CFR 21 Part 11 Compliance
Fully validated software with electronic records capability, audit trails, digital signatures, and advanced data integrity controls to meet FDA requirements for pharmaceutical testing.
๐ CFR 21 Part 11 Compliant
Pharmaceutical Testing Machines | CFR 21 Part 11 Compliant Systems
Universal Testing Machines (UTM) and barrier testing systems for mechanical testing, OTR/WVTR analysis of pharmaceutical packaging materials, drug delivery components, and medical devices with CFR 21 Part 11 validated software.
CFR 21
Part 11
IQ-OQ-PQ
Validated
Pharmaceutical Testing Machine Specifications
Universal Testing Machines and barrier testing systems for mechanical and permeability testing of pharmaceutical materials
CFR 21 Part 11
Compliant
Validated Software
Validated Software
Load Capacity
1 kN โ 1000 kN
Electromechanical
Electromechanical
Accuracy
ยฑ0.000001
mm resolution
mm resolution
Validation
IQ-OQ-PQ
Available
Available
Why Choose Testometric for Pharmaceutical Testing
Comprehensive testing solutions including UTM mechanical testing and barrier analysis for pharmaceutical packaging characterization
Testometric UK UTM Fixtures
Specialized fixtures for tensile testing of films, compression testing of tablets, peel testing of seals, puncture testing of packaging, and three-point bend testing with precision Testometric UK UTM configurations.
Barrier Testing (OTR/WVTR)
Oxygen Transmission Rate and Water Vapor Transmission Rate testing for pharmaceutical packaging materials, ensuring optimal product protection and shelf life validation using Systech Illinois technology.
Advanced Data Management
Electronic records with secure data storage, automated reporting, statistical analysis tools, and compliance documentation for regulatory submissions and quality assurance.
Medical Device UTM Testing
Mechanical testing of syringe components, medical tubing tensile properties, catheter pull-out forces, needle penetration resistance, and packaging material strength using UTM systems.
Pharmaceutical Testing Standards & Compliance
Supporting all major pharmaceutical testing standards including USP, ASTM, ISO, and FDA requirements
๐ USP & Pharmaceutical
- USP <1217> Tablet Breaking Force
- ISO 7886-1 Syringe Force Testing
- ASTM D2256 Tensile Properties of Yarns
- CFR 21 Part 11 Electronic Records
๐ฆ Packaging Testing
- ASTM D882 Tensile Properties of Films
- ASTM F88/F88M Seal Strength Testing
- ASTM F1306 Slow Rate Penetration
- ASTM D1938 Tear Propagation Resistance
๐ฌ Adhesion & Peel Testing
- ASTM D3330 Peel Adhesion Testing
- ASTM D1876 T-Peel Test
- ASTM D903 Peel Strength Testing
- ISO 527 Tensile Properties
๐ก๏ธ Barrier Testing Standards
- ASTM D3985 Oxygen Transmission Rate
- ASTM F1249 Water Vapor Transmission
- ASTM F1927 Permeation Testing
- ASTM F2096 Seal Integrity Testing
๐งช Mechanical Testing Standards
- ASTM D638 Tensile Properties of Plastics
- ISO 527 Tensile Properties
- ASTM D695 Compressive Properties
- ASTM D790 Flexural Properties
Advanced Pharmaceutical Testing Capabilities
Testometric UK UTM systems and Systech Illinois barrier analyzers for comprehensive pharmaceutical testing and regulatory compliance
Syringe Component UTM Testing
Plunger force testing, syringe barrel tensile strength, needle penetration force measurement, and stopper compression testing using universal testing machines with automated data capture.
Blister Pack UTM Testing
Seal strength peel testing, puncture resistance measurement, blister film tensile properties, and foil tear strength testing with specialized UTM fixtures for pharmaceutical packaging.
Tablet Compression Testing
Tablet crush resistance testing, compression strength measurement, diametral tensile strength testing, and coating adhesion pull-off testing using UTM compression platens and fixtures.
Validated Software Suite
CFR 21 Part 11 compliant software with electronic signatures, audit trails, secure data management, and automated compliance reporting trusted by leading pharmaceutical manufacturers worldwide.
Data Security & Integrity
Advanced data protection with encrypted storage, access controls, backup systems, and comprehensive audit trails to ensure data integrity and regulatory compliance.
Barrier Testing Systems
Systech Illinois OTR/WVTR analyzers for oxygen and water vapor transmission testing of pharmaceutical packaging, providing critical barrier property data for shelf life validation.
Barrier Testing Equipment
Systech Illinois OTR and WVTR analyzers for comprehensive pharmaceutical packaging barrier analysis
OTR Analyzer
Oxygen Transmission Rate testing system for pharmaceutical packaging materials with CFR 21 Part 11 compliance and automated data collection.
WVTR Analyzer
Water Vapor Transmission Rate testing system for pharmaceutical packaging with validated software and electronic records capability.
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