The definition of the proper containment strategy is a necessary requirement for the correct design of the facility and the process equipment. Containment is necessary to reduce the exposure of operators to potent products.
The starting point is the sound knowledge of the products to be handled and their specific characteristics as well as their occupational exposure limits (OEL), the quantities involved and the duration and the frequency of each process to be contained.
Powders are extremely volatile and can be easily inhaled, so it is essential that proper PPEs are worn and a separation system is used to minimize the quantity of product the personnel is exposed to. The choice of such system is mainly based on the potency of the compound: while non-potent products may require equipment as simple as a downflow booth, highly active APIs must be handled within a rigid isolator.
The longer or the more frequently a task is performed, the higher is the potential exposure of the operator to the product. If the substance is potent a rigid wall isolator is essential to minimize the exposure, while less potent products require different containment strategies.
Process equipment not designed for containment can be fully or partly integrated in isolators. A technical evaluation and a close cooperation between the equipment manufacturer and the isolator maker can lead to excellent containment performances.
SMEPAC tests are carried out simulating the whole process using placebo compounds. Specific sensors are installed in the room, close to the breathing area of the operator and on the sensitive areas of the containment systems to measure the total exposure of the operator and verify that the measured value are not exceeding the maximum exposure limits of the APIs.