Instruction Manual Suppository Penetration Tester Type PM 30 ERWEKA GmbH * Ottostr. 20 22 * 63150 Heusenstamm * Germany * Tel: +49 (0) 6104 6903-0 Fax: +49 (0) 6104 6903-40 * E-mail: info@erweka.com * www.erweka.com Directors: Werner G. Müller, Claudia Müller, Manfred Koller * District court Offenbach HRB 2382
Document version PM 30 Version table Date Document version* Change 16.07.2015 1.0 based on PM 3 / 30, document: 61-467-9998 07.03.2016 1.1 new number (old No.: 513-309-0001), layout (CE) * When the document version X.Y is increased, X means a technical change and Y a document change only. Date: 2016-03-07 Document No.: 21845 Document version: 1.1 Language: English Copyright The material in this document is the intellectual property of ERWEKA. Any copy or reproduction of this document or its parts without the written permission of and reference to ERWEKA is prohibited and will be prosecuted according to the law. All trademarks are the property of their respective owners. Copyright 2016 by ERWEKA
Table of Contents 1 INTRODUCTION... 5 1.1 ABOUT THIS INSTRUCTION MANUAL... 5 1.2 SERVICE... 5 1.3 SAFETY INSTRUCTIONS AND SYMBOLS... 6 1.4 PROTECTION OF THE ENVIRONMENT... 6 2 SAFETY... 7 2.1 SAFETY INSTRUCTIONS... 7 2.2 INTENDED USE... 7 3 OVERVIEW... 8 3.1 DESCRIPTION... 8 3.2 OVERVIEW DIAGRAM... 9 3.2.1 PM 30 Apparatus A (EP)... 9 3.2.2 PM 30 Apparatus B (EP)... 9 3.3 TECHNICAL DATA... 10 4 INSTALLATION... 11 4.1 STORAGE AND TRANSPORT CONDITIONS... 11 4.2 UNPACKING AND CHECKING... 11 4.3 INSTALLATION... 11 4.3.1 Positioning... 11 4.3.2 Acclimatization... 11 4.3.3 Required installation environment... 11 4.4 ASSEMBLY... 12 4.5 ZERO POINT ADJUSTMENT... 13 5 TESTS... 14 5.1 PERFORMING TESTS ON APPARATUS A (EP)... 14 5.2 PERFORMING TESTS ON APPARATUS B (EP)... 15 6 MAINTENANCE... 16 6.1 CLEANING... 16 6.2 INSPECTION AND MAINTENANCE... 17 6.3 SPARE PARTS... 18 PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 4 of 18
Introduction 1 Introduction Thank you for purchasing the ERWEKA Suppository Penetration Tester type PM 30! 1.1 About this instruction manual This instruction manual supports you in work with your ERWEKA device. It describes the device, its operation and gives you useful tips on its handling. Furthermore, read descriptions of installation and setting as well as detailed step-by-step work operations in the present manual. Pictures facilitate the understanding of processes described here. The instruction manual is a part of the product. Read it completely and make sure that you understand its content. Keep this manual in a safe place so that it will be available for any questions at a later date. This is important for warranty of permanent and accurate operation of the corresponding device. The editorial team of ERWEKA appreciates your feedback regarding the present manual. Just send an e-mail to quality@erweka.com with your topic and technical documentation as a subject. Your reply contributes to our high quality level. 1.2 Service Contact ERWEKA at service@erweka.com to order the spare parts, in case of technical troubles or possible repairs. Please supply the following information: Type of the instrument (on the type label) Serial number of the instrument (on the type label) A short description of the case PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 5 of 18
Introduction 1.3 Safety instructions and symbols WARNING Warning indicates a possible hazardous situation which, if not avoided, could result in death or serious injury. CAUTION Caution indicates a possible hazardous situation which, if not avoided, could result in moderate or minor injury. Hazard due to electric shock! Notice sign indicates a possible hazardous situation which, if not avoided, can lead to the equipment damage. This symbol provides you with additional useful information. This symbol emphasizes the information to ensure smooth work process. 1.4 Protection of the environment Note that residues of the test products must be properly disposed of in accordance with the applicable environmental regulations. According to the valid EC directives, all the electrical parts (electrical waste) must be disposed of appropriately. PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 6 of 18
Safety 2 Safety 2.1 Safety instructions To guarantee the health and safety, read the following safety instructions before using the instrument. WARNING Wear the personal protective outfit and glasses, if necessary! ERWEKA instruments should be operated by qualified and trained personnel only! WARNING This manual contains additional safety instructions. Disregard of these instructions can lead to property or personal damage. Read the manual thoroughly and follow the instructions of the safety notes! Pay attention to the on-site safety instructions for work in the laboratory and with the laboratory equipment! 2.2 Intended use The ERWEKA Suppository Penetration Tester, Type PM 30, should be used only to determine the softening time of suppositories at the predetermined temperatures in the installation environment defined by ERWEKA. ERWEKA instruments should not be used for processing: products that are easily flammable or explosive products that develop vapours which may create flammable or explosive mixtures in combination with air products that release harmful or poisonous substances The instrument should be operated and maintained only as it is foreseen and due to the instructions presented in this manual. PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 7 of 18
