thermoplastic color development, control, and change...
TRANSCRIPT
Thermoplastic
Color Development,
Control, and Change
Management for
Medical Devices
Copyright © RTP Company Page 1 of 13
Thermoplastic Color Development, Control, and Change
Management for Medical Devices
Abstract – Medical devices with plastic components may be required to pass biologic testing,
may be scrutinized for drug interaction, and may need to meet stringent branding requirements
of the manufacturer. This paper provides a technical view as it relates to selecting color for use
in medical devices, guidance on current regulations, plastic formula selection, color control and
change management.
Josh Blackmore
Global Healthcare Manger
Mike Chappell
Color & Additive Marketing Specialist
RTP Company, 580 E. Front St., Winona, Minnesota, USA
Telephone: +1 (507) 454-6900, Internet: www.rtpcompany.com
Table of Contents
I. Importance of Color in Medical Devices ................................................................................................... 2
II. Color Development Criteria for Medical Devices.................................................................................... 2
Medical Devices with Patient Body Contact ............................................................................................ 3
Medical Device Classification .................................................................................................................. 3
Biocompatibility Testing Definitions ........................................................................................................ 5
Medical Devices used for Drug Delivery with Patient and/or Drug Contact ............................................ 5
III. Plastic Formulation Selection, Control and Change Management ......................................................... 5
Color Control for Medical Devices ........................................................................................................... 6
Sterilization Techniques Effect on Color .................................................................................................. 7
IV. Formulation Change Control .................................................................................................................. 8
Measuring Change Using Fourier Transform Infrared Spectroscopy (FTIR)........................................... 8
Formulation Change Management ............................................................................................................ 9
V. Special Effects and Value-Added Options ............................................................................................... 9
Antimicrobial: Value-Added, Masterbatch, and Precolor Technology................................................... 10
VI. Summary and Conclusions ................................................................................................................... 10
VII. References ........................................................................................................................................... 12
VIII. Appendix ............................................................................................................................................ 12
Additional Resources .............................................................................................................................. 12
Selection Check List for Evaluation of Color Compounders for Medical Devices ............................... 13
Copyright © RTP Company Page 2 of 13
I. Importance of Color in Medical
Devices
Color is an integral part of our daily lives and is used
to convey vast amounts of information regarding
quality, brand, size, and function coding, and even
convey a sense of how safely a device operates. The
importance of color is recognized by device
manufacturers, consumers, and doctors and nurses,
but each for different reasons.
For doctors and nurses, color plays a more functional
role as they commonly rely on color-coded medical
devices to indicate the size, type and function for split-
second identification during medical emergency and
surgical procedures.
For example, emergency room nurses often report that
color coding helps them find the correct devices
quickly, thus reducing the risk of an error. Color-
coded devices help provide timely and lifesaving care
because healthcare professionals don’t have to
question whether they have the right equipment [1].
Most medical devices were developed for use in
hospital or exam rooms and their main feature was
effective function. Today, aesthetics, branding,
consumer preference and ergonomics are now
topping the list of critical design criteria.
Toothbrushes entered this phase of design more than
10 years ago by applying colors and soft grips to
improve ergonomics and create brand preference.
Now nearly every medical device from drug
injection pens to home blood pressure cuffs that
crossover from institutional to consumer use are
adding features designed to improve patient
acceptance and improve brand recognition.
Leading medical device manufacturers are seeking
to improve the consistency for how their brand
colors are represented and ultimately the value color
produces for their company. As the medical industry
continues to globalize and competition increases, the
importance of a brand identity system becomes more
relevant. The function of a brand identity system is
to encode the brand in people's memory and create a
positive association with the product which
facilitates rapid retrieval from their memory. Color
can have a significant effect on people's perception
of a product or brand [2]. Device manufacturers are
combining branding with insight into consumer
preferences to create medical devices tailored to the
needs of consumers and healthcare professionals.
Although color is considered a “soft science”,
substantial research demonstrates that color is one of
the most powerful tools that can be used to create
brand equity, loyalty and value. Consider the
following statistics: research reveals people make a
subconscious judgment about a person, environment,
or product within 90 seconds of initial viewing and
between 62% and 90% of that assessment is based
on color alone [3]. Additionally, color increases
brand recognition by up to 80% [4].
With this in mind, it is essential that color is
considered early in the medical device development
process to ensure the device appeals to the end-user
aesthetically and represents the brand effectively. As
we have demonstrated, color is an important factor
in many aspects of medical devices, from design to
how the device is used and by whom.
II. Color Development Criteria for
Medical Devices
Once important branding and device acceptance
color influences have been established we turn our
focus to using resins and colorants that are suitable
for the application and will pass the regulatory
testing requirements for safe and effective use. In
2010 the FDA and regulatory bodies around the
world increased their scrutiny of colors as additives
in all materials and are paying special attention to
the biologic testing performed on pigments used in
plastic in an effort to reduce potential safety risks.
To determine what biologic testing is required, you
will need to know what the medical device will be
Excellent example of use of color by the
Coca-Cola Company.
Coca-Cola® and the Contour Bottle are registered trademarks of The Coca-Cola Company.
Copyright © RTP Company Page 3 of 13
used for and where it will be sold. Most of the world
follows the International Standards Organization
(ISO) 10993 guidelines for the testing of raw
materials and finished devices, but each country
implements these standards a little differently. Once
you determine which regulatory body has
governance over your device it will be easier to
determine the various biologic tests that will be
required.
Medical Devices with Patient Body Contact
It is important for the design engineer to use plastics
that will pass the required biologic testing of the
finished, molded and assembled device. Plastics
used in medical devices that will be sold in the
United States and have patient contact will follow
the 510(k) #G95-1 Blue Book Memorandum [a].
