CS Analytical Laboratory, the world’s only FDA regulated contract laboratory exclusively dedicated to providing regulatory solutions and qualification testing services for drug product and medical device container systems, is excited to announce that Chief Scientific Officer Brandon Zurawlow has been formally recognized by the Parenteral Drug Association (PDA) for his contributions to Technical Report No. 86, Industry Challenges and Current Technologies for Pharmaceutical Package Integrity Testing. PDA Technical Report No. 86 offers guidance on container closure integrity testing, expanding on and offering additional insights to the now well-established USP 1207.

“As an organization, the entire CS Analytical Team is proud of the work that Brandon has performed and we, like all of industry, appreciate the contributions he has made in helping to improve and advance the integrity and overall qualification testing requirements of medical product package systems,” commented CS Analytical CEO Brian Mulhall, “He brings a logical and scientific outlook, along with passion and dedication, to helping clients and the marketplace as a whole interpret and meet strict and everchanging regulatory requirements for package integrity testing. We see it daily and it is nice to see an organization like the PDA recognize his contributions. Patient safety is improved because of people like Brandon.”

As outlined by the PDA “this technical report is a consensus-based resource surrounding the challenges encountered in using complex package systems and introduces important elements to consider in decision-making. It also offers an examination of the technologies available for package integrity testing not yet established by peer-reviewed research. This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., syringes, syringe assemblies, bulk containers). It also presents information on some innovative methods for package integrity testing using existing technologies, including the potential impact of cryogenic conditions. The intent is to update information and incorporate experiential learning which is not addressed in PDA Technical Report 27 and USP 1207. It also serves as a technical resource, focusing particularly on sterile products and encouraging a risk-based approach and leveraging testing to better understand, analyze, and eliminate the risks during developmental phases. Use of the appropriate testing during each manufacturing phase can help in evaluating and mitigating residual risks.”

To further review or purchase this report, please use this link: https://www.pda.org/bookstore/product-detail/6132-tr-86-pharmaceutical-package