FDA FDA Releases Q&A Guidance On Human Factors Engineering For Combination Products

Developing an effective combination product can be easily undone if it is not used correctly, and errors made by patients or clinicians are often a direct result of design limitations. To support the co-packaged design process, the FDA has issued a new guidance document titled Application of Human Factors Engineering Principles for Combination Products: Questions and Answers.


"One stop” sterile injectable fill/finish capabilities can accelerate timelines and reduce costs. Explore August Bio’s operational flexibility and available capacity to support small-, mid-size, and large-scale batches.

For small molecule pharma or biotech companies looking for “one stop” sterile injectable fill/finish capabilities, August Bio has significant available capacity to support small-, mid-size, and large-scale batches today and as client volumes grow.



  • B. Braun manufactures a wide variety of interventional product solutions for a multitude of medical applications and procedures. Products can be made available as stand-alone solutions or incorporated into a sterile private-labeled device or kit.

  • In recent years, hospitals, clinics, and others have experienced chronic shortages of medical solutions. The Solutions for Life initiative is a billion-dollar investment in meeting nationwide demand for these products.

  • These containers can be delivered with a full line of solutions used in clinical settings, including basic saline, heparin premix, and lidocaine. The chemistry used to produce the container uses neither polyvinyl chloride (PVC) nor the plasticizer DEHP.

  • August Bioservices is a US-based, quality-driven CDMO that offers end-to-end drug development, analytical testing, and fill/finish manufacturing services to clients of all sizes and stages, from pre-clinical to commercial.

  • BD Neopak™ XtraFlow™ Glass Prefillable Syringe solution leverages 8 mm needle length in combination with thin wall cannula to reduce pressure drop and enhance flow.

  • RASR filling and closing machines are designed to treat IV bags. These machines are able to fill single chamber as well as dialysis multi-chambers bags.

  • B. Braun OEM Division is experienced in designing and manufacturing standard and custom valves ranging from small to large scale volumes. These valve products are available as stand-alone components, or may be incorporated into sterile, private-label kits and assemblies.

  • Capabilities that improve efficiency and accelerate development.

    B. Braun's OEM Division offers a variety of in-house molding capabilities including injection molding, insert molding and over molding. They own a primary 400,000-square-foot U.S. plant that includes a 16,500-square-foot ISO Class 8 molding facility housing some of B. Braun’s 80 injection molding presses, which range from 55-330 tons.