APPLICATION OF QbD PRINCIPLES TO BIOLOGICS PRODUCT: FORMULATION AND PROCESS DEVELOPMENT - Quality by Design for Biopharmaceuticals - page 188

TABL E 10.7. Infusion Component Materials of Construction Qualified for Use with Biologic
Intravenous Injection

Normal
Saline Bags

IV Infusion
Lines

Catheter/Infusion
Sets

Syringes/
Needles

Infusion
Pumps

PVC/DEHP PVC/DEHP Catheter:

polyurethane,
silicone,
stainless steel

Polypropylene,
latex-free
rubber, silicone,
stainless steel

Peristaltic

PVC/DEHP PVC/DEHP/

polyethylene
(PE)

Catheter: teflon,
silicone,
stainless steel

— Volumetric

(cassette)

Polyolefin
(polyethylene/
polypropylene)

PVC/TOTM
(tri octyl
trimellitate)

Infusion set: teflon,
silicone,
stainless steel,
PVC (tubing)

— Volumetric

(shuttle)

— Polyurethane

(DEHP-free)

Polyurethane,
silicone,
stainless steel

— —

Figure 10.8. Experimental design for testing compatibility of infusion components with a
biologic infusion product. (See the insert for color representation of this figure.)