Visante conducts sterility studies in three UK health organisations

Numerous studies have shown that BD’s PhaSeal® technology can greatly reduce contamination in the workplace environment. The system has also been shown to help reduce waste of high cost medicines. This is done by eliminating the contamination potential during preparation of high cost single use medicines and allows organisations to extend compound sterility beyond use date (BUD) thereby reducing waste.

It has been demonstrated that organisations originally drawn to use this technology for improved occupational safety have been pleasantly surprised to achieve substantial savings through more efficient use and storage of these pharmaceuticals. In some cases annual savings of over £ 500,000 have been achieved.

Initial sterility studies at the London Clinic demonstrated that the PhaSeal system, when applied properly in sterile conditions, is capable of maintaining a sterile environment in single use injectable medicines out to 168 hours. This creates opportunities to re-examine sterility BUD assignment with the goal of reducing waste of chemically viable medicine.

The PhaSeal system has also been a welcome addition to staff at the London Clinic in terms of reducing the risk of exposure to hazardous medicines during preparation and administration. “We were very pleased with the performance of the PhaSeal system and with the program review and safety enhancements suggested by Visante consultants for our overall safe handling of chemotherapy agents at the London Clinic” said clinical trials director, Alistair Gifford Moore, RN.

As part of these clinical trials Visante has performed comprehensive assessments of intravenous admixture and safe handling processes at Southampton University Hospital as well as with Bupa Home Health. From our work we see that overall quality control and process validation performed by UK pharmacy operations exceeds those in practice in the US. However, the majority of sterile products are not produced in the pharmacy in the UK and these enhanced processes are only used on less than 5% of total admixtures prepared for patients. In the US, pharmacy departments prepare virtually 100% of all sterile products in a clean room environment. It should be noted that the USP 797 performance standards in the US are less than the GMP level standards in use in UK pharmacy practice.

The goal of Visante is to combine the best elements of sterile products practice from the UK with the US to increase pharmacy preparation of sterile products in the UK and to raise the bar for quality assurance and process validation in the US.