Pharmaceutical Testing Machines | CFR 21 Part 11 Compliant Systems
Universal Testing Machines and barrier analysers purpose-built for pharmaceutical packaging, drug delivery components, and medical devices. Full CFR 21 Part 11 validated software, IQ-OQ-PQ documentation, and electronic audit trails — trusted by GMP-regulated labs across India.
Technical Specifications for Pharmaceutical Testing
Precision engineering built for GMP environments — delivering repeatable, audit-ready results on every test run
Why Pharma Labs Choose Testometric
From blister pack seal strength to syringe plunger force — comprehensive, regulation-ready testing that keeps your QC one step ahead of the audit
CFR 21 Part 11 Compliance
Fully validated software with electronic records and signatures, comprehensive audit trails, user access controls, and advanced data integrity safeguards to satisfy every FDA inspection requirement.
Specialised Pharmaceutical Fixtures
Purpose-built grips for blister pack peel, syringe plunger compression, tablet crush platens, film tensile grips, seal peel jigs, and medical tubing pull — ensuring perfect specimen alignment and repeatable results every time.
USP and ASTM Standards-Ready Software
Pre-loaded test methods for USP 1217, ASTM F88, ASTM D882, ISO 7886-1, and 40+ more pharmaceutical standards. Auto-calculated results with one-click PDF/CSV export for batch records and regulatory submissions.
Barrier Testing: OTR and WVTR
Systech Illinois oxygen and water vapour transmission rate analysers measure the critical barrier properties of blister films, pouches, and bottles — providing shelf-life evidence for packaging teams and regulatory affairs departments.
Medical Device UTM Testing
Mechanical testing of syringe assemblies, medical tubing tensile properties, catheter pull-out forces, needle penetration resistance, IV bag seal strength, and packaging material characterisation — all on a single universal testing platform.
Advanced Data Management
Encrypted data storage, role-based access, automated statistical reporting, and seamless LIMS integration. Every test record is timestamped, signed, and retrievable — giving complete traceability from raw data to final release report.
Built-in Pharmaceutical Standards Compliance
Pre-loaded test templates and automated compliance reporting for USP, ASTM, ISO, and FDA requirements referenced by pharma QC labs worldwide
USP and Pharmaceutical
- USP <1217>Tablet Breaking Force
- ISO 7886-1Syringe Force Testing
- ISO 11040Pre-fillable Syringes
- CFR 21 Part 11Electronic Records
- 21 CFR Part 820Device Quality System Reg.
Packaging and Film Testing
- ASTM D882Tensile Properties of Films
- ASTM F88/F88MSeal Strength Testing
- ASTM F1306Slow Rate Penetration
- ASTM D1938Tear Propagation
- ASTM F2929Film Formability
Adhesion and Peel Testing
- ASTM D3330Peel Adhesion Testing
- ASTM D1876T-Peel Test
- ASTM D903Peel Strength Testing
- ISO 527Tensile Properties
- ASTM D638Tensile of Plastics
Barrier Testing Standards
- ASTM D3985Oxygen Transmission Rate
- ASTM F1249Water Vapour Transmission
- ASTM F1927Permeation Testing
- ISO 15105-2Gas Permeability
- ASTM F2096Seal Integrity Testing
Quality and Regulatory Systems
- ISO 17025Laboratory Competence
- ISO 9001:2015Quality Management
- EN ISO 11135Sterilization Validation
- GMP / cGMPGood Manufacturing Practice
Need a Custom Pharma Testing Solution?
Our specialists configure systems to your exact pharmaceutical materials, standards, and workflow requirements.
Systech Illinois OTR and WVTR Analysers
High-accuracy oxygen and water vapour transmission rate instruments — the industry standard for pharmaceutical packaging shelf-life validation
OTR Analyser
Measure oxygen transmission rates across pharmaceutical films, foils, and laminates. Supports ASTM D3985 and ISO 15105-2 with automated test sequences and fully documented electronic results ready for regulatory submissions and stability dossiers.
WVTR Analyser
Quantify moisture ingress rates through packaging used for moisture-sensitive APIs, biologicals, and solid dosage forms. Fully compliant with ASTM F1249 and ISO 15106-3, with validated GMP-ready software and automated data collection built in.
Every Pharma Testing Application Covered
One integrated platform handles mechanical, peel, puncture, barrier, and compression testing across the full pharmaceutical packaging and device portfolio
Trusted by Leading Pharmaceutical Organisations
From global medical device OEMs to pharmaceutical packaging leaders, FITCO delivers testing systems trusted by the industry's most demanding quality teams
Frequently Asked Questions
Common questions about pharmaceutical materials testing equipment and compliance
Testometric supports USP 1217, ASTM D882, ASTM F88/F88M, ISO 527, ISO 7886-1, ISO 11040, ASTM D3985, ASTM F1249, and over 40 additional pharmaceutical, packaging, and medical device standards. Pre-loaded test methods are included in the software, with custom method configuration available for specialist applications.
Yes. Testometric software is designed for full CFR 21 Part 11 compliance, including secure electronic records, electronic signatures, comprehensive audit trails, role-based user access, and data integrity controls. The system can be configured and validated to satisfy FDA inspections and internal QA requirements.
Yes. Full Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) validation support is available. Validation documentation packages are prepared to GMP standards and are supplied as part of the system commissioning process to meet internal QMS and external regulatory requirements.
The Testometric UTM platform covers: tensile strength of packaging films and foils, blister pack seal peel, tablet hardness and crush resistance, syringe plunger force and break-loose tests, medical tubing tensile properties, puncture resistance, peel adhesion, and three-point flexural testing. Systech Illinois instruments add OTR and WVTR barrier analysis for complete end-to-end pharmaceutical packaging characterisation.
Systech Illinois OTR and WVTR analysers measure oxygen and water vapour transmission rates of pharmaceutical packaging materials per ASTM D3985, ASTM F1249, ISO 15105-2, and ISO 15106-3. These instruments deliver the shelf-life performance data required for new product development, packaging change control, and stability studies under ICH guidelines.
Ready to Upgrade Your Pharmaceutical QC Lab?
Speak with our pharmaceutical testing specialists to configure a CFR 21 Part 11 compliant system for your exact materials, standards, and compliance requirements.