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Learning Experiences
Acknowledgements
Enhancement of Solution Mixing Using Baffles
• Entire Technology Transfer Team
• Katie and Jared
• Other summer interns
Technology Transfer Internship – Jami Turnquist
Evaluation of Masterflex Cytoflow Pump Head vs. Standard Peristaltic for Blood Cell Integrity
The majority of Streck’s products are packaged in vials with
screw-top cap closures. To ensure each vial/cap combination is
properly packaged to prevent leakage, removal torque
specifications are currently in place. These are obtained using
a manual testing device (Secure-Pak Torque Tester) which
measures necessary torque to unscrew the cap.
Methods
Five different times were chosen to test the removal torque of the caps and comparisons
were made. These five times were 1 day, 3 days, 7 days, 10 days, and 14 days after initial
application. Currently, testing is performed immediately after cap application and 7 days later.
Data obtained suggests torque is highly variable but averages out after 3 days. The current
time to check of 7 days seems to be acceptable. Data suggests that testing of retention could
be done at 3 days, but more studies should be conducted to confirm this. Data also suggests
lower initial application torque results in a lower decrease in torque.
Results & Recommendations
Background
Streck manufactures over 200 different process solutions. Some
solution formulations include chemicals that are difficult to
dissolve and require extensive mixing. There has been
speculation on whether the addition of baffles might accelerate
the dissolution rates and speed up mixing time.
Methods
Three different chemicals were investigated. These include
sulfasalazine, hydroxyethyl cellulose (HEC), and propyl paraben.
Concentration measurements were established and data was
collected at varying time points of the dissolution process both
with and without the baffles. The 5” 3-blade hydrofoil was used
with StirPak at setting 2 (approximately 300 rpm).
Results & Recommendations
Solutions with long mixing times:
E-Check Final Diluent (sulfasalazine),
Prewash Solution (HEC), Hemocue
RBC Final Diluent (methyl
paraben/propyl paraben)
Propyl Paraben
• UV/Vis Spectrophotometer, 295
nm
• Diluent is 20mg% propyl paraben
• 3.40 g of propyl paraben added to
15.30 L of ozonated water (lot
volume of 17 L)
Background
Streck utilizes EPS Styrofoam shipping containers to ship all
temperature-sensitive products, loaded with frozen and
ambient gel packs for temperature control. A local vendor
(Plastilite) developed a biodegradable form of Styrofoam
known as REFOAM. Any alternative for shipping would have to
be proven to physically protect Streck’s products, both in terms
of temperature exposure as well as damage from impact.
Background
Streck utilizes peristaltic-style pumps for liquid transfer of non-
cellular fluids. Fluids which contain cells have been considered
“off-limits” due to concerns with shear imparted by the
mechanical pump. A Cytoflow low-shear pump head was
recently purchased and studies needed to be done to assess the
feasibility of its use in transfer of hematology materials.
Methods
Red Blood Cells
• 15 minute runs, 4 different flow rates (0.1, 0.3, 0.5, 0.7 L/min)
• 30 minute runs, 1 flow rate (0.75 L/min)
• 60 minute runs, 1 flow rate (0.75 L/min)
• Repeated 60 minute run on Easy-Load (0.75 L/min)
White Blood Cells (fixed)
• 60 minute runs, 1 flow rate (0.75 L/min)
Combination
• 60 minute runs, 1 flow rate (0.75 L/min)
Results & Recommendations
No damage to RBC seen for small run times (<30 minutes).
Easy-Load pump damages RBC at 60 minutes.
Neither pump damages fixed WBC significantly.
Good evidence Cytoflow pump suitable for transport of cellular fluids.
Background
Basis
-10 of each combo within normal range
Trial 1
-12x80 mm vials, 13x425 caps
-100 vials AT between 1.5-3.9 in-lbs.
-10 vials AT <1.4 in-lbs., 10 >4.0 in-lbs.
Trial 2
-12x76.5 mm vials, 13x415 caps
-100 vials AT between 1.5-3.9 in-lbs.
-10 vials AT <1.4 in-lbs., 10 >4.0 in-lbs.
Trial 3
-12x80 mm vials, 13x425 caps (red)
-30 vials AT between 2.5-4.5 in-lbs.
