00 Automated Disintegration Apparatus Operator’s Manual Agilent Technologies
Notices © Agilent Technologies, Inc. 2014 Warranty No part of this manual may be reproduced in any form or by any means (including electronic storage and retrieval or translation into a foreign language) without prior agreement and written consent from Agilent Technologies, Inc. as governed by United States and international copyright laws. The material contained in this document is provided “as is,” and is subject to being changed, without notice, in future editions.
Contents Figures 1 Safety 7 9 Electrical Hazards 9 Warning 11 Caution 11 Note 11 Information Symbols 2 Introduction 12 13 Conventions Used in this Manual Serial Number Format 3 Setting Up the 100 14 15 17 Unpacking Your 100 18 Environmental Requirements for Installation Setting up the Water Bath 20 Initial Power Up 21 Electrical Connections 21 Installing the Temperature Probe Water Bath Status LEDs 22 23 Setting the Date / Time Clock 24 Mounting Baskets and Filling Beakers Draining the W
Contents Hidden Key Functions 4 Operating the 100 26 27 Setting Water Bath Temperature 28 Setting Print Frequency for the Report Center Printer Adjusting Basket Height 29 Placing Dosage Units in the Baskets Selecting Operating Mode Single-basket Operation Multi-basket Operation Three-Basket Operation 28 30 30 30 31 34 Printer Operation During Manual or Program Operation (Optional) 34 5 Troubleshooting and Maintenance 35 Preventive Maintenance 36 Weekly Maintenance 36 Monthly Maintenance 36 Ev
Contents Troubleshooting 49 Obtaining Warranty and Other Services Index 100 Operator’s Manual 51 53 5
Contents This page was intentionally left blank, except for this message.
Figures Figure 1. Figure 2. Figure 3. Figure 4.
Figures This page was intentionally left blank, except for this message.
100 Automated Disintegration Apparatus Operator’s Manual 1 Safety Electrical Hazards 9 The Agilent 100 has been designed and tested so that when used properly you have an accurate, fast, flexible, and safe instrument. If the equipment is used in a manner not specified by the manufacturer, the protection provided by the equipment may be impaired. The Agilent 100 is operated in conjunction with equipment that uses aqueous liquids.
1 Safety Application of the wrong supply voltage, connection of the instrument to an incorrectly wired supply outlet, or lack of proper electrical grounding can create a fire hazard or a potentially serious shock hazard and could seriously damage the instrument and any attached ancillary equipment. Always use a three-wire outlet with ground connection which is adequately rated for the load. The installation must comply with local, state, and federal safety regulations.
Safety 1 Warning WA RNING A ‘Warning’ message appears in the manual when failure to observe instructions or precautions could result in death or injury. Read all warnings and cautions carefully and observe them at all times. Caution CAUTION A ‘Caution’ message appears in the manual when failure to observe instructions could result in damage to equipment (Agilent supplied and / or other associated equipment). Note NOT E A ‘Note’ appears in the manual to give advice or information.
1 Safety Information Symbols I 0 Switches main power on Switches main power off Indicates single-phase alternating current Indicates the product complies with the requirements of one or more European Union (EU) directives. Indicates specific equipment meets standards of safety. These products are safe for use in the workplace for North America. Indicates that this product must not be disposed of as unsorted municipal waste.
100 Automated Disintegration Apparatus Operator’s Manual 2 Introduction Conventions Used in this Manual Serial Number Format 15 14 Agilent Technologies 13
2 Introduction The 100 is designed to provide versatility and reliability, while meeting all current USP testing requirements. Its three basket positions can be programmed to dip together or independently, allowing up to three different tests to be run at the same time. In addition to the standard six-tube USP-approved basket rack, a variety of optional basket racks are available for large and bolus tablets. The 100 is used for disintegration testing in accordance with current USP requirements.
Introduction 2 Serial Number Format The serial number contains 10 characters and follows this syntax: CC1234xxxx Syntax Code Meaning Description CC Country of origin 2 alpha characters matching the required trade designation for the country of origin 12 Year of manufacture ‘09’ for 2009, ‘10’ for 2010, etc.
2 Introduction This page was intentionally left blank, except for this messsage.
100 Automated Disintegration Apparatus Operator’s Manual 3 Setting Up the 100 Unpacking Your 100 18 Setting up the Water Bath 20 Initial Power Up 21 Installing the Temperature Probe 22 Water Bath Status LEDs 23 Setting the Date / Time Clock 24 Mounting Baskets and Filling Beakers Draining the Water Bath 25 Hidden Key Functions 26 25 Agilent Technologies 17
3 Setting Up the 100 Unpacking Your 100 1 Open each carton and check the contents for damage which may have occurred during shipping. Shipping damage rarely occurs, but if it does contact both the carrier who delivered the instruments and the Dissolution Systems Service Department. Though claims for damage should be filed with the carrier, we can help you file a claim. 2 Carefully remove the 100 from its shipping carton. Hold the unit firmly to prevent it from dropping.
