Professional Documents
Culture Documents
Lens Materials
& Manufacturing
Technology
2013
Cryo Blocking
Cryo Machining
Cryo Milling
Sterilization
HF-2 can be cryo milled using either the Benz Peltier Cryo
Mill or a MLC (mill/lathe combo), DAC or Optoform, fitted
with a Benz Vortex cooling device. The use of an MLC is a one
stop process of machining and milling. Using a separate Cryo
Mill requires cleaning the Universal Blank after machining
and re-freezing it on the Peltier plate of the mill. The milling
parameters are the same as HF-1.2, p. 15.
HF-2 SPECIFIFATIONS
opening times. Lenses made from HF-2 are dry sterilized in plasma or ethylene oxide and do
Benz HF-2 Natural Yellow
not require wet packaging to achieve both non-stickiness and very low glistenings that are
well below the clinical threshold. HF-2 is a unique hydrophobic acrylic polymer that achieves
these very advantageous characteristics while maintaining an Abbey number of 47, becoming
the first MICS capable hydrophobic material with low chromatic aberration.
HF-2 Natural Yellow IOLs have the same Abbey number (47) AND the same transmission
spectrum as the young Human Crystalline Lens. The spectral characteristics of HF-2 Natural
Yellow IOLs provide the cataract patient with visual characteristics that are the closest yet
to the young Human Crystalline Lens.
< 5%
< 5%
< 2% @ 400nm
Residuals; %
< 0.15%
< 0.15%
Optic Purity
>99.98%
>99.98%
Severity Index
< 750
< 750
At 20C
At 35C
1.519
1.514
At 20C
At 35C
1.519
1.514
At 20C
At 35C
1.520
1.515
At 20C
At 35C
1.520
1.515
ABBE Number
47
47
Tg
10C
10C
10 sec
10 sec
*Opening Times based on a +27 D C-Loop with a 6.0 mm optic using a 2.2 mm Medicel Accuject Injector
Since entering the IOL materials market in 1998, Benz Research and Development has become the
preeminent supplier of quality high performance materials and state of the art technology to the IOL
industry. The reason for our strong growth is our dedication to excellence in both Quality and Innovation.
Our 26 years experience in producing high quality materials for the soft contact lens industry also provides
a very significant foundation for hydrophilic IOL materials.
Expertise in high purity 2-HEMA monomer production extends over 27 years of continuous development.
Our hydrophilic polymer experience of 22 years is substantial. In conjunction with producing 15 novel
polymer materials, we have 19 US patents and 14 foreign patents. Combining this level of expertise in
developing new materials, it is apparent why we have quickly become the leader in IOL materials and we
continue our innovation with 9 US patents pending and
16 foreign patents pending.
Our current product line consists of three hydrophilic
Optical Blocking
COO - + Ca + 2 HPO 4 - 2 +H 3 O +
Calcium Phosphate
COO - Ca + 2 H 2 PO 4- + H 2 O
Calcium Phosphate Particle
U LT R A P U R E M O N O M E R
monomer
2
Polymer Matrix
Polymer Matrix
99.9%
3
Figure 1
Residuals Comparison
Competition
Residuals
1.8
1.2
1.6
B E N Z P O LY M E R I Z AT I O N
TECHNOLOGY
1.4
Relative Diffusion Rate
BENEFITS OF
1.0
0.8
0.6
1.2
1
0.8
0.6
0.4
0.4
0.2
0.2
BenzFlex 26
Competitor
BenzFlex 26
Competitor
Figure 2
Figure 3
First, our quality starts with ultra high purity raw materials.
The purity of our raw materials is much higher than that
provided as high purity by the chemical companies that
currently manufacture 2-HEMA. Our ultra pure, L3 Monomer
significantly reduces batch-to-batch variability and lowers
the residual monomer content of
our hydrophilic IOL materials.
Second, our polymerization process is carried out in virgin
glass tubes, not the plastic molds of competitor materials.
