Pharmaceutical Testing
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COPLEY SCIENTIFIC

Who are Copley Based in Nottingham, Copley Scientific was founded by Frank Copley in 1946 to manufacture and supply general laboratory equipment and glassware. In 1957, Copley Scientific began to focus on the supply of pharmaceutical test instrumentation. During the intervening years, we have built up a wealth of experience in supplying and supporting such equipment and systems both 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...

Scientific? 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: 2008. ISO 9001: 2008 Quality...

Equipment Selection Guide Equipment Selection Guide 6 Current Issues Minimising Variability Disintegration Testing Disintegration Testers Series DTG Tablet Disintegration Tester Tablet Disintegration Tester Tablet Disintegration Tester Tablet Disintegration Tester Tablet Disintegration Tester Tablet Disintegration Accessories 11 Dissolution Testing Introduction to Dissolution Testing Basic Concepts Food and Drug Administration European Medicines Agency Pharmacopoeial Requirements United States Pharmacopoeia European Pharmacopoeia (Ph.Eur.) Dissolution/Drug Release Apparatuses - Summary...

Hardness Testing (Breaking Force) | | Semi Solid Testing Introduction to Hardness Testing 47 Terminology employed in Hardness Units of Measurement employed in Tablet Hardness Tester TH3 48 Tablet Hardness Tester TBF 1000 IQ/OQ/PQ Qualification Weight & Thickness Measurement 52 Powder Testing Introduction to Powder Testing 53 Powder Flowability Flowability Tester Model BEP 54 Cylinder Attachment (Flow Method A - Mass vs Time 55 Method B - Intrinsic Flowability 55 Funnel Attachment (Flow Angle of Repose Attachment 56 Shear Cell Attachment 57 Powder Density Tapped Density (Jolting Volumeter)...

EQUIPMENT SELECTION GUIDE EQUIPMENT SELECTION GUIDE European Pharmacopoeia Dosage Form United States Pharmacopoeia Page No. (in this brochure) GASTROINTESTINAL - Tablets & Capsules - Disintegration GASTROINTESTINAL - Tablets & Capsules - Dissolution GASTROINTESTINAL - Tablets & Capsules - Friability GASTROINTESTINAL - Tablets & Capsules - Breaking Force GASTROINTESTINAL - Tablets & Capsules - Weight & Thickness Chapter 2.9.5 GASTROINTESTINAL - Powders - Bulk & Tapped Density GASTROINTESTINAL - Powders - Flowability GASTRONINTESTINAL - Granules & Pellets - Friability MUCOSAL MEMBRANE -...

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 recognised 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. Copley Philosophy Robust Reliable Easy to use The current apparatus described in the pharmacopoeia was designed to...

DISINTEGRATION TESTERS SERIES DTG The Disintegration Tester Series DTG is the result of over 50 years experience in the field of pharmaceutical testing. The Testers have been specifically designed for use in the quality and production control of normal, plain coated and delayed release coated tablets and gelatin capsules in accordance with the specifications as laid down in European, United States and associated Pharmacopoeias. 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...

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...

“Quick-Release” Basket Assembly 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 Drain tap used on rear of DTG 3000 and DTG 4000 water bath • “Quick-Release” basket design combines stability with easy removal •...

Left: Basket fitted with Special Cover Right: Special Basket for Large Tablets Glass Tubes, Fluted Discs and Sieve Meshes DISINTEGRATION ACCESSORIES STANDARD ACCESSORIES Copley Scientific offers a complete range of accessories for use with the DTG series, from complete basket rack assemblies to individual tubes, discs and sieve meshes. All parts are manufactured to tolerances that are equal to or better than those quoted in the respective Pharmacopoeias and carefully checked prior to despatch. BASKET RACK ASSEMBLY COVER FOR HARD & SOFT GELATINE CAPSULES (as per USP Chapter <701>) Converts...