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
Graph of number of cfu after 5 days storage under different environmental conditions
0
5
10
15
20
25
30
35
From
man
ufactu
rers
box
Gra
de C cl
eanr
oom
Gra
de D st
orag
e ar
ea
Unclas
sified
sto
rage
are
a
Storage condition
Nu
mb
er o
f cf
u
Glass
Plastic
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)
Comparison of transfer validation results obtained using SteriVal method compared to contact plating
0
5
10
15
20
25
30
Study 1 Study 2
Me
an
cfu
Contact plating
SteriVal method
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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