Dosage Delivery System Operation Manual Document: Revision: A Distek, Inc. Operation Manual

Transcription

1 Dosage Delivery System Operation Manual Document: Revision: A Operation Manual

2 Dosage Delivery System Operation Manual Document Distek, Inc. 121 North Center Dr. North Brunswick, NJ Phone Fax inc.com

3 All rights reserved. No parts of this work may be reproduced in any form or by any means - graphic, electronic, or mechanical, including photocopying, recording, taping, or information storage and retrieval systems - without the written permission of Distek, Inc. Products that are referred to in this document may be either trademarks and/or registered trademarks of the respective owners. Distek, Inc. makes no claim to these trademarks. The information contained in the document is subject to change without notice. While every precaution has been taken in the preparation of this document, Distek, Inc. assumes no responsibility for errors or omissions, or for damages resulting from the use of information contained in this document or from the use of programs and source code that may accompany it. In no event shall Distek, Inc. be liable for any loss of profit or any other commercial damage caused or alleged to have been caused directly or indirectly by this document. Warranty The material in this document is provided "as is", and is subject to changes without notice in future revisions. Distek, Inc. disclaims all warranties, either express or implied, with regard to this manual and any information contained herein, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Distek, Inc. shall not be liable for errors or for incidental or consequential damages in connection with the furnishing, use, or performance of this document or of any information contained herein. Distek, Inc. 121 North Center Dr. North Brunswick, NJ Phone Fax inc.com

4 Contents 4 Table of Contents Chapter 1 Introduction Specifications... & Requirements 1.2 Document... Revision History 8 Chapter 2 Installation & Operation Installation... - Evolution Operation... - Evolution Operation... - Evolution 4300 Controlling an Evolution Index 18

5 Chapter Introduction 1

6 Introduction 6 1 Introduction The Dosage Delivery System is installed into the vessel cover and allows for automatic introduction of the dosage form (tablet, capsule, sinker, etc.) into the vessel. Simultaneous sample delivery into non-stirring paddle (stand-alone Evolution 6100/6300, 2100C and non-distek dissolution baths). Automated options using the instrument programmed methods (Evolution series only). Option to manually introduce the sample by simply pushing the drop dosage push button switch. Modularity allows the customer to specify the number of positions (1 to 8) desired, allowing the flexibility for users to scale up the dissolution unit to meet their needs. Flexible enough to work with non-distek dissolution instruments.

7 Introduction Specification Dosage Delivery System 1 to 8 positions Modes o Automated Programmed Method (Evolution series only) o Manual Interface Ports 1 RS-232 Dimensions (each module) Height: 1.6 inch (4 cm) Width: 2.0 inches (5 cm) Depth: 2.4 inches (6 cm) Weight 2.8 ounces (9 grams) per module/position (not including wiring) Electrical Power AC Power Adapter Volts/2.5A /50-60 Hz Requirements Firmware Evolution 6100/6300 Rev. 2.1 and higher Standard DB-9 Male to Female Serial Cable RS232 DB9 pin assignment

8 Introduction 8 Document Revision History Revision Date A 21 Jun 2011 Comments Initial release Manual Part Number

9 Chapter Installation & Operation 2

10 Installation & Operation 10 2 Installation and Operation Installation and Operation contains information on how to properly install and operate the Dosage Delivery Modules on a Evolution 6300 dissolution system.

11 Installation & Operation 11 Installation - Evolution 6300 The dosage delivery system is primarily used to introduce the sample when using paddles with preprogrammed methods. Installation: 1 Locate the dosage delivery control box and peel off the paper backing of the Velcro strip. Install the dosage delivery control box on the left hand side column of the dissolution bath as shown below. Dosage Delivery System Control Box 2 Connect the DC power source from the adapter, the serial cable and the dosage delivery connector on the control box. Control box hookup

12 Installation & Operation 12 3 Install the vessel covers intended for the dosage delivery modules. Position the vessel covers so that the hinge on the cover sits behind the shafts and the cover sits squarely on the vessels. 4 Loosen the two front feet that holds the water bath in place. Push down the water bath slightly to partially separate it from the vessel plate. Bath front support feet location 5 Install the two bath wiring bracket clips by sliding them on the lip of the water bath as shown. Locate the bath clips approximately in between the front four vessel positions (between vessels 2 and 3, 4 and 5). Tighten the water bath support feet so that the bath creates a tight seal against the vessel plate. DO NOT OVER TIGHTEN THE BATH. Bracket clip for wiring harness 6 Install the dosage delivery module onto the vessel covers by lining up the module's bottom tabs with the tabs on the vessel covers.

