Powder Systems Ltd (PSL) is a pioneering manufacturer of high containment systems and has long been recognised as one of the most reliable containment suppliers in the world. For more than 10 years now PSL has achieved nanogram containment levels with its glovebox isolator systems. With the ever-increasing demands of oncology and highly potent products the need for high containment with lower OEL levels has become a necessity.
OEL test method
PSL provides an OEL test as part of the client’s onsite PQ to fully validate the performance of the isolators. A protocol in accordance with the SMEPAC guidelines is applied whereby the standard isolator operation is conducted with micronised lactose at a particle size of d50 = 20µm. For the results shown below, 12 sampling points on the operator and isolator were used to collect the data.
OEL test results
The following table shows typical OEL test results for PSL’s standard Dispensing Isolator, where product is dispensed from bulk-size drums and sub-divided into small quantities.
| Latest OEL test results from a standard PSL Dispensing Isolator – verified by independent industrial hygienists* | ||||||
| Sample Details | Sampling Time (minutes) | Mean Flow Rate (l.min-1) | Total Volume (m3) | Mass of Lactose Detected (μg) | Airborne Concentration of Lactose (μg.m-3) | 8-hour TWA Exposure (μg.m-3) |
| Run 1 | 82 | 2.0 | 0.164 | < 0.0025 | < 0.015 | < 0.0026 |
| Run 2 | 92 | 1.95 | 0.179 | < 0.0025 | < 0.014 | < 0.0027 |
| Run 3 | 78 | 2.0 | 0.156 | < 0.0025 | < 0.016 | < 0.0026 |
| *This does not include an allowance for statistical safety multiples. | ||||||
The results show the sampling value during the OEL test, and the equivalent on an 8-hour TWA. The sampling ‘Airborne Concentration of Lactose’ is fundamental data that is used to produce the 8-hour TWA. In this test the sampling period was 1 hour 20 minutes with a result of 15 nanograms on average, producing an 8-hour TWA of 2.6 nanograms (the detection limit of micronised lactose in the OEL test is 2 nanograms over the three runs).
PSL’s containment guarantee
With PSL isolators achieving validated OEL test results of 2 nanograms, our clients have the potential to handle the most potent products available on the market.
PSL’s high containment products have been designed to fulfil a range of applications including: dispensing and sampling, charging, drum filling, off-loading (continuous liner system), milling and micronising, sieving and tray drying.
