Tablets & Capsules

camfilapc.com US Pharmacopeia 12 It's very important to verify that the fil- ter elements and filtration media used in the testing are the same ones that you'll receive when ordering the dust collector. Some manufacturers might test their best elements, then switch to less costly and poorer performing el- ements when packaging the collector. Using the test data to compare costs Standard 199 enables you to review and compare the results of different dust collectors and filters, includ- ing emissions, pressure drop, com- pressed air consumption, and energy usage. With these data, you can eval- uate the total cost of ownership (TCO) of a dust collector. That's important be- cause two collectors with similar price tags may incur very different costs over time. TCO helps you determine what it really costs to operate the dust collector by calculating expenses in three areas: energy, consumables, and maintenance and disposal. Energy. This tallies how much energy the dust collector uses in day-to-day operation. It includes electrical costs and compressed air usage. Consumables. A number of items re- quire periodic replacement through- out the equipment's service life. Al- though Standard 199 cannot directly predict how long a filter will last, it provides comparative data on pres- sure drop that can shed light on which filter elements may last longest. Com- parative emissions data are also use- ful, because lower emissions through the primary filters translate into a lon- ger service life of costly secondary HEPA filters, which are required in po- tent and hazardous dust applications. In other applications, low emissions might even eliminate the need for HEPA filters. Maintenance and disposal. How long it takes to service the equipment and the costs of disposing of the consum- ables can be major cost factors in any system, but especially in contained dust collectors and systems with HEPA filters. Be sure to consider both the primary and secondary filters. A reputable equipment supplier should be able to calculate the TCO using data from a Standard 199 test re- port and other data unique to your ap- plication. Because it helps you choose the most cost-effective equipment, a TCO evaluation saves you money, but it also saves time and energy. Applying other rules and standards to dust collector design Standard 199 does not measure all aspects of dust collector design and performance. It must be applied in conjunction with the normal risk as- sessment and hazard analysis that precede equipment selection. Com- bustible dust control is one area of concern. As part of the upfront anal- ysis, your dust should undergo ex- plosibility testing to determine its combustible and explosive properties. Explosibility testing is essential to an- alyzing which type of dust collection system is best for a specific applica- tion. It will also inform your selection of the explosion protection/prevention devices needed in order to comply with applicable NFPA standards. Fig- ure 4 shows a rendering of a dust col- lector equipped with explosion sup- pression equipment. Where containment risks are a con- cern, you should also consider sur- rogate testing. Surrogate testing of contained dust collection equipment— when performed under controlled parameters using a surrogate that mimics the particle characteristics and flowability of the active pharmaceuti- cal ingredient—is a safe and effective method to help predict how well the system will contain the process and remain in compliance with emission requirements. For best results, follow the testing protocol of ISPE's "Good Practice Guide." Many manufacturers will also need to consider threshold limit values, or TLVs, which are established by the American Conference of Governmen- tal Industrial Hygienists. The other op- tion is to use internally prescribed oc- cupational exposure limits, or OELs. Both measure the airborne concen- tration of a substance below which workers are believed to be protected while exposed to the substance daily for 8 hours. Emissions readings from Standard 199 test reports can help you perform a risk assessment to de- termine which equipment best suits your application. Although Standard 199 test reports are widely available, equipment specifiers sometimes continue to compare filters using MERV rankings or other efficien- cy ratings. Although a MERV ranking is a good indicator of a filter's initial efficiency, keep in mind that it doesn't measure pressure drop, emissions while pulsing, energy performance, or the other parameters included in Stan- dard 199 testing. References TLV/BEI Guidelines. American Confer- ence of Governmental Industrial Hygien- ists, Cincinnati, OH. www.acgih.org. ANSI/ASHRAE Standard 199-2016, Method of Testing the Performance of Industrial Pulse Cleaned Dust Col- lectors. American Society of Heating, Air-Conditioning and Refrigeration En- gineers, Atlanta, GA. www.ashrae.org. ANSI/ASHRAE Standard 52.2, Meth- od of Testing General Ventilation Air-Cleaning Devices for Removal Effi- ciency by Particle Size. Assessing the Particulate Containment Performance of Pharmaceutical Equip- ment, 2012. International Society for Pharmaceutical Engineering (ISPE), Bethesda, MD. www.ispe.org. NFPA 652: Standard on the Funda- mentals of Combustible Dust. Nation- al Fire Protection Association (NFPA), Quincy, MA. www.nfpa.org. NFPA 654: Standard for the Prevention of Fire and Dust Explosions from the Manufacturing, Processing, and Han- dling of Combustible Particulate Solids. More ASHRAE 199, Click Here

• Cover