Data-Pak Dissolution Software Package Complete Data-Pak Extra Copy for Network Installation Measure Software version 2.2 for 3 1/2" Diskettes Measure Software version 2.2 for 5 1/4" Diskettes Lotus version 2.4 for 3 1/2" Diskettes Lotus version 2.4 for 5 1/4" Diskettes Please see following pages for sample of Data-Pak printouts.

4 DATE: TEST #: 06/16/92 PRODUCT: Generic (10 Mg.) 1 LOT NO.: 1A ANALYST: Bill Meneses BADGE: A101 PROCEDURE: Dissolution MEDIA: 900 ml, deaerated water METHOD: Apparatus 2 SPEED: 50 (+/ 1 RPM) TEMP: 37 (+/ 0.5 DEGREES C) DOSE (Mg): 50.0 WLENGTH: 242 WEIGHT: 10 mg HARDNESSn/a PURITY: n/a FLOWCELL:Std 10 mm (1:1) PROTOCOL: #1 INTERVALS: & 6 Hrs SAMPLE VOL: 5 MI MED REPLACE: YES SYSTEMS: STD.ABS: STD.0 (%): Hanson Research Dissoette II/SR6, Data Pak 3.1 FILE PATH: COMMENTS: C:\LOTUS123\DATAPAK.WK1 Approved by: Dissolution Test Report Page 4 Printed 16 Jun-92

5 HANSON RESEARCH DATA-PAK VERSION 3.1 Product: Generic (10 mg) Operator: Bill Meneses Test No.1 Date: 06/16/92 RAW ABSORBANCE DATA INTERVAL TIME 0:00 1:00 2:00 3:00 4:00 5:00 6 STD(ABS): Flask 1: Flask 2: Flask 3: Flask 4: Flask 5: Flask 6: Maximum: Minimum: Mean: StDev: RSD: Speed: Temp: RPM 50.0 RPM 50.1 RPM 50.0 RPM 50.0 RPM 50.0 RPM 37.0 C 37.0 C 37.0 C 37.0 C 37.0 C 37.0 C PERCENT DISSOLVED CALCULATIONS INTERVAL TIME STD(ABS): Flask 1: Flask 2: Flask 3: Flask 4: Flask 5: Flask 6: Maximum: Minimum: Mean: StDev: RSD: :00 2:00 2:00 3:00 4:00 5: Dissolution Test Report Page 5 Printed 16-Jun-92

6 HANSON RESEARCH DATA PAK VERSION 3.1 Product: Generic (10 mg) Test No.1 Date: 06/16/ Maximum Minimum 0.1 0:00 1:00 2:00 3:00 4:00 5:00 Dissolution Test Report ELAPSED TIME (hrs) Page 6 Printed 16 Jun-92