About us - PM Group
Aseptic cleanrooms need to provide safe and clean conditions when making sterile injectable products. But how is this achieved?
Aseptic Production Subject Matter Expert Kevin Owen recently spoke at the C&VS ‘Understanding Pharmaceutical Sterilisation’ conference. He explained the importance of correct behaviours being practiced by the cleanroom operators.
Aseptic technique and behaviours relate to comportment i.e. how the operators move and behave. Comportment requires embedding into the operator to consistently avoid contaminating the cleanroom. Even standing still is an art – with arms bent at the elbow, palms up and away from the body. This technique minimises contamination within the critical sterile areas. The desire to act on normal human instinctive behaviour must be avoided eg scratching, sneezing, sudden movement.
These aseptic behaviours need to be performed regardless of anybody looking. Doing the right thing, because it is the right thing to do.
According to Kevin, “These principles are comparable to our own behaviour when entering a supermarket in recent times. After over a year of rules and regulations, it is now second nature to wear our mask within the shop. Similarly, when an operator enters a cleanroom, the environment triggers the proper aseptic behaviours – akin to wearing a mask, sanitising and following social distancing rules.”
All these critical behaviours need to be ingrained into sterile operators, and they must conform to the correct exacting behaviour at all times within the aseptic suite. Their attitude and diligence to these behaviours keep the sterile products safe for all of us to use without fear.