Download Containment in the Pharmaceutical Industry by James P. Wood PDF

By James P. Wood

The ebook reports the ancient context, definition, evolution, and alertness of containment know-how, analyzes numerous containment thoughts in new and retrofitted development, and examines «people security» vs. «product safeguard» and the function of source-contamination in each one. It additionally indicates conceptualizing containment recommendations from the inception of a venture for low-priced, at-the-source containment, identifies containment necessities and tracking tools, in addition to the present nation of emission controls, and discusses the «dustiness» of powders and the way this study is being outlined, quantified, and utilized in containment layout.

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Additional resources for Containment in the Pharmaceutical Industry

Example text

Instruments have been classified into three broad categories basedon thcir method of dispersing the powder: gravity dispersion (drop tests), mechanical dispersion, and gas dispersion (fluidized beds). A. GravityDispersion This class of method allows a mass of product to fall into an enclosed space, usually a box-shaped chamber or to be tipped from a container within the chanber. Further classificationmay be obtained according to the method used to evaluate the resultant dust. 1. MassDetermination Determinc the mass of the amount of dust gencratcd using a membrane or glassfiber filter to collcct the dust.

Therefore, powder particle size and size distribution have the greatest impact on powder dustiness. Generally, an increase in particle size results in a decrease in powder dustiness. Using a fluidized bed device, it was shown that increasing the mean particle size of a powder reduces its dustiness (20). 2 - 0 U Spray Dried Lactose 0 - m u l 0 . I . 5 . I I . l I . 1 I I I 15 . . I l 2 Moisture Content (%) Figure 2 Effect o f moisture content o n the dustiness index o f powders that absorb less than 2% moisture even athighrelative humidities up to 70% RH.

Although this biologicnl effect is considered to be beneficial t o the patient, any biological effect i n the worker is undesirable. In addition. although pharmaceutical co111pounds undergo rigorous safety testing. toxic effects, such as reproductive toxicity, mutagcnicity. and allergic reactions, have been reported. 11. ROUTES OF ENTRY A. pharmaceutical compounds can be inhaled ;IS eitherdusts or mists. Dusts. During synthesis. dusts are generated and released during centrifuging. drying. milling andweighingactivities.

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