Inspired by Jeanne Moldenhauer
Vice President at Excellent Pharma Consulting
At a local Northeast PDA meeting on May 18, 2016, over 130 attending, eleven BSM colleagues attended a 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. Jeanne went on to explain that the US is slow to adopt changes in the drug manufacturing industry. Her entertaining, 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:
What happens if:
- Personnel wear these outside the facility
- Personnel are seen outside smoking with them on
- Personnel are seen in meeting rooms with them
- Personnel are seen with them on in offices
- Personnel are seen with them in other (non-cleanroom) and laboratory areas
- Replacement frequency
- Sterilization methods
- Material of construction
Then SOCKS was the next step past shoes and again there are many things to consider (antibacterial, anti-fungal, keep moisture in and out, stain proof, etc.). What would be the next consideration? Garments and gowning materials. What’s the frequency of washes and replacement which can be measured by sensors? There are sensors that can basically tell you the impact to these garments which is not typically monitored. Are sensors employed? No? Why? Is it the cost? Industry acceptance? Sustainability?
There are many technologies that can reduce microbial ingress and increase personnel comfort but they are not considered in the US. These technologies would not only protect the product from contamination but also increase personnel comfort.