Linking Product And Process: How Harro Höfliger's Robust Database Characterizes And Optimizes Product Development

By Karin Marek, Maximilian Fuchs, Dr. Elke Sternberger-Rützel

Modern pharmaceutical development relies on Quality by Design principles to establish clear links between Critical Material Attributes, Critical Process Parameters, and Critical Quality Attributes. Building a centralized material characterization database that documents powder rheology, compressibility, and historical dosing performance enables systematic risk assessment and accelerates process development. Employing Design of Experiments methodologies allows engineering teams to map complete operational windows, revealing how machine speed, vacuum levels, and stirrer geometries influence fill weight uniformity. Standardizing material testing protocols minimizes batch variability, simplifies technology transfer, and drastically reduces empirical testing requirements during scale-up. Read the full paper to discover how structured material characterization databases optimize process development and strengthen regulatory compliance strategies.

Harro Höfliger designs, engineers and manufactures state-of-the-art production equipment for pharmaceutical and medical device clients around the world. Our global presence in automation technologies facilitates production in:

• Medical Device Assembly
• Parenteral Device Assembly
• Pharmaceutical Dosing Technologies
• Capsule Filling and Weighing
• Cell & Gene Therapy Automation
• Aseptic Applications
• Packaging Equipment
• Diagnostics Manufacturing
• Surgical Suture Production
• Inhalation Dosing and Assembly
• Web Processing and Converting
• Eye Care and Contact Lense Manufacturing
• Wound Care, Transdermal, and Oral Dissolvable Film Production

Whether your application requires manufacturing, assembly, filling, sealing, packaging, technical consulting – or any combination of the above – Harro Höfliger brings 50+ years of expertise to each customer’s unique pharmaceutical and/or medical device project. No matter if your product is in the laboratory and development phase or it demands commercial production, our global team of engineers, designers, pharmacists, and customer service providers are equipped to support the success of each project, well into its future.