RT Journal Article
SR Electronic
T1 New Concepts in the Manufacturing and Sterilization of LVP’s in Plastic Bottles
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 170
OP 175
VO 35
IS 4
A1 Uotila, Jaakko A.
A1 Santasalo, Niilo T.
YR 1981
UL http://journal.pda.org/content/35/4/170.abstract
AB The increased use of plastics as a packaging material for large volume parenterals has created new requirements for the manufacture of LVP’s. This paper concerns the manufacture of I.V. solutions in polyethylene bottles recently started at a pharmaceutical plant in Finland. The equipment used in the manufacturing is discussed; i.e., a distillation apparatus, an automatic water system, and a compact filling machine which blowmolds, fills, and seals the bottle. Special attention is paid to the sterilization process. The principle of the air cooling autoclave is presented as well as the validation studies. The methods employed to assure sterility of the product are discussed. Additionally, some of the European GMP regulations are compared with American LVP proposals by presenting a few examples.