PT  - JOURNAL ARTICLE
AU  - Uotila, Jaakko A.
AU  - Santasalo, Niilo T.
TI  - New Concepts in the Manufacturing and Sterilization of LVP’s in Plastic Bottles
DP  - 1981 Jul 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 170--175
VI  - 35
IP  - 4
4099  - http://journal.pda.org/content/35/4/170.short
4100  - http://journal.pda.org/content/35/4/170.full
SO  - PDA J Pharm Sci Technol1981 Jul 01; 35
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.