Overview 3 Overview 3.1 Description The ERWEKA Suppository Penetration Tester has been designed to determine the softening time of suppositories at the predetermined temperatures. Judging by the obtained value it is possible to identify at what time suppositories disintegrate, dissolve or melt in the body and thereby release their active ingredients. The instrument consists of a Perspex water bath, a test assembly, an immersion thermostat and a thermometer. Before each test the water bath is filled and preheated to the necessary temperature. The test assembly consists of three test stations of precise shape and dimensions. The test samples are placed into the test stations and secured by means of the sample holders provided for this purpose (in the standard delivery there are holders for suppositories weighing 1, 2 or 3 grams). As soon as the samples are inserted, three stainless steel penetration rods are gently lowered into the test stations until they rest on top of the samples and the test can begin. As the test proceeds, the rods slowly penetrate the samples. The test is finished when full penetration occurs and the rod can be observed at the bottom of the test station. The time required for the rod to press through the sample is the suppository penetration time. PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 8 of 18
Overview 3.2 Overview diagram 3.2.1 PM 30 Apparatus A (EP) Penetration rod, top O-ring Thermostat Support Clamp Penetration rod, bottom Glass tube Thermostat holder Screw Cover Water bath Rubber plate Base plate 3.2.2 PM 30 Apparatus B (EP) Penetration rod Testing tube Plug Clamp Guide tube Locking cap PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 9 of 18
Overview 3.3 Technical data PM 30 Apparatus A (EP) PM 30 Apparatus B (EP) Dimensions Height [mm] 340 Width [mm] 290 Depth [mm] 230 Penetration rod weight 30 g ± 0.4 g 7.5 g ± 0.1 g Thermostat Type E Power 220 VAC / 1600 Watt 110 VAC / 1100 Watt Other Test stations 3 Instrument voltage 230 VAC / 50 Hz 110 VAC / 60 Hz PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 10 of 18
Installation 4 Installation 4.1 Storage and transport conditions The instrument should not be exposed to punches and vibrations. Temperature and humidity should not be lower or higher than the values defined by ERWEKA (see 4.3.3 Required installation environment). 4.2 Unpacking and checking Upon receiving the equipment, please, check that no physical damage has occurred to the packaging, material and the instrument itself during the transportation. If any damage is evident, notify ERWEKA immediately. 4.3 Installation 4.3.1 Positioning Position the instrument on a horizontal, plane, stable surface, e.g. on a laboratory table, and pay attention so that not to displace it during operation. For operation and access, when positioning the instrument, pay attention to the sufficient distance to the walls, cabinets or other fixed components of the facility. Besides sticking to the requirements for installation environment defined by ERWEKA, avoid the following: Heat (heating, insolation) Direct draught through open windows or doors Shaking Dampness 4.3.2 Acclimatization When a cold instrument is taken into the warm environment, this can lead to the condensation. Therefore, acclimatize the switched off instrument during approximately 2 hours at the room temperature. 4.3.3 Required installation environment Ambient temperature in operation: Storage and transport temperature: Relative humidity: +10 C up to +30 C -10 C up to +55 C 25-80% / no condensation PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 11 of 18
Installation 4.4 Assembly To get an overview of the instrument components, refer to the overview diagram in 3.2 Overview diagram. 1. Put the rubber plate onto the base plate. 2. Place the water bath onto the rubber plate. Adjust the water bath at the centre by using the angles on the base plate. 3. Fill the water bath up to the marking. 4. Place the water bath cover on top of the water bath and lock it with screws. 5. Insert the immersion thermostat into the water bath and fasten it with screws at the rear side. Before operating the thermostat, the water bath must be filled with water to the marked filling level. Otherwise the thermostat can be damaged. For more information on operating the thermostat, see the separate instruction manual for the immersion thermostat. 6. Connect the thermostat to a safety socket. HAZARD DUE TO ELECTRIC SHOCK! Electric instruments are to be plugged in to safety sockets only! The voltage of the existing current supply is to be compared to the indications on the type label! Before assembling electrical instruments, switch them off and disconnect from the rear panel! ERWEKA accepts no liability in case of wrong connection! Defective instruments are to be opened by the ERWEKA authorized staff only! 7. Switch on the immersion thermostat. WARNING You may burn yourself! Do not touch the dry heating rods on the thermostat! PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 12 of 18
