Vice President at Excellent Pharma Consulting
At a local Northeast PDA meeting on 5/18/16, over 130 attending, eleven BSM colleagues attended a great meeting where the “The Cleanroom of the Future” was presented, by Jeanne Moldenhauer.
She posed the question:
“What is new in cleanrooms and environmental monitoring?”
Great question and Jeanne went on to explain that change in the drug manufacturing industry is slow to adopt in the US. Her entertaining, but yet, somewhat depressing talk, went through a litany of issues with people and cleanrooms. One example was dedicated shoes – a small change but how difficult it can be to actually implement and see the desired effect of the change:
Have or did one consider the following?
- Personnel wearing these outside the facility
- Personnel seen outside smoking with them on
- Personnel seen in meeting rooms with them
- Personnel seen with them on in offices
- Personnel seen with them in other(non-cleanroom) and laboratory areas
Did they consider?
- Replacement frequency
- Sterilization methods
- Material of construction
Then SOCKS was the next step past shoes and again many things to consider, antibacterial, antifungal, keep moisture in and out, stain proof etc… what would be the next consideration – yes – now the garments – gowning materials. The frequency of washes and replacement which can be measured by sensors. There are sensors that can basically tell you about the impact to these garments. These are not typically monitored. Are sensors employed – no – why?
- Industry acceptance?
There are so many technologies that can reduce microbial ingress and increase personnel comfort but yet they are not considered in the US and they would not only protect the product from the people contamination more but also increase people’s!