3.2 Filling Container
1. The formulation must be filled into containers before freezing.
2. Choose containers made of glassware such as round-bottomed
glass flasks or glass vials (see Note 6).
3. The method of dispensing the product depends on the number
of containers to be filled and the accuracy and consistency of
the desired fill volume.
4. Containers should not be filled more than one-third of their
total volume. Sudden volume and thermal changes may result
in shattering of the container with catastrophic loss or crosscontamination of valuable samples.
Table 6
(continued)
Brand
name
Generic name
Excipients
Intron A
Interferon alfa-2b
Glycine, sodium phosphate monobasic, sodium
phosphate dibasic, human serum albumin, benzyl
alcohol
Koate-DVI Antihemophilic factor
Polyethylene glycol, glycine, polysorbate 80, tri-nbutyl phosphate, calcium, albumin, aluminum,
histidine
Kogenate
Antihemophilic factor
Glycine, calcium chloride, sodium chloride,
polysorbate 80, imidazole, albumin
Kogenate
FS Antihemophilic Factor
Sucrose, glycine, histidine, calcium chloride, sodium
chloride, polysorbate 80, imidazole, tri-n-butyl
phosphate, copper
Leukine
Sargramostim
Mannitol, sucrose, tromethamine
Lupron
Depot
Leuprolide
Purified gelatin, DL-lactic/glycolic acid copolymer,
mannitol, CMC sodium, polysorbate 80, mannitol
Neumega
Interleukin 11
Glycine, sodium phosphate monobasic, sodium
phosphate dibasic
Novarel
Human chorionic gonadotropin
Mannitol, benzyl alcohol
NovoSeven Coagulation factor VIIa
Sodium chloride, calcium chloride dihydrate,
glycylglycine polysorbate 80, mannitol
Nootropic Human growth hormone
Mannitol, sodium phosphate monobasic, sodium
phosphate dibasic, glycine, benzyl alcohol
Nutropin
DepotTM
Human growth hormone
Zinc acetate, zinc carbonate, polylactic/polyglycolic
copolymer
Pacis
BCG (Bacille Calmette-Gue ´rin)
Lactose
PEGIntron
Peginterferon alfa-2b
Sodium phosphate monobasic, sodium phosphate
dibasic, sucrose, polysorbate 80
Freeze-Drying of Proteins
693