Comparative studies of transfer methods

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Comparative studies of transfer methods

• Mark Oldcorne

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Objectives

• 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

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Comparison of environments 1

• 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.

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Comparison of environments 2

• The surface bioburden of each (n10) was
  determined immediately (t0) and then after
  exposure to three different environmental
  conditions for 5 days
• Grade C cleanroom
• Grade D storage area
• Unclassified storage area

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Comparison of environments 3
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Comparison of SteriVal and Contact Plating 1

• The surface bioburden of 50ml vials from a single
  manufacturer was determined
• 2 methods utilised
• the SteriVal total immersion method (n10)
• contact plating with Tryptone Soya Agar (n10)

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Comparison of SteriVal method to contact plating
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Conclusions

• 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

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