Future Studies
• Try other flow rates at 60 minute time
• Try whole blood or cellular products
• Pump through leukocyte filter
• Try times between 30-60 minutes, find when
significant damage begins
• Trouble shoot Easy-Load pump
• Teamwork, exposed to all parts of the company
• Experimental design
• New technologies and equipment
• Research and explore new topics
• Data analysis
• Trouble shooting
• Networking
• Coolers chosen for study: S13, S20L, larger REFOAM (R-SL16)
• Packed with expired product in 12-slot clamshells, frozen ice packs, and filling paper
• Four thermocouples in each cooler
• One LogTag in center of each cooler
• Use of Thermotron temperature chamber
• International 5-day summer runs
• FedEx Drop Testing
Future Studies:
• Try international winter, domestic summer, domestic winter runs
• Have dimensions/contents matching exactly to current EPS
• More in-depth strength testing, find force at which coolers break
Mean Kinetic Temperatures of REFOAM:
• Bottom: 26.84OC
• Middle: 26.48OC
• LogTag: 26.61OC
• Side: 26.72OC
• Top: 26.20OC
In the LogTag, an alarm occurs if the temperature goes out of
range (2-30OC). Alarms went off for the S13/S20 coolers, but
not the R-SL16 cooler. Overall the REFOAM had good
performance on the international summer testing, passing all
three acceptance criteria (SQP-11013).
Strength Testing
• Weights on 1-inch pieces of material
Drop Testing
• Package <75 lbs. drop height at 30 inches
• 10 different spots
• Same configuration, shrink wrapped using ARPAC machine
• S20 and R-SL16 withstood small cracks
• All passed test
Characterization of Time-Dependent Behavior of Closure Removal Torque Preliminary Performance Testing of REFOAM Coolers from Plastilite
Left to Right: Pre-Process,
Easy-Load for 30 minutes,
Cytoflow for 30 minutes, Easy-
Load for 60 minutes, Cytoflow
for 60 minutes
Basis showed an average decrease of 18% for Trial 1, a 28% decrease for Trial 2, and a 29% decrease for Trial
3. These averages were subtracted off the obtained data.
Trial 1 showed an average decrease of 19% at 1 day, and fluctuating between 33-37% for the following days.
The high range of vials came in with 34% decrease and the low range 21% decrease.
Trial 2 showed an average decrease of 13% at 1 day, 15% at 3 days, 16% at 7 days, 23% at 10 days, and back
to 13% at 14 days. The high range of vials came in with 20% decrease. The low range vials gave incorrect
readings.
Trial 3 showed an average decrease of 19% at 1 day, 21% at 5 days, and 21% at 7 days.
0
0.5
1
1.5
2
2.5
RBCCount(x10^6/uL)
RBC Comparison for 30/60 Minute Runs
Pre-Process
Easy-Load 30 Minutes
Cytoflow 30 Minutes
Easy-Load 60 minutes
Cytoflow 60 Minutes
Immediate 2 Weeks 4 Weeks
Red Blood Cells
White Blood Cells Left to Right: Easy-Load
for 60 minutes, Cytoflow
for 60 minutes
Combination
RBC Count WBC Count
[x106/uL] [x103/uL]
Pre 1.84 9.2
Easy-Load 1.78 9.55
Cytoflow 1.82 9.4
REFOAM after months of sun
and moisture exposure
13x425 caps
13x415 caps
12x80 mm vials
12x76 mm vials
REFOAM and EPS placed under same
weight
Results & Recommendations
0
0.05
0.1
0.15
0.2
0.25
0 0.05 0.1 0.15 0.2 0.25
Absorbance
Concentration (g/L)
Propyl Paraben
0
2
4
6
8
10
12
14
16
18
20
22
24
26
28
30
32
34
36
38
40
42
0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120
Integritemp R-SL16 Cooler - International Summer
16C Bottom 16C Middle 16C Logtag 16C Side 16C Top Chamber Temperature
Methods
S20L after drop 2
REFOAM after drop 4
All three coolers packaged up
(top to bottom: S13, R-SL16,
S20L)
6.15 lbs.
9.65 lbs.
13.15 lbs.
13x425
caps
12x80
mm
vials
0%
5%
10%
15%
20%
25%
30%
35%
40%
TorqueDecrease
Torque Retention for Various Vial/Cap Combos
80-425 76-415 Red 80-425
1 day 3 days 7 days 10 days 14 days
0
0.05
0.1
0.15
0.2
0.25
0.3
0.35
0.4
30 60 900 1800 2700 3600
Absorbanceat295nm
Time (seconds)
Absorbance of Propyl Paraben in Water
No Baffles
Baffles
Mixing with no baffles, vortex
formed
Mixing with baffles, prevents swirling and
promotes top to bottom fluid movement
Addition of baffles caused faster initial
dissolution and more uniform dissolution
throughout the mixing process.
