Tablets & Capsules

TC0114

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m-MiniCH_48-62_MINICH 12/30/13 2:09 PM Page 51 January 2014 51 Tablets & Capsules Product Review Surrogate Testing Predicts Performance of Contained Dust Collection System Proper selection and operation of contained dust collection equipment is critical to pharmaceutical plants for many reasons, from environmental requirements and employee health and safety to production cleanliness and efficiency. Historically, no performance data has existed on contained dust collection systems until they were already installed. Surrogate testing offers a way to provide meaningful performance information prior to installation, to help pharmaceutical manufacturers determine if the equipment will meet required guidelines and standards for a specific project. Camfil APC worked with a certified independent laboratory to run a surrogate test on behalf of a pharmaceutical manufacturer. Lactose was chosen as a substitute or surrogate compound to simulate an active pharmaceutical ingredient (API) for verifying the effectiveness of dust containment options for handling hazardous materials. Test conditions were designed Dust collection equipment used in the to mimic workplace surrogate test operations as closely as possible without incurring the expense or health concerns of handling the actual API. The dust collector in the test was a Farr Gold Series® contained system with four cartridge filters rated at 99.999 percent efficiency (MERV 16) on 0.5 micron particles and larger. It utilized bag-in bag-out (BIBO) technology at the filters and a continuous liner discharge (CLD) system to contain the dust that would be released from the cartridges to the angled hopper below during cleaning. The goal of the surrogate testing was to validate that this equipment would perform at or below the standard emissions threshold limit of 1.0 µg/m3 for a timeweighted average (TWA). During the test period, an employee charged the lactose surrogate dust to the collection system on a predetermined schedule. Two operators equipped with air sampling devices performed four Continuous liner discharge operation BIBO filter change-out operations, working through the bags to accomplish safe change-out. They also performed three discharge operations to safely release the accumulated dust in the hopper, and a change-out of the continuous liner in the discharge system. All test conditions duplicated shift-equivalent operations as closely as possible to ensure meaningful results. Results A combination of air, surface wipe and personal samples were taken to evaluate dust collector performance. Of the 47 samples taken during the operational test, all were below the established OEL of 1.0 µg/m3, and many of these were significantly below the established threshold. Based on these results, the customer accepted the surrogate test as evidence that the contained dust collection system as designed could be expected to provide the required level of emission control performance under real-world operating conditions. By validating equipment performance during the engineering phases of the project, they were able to reduce costs while also reducing risk. Camfil Air Pollution Control Phone: 800-479-6801 or 870-933-8048 Fax: 877-910-2981 Email: filterman@camfil.com Web: www.camfilapc.com/pharma Operators perform BIBO filter cartridge change

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