1. Catalogs
  2. Copley Scientific
  3. Pharmaceutical Testing
video corpo

Pharmaceutical Testing

Pharmaceutical Testing
1 / 76 PagesView full catalog

Pharmaceutical Testing

Product catalog summary
Introduction
Copley Scientific, established in 1946, is a leader in manufacturing pharmaceutical test instrumentation. The company offers a wide range of equipment for testing various pharmaceutical forms, including tablets, capsules, and inhalers, and collaborates with MSP Corporation for aerosol particle science.
Philosophy and Quality Management
Copley Scientific adheres to 'quality by design' principles, focusing on precision and robustness. It is ISO 9001:2008 certified, ensuring high-quality products and services.
Equipment Overview
The document details various testing equipment, such as:
  • Disintegration Testing: For tablets and capsules.
  • Dissolution Testing: Measures drug dissolution rates.
  • Friability Testing: Assesses tablet durability.
  • Hardness Testing: Measures tablet breaking force.
  • Powder Testing: Evaluates flowability and density.
  • Semi-Solid Testing: For creams and ointments.
  • Suppository Testing: Assesses disintegration and softening time.
  • Detergent Testing: Evaluates detergent effectiveness.
Key Features and Innovations
Copley Scientific's equipment is user-friendly, reliable, and compliant with international standards, offering accessories and calibration tools for enhanced accuracy.
Services
Copley provides instrument qualification, servicing, and training to ensure optimal performance and customer satisfaction.
Compliance and Qualification
The document emphasizes compliance with Pharmacopoeia standards and outlines a three-tier approach for disintegration testers, including certification and qualification documentation.
Design and Construction
The DTG series features a motor drive, membrane keypad, and easy-to-clean design, suitable for testing multiple tablet batches.
Operation
The DTG series requires minimal actions for testing, with features like automatic basket rack systems and temperature monitoring.
Disintegration Testers Series DTG
Ideal for quality control and R&D, offering compliance with Ph.Eur. and USP specifications and independent control over test stations.
Standard Accessories
Includes basket rack assemblies and hygiene solutions, manufactured to Pharmacopoeia standards.
Dissolution
Discusses regulatory responsibilities, Process Analytical Technology (PAT), and Quality by Design (QbD) approaches, emphasizing the importance of dissolution testing for drug release and bioavailability.
Pharmacopoeial Standards
Highlights the role of pharmacopoeias like the USP in setting drug quality standards.
Dissolution Apparatuses
Describes various apparatuses for different dosage forms, including tablets and transdermal patches.
Minimizing Variability
Discusses controlling variables in dissolution testing and the Enhanced Mechanical Calibration (EMC) method.
Calibration and Current Issues
Addresses calibration methods, comparing traditional and enhanced specifications.
Specifications and Procedures
Outlines specifications for dissolution testing, including wobble, shaft centricity, and temperature parameters.
Dissolution Testing Apparatus
Describes the use of basket and paddle apparatus for measuring dissolution rates.
Copley Dissolution Testers
Features of the DIS 8000 model include sturdy construction, simple operation, and precision-ground drive shafts.
Design and Features
The DIS 8000 is designed for visibility and includes features like interchangeable baskets/paddles and digital monitoring.
Calibration and Automation
Emphasizes routine calibration and offers automation options to reduce manual testing time.
Specifications
The Dissolution Tester DIS 6000 includes advanced technologies for enhanced precision.
Procedures
Outlines test initiation processes and sampling systems for dissolution testing.
Transdermal Patch Testing
Details methods for testing drug release from transdermal patches.
Special Applications
Includes conversion kits for small volume testing and intrinsic dissolution studies.
Compliance and Standards
The DIS-EMC model exceeds FDA and USP specifications, offering improved precision.
Introduction
Dissolution is critical for oral dosage forms, ensuring drug dissolution before absorption.
Special Applications - Inhaled Drugs
Focuses on drug delivery and deposition for inhaled drugs, using tools like the NGI and ACI.
NGI Dissolution Cup and Membrane Holder
Allows size-fractionated particles to be tested in a conventional dissolution tester.
Performance Verification Testing (PVT)
Standardized drug forms are used for reproducible results under standard conditions.
Media Preparation (Deaeration)
Discusses the importance of removing gases from dissolution media.
Calibration Tools
Various tools ensure the accuracy and precision of dissolution testing equipment.
Conclusion
Dissolution testing is essential for ensuring the quality and efficacy of oral dosage forms.
Introduction
Discusses the use of automated systems in dissolution testing for improved accuracy and efficiency.
Media Preparation - The "Dissomate"
