Depart, depart, go out from there, touch nothing unclean.

Training is a critical element for personnel involved in pharmaceutical aseptic manufacturing operations. To maintain product sterility, operators involved in the activities use aseptic techniques (behaviors) at all times. The US FDA and other cGMP guidances prescribe routine media fill studies to ensure that the particulate and microbial quality is adequate. The challenge study requires maximum personnel to be present with an elevated activity level (as permitted by SOP). NIH Human Microbiome Project has determined that bacterial species on the skin layer are diverse, comprising of more than 1000 species.

Case studies have attributed aseptic processing contamination to one or a combination of:

The behaviors that we have diligently learned and routinely practice in parenteral manufacturing suits may now come handy during this COVID-19 outbreak. Let’s examine some of them:

• Opening doors with the forearm is a behavior that prevents contamination of the operator’s gloved fingers and hands. This approach can be applied in crowded places instead of using doorknobs. 

• Washing hands for NLT 20 seconds with flowing lukewarm water, applying soap and vigorously scoping until elbow and rinsing hands without touching anything is another behavioral requirement described in SOPs. Handwashing is critical in the fight against COVID-19.

• 70% isopropyl alcohol (IPA) is required to be routinely used by operators to disinfect. 70% IPA is better than 100% for two reasons:

1. 100% IPA quickly coagulates protein creating a protective layer while 70% IPA is more lethal as it slowly penetrates the cell wall and coagulates all protein.
2. 100% IPA evaporates fast while 70% IPA stays active longer. 

• Wiping in a circular motion is avoided during aseptic processing. For effective removal of contaminants and to minimize their spread, uni-directional wiping using parallel stokes is ideal. Wiping is done from the cleanest area to the least clean area. 

• The mask is tied snugly so that it conforms to the contour of the face. The mask is formed to the bridge of the nose. While removing and discarding, the front of the mask and inside of the glove is not touched.

Are you ready to display pharmaceutical aseptic behaviors at home, with friends and family?

Do you agree that aseptic behavior training and the skills that we gained through practice may help in protecting us from some of the rapidly transmitting viruses like COVID-19?

Share, comment and voice your thoughts.

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