Solo Containment, a UK-based supplier of flexible film containment systems to the pharmaceutical and chemical industries, has independent test results showing that nanogram level containment can be achieved in one of its soloFLEX isolators.
A benchtop soloFLEX three-glove unit for product formulation development was supplied to PCI Pharma Services, a CDMO based in Tredegar, South Wales, in only four weeks at a cost of around 15% that of a comparable size rigid stainless steel isolator, the Poynton, Cheshire-based firm said.
PCI Pharma Services then commissioned VEGA Environmental Consultants, a UK Testing Authority, to independently test the containment levels achieved inside the isolator during operation. The challenge involved PCI dispensing 10kg of sodium naproxen (a surrogate API compound). The Limit Of Quantification (LOQ) for this material is 0.0002µg per sampling filter.
As with any containment trial, a statistical evaluation over several runs is essential to prove the reliability of the data. In this instance, three runs, each dispensing 10kg of surrogate API, were carried out with one further run being undertaken following clean down.The performance target was OEB 5 level, with a target Occupational Exposure Limit (OEL) of <0.1µg/m3 (8 hour Time Weighted Average (TWA)). VEGA tested to <25% of this value (<0.025µg/m3) to be sure that all future results meet the required target level.
The results were as follows:
- Run 1: 0.0031µg/m3
- Run 2: 0.0012µg/m3
- Run 3: 0.0015µg/m3
- Post clean down: 0.0077µg/m3
With such results, Solo said it has proved that even its entry level negative air pressure flexible isolator can achieve outstanding levels of containment performance.
PCI Pharma Services Director of Pharmaceutical Development, David O’Connell, said: 'We were really delighted with the test results achieved on the soloFLEX isolator, which proved to be considerably better than we were expecting. The rapid delivery and installation of the unit meant we were able to get production underway quickly.'
He continued: 'We now benefit from the flexibility of simply changing the film enclosure as we change product batches, ensuring minimal disruption to our production schedule.'