Plastic molds contain many impurities that affect the
polymerization process as well as contaminate the resulting
polymer, sometimes with toxic components not intended for
IOL use. To understand the scope of the contamination from
BenzFlex 26UV
0.010 mm
TH E P R ECI S I O N
USL
-3.0s
0.010 mm
or
14.5
0.010 mm
or 16.0
0.010 mm
12
12.692
12.689
0.008 mm MAX
Figure 6
18
12.686
0.003 mm
+3.0s
27
USL
-3.0s
36
Frequency
12.7
Tag
LSL
+3.0s
18
Frequency
GR O U N D B L A N K &
Tag
LSL
24
12.697
12.694
12.702
12.699
12.707
12.704
12.712
12.709
12.717
2.987
12.714
2.992
2.990
2.996
2.994
3.000
2.998
3.005
3.003
Microns
Microns
Figure 7
3.009
3.007
3.014
3.011
Figure 8
Figure 9
23.878
Edge Height
Provided In Data Table
0.23 Clearance
23.65
12.700 0.010
Section C-C
0.006
0.006
0.006
6 UM Or Better
Lens Concentricity To Mandrel Shank
Figure 9
Figure 10
0.005
Property
Water Content (wt %)
Benz IOL
25
25
BenzFlex
IOL 25
26
Universal Blank
26
25
1.507
1.509
1.507
Hydrated 20C
1.460
1.462
1.460
the retina without blocking needed blue light. Blue blocking IOLs reduce low light contrast sensitivity
Dry 20C
1.509
1.510
1.509
as well as color perception. These capabilities are critically needed for optimum vision of implant
Hydrated 20C
1.462
1.464
1.462
Linear
1.125
1.125
1.125
Radial
1.125
1.125
1.125
33
95
31
62
92
69
12.70.01
12.70.01
14.50.01
14.50.01
patients, particularly at night. Benz Natural Yellow achieves complete natural protection
Expansion
Tensile g/mm2
Youngs Modulus g/mm2
Diameter (mm)
Thickness (mm)
16.00.01
160.01
3.00.01
3.00.01
without loss of contrast sensitivity or color perception. The human retina has already specified the
exact chromophore it needs for energetic light protection through millions of years evolution,
and that is exactly the chromophore we deliver to our customers, in Benz Natural Yellow.
9
Table 1
BenzFlex 26
BenzFlex 26 is a generic material made from
2-Hydroxyethylmethacrylate and Methylmethacrylate.
This materials primary components are the same as other
products available on the market and has similar mechanical
properties. The main differences are that BenzFlex 26UV is
made with Benz Zero Technology ultra pure monomer and our
superior polymerization technology as well as made in virgin
glass molds. There are important quantitative differences
resulting from Benz Zero Technology monomer, Benzs superior
Polymerization Technology and virgin glass molds. These
advantages are: very low residuals, zero ionicity, a smaller
matrix (pore size), more precise expansion characteristics
than competitor materials and no contamination from
impurities found in plastic molds. The physical properties of
BenzFlex 26 UV are shown in Table 1.
5.0
90
4.5
UV-A Blocking
4.0
M(LY)
80
3-HydroxyKynurenine in Saline
3.5
Absorbance
I O L M AT E R I A L
% Transmission
BENZ HYDROPHILIC
3.0
2.5
Violet Filtering
2.5
1.5
Improved
Scotopic Vision
1.0
60
50
40
30
20
10
0.5
0.0
320
70
340
360
380
400
420
440
340
460
Figure 11
360
380
400
420
440
460
480
500
Wavelength (nm)
Wavelength (nm)
Figure 12
520
540
560
580
600
620
13.40 0.15
0.070
R0.04
BENZ HF-1.2
CT
6.05
Posterior Side:
Aspheric (Rb)
6.00 (OZ)
HYDROPHOBIC
I O L M AT E R I A L
5
R0.1
A
Section A-A
10
11
80
% Transmission
70
60
40
30
20
10
340
380
420
460
500
Wavelength (nm)
Figure 13
Figure 15
Figure 16
50
0
300
Figure 14
540
580
620
Material
1)
HF-1.2
SA60, SN60
2)
Std. Dev
Minimum
Maximum
718
14
699
749
8,589
9,442
327
46,361
Table 2
1) Data from Benz Research and Development QA Dept.
