PT  - JOURNAL ARTICLE
AU  - Whyte, W.
TI  - A Multicentred Investigation of Clean Air Requirements for Terminally Sterilized Pharmaceuticals
DP  - 1983 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 138--144
VI  - 37
IP  - 4
4099  - http://journal.pda.org/content/37/4/138.short
4100  - http://journal.pda.org/content/37/4/138.full
SO  - PDA J Pharm Sci Technol1983 Jul 01; 37
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.