S C I E N T I F I C. Q u a l i t y S o l u t i o n s f o r t h e Te s t i n g o f P h a r m a c e u t i c a l s EDITION

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S C I E N T I F I C Q u a l i t y S o l u t i o n s f o r t h e Te s t i n g o f P h a r m a c e u t i c a l s EDITION CREAMS AND OINTMENTS POWDERS SUPPOSITORIES TABLETS AND CAPSULES TRANSDERMAL
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S C I E N T I F I C Q u a l i t y S o l u t i o n s f o r t h e Te s t i n g o f P h a r m a c e u t i c a l s EDITION CREAMS AND OINTMENTS POWDERS SUPPOSITORIES TABLETS AND CAPSULES TRANSDERMAL PATCHES INTRODUCTION WHO ARE COPLEY SCIENTIFIC? Copley Scientific was founded by Frank Copley in 1946 to manufacture and supply laboratory equipment and glassware to the pharmaceutical industry. The company has been based in Nottingham, UK, since this time. In 1957 Copley Scientific began to focus on test equipment for pharmaceutical solid dosage forms. As a result we have built up a wealth of experience in supplying and supporting such equipment and systems in the UK and abroad. As part of our rapid expansion Copley Scientific is now responsible for the manufacture and supply of its own innovative range of tablet dissolution, disintegration, friability and hardness testers, in addition to test equipment for creams, ointments, powders, suppositories and transdermal patches, to the global marketplace. Whilst still operating as a family owned company, Copley Scientific has continued to expand and increase its range of products and services. During the 1980s Copley Scientific began developing a new range of inhaler test equipment to meet the growing demand for drugs delivered to the respiratory tract. We are now recognised as one of the world s largest manufacturers of inhaler test equipment, with a broad range of equipment, software and services to meet the requirements of inhaled drug development, for both topical and systemic applications. Since the formation in 2000 of a strategic partnership with MSP Corporation, a US based company that specializes in aerosol particle science, we have been able to offer the full range of United States and European Pharmacopoeia specified cascade impactors for the aerodynamic particle size measurement of inhaled drugs. Furthermore, since 2006, we have been MSP s exclusive European distributor for their range of air sampling and aerosol characterisation products, making Copley Scientific a major supplier of research grade aerosol analysis equipment in Europe. Our Philosophy The pharmaceutical industry of today demands instrumentation that is (a) precise and accurate (b) simple to use and operate and (c) robust and rugged in operation. The Copley Philosophy is based on the premise that the accuracy and reproducibility of test results and hence the ability to discern between products can only be achieved using instrumentation conceived using quality by design principles and maintained through the rigorous application of quality control standards within a Quality Management System such as ISO 9001: It is the application of this philosophy to the manufacture of all our instruments that guarantees you, the user, an instrument of the highest quality and reliability. ISO 9001: 2008 Quality Management System Copley Scientific is committed to delivering quality products and services to our customers. Continual improvement is an essential part of achieving customer satisfaction and we constantly strive to exceed the expectations of the industries we serve. In pursuance of these goals, Copley has gained certification for its Quality Management System to the new ISO 9001: 2008 standard. This standard, which revises the previous ISO 9001: 2000 standard, was published only in November In 2003 we proudly opened a new sales and service company in Switzerland, to assist in supporting our increasing number of customers on the European continent. This was followed in 2005 by the relocation of Copley Scientific s UK based headquarters to a new, larger, purpose-built facility in Nottingham. Copley Scientific also works closely with a number of specialist distributors, to ensure that our broad range of products is supplied and supported around the world. The combination of both experience and flexibility within the industries we support, ensures that Copley Scientific will continue to provide innovative, high quality solutions to our customers, well into the future. 