2) Aaron Waite, Nathan Faulkner, and Randall J. Olson. Glistenings in the Single-Piece Hydrophobic,
Acrylic Intraocular Lenses. J Ophthalmol 2007; 144:143-144
Property
Benz HF-1.2
Natural Yellow
Universal Blank
Water
<4
Tg C
3.6
1.485
35C
1.483
1.487
1.485
Tensile
288 g/mm2
Modulus
560 g/mm2
Abbe Number
Table 3
49
IOL 25 UV-Vis
100
100
90
90
5.0
80
4.5
UV-A Blocking
% Transmission
B L O C K I N G M AT E R I A L S
Absorbance
B E N Z U V- A
3.0
2.5
Violet Filtering
2.5
1.5
1.0
70
70
Yellow Chromophore
3.5
80
% Transmission
BENZ Natural
4.0
Benz IOL 25 UV
60
50
40
60
50
40
30
30
20
20
10
10
0.5
0.0
320
340
360
380
400
420
440
460
Wavelength (nm)
200 210 220 230 240 250 260 270 280 290 300 310 320 330 340 350 360 370 380 390 400 410 420 430 440 450
12
200 210 220 230 240 250 260 270 280 290 300 310 320 330 340 350 360 370 380 390 400 410 420 430 440 450
Wavelength (nm)
Wavelength (nm)
Figure 17
Figure 18
Figure 19
13
MACHINING
R E C O M M E N D AT I O N S
14
15
Figure 20
Figure 21
Lathe Tools
Tool
Radius
Top Rake
Relief
0.40 mm
0/-2.5
15
0.30 mm
0/-2.5
15
Table 4
Tool
Radius
.20 mm
.20 mm
10,000
89
0.35
Lathe Parameter*
Fine Cut
<-20
Speed (rpm)
9,500
26
0.12
<-20
Speed (rpm)
Rough
Fine
Milling
1st pass
Milling
2nd pass
55,000
9,000
7,500
50,000
33
15
80
.06
.04
88
0.10
Table 6
Fine Cut
9,000
Speed (rpm)
9,000
18
0.13
Depth of Cut
0.07
<-20
<-20
10
Table 7
Speed (rpm)
Rough
Fine
12000
11500
60
25
.06
.04
Table 5
Lathe Tools*
Fine Cut
50,000
30
<-20
Speed (rpm)
Tool Feed (mm/min)
Blank Surface Temp (C)
50,000
45
<-20
Milling Parameters
Equipment, Optomill 363
0.400mm x 1.2mm Diamond Endmill (Wiediam Diamonds)
1st & 2nd Cut Feed, 88mm/min, 80,000 rpm
3rd Cut Feed, 91mm/min, 90,000 rpm
1st Cut Stops 0.050mm ( approximately 0.250mm depth)
shy of breaking through to wax
2nd Cut Goes 0.050mm ( approximately 0.350mm total)
past the lens into the wax
3rd Cut Backs off 0.030mm depth, with a radial cut of
0.030 0.040mm
Cycle time, 150 seconds
Environmental
70 3F (21 2 C)
35 3% RH
Isotonic Saline
Borate Buffer pH 7.2; 295 mOs
NaCl
8.01 grams
H3BO3
2.47 grams
Na2B4O7 10H2O
0.14 grams
H Y D R AT I O N O F
The weights for the buffered saline
formula is based on a 1 liter solution.
The borate solution shows excellent
performance through the sterilization
process (autoclaving) and leaves the
lenses free of residue.
BENZ HYDROPHILIC
M AT E R I A L S
16
17
Table 9
B E N Z M A N U FA C T U R I N G T E C H N O L O G Y
Reading #
ACHIEVING
COLLET TO COLLET
PRECISION
0.49950.0001
[12.687mm0.0025mm]
20
0.0036
0.0038
0.0039
0.0036
0.0036
0.0041
0.0034
0.0025
0.0036
10
0.0029
Average
0.0035
SD
0.0005
Figure 24
Figure 25
Table 10
21
O P T I C A L B LO C K I N G &
O P T I C A L C RYO B LO C K I N G
22
Part
# Center
(mm) Y1
(mm) X2
(mm) Y2
(mm) X1
(mm) Max-Min
0.158
0.135
0.135
0.131
0.131
0.004
0.153
0.145
0.147
0.146
0.142
0.005
0.155
0.145
0.146
0.141
0.141
0.005
0.155
0.143
0.147
0.142
0.140
0.007
0.152
0.142
0.145
0.141
0.141
0.004
Average
0.155
0.142
0.144
0.140
0.139
0.005
SD
0.002
0.004
0.005
0.006
0.005
0.001
23
Table 11
Figure 26
ILM CRYO
I L M- C
CRYO MA N U FACTU R I N G
Cryo Blocker
O F H F -1 . 2 & H F -2
24
25
Mill / Lathe
Combo 1
The blocker cycle is <60 sec from picking the Universal Blank
from its tray and blocking on a cryo mandrel and cooled to
-28C. ILM-C, with its robotic part handling, keeps 2-MLCs
working at full capacity. When the MLC finishes cutting the
lens the cryo mandrel is moved to an automatic station
that warms the mandrel, removes the finished lens to a
special container, and cleans the mandrel to start another
manufacturing cycle.
