Several studies have been done in Europe to evaluate exposure to dust and fumes in the rubber industry. However, different aerosol sampling devices have been used which perform differently depending on the environmental conditions and particle size distribution. To compare measurements of rubber dust and fumes among countries and surveys we initiated a field comparison of personal inhalable samplers using a novel reference inhalable aerosol sampler (CALTOOL). Measurements were done in four factories in the Netherlands, Sweden, Poland and Germany in the mixing and milling and curing department. The Seven-hole sampler, PAS-6 sampler, Millipore (25 and 37 mm) cassette, IOM sampler and a Polish sampler were mounted on the reference CALTOOL device and used simultaneously. All samplers except the IOM sampler under-sampled inhalable dust. To compare measurements from different studies and countries, correction factors should be applied to all but the IOM sampler, which was the only sampler that performed similar to the CALTOOL sampler.
Due to newly introduced EU GMP (Good Manufacturing Practice) guideline for Medicinal Products for Human and Veterinary use, product specific permitted daily exposure (PDE) for toxicological evaluation in multi-purpose facilities are required within a documented process for risk assessment. European Medicines Agency (EMA) guidance on setting PDE limits so far focused on systemic administration routes such as intravenous (IV), oral or inhalation. This article provides guidance on setting PDE values for risk management purposes in multi-purpose facilities for active pharmaceutical ingredients (APIs) applied as topical otic drugs to the outer ear canal. The therewith determined PDE otic, is used for the calculation of maximum safe carry-over (MSC) in manufacturing scenarios where a topical otic product is manufactured followed by another topical otic product.
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