Quality by Design White Papers & Case Studies

1. Characterization Of Protective Face Masks 10/7/2020

   Face masks, such as surgical masks, are intended to prevent large particles from being expelled by the wearer into the environment. This report focuses on the physical characterization of a three-layer pleated mask and a molded cup mask.

2. 100% Container Closure Inspection Of Freeze Dried Drug Product In Quarantine 12/26/2018

   A leading contract manufacturer approached LIGHTHOUSE for help after a suspected raised stopper issue motivated the manufacturer to place several batches into quarantine. A decision was made to perform 100% container closure inspection of the product vials with the help of LIGHTHOUSE.

3. Quality By Design In Biomanufacturing 12/22/2011

   QbD is increasingly required in our industry, but there are still gaps in understanding how QbD applies to the biomanufacturing process.

4. MTOSoftgels: Providing Cohort Specific Hand Filled Softgel Capsules For Dose Escalation Studies 11/2/2011

   Formulation and automated manufacture of capsules for early phase dose escalation clinical trials can be costly and wasteful. By Lisa Z Crandall

5. White Paper: Advancing Regulatory Science For Public Health 12/9/2010
   This document outlines a broad vision for advancing regulatory science and unleashing its potential to improve public health. It discusses the role of the FDA, working with partners, to strengthen the field, both within the agency and throughout the Nation. By Food and Drug Administration (FDA)
6. Case Study: Wyeth Pharmaceuticals, Ireland, Getting Production Down PAT 2/28/2010
   The 10th-largest pharmaceutical company in the world, Wyeth Pharmaceuticals, features strongly in the development of innovative products in the pharmaceutical sector and biotechnology. By Siemens Industry, Inc.
7. Flexibility In Sterility Testing And Managing Risks Of False Positives

   This paper reviews the background to false positives and false negatives associated with the sterility test process. It explores the potential causes of such results and suggests methods of mitigation. By James Drinkwater, Bioquell UK Process & Compliance Director 

8. A Strategy For Implementing Rapid Microbial Methods

   The purpose of this white paper is to present a strategy to be used and applied for rapid microbiological methods (RMM). By Gilberto Dalmaso, Sterility Assurance Consulting, A&L Co

9. Biological Contamination Management In Aseptic Environments: Requirements And Expectations

   Bio-contamination found in critical zones within processing environments can affect the whole process and sterility of the final products, potentially putting patients at risk. This can lead to significant financial costs and impact operational resources. By James Drinkwater

10. Detecting Integrity Breaches In A Range Of Pharmaceutical Blister Package Types

    Demonstrating the integrity of pharmaceutical blister packs is critically important, as any defects can affect the shelf life and efficacy of the contents. By Dr. D. Dixon, University of Ulster