Biomedical Engineering Reference
In-Depth Information
d.
Operating cost
e.
Capital cost
f.
Turnaround time
g.
Reduced process steps
h.
Smaller foot print
i.
Rapid scale-up
j.
Improved environment
15. Selection of specific disposable systems depends on
a.
Availability
b.
Price
c.
Quality
d.
Approved supplier
e.
Documentation
f.
Customer service
g.
Product offering
h.
Past purchase history
i.
Engineering support
16. The disposable systems are disposed of 57% by incineration, 37% by
landfill, 20% waste to energy, and 10% converted for alternate purposes.
17. Over 80% of users are satisfied with their adoption of disposable
systems and have demonstrated savings in cost.
18. The main misconceptions in the use of disposable systems include
a.
May be more costly over time, specially filtration
b.
Not sure of savings
c.
New investment needed
d.
Have no need to save cost
19. The main regulatory concerns about disposables include
a.
Sterilization and extractables/leachables
b.
Leaking of containers
c.
Bag integrity
d.
Validation of sterility/manufacturing process
e.
Aseptic process validation
f.
Quality of multiple suppliers
g.
Validation, lot-to-lot variability
h.
Material compatibility
i.
Reproducibility of batch process
