Driving Results in Pharmaceutical Testing TABLETS & CAPSULES • SUPPOSITORIES • TRANSDERMALS POWDERS & GRANULES • SEMISOL

Pharmaceutical Testing About Us Copley: Driving Results for Over 70 Years Founded in 1946 in Nottingham, UK, Copley remains family owned and managed. We are recognised as the world’s leading manufacturer of inhaler test equipment, in addition to being a trusted provider of test instrumentation for other pharmaceutical dosage forms. We continue to work closely with industry groups and leading experts to bring relevant new products to market, with all equipment backed by expert training and lifetime support. These commitments are exemplified by our investment in the ISO 9001:2015 Quality Management...

Pharmaceutical Testing Background: Hardness Testing 50 Test Apparatus & Method 51 Equipment Selection Guide Organisations and their Roles Background: Disintegration Testing 12 Test Apparatus & Method 13 Disintegration Testers: DTGi Series 14 DTGi Series: Key Features 15 DTGi Series: Touchscreen User Interface 16 Key Features 16 Choose your DTGi DTGi Series: Technical Specifications 20 Temperature Calibration 20 Choose your DTGi System Accessories 21 Automatic Tablet Drop 34 Performance Verification Testing 35 DISi Series: Qualification & Maintenance 36 DISi Series: Qualification Tools 36 Hygiene:...

Pharmaceutical Testing Classification of Medicines Equipment Selection Guide Tablets & Capsules - Disintegration Chapter 2.9.1 Chapter 701 Pages 14-21 IntroductionOne of the clearest taxonomic guides for the classification of pharmaceutical dosage forms is to be found in Chapter <1151> of the US Pharmacopeia (USP) entitled “Pharmaceutical Dosage Forms”.The guide is depicted in “Figure 1. Compendial taxonomy for pharmaceutical dosage forms”, a modified version of which appears below. This proposes a three tier system with the first tier being based on the region of the body to which the drug is...

Pharmaceutical Testing Q1A - Q1F Stability Q8 - Pharmaceutical Development Q2 - Analytical Validation Q9 - Quality Risk Management Q3A - Q3D Impurities Q10 - Pharmaceutical Quality System Q4 - Q4B Pharmacopoeias Q11 - Development and Manufacture Q5A - Q5E Quality of Q12 - Lifecycle Management Biotechnological Products Q6A - Q6B Specifications Q13 - Continuous Manufacturing Q7 - Good Manufacturing Q14 - Analytical Procedure Development In Europe, Japan and in the USA this function is performed by the European Medicines Agency (EMA), the Ministry of Health, Welfare and Labor (MHWL) and the Food...

Pharmaceutical Testing Organisations and their Roles Organisations and their Roles 3. DRUG SAFETY, QUALITY AND EFFICACY – THE PHARMACOPOEIAS The main role of the Pharmacopoeias is to define the standards with which medicines must comply and the methods by which compliance will be adjudged. As with the regulatory groups, the leading Pharmacopoeias tend to be those of the European Union, Japan and the USA. a) European Pharmacopoeia This is published by the Directorate for the Quality of Medicines and Healthcare of the Council of Europe (EDQM). In the European Pharmacopoeia (Ph.Eur.), the main information...

Pharmaceutical Testing Background: Disintegration Testing Test Apparatus & Method Before the active ingredient(s) of an oral solid dose drug product can be absorbed into the body, the tablet or capsule in which they are contained must first disintegrate into smaller particles. Typically, the tablets and capsules to be tested are each placed in one of six vertical tubes each measuring approx. 77.5 mm long x 21 mm inside diameter, positioned in a circular basket arrangement. Chapters Ph. Eur. 2.9.1 and USP <701> and <2040> describe reproducible and standardised methods for quantifying the disintegration...

Pharmaceutical Testing Disintegration: DTGi Series Reproducible, standardised and affordable disintegration testing The result of decades of innovation and experience in the field of pharmaceutical testing, the Copley DTGi series of disintegration testers simplifies testing within R&D and QC environments. Suitable for a wide range of tablet and capsule types (e.g. plain-coated tablets, delayed-release, gelatine etc.), the DTGi tester series is an affordable range of disintegration testers, that complies fully with specifications defined in Ph. Eur., USP and associated Pharmacopoeias. DTGi Series:...

Pharmaceutical Testing DTGi Series: Touchscreen User Interface Extensive data output options are available as standard, including direct reporting to a printer or PC. Reported parameters Setting a test parameter Set v Actual test parameters (before test run) Set v Actual test parameters (during test run, with test progress bar) • Speed (cycles per minute) Set Average Maximum Minimum • Temperature (°C) Set Average Maximum Minimum Settings menu Passcode-protected temperature calibration process • Test Duration (HH:MM:SS) Set Actual • Calibration Data Calibration date Temperature calibrated at (°C)...

Pharmaceutical Testing Choose your DTGi Disintegration System DTG IQQi Cat. Number Cat. Number Cat. Number Cat. Number Cat. Number 1231 Independent Station Control: DTG 200i-IS With the same standard features as the other DTGi systems, the DTG 200i-IS offers independent control over each test station, making it ideal for the following types of applications: • Comparing one formulation directly against another • Comparing the performance of a single formulation under different conditions • Assessing delayed release or enteric coated tablets where samples must be immersed for specified periods...

Pharmaceutical Testing DTGi Series: Technical Specifications Choose your DTGi System Accessories Copley offers a complete range of accessories for use with the DTGi 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. Certificates of Compliance can be supplied upon request. Temperature Calibration DTGi Series AccessoriesCat. No. Description 1210 Standard Basket Rack Assembly 1205 Extra for Numbering and Certification (per basket) 1211 Set...