Aseptic Technique and Gowning

by | Mar 13, 2023 | Pharmaceuticals, Product Development, Quality

One of the most common techniques to prevent contamination of products and reduce quality impacts in the pharmaceutical industry is called aseptic gowning. Humans are the biggest sources of microbial contamination in cleanroom environments and therefore proper gowning procedures are essential to ensuring product quality. Proper training, education, hygiene, qualification, and authorization must be put in place and be required for entry to all clean room environments.

For authorization, badge access is one of the more common methods to ensure that only employees who have successfully completed the required trainings and are qualified to be in the cleanrooms, can be in the cleanrooms.

All personnel must also have good hygiene prior to entry. This would not only include personnel taking a daily shower and washing their hair, washing their hands prior to entry, but also removing any jewelry, makeup, and being open to communicating with management about overall health and any skin conditions.

Gowning supplies are often single use and come sterile but also can come in reusable forms. Reusable gowning must be washed and sterilized in a validated process and carefully managed to ensure the clothing integrity is maintained. These must be kept free of loose threads and be always non-shedding. Different gowning levels are used for different grades of cleanroom depending on the process being used in the environment. As a general rule, all gowning should be done from the top down, starting with a hairnet, and working down from there. After gowning is complete a final check is required to ensure there is no hair or skin exposed that could allow for contamination.

Periodic refresher trainings are often very helpful in ensuring that colleagues understand the importance of gowning. These can provide additional information as well as reiterating the previous information to ensure gowning techniques are applied correctly and consistently to reduce the risk of microbial contamination and ensure good product quality.

If you need support for implementing successful aseptic technique and gowning trainings to improve product quality, the experts at EMMA International can help! Call us at 248-987-4497 or email us at to learn more.

Jacob Wright

Jacob Wright

Jacob Wright is a Quality Engineer at EMMA International with expertise in regulatory compliance, process validation, and quality management systems. He received his Bachelor of Science and Master's degrees in Biological/Biosystems Engineering from Michigan State University, where he developed a deep understanding of living organisms and engineering systems. Jacob's strong commitment to quality, attention to detail, and risk mitigation skills make him an effective advocate for regulatory compliance and product safety.

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