The productivity of ILM-C is >140,000 finished lenses per year
when operated 16 hours/day, 250 days/year. One operator is
required per shift. Guaranteed yield is 96%.
Robot
Mill / Lathe
Combo 2
Cleaning
Station
I N T E G R AT E D
9. Hydration &
or Inspection
L E N S M A N U FA C T U R I N G
The ILM system has been designed for both function and flexibility. ILM-3 also allows
Automation
Software
& Database
8. Polishing
(ILM)
7. 2nd Side Optics
Lathing
(Robotic)
3. Blank
Mounting
(Robotic)
the system manager to easily add or delete equipment under its control while remaining in
continuous operation. The process manager can select each machine mode, thereby
optimizing operation time and allowing for other functions like maintenance, or diamond change,
that takes a single machine off line while the remaining equipment remains in automation.
Adding cells and rearranging equipment within cells is easy through the secure operator interface.
6. Deblocking
& Cleaning
(Robotic)
5. Optical Blocking
(Robotic)
There is no limit to the size of the total ILM-3 system imposed by the Benz Automation Program.
26
27
Figure 27
Measurement
RO Error (microns)
I L M -3
Calibration
20.0 m
0.0 m
-20.0 m
-40.0 m
-60.0 m
28
13:00
13:30
14:00
14:30
15:00
15:30
Figure 28
Auto-Lathe Calibration
One of the unique features of the ILM-3 is auto-lathe
calibration. This feature allows for automatic adjustments
to be made to all the lathes in this system for radius and
sphere. During initial start-up, two calibration parts are
machined on each lathe, one to calibrate and a second to
verify both the radius and the sphere. During the production
day, calibration parts are automatically run on the lathes in
the system at an interval chosen by the operator. Production
parts can also be used for calibration. Lathes are maintained
to tighter operational tolerances using the precision of the
Optical Blocker inspection and the auto-calibration feature.
All first side lathes are 100% monitored because all first sides
are optically inspected before being blocked. An example of
a DAC ALM calibration record and its optical blocker radius
measurements are shown in Figure 28.
ILM-3
DAC MLC
Optical
Blocker
Blank Mounting,
Deblocking and
Cleaning
Productivity of ILM
The productivity of ILM has been extensively studied at BRD.
We have used a 3-cell system in full production for almost
eight years. With this level of experience, Benz Research and
Development will guarantee the productivity of your ILM-3 system.
Transfer
Track
DAC MLC
Tray Feed
System
DAC MLC
DAC MLC
29
ILM Performance
Confidence (R2) = 0.9993
Target 11.030 mm
32
1st Side
VA L I D AT I O N
30
ILM PERFORMANCE
Target 0.967 mm
Target 0.270 mm
Target 5.370 mm
Barcode #
Measured Radius
Center Thickness
Haptic Thickness
OZ Diameter
28
6269
11.0316
0.971
0.272
5.378
26
6615
11.0338
0.971
0.271
5.374
24
5775
11.0371
0.966
0.276
5.379
22
7414
11.0344
0.968
0.270
5.373
20
6702
11.0341
0.965
0.268
5.376
18
7455
11.0371
0.964
0.272
5.369
16
7481
11.0308
0.970
0.275
5.373
6659
11.0276
0.974
0.274
5.374
6538
11.0341
0.967
0.274
5.369
5541
11.0318
0.964
0.268
5.380
6415
11.0328
0.956
0.274
5.373
6380
11.0298
0.956
0.271
5.376
AVERAGE
11.0329
0.966
0.2721
5.3745
SD
0.0028
0.0056
0.0026
0.0035
14
12
10
8
6
30
6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32
Before Polishing
After Polishing
Power
19.8
19.8
19.8
19.8
19.8
19.8
19.8
19.8
19.8
19.8
MTF
0.45
0.60
0.58
0.53
0.55
0.63
0.56
0.54
0.63
0.57
Power
19.8
19.8
19.8
19.8
19.8
19.8
19.8
19.8
19.8
19.8
MTF
0.59
0.57
0.56
0.53
0.59
0.58
0.58
0.58
0.56
0.54
19.8
19.8
19.8
19.8
19.80
0.05
0.56
0.51
0.58
0.54
0.60
0.046
19.8
19.8
19.8
19.8
19.80
0.02
0.59
0.59
0.59
0.59
0.60
0.03
AVG
SD
Figure 29
Table 13
Table 14
ILM Performance
To determine the true accuracy of ILM we have made many
tests utilizing groups of 120 identical lenses and measured
each lens both dry and wet on a Rotlex IOLA. We also calculated
what the wet power should be from the measured dry power
and compared this to the actual measured wet power. The
results of over 200 of these tests are shown in Figure 29.