Visual inspection showed less clumping in
solution when baffles were used.
Future Studies
• Try different propeller speeds
• Try different chemicals (sulfasalazine and
HEC)
• Redo experiment and standard curve to see
if results are repeatable

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Overview of Summer Internship Projects

  • 1. Learning Experiences Acknowledgements Enhancement of Solution Mixing Using Baffles • Entire Technology Transfer Team • Katie and Jared • Other summer interns Technology Transfer Internship – Jami Turnquist Evaluation of Masterflex Cytoflow Pump Head vs. Standard Peristaltic for Blood Cell Integrity The majority of Streck’s products are packaged in vials with screw-top cap closures. To ensure each vial/cap combination is properly packaged to prevent leakage, removal torque specifications are currently in place. These are obtained using a manual testing device (Secure-Pak Torque Tester) which measures necessary torque to unscrew the cap. Methods Five different times were chosen to test the removal torque of the caps and comparisons were made. These five times were 1 day, 3 days, 7 days, 10 days, and 14 days after initial application. Currently, testing is performed immediately after cap application and 7 days later. Data obtained suggests torque is highly variable but averages out after 3 days. The current time to check of 7 days seems to be acceptable. Data suggests that testing of retention could be done at 3 days, but more studies should be conducted to confirm this. Data also suggests lower initial application torque results in a lower decrease in torque. Results & Recommendations Background Streck manufactures over 200 different process solutions. Some solution formulations include chemicals that are difficult to dissolve and require extensive mixing. There has been speculation on whether the addition of baffles might accelerate the dissolution rates and speed up mixing time. Methods Three different chemicals were investigated. These include sulfasalazine, hydroxyethyl cellulose (HEC), and propyl paraben. Concentration measurements were established and data was collected at varying time points of the dissolution process both with and without the baffles. The 5” 3-blade hydrofoil was used with StirPak at setting 2 (approximately 300 rpm). Results & Recommendations Solutions with long mixing times: E-Check Final Diluent (sulfasalazine), Prewash Solution (HEC), Hemocue RBC Final Diluent (methyl paraben/propyl paraben) Propyl Paraben • UV/Vis Spectrophotometer, 295 nm • Diluent is 20mg% propyl paraben • 3.40 g of propyl paraben added to 15.30 L of ozonated water (lot volume of 17 L) Background Streck utilizes EPS Styrofoam shipping containers to ship all temperature-sensitive products, loaded with frozen and ambient gel packs for temperature control. A local vendor (Plastilite) developed a biodegradable form of Styrofoam known as REFOAM. Any alternative for shipping would have to be proven to physically protect Streck’s products, both in terms of temperature exposure as well as damage from impact. Background Streck utilizes peristaltic-style pumps for liquid transfer of non- cellular fluids. Fluids which contain cells have been considered “off-limits” due to concerns with shear imparted by the mechanical pump. A Cytoflow low-shear pump head was recently purchased and studies needed to be done to assess the feasibility of its use in transfer of hematology materials. Methods Red Blood Cells • 15 minute runs, 4 different flow rates (0.1, 0.3, 0.5, 0.7 L/min) • 30 minute runs, 1 flow rate (0.75 L/min) • 60 minute runs, 1 flow rate (0.75 L/min) • Repeated 60 minute run on Easy-Load (0.75 L/min) White Blood Cells (fixed) • 60 minute runs, 1 flow rate (0.75 L/min) Combination • 60 minute runs, 1 flow rate (0.75 L/min) Results & Recommendations No damage to RBC seen for small run times (<30 minutes). Easy-Load pump damages RBC at 60 minutes. Neither pump damages fixed WBC significantly. Good evidence Cytoflow pump suitable for transport of cellular fluids. Background Basis -10 of each combo within normal range Trial 1 -12x80 mm vials, 13x425 caps -100 vials AT between 1.5-3.9 in-lbs. -10 vials AT <1.4 in-lbs., 10 >4.0 in-lbs. Trial 2 -12x76.5 mm vials, 13x415 caps -100 vials AT between 1.5-3.9 in-lbs. -10 vials AT <1.4 in-lbs., 10 >4.0 in-lbs. Trial 3 -12x80 mm vials, 