Setting Up the 100 3 Environmental Requirements for Installation • Humidity: max relative humidity 80% for temperatures up to 31 ºC decreasing linearly to 50% relative humidity at 40ºC • Indoor use only • Pollution Degree: 2 • Installation Category: II • Altitude: 2000m • Temperature: 5 ºC to 40 ºC • Power: 115 V/60 Hz, 230 V/50 Hz, 10 A Main supply voltage fluctuations are not to exceed ± 10% of the nominal supply voltage 100 Operator’s Manual 19
3 Setting Up the 100 Setting up the Water Bath 1 Ensure the 100 is not plugged in. 2 Place the water bath on the 100 with the lower quick-connect fitting positioned on the left side of the apparatus. Use the locator holes on the water bath and the locator pins on the 100 to ensure proper placement. 3 Locate the two tubes with quick-connect fittings and insert them into the appropriate quick-connect fittings on the 100 water bath (see Figure 1, “Water Bath Connections,” below).
Setting Up the 100 3 Initial Power Up Electrical Connections WA RNING Before plugging the 100 into any power outlet, ensure the instrument is configured for the voltage provided. Check the serial number tag on the rear panel to confirm the voltage requirement. The electrical connection at the back of the apparatus is the primary disconnect for the instrument. See Figure 2, “100 Rear Panel,” to complete the steps that follow. Figure 2 100 Rear Panel 1 Ensure the power is off.
3 Setting Up the 100 from the system. NOT E Check for leaks. Allow the circulator to run for five minutes, then check the bath, tubing, connectors and the bench area immediately surrounding the apparatus. If any water leaks are seen, turn off the power immediately and remove the power cord. Locate and fix the source of the leak before proceeding. 4 Place the disintegration beaker(s) through the holes in the top cover of the water bath.
Setting Up the 100 3 4 Press INT/EXT to view the temperature readings for each probe. When the external probe reading displays, the Ext Temp Probe LED illuminates. Water Bath Status LEDs water bath status LEDs Figure 3 100 Keypad The Heater On LED flashes to indicate heater activity. When the heater is on continuously, as will occur when the water bath is cold, the LED remains illuminated. As the target temperature is approached, the LED flashes indicating the heater is cycling on and off.
3 Setting Up the 100 The Ext Temp Probe LED illuminates when the external temperature probe reading displays in the temperature screen. Otherwise the internal probe reading displays. NOT E If the external temperature probe is not connected, the temperature display reads 4.4. This is normal and changes as soon as the probe is installed. The Printer On LED illuminates when the Report Center Printer has been enabled.
Setting Up the 100 3 Mounting Baskets and Filling Beakers 1 Ensure the water bath cover is in place on the water bath. 2 Place one, two, or three 1000 mL USP disintegration beakers through the water bath cover holes so they are suspended in the water bath. 3 Hold the beaker(s) down and pour 900 mL of the required disintegration medium in each beaker. When full, the beakers sit securely in the cover and do not float. 4 Place one, two, or three basket racks onto the horizontal basket supports.
3 Setting Up the 100 Hidden Key Functions The following seldom-used operations can be performed by pressing and holding CLEAR and then pressing the number on the keypad and releasing both keys at the same time. Refer to Figure 3, “100 Keypad,” . Table 1 26 Hidden Key Functions Key Sequence Function CLEAR > 0 Use this key sequence to set the communication port identification numbers. Enter the identification number and press ENTER. CLEAR > 2 Use this key sequence to enable or disable alarm function.
100 Automated Disintegration Apparatus Operator’s Manual 4 Operating the 100 Setting Water Bath Temperature 28 Setting Print Frequency for the Report Center Printer 28 Adjusting Basket Height 29 Placing Dosage Units in the Baskets 30 Selecting Operating Mode 30 Printer Operation During Manual or Program Operation (Optional) Agilent Technologies 34 27
4 Operating the 100 Setting Water Bath Temperature To set the water bath temperature, press SET TEMP. Enter the desired water bath temperature and press ENTER. NOT E It may be necessary to set the water bath temperature up to 0.5 °C higher than the desired temperature of the medium in the beakers to compensate for heat loss through the walls of the beakers.
Operating the 100 4 Adjusting Basket Height 1 Lower the basket to the lowest position and measure the distance from the bottom of the beaker to the bottom of the basket. This measurement should be no less than 2.5 cm. 2 If necessary, adjust the basket height by loosening the screw on the basket hanger with an Allen wrench. Extend or retract the two parts and tighten the screw to achieve the proper distance of not less than 2.5 cm from the bottom of the beaker.