Following lathing the 1st side optics and milling the haptics,
each part is precision blocked, in the optical blocker, after
the optics have been examined and centered and the radius
measured. This radius data is used to re-calculate the target
radius on the 2nd side optic to ensure optimum target
hitting. Second side optic is then lathe-cut and the dry IOL
de-blocked and cleaned. A sample size consisting of 60 lenses
was selected at random from each Diopter batch. Out of this
sample, a set of thirty (30) lenses were hydrated directly after
lathing (before dry polishing) and a second set of thirty (30)
lenses were polished using the Benz proprietary dry-polish
process followed by hydration. While in the dry-state, we
measured each lens OZ diameter, center thickness and haptic
thickness. Table 13 shows the measured radius of 12 randomly
selected 20 D lenses from a 120-part order along with the data
for CT, haptic thickness and optic diameter.
+20.0
+12.0
+28.0
Target
+20.0
+12.0
Measured
Dimension (mm)
Center Thickness
1.269
0.967
0.686
1.262
0.964
0.678
SD
0.020
0.020
0.020
0.006
0.007
0.007
OZ Diameter
5.370
5.370
5.370
5.372
5.374
5.375
SD
0.020
0.020
0.020
0.004
0.004
0.005
28.0
20.0
12.0
27.8
19.8
12.0
SD
0.25
0.25
0.25
0.04
0.03
0.06
28.0
20.0
12.0
27.8
19.8
11.9
SD
0.25
0.25
0.25
0.04
0.02
0.05
0.46
0.54
0.58
0.03
0.05
0.04
0.48
0.55
0.56
0.02
0.03
0.02
ILM Calculation
MTF
Radius (mm)
OZ Diameter (mm)
+28.0
7.80
1.269
5.370
SD
+20.0
11.03
0.967
5.370
+12.0
18.44
0.686
5.370
Table 12
+28.0
SD
Table 15
31
I L M -3
Item
Hours
Quantities
Number of BLANKS
Per Day
1125
22.5 hrs
Average Production
Operator Cost
24hr
Average Consumable
Costs
22.5 hrs
Cost
Description
Estimated Daily
Expense
$1.50
98.5% yield
$1,688.00
$432.00
$80.00
Including
Polishing
Environmental Requirements
Temperature
21C + 2
RH
37% + 5 at 21C
Air
$80.00
$2,200.00
$550.00
$2,750.00
Electrical
UPS
32
$2.48
33
Table 16
224 [5.700m]
283 [7.200m]
Profitability of ILM-3
Using Table 16 you can determine the appropriate gross profit
potential of an ILM production cell shown in Figure 30.
The following assumptions have been made:
A 24 hours/day operation (1 hour set-up and calibration,
22.5 hours of production)
Use 4 DAC MLCs
Average yields of 98.5% through machining. Yields are
guaranteed and based on our experience manufacturing
semi-finished lenses.
Figure 30
B E N Z U N I V E R S A L B L A N K M A N U FA C T U R I N G ( U B M )
UNIVERSAL BLANK
M A N U FA C T U R I N G ( U B M )
36
37
Figure 31
Figure 32
Figure 33
Figure 34
Figure 35
Benz Research and Development has implemented a major program towards renewable energy and conservation. Beginning
in the summer of 2007, Benz Research and Development installed a 25,000 watt solar panel array and began a comprehensive
program to examine energy use. This has resulted in several important energy conservation projects that have reduced our
electrical power demand by 50,000 watts. Our current energy conservation projects include 250 KW of gas turbine power
combined with a high efficiency heat recovery system to provide 1,080,000 BTUs of air conditioning via LiBr absorption
chillers and 400,000 BTUs of process hot water. The overall efficiency of our Combined-Heat-and-Power system (CCHP) is
approximately 70%, which has helped us to further trim our electrical power demand by 100,000 watts.
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