RT Journal Article
SR Electronic
T1 A Multicentred Investigation of Clean Air Requirements for Terminally Sterilized Pharmaceuticals
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 138
OP 144
VO 37
IS 4
A1 Whyte, W.
YR 1983
UL http://journal.pda.org/content/37/4/138.abstract
AB Experiments were carried out in four manufacturing pharmacies to assess the effect of ventilation and airborne contamination on terminally sterilized products. Each pharmacy manufactured containers of 0.9% sodium chloride and carried out experiments in widely differing conditions of airborne cleanliness. No correlation could be demonstrated between the cleanliness of the air and the quality of the product (as established by bacterial and dust particle counts) and it was concluded that the containers and closures (especially after autoclaving) were the main source of contamination. It is suggested that complex ventilation schemes for the production of terminally sterilized products are not necessary.