Double gloving proved to be effective barrier

Sterile latex gloves made by hand hygiene specialist Marigold Industrial were shown to provide an effective barrier against product contamination in a recent programme of experimental work carried out by pharmaceutical giant AstraZeneca.

The programme was designed to determine the effectiveness of the double gloving method to control the risk of contamination when manufacturing aseptically prepared pharmaceutical products. Carried out at AstraZeneca’s UK site in Macclesfield, Cheshire, it focused on workers using two pairs of Marigold Industrial’s sterile, single use Suretech Biogel P gloves.

According to AstraZeneca, the Suretech Biogel P single use gloves were chosen because they had been assessed as being a good quality glove. However, there was little available data regarding the robustness of these gloves for such manufacturing activities.

The programme of work determined the puncture rate of 400 Biogel P gloves following their use for manufacturing activities and compared them with the integrity of the same unused Biogel P gloves.

For the 400 used gloves examined, comprising of 200 inner and 200 outer gloves, worn by 100 cleanroom personnel in the aseptic processing area, results indicated an increase in the puncture rate compared with the unused gloves which were all found to be integral.

The detected failure rates were found to be 8.5% and 6% for the outer and inner gloves respectively – but with only one instance of a puncture occurring in both the outer and inner glove combined – but not in the same location.

Tim Eaton, AstraZeneca's sterile manufacturing specialist at Macclesfield, indicated the increase in holing was likely to be associated with the stress placed on the gloves during use.

The results demonstrated that punctures occurring to the outer glove did not, however, penetrate the inner glove and, therefore, an effective barrier was maintained.

“For the type of gloves used in this programme, the probability of having holes in both inner and outer gloves can be considered so low as to confirm that double gloving, using good quality products, is an effective control method in reducing the threat of product contamination.”

Marigold Industrial says not only does the work highlight the quality of the Suretech Biogel P gloves it also provides performance data in a true working environment.

John Thorne, Marigold Industrial’s country manager, said: “To have our gloves placed under this test spotlight and come out in such a positive way is a testament to the quality manufacturing processes which we adopt for our pharmaceutical gloves.

“The research shows that while gloves may become holed during regular cleanroon working practices, double donning is an effective control method to minimise the risk of product contamination caused by ruptured gloves and we are delighted with these findings”.