Pharmaceutical Testing
Contents
Hardness
50
Choose your DISi System Accessories 32 Baskets, Paddles and Rotating Cylinders 32 Vessels 33
About Us
2
Background: Hardness Testing
50
ISO 9001: 2015 Quality Management System The Copley Promise
51
Test Apparatus & Method
2 3
Hardness Testers
52 52 53 54 54 55 55 56 57 58 58 59 59 59
EMC Ultra-Precision Dissolution Vessels
TBF 100i
Table of Contents
4
33 33 34 34 35
TBF 100i: Key Features
Vessel Covers
TBF 100i: Touchscreen User Interface
Classification of Medicines
6
Automatic Tablet Drop
Key Features
Sampling Probes
Reporting
Equipment Selection Guide
7
Performance Verification Testing
Compliance & Maintenance
DISi Series: Qualification & Maintenance
Choose your Tablet Hardness Tester TBF 100i Technical Specifications Choose your TBF 100i Accessories
Organisations and their Roles
8
36 36
DISi Series: Qualification Tools
Disintegration
12
Hygiene: Anti-Bacterial/ Algae Treatment
Tablet Weight & Thickness
36
Background: Disintegration Testing
12 13
Tablet Hardness Tester: TH3
Test Apparatus & Method
Special Applications
37 37 37 37 37 38 38 39 39
TH3: Key Highlights
Transdermal Patch Testing
Disintegration Testers: DTGi Series
14
Reporting
Paddle Over Disk Watch Glass/Patch Rotating Cylinder Intrinsic Dissolution
DTGi Series: Key Features 15 DTGi Series: Touchscreen User Interface 16 Key Features 16 Reporting 17 Compliance & Maintenance 17 Choose your DTGi Disintegration System 18 DTG 100i 18 DTG 200i 18 DTG 300i 18 DTG 400i 19 DTG 200i-IS 19 DTGi Series: Technical Specifications 20 Temperature Calibration 20 Choose your DTGi System Accessories 21 Standard Accessories 21 Accessories for Specialist Dosage Forms 21 Dissolution 22 Background: Dissolution Testing 22 Test Apparatus & Method 24 Pharmacopoeial Requirements 24 United States Pharmacopeia (USP) 24 European Pharmacopoeia (Ph.Eur.) 24 Dissolution Testers DISi Series 26 DISi Series: Key Features 27 DISi Series: Touchscreen User Interface 28 Key Features 28 Reporting 29 Compliance & Maintenance 29 Choose your DISi Dissolution System 30 DIS 600i 30 DIS 800i 30 DISi Series: Technical Specifications 31 Temperature Calibration 31
Powders
60
Background: Powders Powders: Flowability Flow Through an Orifice
60 61 61 62 62
Small Volumes Special Baskets
Basket for Suppository Dissolution
Angle of Repose
Shear Cell Attachment
Friability
40
Powders: Bulk and Tapped Density
63
Compressibility Index and Hausner Ratio
Background: Friability Testing Test Apparatus & Method
40
63
41
Powders: Flowability Testers BEP2 with Cylinder Attachment BEP2 with Funnel Attachment BEP2 with Funnel and Shear Cell Attachment BEP2 with Funnel and Angle of Repose Attachments
64 64 64
Friability Testers
42 42 43 44 44 45 45 46
FRVi Series
FRVi Series: Key Features FRVi Series: Touchscreen User Interface
65
Key Features
65
Reporting
Compliance & Maintenance Choose your Friability System
Powders: Bulk Density Tester
67
Powders: Tapped Density Testers
68
FRVi Series: Friability Calculator 46 FRVi Series: Friability & Abrasion Drums 47 FRVi Series: Technical Specifications 47 Friabimat SA-400 48 Friabimat SA-400: Key Highlights 48 Friabimat SA-400: Technical Specifications 49
JVi Series: Key Features 69 JVi Series: Touchscreen User Interface 70 Reporting 71 Compliance & Maintenance 71 Choose your JVi Tapped Density System 72 JVi Series: Technical Specifications 73
4
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