Installation Make sure that the water bath has reached the necessary operational temperature before you start a test. 4.5 Zero point adjustment To perform the zero point adjustment for your PM30: 1. Insert the glass tube together with the clamp into the water bath. 2. Check the immersion depth of the glass tube. 3. To re-adjust, loosen the clamp at the glass tube and move it accordingly. Graduated ring Support Clamp Water bath cove Glass tube Penetration rod 4. To adjust the zero point of the penetration rod, pull it to the bottom of the glass tube and then pull the graduated ring down onto the support. Do not change the zero point of the penetration rod! PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 13 of 18
Tests 5 Tests 5.1 Performing tests on Apparatus A (EP) To perform a penetration test: 1. Put a test sample into the glass tube. 2. Lower the penetration rod until it rests on top of the sample. 3. Close the glass tube using the support. Penetration rod Test sample 4. The test begins. Note the start time or start the stop watch. 5. As soon as the graduated ring has reached the adjusted zero point, the full penetration has occurred. Note the end time or stop the stop watch. 6. Determine and note the test time as the suppository penetration time. Use a stop watch to determine the test time. When working with the suppository penetration tester pay attention that the remaining test samples should be destroyed in accordance with the latest regulations for protection of the environment. PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 14 of 18
Tests 5.2 Performing tests on Apparatus B (EP) To perform a penetration test: 1. Put a test sample into the guide tube and move it into the testing tube. 2. Close the testing tube with the upper plug and the lower locking cap. 3. Lower the penetration rod spearhead until it rests on top of the test sample. 4. Introduce the whole test unit into the water bath. Penetration Rod Plug Clam 5. The test begins. Note the start time or start the stop watch. 6. The test is finished as soon as the full penetration of the sample has occurred. Note the end time or stop the stop watch. 7. Determine and note the test time as the suppository penetration time. Testing Tube Use a stop watch to determine the test time. Guide Tube Test Sample Locking cap When working with the suppository penetration tester pay attention that the remaining test samples are destroyed in accordance with the latest regulations for protection of the environment. PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 15 of 18
Maintenance 6 Maintenance 6.1 Cleaning Ensure that the instrument is cleaned regularly. Read the instructions thoroughly before starting the cleaning procedure. Hazard of electric shock when cleaning the electric instruments! Disconnect the mains supply for cleaning the electric instruments! Switch the instrument off and unplug it for cleaning! Clean the electric instruments without liquids. Cleaning procedure 1. Disconnect the mains supply! 2. Empty the water bath. Clean the water bath using a special cleansing agent for acrylic glass and then rinse it with warm water. The water bath and the cover are made of high-grade acrylic glass and therefore are sensitive to the aggressive cleansing agents. Do not use organic solvents (e.g. ethanol or methanol) because this causes damage. Use only a special cleansing agent for acrylic glass. Acrylic glass can be scratched during the dry cleaning with the present dust particles. That s why wipe the acrylic glass always with a damp cloth. The best way is to have special microfiber clothes at hand that you can damp with the lukewarm water. 3. Clean the glass tubes with water. The glass tubes can also be washed in a dish washer. 4. To clean the penetration rod and the support, unscrew the penetration rod and remove the support. Clean them with a wet cloth. Do not use an excessively damped cloth for cleaning! This can damage the instrument! PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 16 of 18
Maintenance 6.2 Inspection and maintenance Ensure that the instrument is regularly inspected and each time is clean. To ensure a long lifetime of your units and systems, we recommend regular maintenance performed by our specialised staff. Check regularly: The quality of demineralized water in the water bath. In case of poor quality the demineralized water must be replaced with the fresh demineralized water! The tightness and fixed placement of the tubes The tubes are inserted manually and it is enough to obtain the tight connection. Do not seal with the sealing material or PTFE band! In longer standstills: If the instrument is not used for a long time, follow the instructions below: Switch the instrument off and unplug it. Empty and clean all containers and tubes. Clean the instrument thoroughly. Store the instrument with its manual under conditions defined for the installation environment. Non-performance of the instructions given above can lead to damages! PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 17 of 18
Maintenance 6.3 Spare parts Electronic and mechanical replacements are to be made by the ERWEKA personnel or approved by ERWEKA! Only the original components and spare parts authorized by ERWEKA are to be used. No repairs or modifications should be made to the instrument except those that have been carried out or authorized by ERWEKA. PM 30 Instruction Manual/ 2016-03 KT/ V1.1 Page 18 of 18