The influence of clean room design on product contamination

This paper reports the results from a series of investigations carried out in the U.K. into the importance of airborne contamination and the ventilation of pharmaceutical manufacturing areas. Practical investigation in five pharmaceutical manufacturing areas producing terminally-sterilized parenterals showed airborne contamination by bacterial and inert particles to be unimportant; the main source of particle contamination came from the containers and closures, especially after sterilization. Theoretical studies were also carried out which enabled the amount of airborne contamination of containers to be calculated; the results showed the airborne route to be a very minor one. An investigation into the airborne contamination of products which were not terminally sterilized showed that airborne microbial contamination could be of major importance