Академический Документы
Профессиональный Документы
Культура Документы
7.5
Growth Promotion Testing Stedim
Stedim Flexboy
SAFCPE
JRH
Flexboy Bag
Bio PE Bag
Bag
At zero and 60 weeks, media samples from each bag type Stedim 55 Bag
Stedim
SAFCEVA
Bag
Bio Bag
EVA Bag
JRH
underwent a growth promotion study using Vero cells. To 7.4
ensure that the media was not cytotoxic and retained growth
promoting capabilities, cells were monitored in each media
sample for three passages. The medium was supplemented 7.3
pH Value
with FBS and L-glutamine at the time of the test. Vero cells
were seeded in T-25 flasks at 1-2 x 104 cells/cm2 in each
7.2
media sample (triplicate flasks for each sample). The flasks were
incubated in a 5% CO2 incubator at 36 ± 1 C for three days.
The cells were harvested using standard trypsinization 7.1
procedures, pooled and reseeded in each respective medium.
The cultures were continued for three passages. The control
medium was DMEM stored in PETG bottles which has a 7
Week 0 Week 1 Week 4 Week 12 Week 24 Week 36 Week 48 Week 60
known stability of > 60 weeks under proper storage conditions. Week of Test
Results
Over the course of 60 weeks, no visible indications of Figure 2
deterioration were noted in any of the bags of media. The
WeekWeek
0 — Growth of of
0 - Growth Vero Cells
Vero CellsininDMEM/High Stored
DME/High Stored in in
PEPE and
and EVA
EVA Bags
Bags
determinations of pH also indicated little variability as shown
in Figure 1. The quality control specification for pH for DMEM 7
Control
Control (PETG Bottle)
(PETG Bottle)
medium is 7.0 - 7.4, and with the exception of one, all time Stedim Flexboy
Stedim Flexboy Bag
Bag
www.safcbiosciences.com
Figure 3
Week 60 —
Week 60Growth ofofVero
- Growth VeroCells
Cellsin
inDMEM/High Stored
DME/High Stored in PE
in PE andand
EVAEVA Bags
Bags
10
Control (PETGBottle)
Control (PETG Bottle)
Stedim FlexboyBag
Stedim Flexboy Bag
9 JRH
SAFCPEBioBag
PE Bag
Stedim
Stedim 55 Bag
Bag
SAFCEVA
JRH Bio EVA
Bag Bag
8
7
Viable Cells x 10 (per flask)
6
6
0
Passage 1 Passage 2 Passage 3
www.safcbiosciences.com
Warranty, Limitation of Remedies
SAFC Biosciences warrants to the purchaser for a period of one year from date of delivery that this product conforms to
its specifications. Other terms and conditions of this warranty are contained in SAFC Biosciences’ written warranty, a
copy of which is available upon request. ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED
WARRANTY OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE EXCLUDED. In no case will SAFC
Biosciences be liable for any special, incidental, or consequential damages arising out of this product or the use of this
product by the customer or any third party based upon breach of warranty, breach of contract, negligence, strict tort,
or any other legal theory. SAFC Biosciences expressly disclaims any warranty against claims by any third party by way of
infringement or the like. THIS PRODUCT IS INTENDED FOR PURPOSES DESCRIBED ONLY AND IS NOT INTENDED FOR
ANY HUMAN OR THERAPEUTIC USE.
Additional Terms and Conditions are contained in the product Catalog, a copy of which is available upon request.
www.safcbiosciences.com Phone
Toll free-USA
Fax
+1 913-469-5580
1 800-255-6032
+1 913-469-5584
Phone
Fax
E-mail
+44 (0)1264-333311
+44 (0)1264-332412
info-eu@sial.com
Phone
Toll free-AUS
Fax
+61 (0)3-9362-4500
1 800-200-404
+61 (0)3-9315-1656
E-mail info-na@sial.com E-mail info-ap@sial.com