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Tiered Banding Concept for Pharmaceutical Intermediates

Winkler, Gian Christian and Lovsin Barle, Ester and Mirwald, Jens (2016) Tiered Banding Concept for Pharmaceutical Intermediates. Chimica oggi; chemistry today, 34 (4). pp. 32-36. ISSN ISSN 0392-839X, EISSN 1973-8250

Abstract

In pharmaceutical manufacturing operations, a suitable tiered banding concept (TBC) is applied to protect workers from the exposure to chemically reactive intermediates (small molecules), compounds with limited or no toxicity information. It has to be optimized for cost efficiency and reduced use of animals for safety testing. In addition to worker safety, results of a TBC (also termed integrated testing strategy) have to be acceptable by regulatory authorities for classification, labelling, packaging and transport of chemicals. This publication describes the presently established TBC for small molecule intermediates (IMs) by the company. A decision tree provides a step by step guidance. The tiered approach is commented and data as well as and rationale are provided for each endpoint.

Item Type: Article
Keywords: Tiered banding, classification labelling and packaging, occupational health, worker safety, pharmaceutical manufacturing, mutagenicity, skin sensitization, skin irritation, eye irritation, integrated testing strategy, alternative testing methods
Date Deposited: 06 Sep 2016 00:45
Last Modified: 06 Sep 2016 00:45
URI: https://oak.novartis.com/id/eprint/29520

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