Case Studies Provide Insight in a Diverse Pharmaceutical Manufacturing Field

Original image via Know Genetics

Original image via Know Genetics

The following is an evaluation of some of the Case Study presentations that will be at INTERPHEX 2014.

Risk is a necessary but uncertain part of our industry.  As individuals assess and decide on a process and scoring system there must be a method for evaluating what constitutes a high risk. Julian Wilkins studied an exercise on perceived risk versus actual risk at multiple sites worldwide and developed an approach to address the issue. Wilkins is speaking on the subject, titled “Case Studies in Making Risk Assessments Meaningful,” at INTERPHEX 2014. His goal is that attendees will leave the presentation with greater understanding of the need for data versus perception driven assessments, the business benefit of data driven assessments and the regulatory benefit of data driven assessments.

The core purpose of this industry is to maximize the value of our time, facility and workers. The fluctuations in air conditioning and electrical system uses throughout the term of a production can be detrimental to the quality of the product. The presentation, “Commissioning and Performance Testing of a Data Center” with Aaron Weinstein and Robert Legland will increase the knowledge of effectively testing the performance of a Data Center while educating them on efficient planning.

As you know, all pharmaceutical manufactures will be required to have in place unit level serialization by 2017 as per DQSA. This is a specific and necessary addition to the pharmaceutical field that will drastically affect any operation. “Serialization Impacts in the Pharmaceuticals Industry” is another case study which will focus on the effect of this requirement. Attendees will gain a greater understanding of various needs for implementing this system in bottle and carton packaging facilities from speakers Jean-Pierre Allard and Ken Fallu. There will be in-depth comparisons of implementation strategies and practical solutions for different challenges.

A current trend in the pharmaceutical industry is the increase in soft gelatin capsule technology. There are many new, high-speed, machines equipped with automation. The decrease in craftsmanship and increase in Process Analytical Technology (PAT) will effectively reuse gelatin and reduce gelatin waste while lowering costs and increasing productivity. Ramiro Goñi’s expertise will lead the presentation on the subject at INTERPHEX. This comprehensive study of the modernizations of this industry will change many people’s viewpoints on the use of softgels.

The diverse range of powder products present in the pharmaceutical and biopharmaceutical industries remains as a dynamic and revolutionary product area. Spray crystallization is one of the newest techniques that can be used to stabilize powder products. This method provides compact freezing processes with a high output. The specific experience of a biopharmaceutical customer with this method will be discussed at the “Cryogenic Spray Crystallization Technology to Improve the Customer Product Quality” presentation with Svetlana Ivanova. In which there will be a discussion on the advantages of this process compared to traditional lyophilisation or pelletizing and how this method can improve cells viability.

For more information on these and other case studies being presented at INTERPHEX 2014 visit the website. Register here.

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About INTERPHEX

Official blog of: INTERPHEX New York - www.interphex.com
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