PT  - JOURNAL ARTICLE
AU  - Whyte, W.
AU  - Bailey, P. V.
AU  - Tinkler, J.
AU  - McCubbin, I.
AU  - Young, L.
AU  - Jess, J.
TI  - An Evaluation of the Routes of Bacterial Contamination Occurring During Aseptic Pharmaceutical Manufacturing
DP  - 1982 May 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 102--108
VI  - 36
IP  - 3
4099  - http://journal.pda.org/content/36/3/102.short
4100  - http://journal.pda.org/content/36/3/102.full
SO  - PDA J Pharm Sci Technol1982 May 01; 36
AB  - Experiments were carried out to establish the amount of bacterial contamination derived from the air and hands of operators and its influence on a semi-automatic vial filling operation in an Aseptic Production Area. Air and hand contamination were found to be important factors, accounting for practically all of the contamination. Only by use of a Class I environment, with an associated microbiology count of less than 1/m3, and adoption of the best hand protection was it possible to achieve the product contamination standard suggested by the Parenteral Drug Association (1) (0.1%). All of the bacteria contaminating the vials were found to be Gram-positive. These bacteria were identified and found to be the type derived from people and correlate with those isolated from the air and the operator's hands. The significance of this as well as the experience of the operator and the efficiency of hand washing techniques are discussed.