4 Operating the 100 Placing Dosage Units in the Baskets Place one dosage unit in each of the six tubes of the basket. USP fluted disks may be added where specified in the individual monograph. Selecting Operating Mode You can select single-basket, multi-basket, or three-basket operation. NOT E The Position 3 screen is the display screen for all programming regardless of which position or parameter you are programming.
Operating the 100 4 The basket stops dipping and lifts from the beaker immediately. NOT E Press STOP to immediately stop all baskets. Multi-basket Operation There are two benefits of multi-basket mode: • You can program any combination of baskets to start and stop at exactly the same time. This feature allows the 100 to function as a conventional two- or three-basket apparatus. • You can program the 100 to drop the baskets at staggered times and to remove them at the same time.
4 Operating the 100 The example on page 31 indicates the previously programmed test length for Position 1 was 30 minutes. • To accept the current test length, press ENTER. • To change it, enter the new value in hhmmss format and press ENTER. • To disable Position 1, enter 000000 for the test length and press ENTER. 2 In the display, the numeral 2 flashes, alternating with the previously programmed delay time for Position 2 in hhmmss format.
Operating the 100 4 The example on page 32 indicates the previously programmed test length for Position 2 was 40 minutes. • To accept the current test length, press ENTER. • To change it, enter the new value in hhmmss and press ENTER. • To disable Position 2, enter 000000 and press ENTER. 4 In the display, the numeral 3 flashes, alternating with the previously programmed delay time for Position 3 in hhmmss format.
4 Operating the 100 6 Press RUN PROG. The programmed sequence displays in the Position 3 screen. If correct, press ENTER. The program begins. To stop any individual basket during multi-basket operation, press STOP # (where # is the basket number you want to stop). To stop all baskets at the same time, press STOP in the lower right corner of the keypad.
100 Automated Disintegration Apparatus Operator’s Manual 5 Troubleshooting and Maintenance Preventive Maintenance 36 Water Bath Temperature Probe Accuracy Test 41 Report Center Impact Printer 43 Troubleshooting 49 Agilent Technologies 35
5 Troubleshooting and Maintenance Preventive Maintenance WA RNING The apparatus contains electrical circuits, devices, and components operating at dangerous voltages. Contact with these circuits, devices, and components can cause death, serious injury, or painful electric shock. Preventive maintenance intervals may vary depending on frequency of instrument usage.
Troubleshooting and Maintenance 5 Every Six Months Maintenance See “Water Bath / Acrylic Care” on page 38 as applicable for additional information on proper maintenance of your equipment. • Ensure media is removed and the system is wiped with a clean, damp cloth. • Lightly spray Lube1/ WD-40™ onto the shafts and run the machine for a few minutes. • Change the bath water and add algaecide. • Inspect the tubing for algae, foreign material, and cracks / damage.
5 Troubleshooting and Maintenance • Do not clean with abrasive cleansers or cloths. Use deionized water whenever possible. If you must use a cleanser or solvent, be sure that it is as mild as possible, non-abrasive, and fully compatible with acrylic before use. If in doubt, call the service department for advice before proceeding. • Do not use window-cleaning sprays, kitchen scouring compounds, or solvents such as acetone, gasoline, benzene, alcohol, carbon tetrachloride, or lacquer thinner.
Troubleshooting and Maintenance 5 stainless steel and should tolerate most clear bath formulations. Check with the product manufacturer to be sure the product is safe for your water bath. • All of our water baths are fabricated entirely of commercial grade acrylic. When using them with corrosive materials such as hydrochloric acid or media containing salts, be sure to rinse them thoroughly with deionized water immediately after each use, and dry thoroughly with a soft towel or cloth.
5 Troubleshooting and Maintenance 7 Reinstall and tighten the bulkhead fitting on the water bath. 8 Reinstall and tighten the elbow fitting to the bulkhead fitting. 9 Fill the water bath and turn on the heater / circulator. 10 Inspect the fitting for leaks. If the fitting still leaks, contact the Dissolution Systems Service Department.
Troubleshooting and Maintenance 5 Water Bath Temperature Probe Accuracy Test The temperature probe can be tested using a high quality voltmeter capable of at least four digit resolution and a known-temperature bath. Both the voltmeter and the bath temperature must be traceable to a known reference standard such as NIST. 1 Place the probe into a known-temperature water bath and allow several minutes for the probe to equilibrate.
5 Troubleshooting and Maintenance Table 2 42 Probe Resistance Values Temp. Centigrade Resistance Ohms Temp. Centigrade Resistance Ohms Temp. Centigrade Resistance Ohms 7.0 5183 36.0 1412 65.0 469.00 8.0 4937 37.0 1355 66.0 452.90 9.0 4703 38.0 1301 67.0 437.40 10.0 4482 39.0 1249 68.0 422.50 11.0 4273 40.0 1200 69.0 408.20 12.0 4074 41.0 1152 70.0 394.50 13.0 3886 42.0 1107 71.0 381.20 14.0 3708 43.0 1064 72.0 368.50 15.0 3539 44.0 1023 73.
