Comparative studies of transfer methods Mark Oldcorne

To determine: ◦ the effect of different storage conditions on the surface bioburden of items used during aseptic preparation ◦ whether the material of the item affects surface bioburden ◦ efficiency of SteriVal® method compared to traditional contact plating

 Manufacturers packaging was removed from two item types: 0.9% sodium chloride 2ml glass ampoule with coated paper label from Phoenix Pharma Lidocaine 2ml plastic ampoule with coated paper label from Braun  SteriVal ® (Helapet) “total immersion” method was used to determine the surface bioburden on items.

 The surface bioburden of each (n=10) was determined immediately (t=0) and then after exposure to three different environmental conditions for 5 days Grade C cleanroom Grade D storage area Unclassified storage area

 The surface bioburden of 50ml vials from a single manufacturer was determined  2 methods utilised ◦ the SteriVal® total immersion method (n=10) ◦ contact plating with Tryptone Soya Agar (n=10)

 Initial surface bioburden affected by: ◦ Storage conditions ◦ Container material type ◦ Container manufacturer  SteriVal® method recovered approximately double the number of cfu compared to contact plating