1 Contents Equipment Selection Guide The Classification of Medicines 4 Equipment Selection Guide 4 Disintegration Testing Introduction of Disintegration Testing 5 Disintegration Testers Series DTG Tablet Disintegration Tester DTG 1000 (1 Station) 6 Tablet Disintegration Tester DTG 2000 (2 Station) 6 Tablet Disintegration Tester DTG 3000 (3 Station) 7 Tablet Disintegration Tester DTG 4000 (4 Station) 7 Tablet Disintegration Tester DTG 2000 IS 8 Tablet Disintegration Accessories 9 Dissolution Testing Introduction to Dissolution Testing Basic Concepts 10 In-vivo / In-vitro Testing 11 Relationship between Dissolution and Drug Release 11 Food and Drug Administration (FDA) 11 European Medicines Agency (EMEA) 11 Drug Safety and Efficacy - the Pharmacopoeia United States Pharmacopoeia (USP) - Chapters 12 United States Pharmacopoeia (USP) - Methods 12 European Pharmacopoeia (Ph.Eur) 12 Dissolution Tester DIS 8000 Pharmacopoeial Compliance and Qualification 13 Baskets, Paddles and Rotating Cylinders 13 Vessels, Vessel Centring and Lids 14 Control and Monitoring of Speed and Temperature 14 Operation 15 Calibration 15 Key Features 15 Dissolution Tester DIS Automatic Tablet Drop 17 Sampling Manual Systems 17 Automated Systems 17 Transdermal Testing Paddle Over Disc Method 18 Rotating Cylinder Method 18 Special Applications Special Baskets 19 Suppository Basket 19 Mini-Paddle Systems 19 Ointment Cells 19 Intrinsic Dissolution Kits 19 Dissolution Testing Accessories Spare Parts Drive Shafts 20 Baskets (USP Method 1) 20 Paddles (USP Method 2) 20 Vessels 20 Vessel Covers 20 Capsule Sinkers & Weights 20 Calibration Tools Calibrators (Performance Verification Testing) 21 Wobble Checker 21 Height Checker 21 Level Checker (Spirit Level) 21 Temperature Checker 21 Speed Checker 21 Centricity Checker 21 Vibration Meter 21 Accessories Anti-Bacteria/Algae Inhibitor 21 Filters 21 Carrying Cases 21 Carrying Racks 21 Automation Introduction 22 Off-Line Systems (Collect only) 22 On-Line Dissolution Systems (UV/VIS) 23 On-Line Dissolution Systems (HPLC) 23 Friability Testing Introduction to Friability Testing 24 Friability Testing (Uncoated Tablets) Introduction 25 Pharmacopoeial Compliance and Validation 25 Design and Construction 25 Drums 26 Operation 26 Friability Testing (Granules and Spheroids) Introduction 27 Design and Construction 27 Operation 28 Key Features 28 Hardness Testing (Breaking Force) Introduction to Hardness Testing 29 Terminology employed in Hardness Testing 30 Units of Measurement employed in Hardness Testing 30 Copley Tablet Hardness Tester TH3 30 Copley Hardness Tester TBF 1000 General 31 Principles of Operation 31 Operation 32 Advanced Features 33 System Suitability 33 Calibration 33 IQ/OQ/PQ Qualification Documentation 34 Weight and Thickness Measurement 34 2 CONTENTS Powder Testing Introduction to Powder testing 35 Powder Density Bulk Density Scott Volumeter 36 Tapped Density (Jolting Volumeter) Introduction 37 Mode of Operation 37 Acoustic Cabinet 37 Powder Flowability Flowability Tester Model BEP Introduction 38 Cylinder Attachment (Flow through an Orifice) Method A - Mass vs Time 39 Method B - Intrinsic Flowability 39 Funnel Attachment (Flow through an Orifice) 40 Balance/Timer Attachment 40 Angle of Repose Attachment 40 Shear Cell Attachment 41 Suppository Testing Introduction to Suppository Testing 42 Suppository Tester SDT Disintegration General 43 Mode of Operation 43 Thickness Testing Introduction to Thickness Testing 46 Digital Caliper for Measuring Tablets 47 Digital Caliper Model Mini Processor Model Tablet Thickness Testing Tablet Thickness Tester Model Tablet Thickness Tester Model Mini Processor Model Vertical Diffusion (Franz) Cell Introduction to Creams, Ointments and Gels 48 Vertical Diffusion Cell Introduction 49 Design 49 Sample Preparation 49 Running a Test 50 Sampling 50 Stirring and Heating 50 Services Qualifying Analytical Instruments 51 Sources of Error 51 Analytical Instrument Qualification 51 Analytical Method Validation 51 IQ/OQ/PQ Documentation 51 Servicing/Training Servicing 52 Training 52 Suppository Tester SDT Softening Time Softening Time Attachment 43 Tergotometer (Detergent Testing) Introduction to Detergent Testing Grey Scale Testing 44 Testing using Reflectance 44 Introduction to Detergent Tester General 45 Soap and Detergent Evaluation 45 Colour Fastness and Washability of Fabrics 45 Temperature, Speed & Water Hardness Optimisation 45 Routine Testing for Soiling 45 Operation 45 COPYRIGHT This edition of the Copley Scientific Limited catalogue and guide is copyright All rights reserved. No portion of this catalogue may be reproduced without the permission of Copley Scientific Limited. Copley Scientific Limited reserves the right to make changes without further notice to any products herein to improve reliability or design. Copley Scientific Limited does not assume any liability arising out of the application or use of any product described herein - neither does it convey any licence under its patent rights nor the rights of others. Any third party documentation or organisation mentioned herein is referential only and implies no company or product endorsement from, or affiliation with, Copley Scientific Limited. 3 EQUIPMENT SELECTION GUIDE THE CLASSIFICATION OF MEDICINES One of the clearest taxonomic guides for the categorisation of pharmaceutical dosage forms is to be found in Pharmaceutical Forum. 