Force Measurement for Quality Drug Delivery

Mechanical force is a critical quality attribute in drug delivery and combination products. Parameters such as plunger resistance, activation force, cap removing force, and packaging strength directly influence usability, dose accuracy, container integrity, and regulatory acceptance.

The Force Measurement Services offered by nuvalore GmbH provide pharmaceutical and medical device development teams with robust, GMP-compliant mechanical data to optimize designs, perform meaningful risk assessments, and support fully validated regulatory submissions.

Tailored to Pharma and Medical Combination Products

All testing is performed in a GMP environment using validated universal testing systems and ISO-aligned methods, ensuring reproducibility, traceability, and regulatory confidence.

Using advanced mechanical testing platforms (including systems such as the ZwickiLine 0.5), nuvalore captures precise force profiles that reveal variability, usability risks, and functional performance across the full product lifecycle.

Comprehensive Force Characterization Capabilities

nuvalore supports force characterization across a broad range of drug delivery systems and primary packaging components, including:

• Prefilled syringes: Measurement of break-loose force and glide force to assess plunger movement consistency, injection smoothness, and leak tightness.
• Autoinjectors and pen injectors: Full force-profile analysis covering activation force, spring deployment, injection force, and functional performance during simulated use.
• Container closures and components: Evaluation of needle penetration force, needle shield removal, cap opening, and closure integrity to balance container security with patient usability.
• Primary packaging materials: Tensile, peel, and seal-strength testing of blister packs, foils, and pouches to verify packaging robustness while maintaining ease of opening.

Actionable Data, Regulatory-Ready Data

Clear force profiles help teams define acceptance criteria, compare lots or design variants, and mitigate mechanical risks early to avoid costly late-stage surprises. nuvalore’s force measurement data is designed to be directly usable in the decision-making development phase, while complying with regulatory documentation standards for use in late-stage development and approval processes.

• Each study delivers:
• Traceable, GMP-generated force data
• Standardized and repeatable test protocols
• Comprehensive, regulatory-ready reports including force profiles and statistical evaluation
• Documentation aligned with pharmaceutical quality standards and regulatory expectations
• By choosing nuvalore’s quality-by-design approach, teams receive profound reliable data to strengthen device robustness, improve patient usability, accelerate timelines, and increase confidence during regulatory review.

Resources

Learn more about nuvalore’s Force Measurement Services and combination product mechanical testing capabilities.
Speak to a nuvalore expert.