13x425 caps (red) -30 vials AT between 2.5-4.5 in-lbs. Future Studies • Try other flow rates at 60 minute time • Try whole blood or cellular products • Pump through leukocyte filter • Try times between 30-60 minutes, find when significant damage begins • Trouble shoot Easy-Load pump • Teamwork, exposed to all parts of the company • Experimental design • New technologies and equipment • Research and explore new topics • Data analysis • Trouble shooting • Networking • Coolers chosen for study: S13, S20L, larger REFOAM (R-SL16) • Packed with expired product in 12-slot clamshells, frozen ice packs, and filling paper • Four thermocouples in each cooler • One LogTag in center of each cooler • Use of Thermotron temperature chamber • International 5-day summer runs • FedEx Drop Testing Future Studies: • Try international winter, domestic summer, domestic winter runs • Have dimensions/contents matching exactly to current EPS • More in-depth strength testing, find force at which coolers break Mean Kinetic Temperatures of REFOAM: • Bottom: 26.84OC • Middle: 26.48OC • LogTag: 26.61OC • Side: 26.72OC • Top: 26.20OC In the LogTag, an alarm occurs if the temperature goes out of range (2-30OC). Alarms went off for the S13/S20 coolers, but not the R-SL16 cooler. Overall the REFOAM had good performance on the international summer testing, passing all three acceptance criteria (SQP-11013). Strength Testing • Weights on 1-inch pieces of material Drop Testing • Package <75 lbs. drop height at 30 inches • 10 different spots • Same configuration, shrink wrapped using ARPAC machine • S20 and R-SL16 withstood small cracks • All passed test Characterization of Time-Dependent Behavior of Closure Removal Torque Preliminary Performance Testing of REFOAM Coolers from Plastilite Left to Right: Pre-Process, Easy-Load for 30 minutes, Cytoflow for 30 minutes, Easy- Load for 60 minutes, Cytoflow for 60 minutes Basis showed an average decrease of 18% for Trial 1, a 28% decrease for Trial 2, and a 29% decrease for Trial 3. These averages were subtracted off the obtained data. Trial 1 showed an average decrease of 19% at 1 day, and fluctuating between 33-37% for the following days. The high range of vials came in with 34% decrease and the low range 21% decrease. Trial 2 showed an average decrease of 13% at 1 day, 15% at 3 days, 16% at 7 days, 23% at 10 days, and back to 13% at 14 days. The high range of vials came in with 20% decrease. The low range vials gave incorrect readings. Trial 3 showed an average decrease of 19% at 1 day, 21% at 5 days, and 21% at 7 days. 0 0.5 1 1.5 2 2.5 RBCCount(x10^6/uL) RBC Comparison for 30/60 Minute Runs Pre-Process Easy-Load 30 Minutes Cytoflow 30 Minutes Easy-Load 60 minutes Cytoflow 60 Minutes Immediate 2 Weeks 4 Weeks Red Blood Cells White Blood Cells Left to Right: Easy-Load for 60 minutes, Cytoflow for 60 minutes Combination RBC Count WBC Count [x106/uL] [x103/uL] Pre 1.84 9.2 Easy-Load 1.78 9.55 Cytoflow 1.82 9.4 REFOAM after months of sun and moisture exposure 13x425 caps 13x415 caps 12x80 mm vials 12x76 mm vials REFOAM and EPS placed under same weight Results & Recommendations 0 0.05 0.1 0.15 0.2 0.25 0 0.05 0.1 0.15 0.2 0.25 Absorbance Concentration (g/L) Propyl Paraben 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100 105 110 115 120 Integritemp R-SL16 Cooler - International Summer 16C Bottom 16C Middle 16C Logtag 16C Side 16C Top Chamber Temperature Methods S20L after drop 2 REFOAM after drop 4 All three coolers packaged up (top to bottom: S13, R-SL16, S20L) 6.15 lbs. 9.65 lbs. 13.15 lbs. 13x425 caps 12x80 mm vials 0% 5% 10% 15% 20% 25% 30% 35% 40% TorqueDecrease Torque Retention for Various Vial/Cap Combos 80-425 76-415 Red 80-425 1 day 3 days 7 days 10 days 14 days 0 0.05 0.1 0.15 0.2 0.25 0.3 0.35 0.4 30 60 900 1800 2700 3600 Absorbanceat295nm Time (seconds) Absorbance of Propyl Paraben in Water No Baffles Baffles Mixing with no baffles, vortex formed Mixing with baffles, prevents swirling and promotes top to bottom fluid movement Addition of baffles caused faster initial dissolution and more uniform dissolution throughout the mixing process. Visual inspection showed less clumping in solution when baffles were used. Future Studies • Try different propeller speeds • Try different chemicals (sulfasalazine and HEC) • Redo experiment and standard curve to see if results are repeatable