13 Installation & Operation 13 Module attached to vessel cover Route the cables into the wire clips (3 each) as shown below. The other end of the cable harness can go underneath the dissolution bath towards the location of the control box. Cable harness routing Make sure that the module cables have enough slack for the end-user to install or remove the dosage delivery modules. Manage the cable of the tablet dropper so that it does not touch the stirring shafts. 8 Connect the plugs of the modules to the dosage delivery connector. 9 Connect the serial cable to the Evolution 6300 RS-232 serial port. 10 Connect the power supply to the appropriate AC outlet.

14 Installation & Operation 14 Operation - Evolution Evolution Series firmware Revision 2.1 or higher must be installed for the Dosage Delivery System to work with the instrument. Configure the Evolution From the main display screen, select SYSTEM CONFIG then SYSTEM SETUP. In the system setup screen, change the setting on the Tablet Dropper to ON (use + or - key to toggle the setting). Exit the SYSTEM SETUP by selecting HOME. System Setup Setting 2 Create a Method. (Refer to the Evolution Operation Manual for more information.) 3 Select and Run a method. The instrument will start pre-heating the dissolution media. The display prompts the user that the Tablet Dropper is enabled. The user needs to select when to introduce the samples. The following modes are available: TEMP Samples are introduced after the set temperature and RPM are achieved. Display Message, TEMP Selected (default) TIME Samples are introduced at a specified time set by the user. Display Message, Time Selected When TIME is selected, the user needs to set the time to introduce the sample into the vessel. If the set temperature and RPM are not reached before the set drop time, the instrument will wait until the settings are reached. This is true also if TEMP is selected. Display Message, Specify Time 4 Once the preheating is complete, depending on the mode chosen to introduce the samples, the

15 Installation & Operation 15 samples are dropped into the vessel and the test timer starts.

16 Installation & Operation 16 Operation - Evolution 4300 Controlling an Evolution Evolution Series firmware Revision 2.1 or higher must be installed for the Dosage Delivery System to work with the instrument. Configure the Evolution From the main display screen, select SYSTEM CONFIG then SYSTEM SETUP. In the system setup screen, change the setting on the Tablet Dropper to ON (use + or - key to toggle the setting). Exit the SYSTEM SETUP by selecting HOME. System Setup Setting 2 On the Evolution 4300 verify that bath communication has been configured and bath parameters are correctly set. See the Evolution 4300 Operation Manual for further information on configuring communication. 3 On the Evolution 4300 select START BATH from the Main screen. 4 The Evolution 4300 will display the message "PLEASE WAIT FOR BATH TEMPERATURE" on the Main screen. 5 The dissolution instrument will start pre-heating the dissolution media. On the dissolution instrument, the display prompts the user that the Tablet Dropper is enabled. The user needs to select when to introduce the samples. The following modes are available: TEMP Samples are introduced after the set temperature and RPM are achieved. Display Message, TEMP Selected (default) TIME Samples are introduced at a specified time set by the user. Display Message, Time Selected When TIME is selected, the user needs to set the time to introduce the sample into the vessel. If the set temperature and RPM are not reached before the set drop time, the instrument will wait until the settings are reached. This is true also if TEMP is selected.

17 Installation & Operation 1 Display Message, Specify Time 6 When the bath temperature has been reached the Evolution 4300 will display the message: BATH_NAME VESSEL TEMP HAS BEEN REACHED. PLEASE FOLLOW INSTRUCTIONS ON THE 6100/6300 Once the preheating is complete, depending on the mode chosen to introduce the samples, the samples are automatically dropped into the vessels, the instruments and the test timer starts.

18 Index 18 Index -DDimensions -EElectrical Power Evolution Evolution 6300 Installation Evolution 6300 Operation 11 14, 16 -FFirmware -IIntroduction 6 -RRevision History 8 -SSerial Cable Specification -WWarranty 8 Weight