Description
Testometric provides specialized test systems engineered for pharmaceutical industry needs, specifically for evaluating the mechanical properties of packaging materials, drug delivery systems, and medical devices. These systems are designed for CFR 21 Part 11 compliance and feature validated software, electronic records capability, and advanced data integrity controls.
Our testing solutions support quality control, R&D, and regulatory validation of materials used in blister packs, sachets, pouches, tablet packaging, syringes, and sealed containers. Systems can be equipped with custom fixtures, environmental chambers, and multi-mode grips to simulate real-world conditions and mechanical stress scenarios.
Typical Test Capabilities:
- Tensile Strength of Packaging Films & Foils
- Seal Strength & Peel Testing
- Syringe Plunger Force Testing
- Tablet Crush Resistance
- Puncture Resistance for Blisters & Containers
- Friction and Coefficient Testing (COF)
- Adhesion and Bond Strength
- Package Integrity and Leak Detection (when integrated with external modules)
Relevant International Test Standards for Pharma:
Tensile & Seal Strength Testing:
- ASTM D882: Standard Test Method for Tensile Properties of Thin Plastic Sheeting
- ASTM F88/F88M: Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1140: Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages
- ASTM F2054: Burst Testing of Flexible Packages
- ISO 527: Determination of tensile properties of plastics (commonly used for blister & film testing)
Adhesion & Peel Testing:
- ASTM D3330: Peel Adhesion of Pressure-Sensitive Tapes
- ASTM D1876: Peel Resistance (T-Peel Test) of Adhesive Bonds
- ASTM D903: Peel or Stripping Strength of Adhesive Bonds
Tablet & Syringe Testing:
- USP <1217>: Tablet Breaking Force
- ISO 7886-1: Syringes for medical use — part 1: test for plunger glide force
- ISO 11040: Prefilled syringes — mechanical testing for needle shield removal and plunger resistance
Friction & Blocking:
- ASTM D1894: Standard Test Method for Static and Kinetic Coefficients of Friction of Plastic Film and Sheeting
- ISO 8295: Plastics — Film and sheeting — Determination of the coefficients of friction