A media preparation station designed to streamline testing processes.
Operation
Details the operation of the "Dissomate" system.
Automation Systems
Describes off-line, on-line (UV/Vis), and on-line (HPLC) dissolution systems.
The "Dissofract" System
An off-line dissolution sampling system that automates sample removal.
Friability
Friability testing assesses a tablet's tendency to chip or break.
Introduction
Overview of friability testing for tablets, focusing on Copley Friability Testers.
Specifications and Design
Details the design of Copley Friability Testers according to pharmacopoeial standards.
Operation and Procedures
Standard procedures for friability testing.
Compliance and Validation
Three-tier approach to regulatory compliance.
Key Features
Features of Copley Friability Testers and the Friabimat.
Applications
Used in research, development, and quality control.
Conclusion
Highlights the importance of friability and hardness testing.
Tablet Hardness Tester TH3
Details the TH3 model, a tablet hardness tester with various data output facilities.
Tablet Hardness Tester TBF 1000
Combines simplicity with advanced features, designed according to Ph.Eur. and USP specifications.
Principles of Operation
Uses electronic load cell technology for testing.
Calibration and Qualification
Includes an automatic load check routine and qualification documentation.
Weight and Thickness Measurement
Measures tablet hardness, weight, and thickness.
Powder Testing
Mentions new harmonized chapters in the Pharmacopoeias for powder testing.
Introduction
Introduces the Flowability Tester Model BEP2 for testing pharmaceutical powders.
Specifications and Attachments
Details the BEP2's specifications and interchangeable attachments.
Testing Procedures
Details procedures for various powder flowability tests.
Additional Equipment
Describes the Scott Volumeter for measuring bulk density.
Conclusion
The BEP2 provides comprehensive solutions for assessing powder flowability.
Introduction
Details the Tapped Density Testers Series JV for measuring tapped density of powders.
Specifications
Available in two versions, JV 1000 and JV 2000.
Mode of Operation
Describes the operation and calculation of tapped density.
Acoustic Cabinet
Optional cabinet to reduce noise levels.
Semisolids Testing
Discusses testing semisolid dosage forms using various cells.
Vertical Diffusion Cell
Used for in vitro testing of drug release from semisolid forms.
Immersion Cell
Used with USP Apparatus 2 for drug release testing.
Suppositories
Briefly mentions suppositories and their testing methods.
Introduction to Suppository Testing
Discusses challenges in dissolution testing for suppositories.
European Pharmacopeia Standards
Outlines procedures for disintegration and softening time of suppositories.
Suppository Disintegration Tester SDT 1000
Designed for testing disintegration and softening time.
Tergotometer for Detergent Testing
Used for testing detergents' efficacy in stain removal.
Tablet Thickness Testing
Describes various models of thickness testers.
Overview
Provides detailed information on analytical instruments and services offered by Copley Scientific.
Specifications
Lists several instruments and their calibration options.
Sources of Error
Discusses potential errors in pharmaceutical analysis.
Analytical Instrument Qualification (AIQ)
Emphasizes the importance of AIQ as per USP Chapter <1058>.
Services
Offers comprehensive servicing options for maintenance and calibration.
Training
Training programs for equipment operation and regulatory requirements.
Index
Includes an extensive index for quick reference.
See more

Catalog excerpts

Pharmaceutical Testing-2

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 testers,...

 Open the catalog to page 2
Pharmaceutical Testing-3

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 Management...

 Open the catalog to page 3
Pharmaceutical Testing-4

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 Comparison...

 Open the catalog to page 4
Pharmaceutical Testing-5

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) Introduction...

 Open the catalog to page 5
Pharmaceutical Testing-6

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 - Rectal...

 Open the catalog to page 6
Pharmaceutical Testing-7

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 provide...

 Open the catalog to page 7
Pharmaceutical Testing-8

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 one...

 Open the catalog to page 8
Pharmaceutical Testing-9

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...

 Open the catalog to page 9
Pharmaceutical Testing-10

“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 • Automatically...

 Open the catalog to page 10
Pharmaceutical Testing-11

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 standard...

 Open the catalog to page 11
*Prices are pre-tax. They exclude delivery charges and customs duties and do not include additional charges for installation or activation options. Prices are indicative only and may vary by country, with changes to the cost of raw materials and exchange rates.