While OEBs and OELs typically specify containment goals, measurements are necessary to measure the effectiveness of containment systems and to document the effectiveness of those systems. The Smepac system (Standardized Measurement of Plant Particle Air Concentration) is a method of measuring the concentration of particles escaping from a system. It defines repeatable test procedures and parameters for evaluating and comparing different control processes in a plant.
Accepted test methods use defined lactose levels (other substances are possible), use equipment in a specific environment (humidity, temperature, air exchange rate) and place designated samplers in different locations. The test consists of performing the intended action and collecting air (through the sampler's filter) for 15 minutes.
Analysis of the filter gives a measure of the amount of lactose in the volumetric air that corresponds to the sealing performance of the device. Because the tests run an average of 15 minutes, this performance is known as the STTWA (Short-Term Time-Weighted Average). It is important to note that this procedure captures the total amount of powder that comes out. When using stronger drugs, usually only a small part of the powder mixture is active and the rest is the carrier.
It is therefore important to distinguish between intermittent exposures, such as e.g. when a container with raw materials is docked in a fluidized bed, and permanent exposure, e.g. B. a tablet press, which is not completely safe to distinguish.
Properly performing exposure measurements under containment conditions is key to safely control aggressive pharmaceutical products. Fette Compacting has developed a protective cover for measuring unevenness on tablets. As a result, the functionality of the sealing system can not only be reliably tested, but also planned, which increases planning security for individual projects and thus reduces costs. This method is based on the well-known guidelines of the ISPE (International Society of Pharmaceutical Engineering).
Other factors affecting the packaging are the position of the measuring probe, the position of the operator during the measurement, the number of tablet samples and possible operating conditions, including error situations that may occur. This advanced process ensures a repeatable assessment, especially when sealing tablet systems. As a result, drug manufacturers reduce the set-up effort, test set-up and any post-production enhancements.
After successful testing, the systems receive a containment protection certificate. The certification levels are based on the OEB safety pyramid limits and acceptable daily exposure values (PDE). The measurement protocol is the basis for the operator to assess the risk and to significantly reduce the amount of work after the system has been commissioned.