Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

ANVISA RDC No. 17 (2010), page 20 NOW OBSOLETE


Section V

Production Areas

Art. 125. There should be used segregated facilities and dedicated to the production of certain medications such as certain biological preparations (e.g. live microorganisms) and the highly sensitizing materials (e.g. penicillin, cephalosporin, carbapenem and other beta-lactic derivatives) in order to minimize the risk of serious damage to health due to cross contamination.

§ 1 In some cases, such as highly sensitizing materials, segregation should also occur between them.

§ 2 The production of certain highly active products, such as some antibiotics, certain hormones, cytotoxic substances should be held in segregated areas.

§ 3 In exceptional cases, such claims (fire, flood etc.) or emergency situations (war etc.) the principle of work campaigning on the same premises can be accepted, provided that they take specific precautions and necessary validations are made ( including cleaning validation).