Troubleshooting and Maintenance 5 Report Center Impact Printer The following is helpful information for using your impact printer. Installing the Cartridge Ribbon If the printer is used infrequently, the print impression sometimes becomes weak because the ribbon dries out. If the printed material is difficult to read and you suspect this is the cause of the problem, advance to a new section of the ribbon by pressing the printer toggle switch to the Paper feed position.
5 Troubleshooting and Maintenance If you get ribbon ink on the printer’s plastic cover, remove it immediately. Once dried, it is difficult to remove. Replacing the Paper Roll 1 Toggle the printer off line by pressing the printer toggle switch to the OnLine / Off Line position. When the printer is off line, the Ready LED does not illuminate. 2 Grasp the paper roll cover firmly by the grooves on the side and the front edge. Pull outward to remove the cover.
Troubleshooting and Maintenance 5 13 Replace the paper roll cover. If the cover is difficult to remove or replace, the left and right edges can be trimmed or shaved with a utility knife allowing the cover to slide easier. 14 Toggle the printer online by pressing the printer toggle switch to the OnLine / Off Line position. The Ready LED illuminates.
5 Troubleshooting and Maintenance Printer Self Test You can test the print head and ribbon only after inserting paper. Do not attempt to print without paper. Follow these steps to perform a printer self test: 1 Turn off the 100. 2 Press and hold the printer toggle switch in the Paper feed position. 3 Turn on the 100. 4 Hold the printer toggle switch until printing begins. The printer prints a list of the current configuration settings and performs a continuous print test.
Troubleshooting and Maintenance 5 Printer Configuration NOT E The printer configuration is set by the factory. This procedure should be performed only if the printer displays erroneous characters. Contact the Dissolution Systems Service Department for assistance, if necessary. 1 Turn off the 100. 2 Press and hold the printer toggle switch in the OnLine / Off Line position while turning on the instrument.
5 Troubleshooting and Maintenance Table 3 Printer Commands *** SETUP MENU*** CONFIGURE [NEXT/OK] Press NEXT to avoid configuration CUSTOM [NEXT/OK] Press OK to enter custom mode ***CUSTOM MENU*** PRINT CUSTOM SETUP [NEXT/OK] Press NEXT AUTO SEQ = NO [NEXT/OK] Press OK ZERO = Ø [NEXT/OK] Press OK POUND SIGN = # [NEXT/OK] Press OK _(UNDERSCORE) [NEXT/OK] Press OK ONLINE/OFFLINE = YES [NEXT/OK] Press OK EXT CH SET = NO Press OK [NEXT/OK] PRINT READY = YES [NEXT/OK] Press NEXT PRI
Troubleshooting and Maintenance 5 Troubleshooting Table 4 Troubleshooting Symptom Probable Cause Possible Solution The displays do not illuminate. The unit is not connected to an AC power source. Connect the 100 to a power outlet. The fuse is blown. Replace the fuse. Dipping does not start immediately at an individual position. Delay is programmed for the position in question. Reprogram the delay. The optional Report Center Printer does not function. The printer is disabled.
5 Troubleshooting and Maintenance Table 4 Troubleshooting Symptom Probable Cause Operation is noisy. Air is trapped in the tank or lines. Attempt to prime the system by raising and lowering the front and rear of the instrument. The water circulates but does not heat. Possible Solution The pump or motor is faulty. Inspect the electrical connection from the pump / motor to the main PCB for damage or excessive wear. Replace the pump if necessary.
Troubleshooting and Maintenance 5 Obtaining Warranty and Other Services To place a service order (warranty or other services), please contact your local Customer Care Center. Contact information can be found at www.agilent.com under your country using the Contact Us link. Place your service request using the displayed phone number or E-mail address.
5 Troubleshooting and Maintenance This page was intentionally left blank, except for this message.
Index Numerics L Single-basket Operation, 30 3-BASKET OPERATION, 34 Leaking Fittings, repairing, 39 T A M Acrylic care, 38 Monthly Maintenance, 36 Mounting Baskets, 25 Multi-Basket Operation, 31 Temperature Probe, 22 Temperature Probe Accuracy Test, 41 Troubleshooting, 49 B Basket height, adjusting, 29 O C Operating Mode, selecting, 30 Over Temp LED, 23 Cartridge Ribbon, 43 Conventions, 14 D P Filling Beakers, 25 Placing Dosage Units, 30 Preventive Maintenance, 36 PRINT FREQ, 28 Print Fre
Index This page was intentionally left blank, except for this message.
