SMEPAC isolator test
The test is performed in accordance with recommendations, the guidelines from the association ISPE.
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The main purpose of the SMEPAC test is to demonstrate that the installed equipment (protective chambers, isolators, weighing machines ...) reduces the presence of potentially dangerous particles in the air during working processes with powdered substances, which are mainly carried out in the pharmaceutical industry. The operator's handling of the device is also checked. Containment ability of systems is an important factor for risk analysis. The Standardized Measurement for Equipment Particulate Airborne Concentrations (SMEPAC) guidelines set a standardized methodology for testing the effectiveness of systems and equipment for retaining dust particles. All necessary information can be found in the ISPE Good Practice Guide - Assessing the Particulate Containment Performance of Pharmaceutical Equipment. The test involves measuring the amount of test material in the air and taking away swabs on exposed surfaces. This exposure is termed as OEL (Occupational Exposure in working with hazardous substances), which prescribes the maximum permissible exposure in a given period and is expressed in g / m3.
Prior to carrying out the test, it is necessary to determine the test material - the replacement material. It is necessary to take into account the characteristics of the active substance that will be used in the actual process and then choose the best approximation. The most common test material is sodium naproxen and lactose. It is also necessary to designate sampling locations in advance. Recommended locations are otherwise found in the guidelines, but they still need to be determined and meaningfully distributed with the customer. Sampling is performed with personal sampling air pumps and sampling heads in which a test filter is installed. The purpose of sampling of surfaces is the assessment of the contamination of the space, the operator's protective equipment and other places with the highest probability of contamination. For surface sampling, we use a 10x10cm template and dedicated sample sticks.
The analysis of samples is carried out by an accredited laboratory. After receiving the results we make an appropriate report in accordance with the ISPE guidelines.
