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
Advanced pharmaceutical testing systems with validated software, electronic records capability, and data integrity controls for packaging materials, drug delivery systems, and medical devices.
CFR 21
Part 11
IQ-OQ-PQ
Validated
Pharmaceutical Testing Machine Specifications
Validated systems designed for pharmaceutical quality control, R&D, and regulatory compliance testing
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 for pharmaceutical packaging materials, drug delivery systems, and medical devices
Pharmaceutical Test Fixtures
Specialized fixtures for blister pack testing, syringe plunger force testing, tablet crush resistance, seal strength testing, and medical device evaluation with custom configurations.
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 Testing
Comprehensive testing capabilities for syringes, medical containers, drug delivery devices, packaging integrity, and biocompatible materials with ISO and USP standard compliance.
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 Plunger Glide Force
- ISO 11040 Prefilled Syringe Testing
- CFR 21 Part 11 Electronic Records
๐ฆ Packaging Testing
- ASTM D882 Tensile Properties of Films
- ASTM F88/F88M Seal Strength Testing
- ASTM F1140 Internal Pressure Failure
- ASTM F2054 Burst Testing
๐ฌ Adhesion & Peel Testing
- ASTM D3330 Peel Adhesion Testing
- ASTM D1876 T-Peel Test
- ASTM D903 Peel Strength Testing
- ISO 527 Tensile Properties
๐งช Friction & COF Testing
- ASTM D1894 Coefficient of Friction
- ISO 8295 Friction Testing
- ASTM D4521 Biaxial Flexure Strength
- ISTA 3A Package Testing
Advanced Pharmaceutical Testing Capabilities
Cutting-edge technology designed specifically for pharmaceutical quality control and regulatory compliance
Syringe & Injection Testing
Comprehensive syringe plunger force testing, injection force measurement, needle penetration testing, and drug delivery system evaluation with automated data capture.
Blister Pack Testing
Specialized testing for blister pack seal strength, puncture resistance, peel testing, and package integrity with custom fixtures for various blister configurations.
Tablet Testing Solutions
Tablet crush resistance testing, hardness measurement, dissolution testing support, and coating adhesion evaluation with USP compliant procedures and reporting.
Validated Software Suite
CFR 21 Part 11 compliant software with electronic signatures, audit trails, secure data management, and automated compliance reporting for pharmaceutical validation.
Data Security & Integrity
Advanced data protection with encrypted storage, access controls, backup systems, and comprehensive audit trails to ensure data integrity and regulatory compliance.
Environmental Testing
Temperature and humidity controlled testing chambers for stability testing, environmental stress evaluation, and accelerated aging studies of pharmaceutical materials.
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