(1999; 168 pages) [Spanish]
4.1 Use of equipment
Many excipients are produced using multipurpose equipment. Fermentation tanks, reactors, driers, grinders, centrifuges and other pieces of equipment are readily used or adapted for a variety of products. With few exceptions such multiple usage is satisfactory provided the equipment can be adequately cleaned according to written procedures. Equipment that contains tarry or gummy residues that cannot be removed easily should be dedicated for use with these products only.
Some fermentation tanks, reaction vessels, and other equipment are not situated within a building and a considerable amount of processing occurs out of doors. Such processing is acceptable provided it occurs in a closed system.
Where temperature control is important, temperature recording devices should be used, with recording charts kept as part of the batch record.