Tablets & Capsules

© Copyright Tablets & Capsules 2021 camfilapc.com 13 For solid dose manufacturing that produces hazardous dusts, ensuring the health and safety of operators through contained dust collection is vital, but determining the appropri- ate system for a particular application can be challenging. Verifying process equipment perfor- mance via surrogate testing can help you select a well-designed system during a project's engineering phases, reducing costs, potential exposures, and contamination risks. Surrogate testing allows you to assess the risks by simulating the hazardous material with a substitute compound. The surrogate-testing process can help verify the effectiveness of dust isolation and containment equipment to support a purchase decision or shed light on necessary changes to an exist- ing system. Surrogate testing The test compound simulates the ac- tive pharmaceutical ingredient (API) in the formulation that the solid dose equipment will handle or process. You manipulate the test compound to sim- ulate operations for either a typical processing workday or a worst-case scenario. Most often surrogate testing occurs under the guidance of a man- ufacturer's health and safety team in conjunction with experts from an in- dependent testing facility. Testing includes performing air and surface-wipe sampling during com- pound manipulations. Prior to test- ing, the health and safety team must develop a protocol to identify which production activities the test will eval- uate. Following the tests, the team will analyze the results to determine if the dust collection system has met prede- termined performance criteria. Reasons for surrogate testing Actual test data is beneficial because it ensures that you have the right sys- tem in place for your application. An API may have unknown toxicological properties, may not have been previ- ously evaluated, or may have no exist- ing analytical procedure or exposure limits, such as a permissible exposure limit (PEL) from the Occupational Safe- ty and Health Administration (OSHA) or a threshold limit value (TLV) from the American Conference of Govern- mental Industrial Hygienists (ACGIH). Data from surrogate testing is also useful when conducting factory and site acceptance tests and performance verifications of process equipment to make sure that the dust containment and isolation equipment is the right fit. Impact on business decisions Surrogate testing enables you to conduct an apples-to-apples com- parison to determine the appropri- ate dust containment equipment for your application. With this informa- tion, you can select the equipment during engineering phases of proj- ects, saving time and money on con- sultants and contractors. Surrogate testing also helps you to generate a list of acceptable vendors and equipment that meet your com- pany's safety and industrial-hygiene guidelines. Generating a vendor list allows you to limit the bidding pro- cess. Tested device or process Your testing team will determine the equipment or process to be tested. For example, you may want to test an entire process and all equipment or only specific activities or access points where potential exposures can occur. The team will evaluate operator ac- tions to understand how the operators interact with the system. The duration of the testing activities depends on whether you are testing for daily ac- tivities, a worst-case scenario, or an upset condition. Surrogate testing will help you deter- mine if the containment equipment is functioning well or actually hindering the process. For example, the testing team can grade each dust-contain- ment manipulation, such as a bag-in/ bag-out process (photo), between one and five as follows: 1. Operation is simple and easy with no issues. 2. Operation makes a technique or manipulation difficult but possible. 3. Operation is so difficult that improvement may be requested. 4. Operation is so difficult that improvements must be made. 5. Operation is impossible and must be corrected. Surrogate Testing of Dust Collection Systems for Hazardous Materials Before installing a dust collection system, it is important to verify that it will adequately contain hazardous materials. By David Steil, Camfil APC

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