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Aseptic production techniques in the pharmaceutical sector require specific processes and practices to prevent contamination of products.
Operators working in aseptic manufacturing areas need specific changes to routine human behaviour. This is where enabling and embedding ‘robotic comportment principles’ comes into play. These help to eradicate the human traits that can cause contamination within these areas.
Poor aseptic practices can affect thousands of vials or syringes containing critical injectable product. This is sobering when each vial or syringe represents the potential to adversely affect a patient’s health.
We caught up with our Aseptic Production Subject Matter Expert, Kevin Owen. He talked to us about the impact of operator behaviour affecting product quality. Kevin also shared how potential contamination risks from people within critical areas can be overcome.
“We must look at the aseptic production process holistically, not just from a manufacturing perspective. Our role is to remove human imperfections using Aseptic processing and microbiology knowledge. This allows us to remove the operator from the aseptic process as much as possible. For example, by using Robots and Restricted access barrier or Isolator systems. Also by embedding strict operator behavioural traits when no other option is possible. It’s all about managing the risk”.
The designs and operations of Aseptic cleanrooms mean microbial contamination enters mainly via people. Typically this is the only route for most contamination.
That is why Aseptic training is so important - to educate and teach people to behave and act in a certain way. This includes ensuring operators walk and move in a slow and methodical fashion. The operator must alter their response to natural human activities e.g. sneezing, folding arms, the need to scratch an itch. Not an easy task to strip away years of human behaviour! Even so, this must become second nature – even when nobody is looking. There is no room for error in aseptic behaviours – after all, each vial represents a patient’s life.
"As engineering and operational specialists, we are responsible for sharing our knowledge and experience. We need to help establish these behaviours as being best Aseptic practice within the sector. It is our duty of care to ensure this is so". Added Kevin.
In addition to providing Aseptic Training expertise to our clients, Kevin is speaking at the following C&VS international training events:
Aseptic Manufacturing of Pharmaceutical Products: 13-15th April & 7-9th September.
Understanding Pharmaceutical Sterilisation: 25-27th May & 16-18th November.
C&VS (Compliance & Validation Services) provide validation and compliance services to the pharmaceutical and related industries.