2003;29: Pages under the title Development of a compendial taxonomy and glossary for pharmaceutical dosage forms. This proposes a three tier system with the first tier being based on the region of the body to which the drug is to be administered, i.e., gastrointestinal (oral), mucosal membrane (rectal, vaginal, oropharyngeal, opthalmic, otic and urethal), skin surface (topical, transdermal), injections incl. infusions or lungs (pulmonary). It is this first tier classification which has been used as the basis for the Equipment Selection Guide to be found on the facing page. This lists the dosage form and test parameter concerned, the chapter relating to that test parameter in both European and US Pharmacopoeia (where applicable) and, in the final column, the page number in this catalogue where a description of the test instrumentation concerned can be found. EQUIPMENT SELECTION GUIDE Dosage Form European Pharmacopoeia United States Pharmacopoeia Page No. (in this brochure) GASTROINTESTINAL - Tablets & Capsules - Disintegration Chapter Chapter 701 Pages 5-9 GASTROINTESTINAL - Tablets & Capsules - Dissolution Chapter Chapter 711 Pages GASTROINTESTINAL - Tablets & Capsules - Friability Chapter Chapter 1216 Pages GASTROINTESTINAL - Tablets & Capsules - Hardness Chapter Chapter 1217 Pages GASTROINTESTINAL - Tablets & Capsules - Weight & Thickness Chapter Chapter 905 Page 34 GASTROINTESTINAL - Powders - Bulk & Tapped Density Chapter Chapter 616 Pages (Apparent Volume) GASTROINTESTINAL - Powders - Flowability Chapter & Chapter 1174 Pages GASTRONINTESTINAL - Granules & Pellets - Friability Chapter Pages MUCOSAL MEMBRANE - Rectal & Vaginal - Drug Release Chapter & Pages MUCOSAL MEMBRANE - Oropharyngeal, Opthalmic, Otic & Urethal Outside the scope of this brochure SKIN SURFACE - Creams & Ointments - Drug Release Pages SKIN SURFACE - Transdermal Patches - Drug Release Chapter Chapter 724 Page 18 INJECTION - Injections & Infusions Outside the scope of this brochure LUNGS - Inhalers & Nebulisers Chapter & 0671 Chapter 601 & 1151 NASAL - Inhalers & Sprays Chapter & 0676 Chapter 601 See seperate brochure See seperate brochure ANALYTICAL INSTRUMENT QUALIFICATION - Guidelines ---- Chapter 1058 Page 51 4 Disintegration INTRODUCTION Approximately two-thirds of all medicines prescribed today take the form of solid dosage forms and half of these are tablets. These tablets comprise a mixture of active drug and other excipients, usually in powder form, pressed or compacted into a solid. It has long been recognized that before a tablet/hard gelatin capsule can dissolve and hence allow the active drug to be absorbed into the body, it must first disintegrate into smaller particles. The current apparatus described in the pharmacopoeia was designed to provide a reproducible and standardized method of ensuring that disintegration had taken place. Each of the tablets to be tested are placed in one of 6 vertical tubes each measuring approx mm long x 21 mm inside diameter arranged in a circular basket arrangement. The lower end of the tubes is covered by a 2 mm sieve mesh. The basket assembly is raised and lowered in simulated gastric fluid at body temperature (37 degrees Celsius) through a distance of 55 mm at a constant frequency of 30 cycles per minute. A plastic disc of defined proportions hammers the tablet during the operation thus assisting in the disintegration process. The tablet is said to pass the test providing that no tablet residue remains on the sieve mesh after the designated time, typically 30 minutes for ordinary tablets and 60 minutes for enteric coated tablets. All Copley Tablet Disintegration Testers feature: Sturdy, robust design including novel quick release basket, one-piece water bath and independent heater/circulator Simple, easy-to-use operation ensures that the number of operations required to perform a test are kept to a minimum Full supporting documentation (including full IQ/OQ/PQ qualification documentation if required) Special accessories available for hard/soft gelatin capsules and large tablets, capsules and boluses 5 DISINTEGRATION DISINTEGRATION TESTERS SERIES DTG The Disintegration Tester Series DTG is the result of over 50 years experience in the field of pharmaceutical testing. They have been specifically designed for use in the quality and production control of normal, plain coated and delayed release coated tablets, and gelatine capsules in accordance with the specifications as laid down in European, United States and associated Pharmacopoeia. The series is available with one (DTG 1000), two (DTG 2000), three (DTG 3000) or four (DTG 4000) test stations. Each individual test station is capable of accepting one batch of six tablets or capsules. Foremost in the design specification were those features that you, the user, identified as being essential to the ideal disintegration tester. PHARMACOPOEIAL COMPLIANCE AND QUALIFICATION The most critical factors in the design of any disintegration tester are (a) that it complies with the respective Pharmacopoeia, (b) that this compliance can be proved or qualified and (c) that both compliance and qualification are documented. Copley offer a three tier approach to address these points: Certificate of Compliance to USP/Ph.Eur.: Provided free of charge with each unit. This is a written statement that the product, by design, complies with the current pharmacopoeial specifications. Laser Numbering and Certification: