• Cleanroom Gowning Programs Compliant With EU GMP Annex 1

    Part 1 of this article series provided an overview of cleanroom gowning per the revised EU GMP Annex 1. This article focuses on establishing an aseptic personnel gowning program compliant with the Annex.

  • Cleanroom Gowning Compliant With EU GMP Annex 1: An Overview

    This article focuses on cleanroom gowning as it pertains to aseptic manufacturing of medicinal products and the updates to gowning requirements in the revised EU GMP Annex 1 document published in August 2022.

  • The Essential Components Of A Sterility Assurance Program

    The first step in developing a sterility assurance program is to list each step in the process, beginning at the point of use and ending in sterile storage. Each step should be evaluated for ways to prevent contamination in the manufacturing process or environments. This article shares the components of a holistic sterility assurance program for an aseptic manufactured product.


Crystal M. Booth

Crystal M. Booth, M.M., is a regional manager at PSC Biotech and has over 20 years of experience in pharmaceutical microbiology. She obtained her master’s degree in microbiology from North Carolina State University. Booth is a seasoned, award-winning technical writer and author of "Method Development and Validation for the Pharmaceutical Microbiologist." During her career, she has worked in microbiology, consulting, quality assurance, CDMOs, R&D, and quality control laboratories. Booth has developed and validated numerous microbial methods and has worked with many different product types.