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Physical-Functional Testing

Life Sciences / Central Laboratory Services / Physical-Functional

Maintain Quality Control with Functional & Performance Testing

Ensure patient compliance and effective drug delivery of your intended dosage form by evaluating its physical properties. From the more subtle and qualitative attributes like visual appearance and mouth feel to the measurable performance of hardness, friability, and disintegration, our team helps evaluate numerous factors about your drug product, medical device, or combination product. More complex aspects we consider include transdermal adhesive characteristics, delivered-dose uniformity of inhalation products, dispensing forces required for pre-filled syringes (PFS), and the physical characteristics of the dosage form matter.

Physical and functional performance testing in pharmaceuticals and drug delivery characterizes product performance and establishes a baseline for quality control. For example, the U.S Food and Drug Administration (FDA) expects container closure systems to provide adequate product protection without affecting safety or efficacy and should also function as intended throughout the shelf life. The combination of functional testing and physical testing provides you with a comprehensive understanding of your product. Functional testing insights ensure a safe and effective product for patient use, and physical testing verifies consistent quality and adherence to regulatory requirements. Partnering with our team to perform this testing safeguards your success with services tailored to your unique product needs.

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Comprehensive Dosage Form Support

We identify the essential performance attributes unique to your product by evaluating its specific characteristics and addressing your specific concerns. Our experience with physical testing spans across solid, liquid, topical, transdermal, and inhalation dosage forms, as well as various devices and component systems used for drug delivery. Leveraging diverse, collective knowledge from decades of experience, our expert team provides actionable guidance to propel your project forward.

Physical Functional Testing Capabilities

  • Instron tensile testing
  • Adhesive peel testing
  • Elasticity testing
  • Transdermal peel force testing
  • Release liner adhesion testing
  • Probe tack test
  • Shear test
  • Viscosity testing
  • Penetrometer testing
  • Burst testing
  • Creep testing
  • Tablet hardness testing
  • Polymer hardness testing
  • Durometer hardness testing
  • Tablet disintegration test
  • Syringe compression delivery force test
  • Force Test
  • Needle break force test
  • Custom method development & validation
  • Custom test fixture development
Physical-Functional, Functional Testing

Functional Testing

For Finished Medical Device Products, we offer a variety of testing methods to verify the critical endpoints for your product. Our evaluations support compliance with USP <382>, USP <660>, USP <670>, USP <671>, USP <2107>, and ISO 11608. Endpoints for evaluation include:

Finished Product Services

PACKAGING

Performance testing of your product packaging is essential for the delivery of a safe and effective product. Our team provides a wide range of services evaluating the strength, integrity, materials, and labels of your packaging to ensure it satisfies key requirements.

STABILITY & STORAGE

Stability studies and shelf-life testing safeguards your products’ performance and regulatory compliance. We support studies for both short-term (accelerated) and long-term stability programs as well as photostability programs for both research and development and commercial products.

DISTRIBUTION

Distribution simulation testing provides a uniform and repeatable way of evaluating packaged products and packaging designs by utilizing standardized equipment and procedures to subject the packaging to anticipated hazards that may occur with routine distribution of packaged products.

Our Expertise

With over 20 years of experience with physical-functional testing, we continuously enhance our state-of-the-art facilities to provide you with the highest level of service. Our dedicated laboratory space is both temperature- and humidity-controlled for accurate pre-test conditioning and seamless completion of testing. When you partner with us, rest assured that your product is tested under GMP quality standards for reliable, compliant results.

Ready To Get Started?
Or Call: 612.656.1175

Integrated Laboratory Services  

When your team needs additional CDMO support, our scientists are ready. Our state-of-the-art facilities and highly trained experts can add power to your project.

Additional Resources

Pace® is a registered facility with the U.S. Food and Drug Administration (FDA), demonstrating our commitment to meeting regulatory requirements for quality and safety in the industries we serve.

Pace® holds a registration with the Drug Enforcement Administration (DEA), allowing us to handle controlled substances and support the specific needs of our clients in regulated industries.

Pace® adheres to current Good Manufacturing Practices (cGMP), ensuring that our laboratory facilities and processes meet the highest quality standards set by regulatory authorities for the pharmaceutical, biopharmaceutical, and medical device industries.

Pace® is accredited to ISO/IEC 17025, the international standard for competence in testing and calibration laboratories, validating our technical competence and commitment to delivering accurate and reliable results.