Identification and measurement of critical components to provide documented verification of compliance with current pharmacopoeial specifications. Available as an optional service. Disintegration Tester DTG 2000 IQ/OQ/PQ Qualification Documentation: Comprehensive documentation to guide the user through the installation, operating and performance checks of the equipment in its operating environment, using specified test protocols. This optional service provides a comprehensive record of the suitability of the equipment to perform its specified task, to be created and archived. Please see the ordering information for further details on our verification and qualification services. DESIGN AND CONSTRUCTION All of the DTG series feature a motor drive operating at a fixed speed of 30 rpm (+/- 1) and a stroke of 55 mm (+/- 1). Depending on the model, the DTG has the capacity of testing one, two, three or four different tablet batches of six tablets/capsules simultaneously, under identical test conditions. The control of all models is provided by a membrane keypad linked to a 4-line 20 character back-lit LCD screen which together with the electronics is mounted in the head of the instrument so as to avoid any accidental spillages in the test area. Particular attention has been given to the design of the basket rack assembly in respect of its removal and cleaning. The novel quick-release basket design not only provides a firm and rigid location for the basket during operation but also allows the basket to be removed from the instrument for rapid cleaning. Another unique feature of the basket design is the use of thumb screws to hold the various components together. Disintegration Tester DTG DISINTEGRATION Disintegration Tester DTG 3000 DISINTEGRATION TESTERS SERIES DTG This means that if it is necessary to disassemble the basket before cleaning, this can be done very quickly and without the use of any specialised tools. A common problem associated with fabricated water baths, used for warming the media, is that of leaks. This problem has now been eliminated through the use of a onepiece water bath vacuum formed in rigid PETG. This construction not only eliminates any possibility of leaks but also makes it far easier to clean because of its rounded corners. The bath is fitted with a sturdy 8 mm clear view lid and secured to the base by four easily removed thumb screws. The temperature of the warming solution is controlled by means of an independent heater/circulator to an accuracy of +/- 0.2 degrees C. This has two advantages: firstly, it removes the necessity for priming and secondly, it can be removed for cleaning without dismantling the whole disintegration tester. A low water-level alarm indicator is built into the unit as standard. OPERATION Considerable attention was paid to the design of the DTG series to ensure that the number of actions necessary to perform a test are kept to a minimum. The membrane keypad allows for the selection of test run times up to 99 hours 59 minutes 59 seconds. Thereafter, it is only necessary to press the START key to automatically lower the basket rack assemblies into the test media and begin or repeat a test. During the test, the time elapsed from the start of the test (or if you prefer, time remaining to the end of the test) is displayed on the LCD screen. At the end of the test, the basket rack assemblies are automatically removed from the test media and an audible alarm alerts the user that the run is completed. Bath and beaker temperatures can be constantly monitored using the PT100 temperature probe provided for this purpose. Temperature is critical to the test and is displayed permanently on the LCD screen as soon as the unit is switched on. Ordinarily, temperature calibration can prove to be a time consuming and inaccurate process involving the use of iced water. This is not the case with the DTG series. Available as an option, the electronic temperature calibration kit comprises two UKAS certified test keys (0 and 37 degrees C) which you simply plug into the PT100 socket to perform the calibration. Dimensions (mm): DTG 1000/2000 = 450 mm (W) x 450 mm (D) x 720 mm (H) DTG 3000/4000 = 700 mm (W) x 450 mm (D) x 720 mm (H) Disintegration Tester DTG Disintegration Tester Model DTG 1000 (1 Station) 1202 Disintegration Tester Model DTG 2000 (2 Station) 1203 Disintegration Tester Model DTG 3000 (3 Station) 1204 Disintegration Tester Model DTG 4000 (4 Station) 1205 Extra for Numbering and Certification (per basket) 1206 IQ/OQ/PQ Documentation Pack 1207 Electronic Temperature Calibration Kit 7 DISINTEGRATION DISINTEGRATION TESTERS SERIES DTG The Disintegration Tester Series DTG described on the preceding two pages is ideal for quality control and R & D where it is important that the testing is carried out under identical test conditions. As previously stated, the series offers the user an unparalleled number of standard features including: Conforms to all current Ph.Eur. and USP specifications Choice of 1, 2, 3 or 4 test baskets Quick-Release
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