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 over 10 years now PSL has achieved nanogram containment levels with their glovebox isolator systems. With the ever increasing demands of oncology and high 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 their isolators. A protocol in accordance with the SMEPAC guidelines is applied whereby the standard isolator operation is conducted with micronized 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*
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 micronized lactose in the OEL test is 2 nanograms over the 3 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 Dispensing Isolator
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 micronizing, sieving and tray drying
*This does not include an allowance for statistical safety multiples.
Powder Systems Ltd (PSL)
Estuary Business Park
Liverpool, L24 8RG, UK
+44 151 448 7700
www.powdersystems.com