Tablets & Capsules

© Copyright Tablets & Capsules 2021 camfilapc.com 3 This is an important part in determin- ing the Occupational Exposure Limit (OEL) of the active pharmaceutical ingredient (API). The OEL is defined as the amount of material determined to be the maximum air concentration– expressed as a time-weighted average in micrograms per cubic meter of air (µg/m 3 )–to which a worker can be safe- ly exposed for an 8-hour shift, 40-hour work week, without potentially suf- fering adverse health effects. A risk- based exposure evaluation should be performed to determine the methods for proper control. In most cases, some level of isolation and containment is required due to the fact that the pharmaceutical dust is hazardous and cannot be released into the surrounding environment. HEPA after-filter systems are typically rec- ommended to provide backup protec- tion for the dust collector and to allow release of the filtered air directly out- doors. In highly potent applications, or in multiproduct manufacturing fa- cilities where cross-contamination is a concern, a contained dust collection system should be specified. A typical containment system will utilize bag-in/ bag-out technology at the filter car- tridges to ensure safe filter change- out, and continuous liner technology at the discharge system to contain the dust released from the cartridges to the hopper during automatic pulse cleaning of the system. Consider surrogate testing for con- tainment applications When containment is necessary, a sur- rogate test program can aid and sup- port the risk assessment. Surrogate testing, which involves the use of a substitute or surrogate compound to simulate an API, is increasingly used to verify the effectiveness of isola- tion and containment equipment and to predict real-world performance. Test conditions are designed to mim- ic workplace operations as closely as possible without incurring the ex- pense or health concerns of handling the actual API. Testing can be performed on equip- ment handling an API with unknown toxicological properties or for verifi- cation of existing systems. Surrogate testing can also be performed during factory acceptance testing (FAT) and/ or site acceptance testing (SAT) af- ter equipment has been purchased to ensure proper performance once installed. By validating equipment performance during the engineer- ing phases of a project, manufactur- ers stand to reduce costs while also ensuring the proper selection of the equipment for a particular project. Consider negative pressure requirements In tableting applications, dust is most often exhausted to the collector from a local pick-up point where the material is fed into the die. Sometimes it will be necessary to maintain a negative pres- sure in the turret enclosure, requiring that the dust be captured inside the tablet press housing. For contained tablet press systems handling a haz- ardous API, the latter approach will be needed to ensure a controlled environ- ment. Using a contained dust collector sized appropriately with the correct air-to-media ratio will help to maintain the negative pressure environment in- side the tablet press housing. Also, having precise control over the reverse pulse cleaning system of the dust collector filter cartridges is critical to avoid creating a positive pressure situation in the tablet press housing. This can lead to a breach in contain- ment, improper operation of the tablet press and ultimately downtime on the operation to correct the situation. Bag-in/bag-out (BIBO) filter change is performed as part of a surrogate test. Surrogate testing helps predict real-world performance of dust collection equipment in containment applications.

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