The basis of this memorandum is the ISO 10993
standard.
The ISO 10993 regulations are essential to
understand because the United States, European
Union, Japan and other countries collaborated to
harmonize various international medical device
regulations resulting in the ISO 10993 standard,
which is the basis for the 510(k) application in the
USA and the CE mark in Europe.
Medical devices with patient body contact are
designated as Class I, II and III in the United States
and Class I, IIA, IIB and III in Europe. In order to
make good choices for the raw materials used in a
medical device you must first understand what
classification will be applied to the device.
Medical Device Classification
The European Union provides MEDDEV 2.4/1 –
rev. 8 PART 2: GUIDELINES FOR THE
CLASSIFICATION OF MEDICAL DEVICES [b],
which is a questionnaire with 18 rules to follow that
result in providing you with a device classification.
The classification allows you to decide the type of
biologic testing that will be required.
In the United States, a similar process is available in
which you answer questions in a decision tree that
flows to the endpoint where you are able to
determine your classification.
The names of these classifications differ slightly, but
the definitions which relate to how the device
contacts the patient and the duration of that contact
are remarkably similar and follow the ISO 10993
guidelines for raw material and finished device
testing.
Both regulatory bodies evaluate a given medical
device by the level of invasiveness or type of contact
(Table 1), as the first step to help prescribe the
biologic tests that will best ensure safe use of the
device. There are often exceptions for device
classification and it is important to refer to the
guidance offered by the appropriate regulatory body.
Once the level of invasiveness is understood, contact
duration must be understood for final determination
of the biologic testing required (Table 2).
Table 2: Contract duration descriptions
US FDA Device Classes
European Union Device Classes
Surface Devices – typical for skin contact
Body Orifice – any natural opening to the body including the surface of the eye ball
Externally Communicating Devices – typical for blood or tissue contact
Surgically Invasive Device – penetrates the surface of the body
Implant Devices – RTP Company does not participate in implant devices
Implantable – totally introduced into the human body
Device Contact Table
US Description
Contact Duration
EU Description
Limited Contact
Less than 24 hours
Transient Contact
Prolonged Contact
24 hours to 30 days
Short Term Contact
Permanent Contact
Greater than 30 days
Long Term Contact
Table 1: Simplified process to determine level of invasiveness
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An easy to use chart titled 510(k) Memorandum -
#G95-1 Table 1 Initial Evaluation Tests for
Consideration published on the FDA website
illustrates how to determine what testing will be
required. A colorized version of this chart is shown
as Fig. 1 and provides an overview of the most
commonly required biocompatibility testing related
to patient contact and duration.
For example, it can be determined that a medical
device in contact with circulating blood for a
prolonged time period will likely be required to pass
6 biologic tests and may be required to pass 2 others
as determined by an FDA reviewer (Fig. 1).
Understanding the type of testing required and the
device classification will help the designer to select
raw materials that will pass the required tests.
During the late 1980’s to the mid 90’s the United
States Pharmacopeia (USP) Class VI was used as
guidance for biologic testing. It is still referenced
today as a selection criterion for plastic raw
materials. There is some overlap with the biologic
testing required by the USP Class VI and ISO
10993, but they are not identical and the similarities
break down with higher risk devices.
Therefore, the ISO 10993 standard is more
applicable to medical device testing. It should be
noted that it is wise to select raw materials that have
been tested for USP Class VI or ISO 10993 but in
most cases the regulatory body will require that the
finished molded and assembled device be tested to
take into account all the manufacturing steps
required to produce the product.
Fig. 1: FDA Initial Evaluation Tests table where X = test per ISO 10993, and O =additional tests that
may be required in the USA.
Contact Duration
A = Limited
(<24 hours)
B = Prolonged
(24 hours - 30 Days)
C = Permanent
(> 30 Days)
A X X X
B X X X
C X X X
A X X X
B X X X O O O
C X X X O X X O O
A X X X O
B X X X O O O
C X X X O X X O O
A X X X X X
B X X X X O X
C X X O X X X O X X X
A X X X O
B X X O O O X X
C X X O O O X X O X
A X X X X O X
B X X X X O X O X
C X X X X X X O X X X
A X X X O
B X X O O O X X
C X X O O O X X X X
A X X X X X X
B X X X X O X X X
C X X X X X X X X X X X
Type of Body Contact
Implant Devices
Tissue/Bone
Blood
Externally
Communicating
Devices
Blood Path, Indirect
Tissue/Bone/Dentin
Communicating
Circulating Blood
Surface Devices
Skin
Mucosal Membrane
Breached or
Compromised Surfaces
Bio
degra
dation
Biological EffectDevice Categories
Chro
nic
Toxic
ity
Carc
inogenic
ity
Repro
ductive/D
evelo
pm
enta
l
Subchro
nic
Toxic
ity
Genoto
xic
ity
Impla
nta
tion
Hem
ocom
patibili
ty
Cyto
toxic
ity
Sensitiz
ation
Irrita
tion/I
ntr
acuta
neous
Acute
Syste
mic
Toxic
ity
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Biocompatibility Testing Definitions
There are many biologic tests that could be
required by a regulatory body depending on
patient contact and duration. The most
commonly required biologic tests by the ISO
10993-1 standard for devices that use plastics
are:
Cytotoxicity – Using cell techniques, these tests
determine the lysis of cells (cell death), the
inhibition of cell growth, and other effects on
cells caused by medical devices, materials
and/or their extracts. Cytotoxicity tests are
described in ISO 10993-5.
Sensitization – These tests estimate the potential
for contact sensitization of medical devices,
materials and/or their extracts, using an
appropriate model. These tests are appropriate
because exposure or contact to even minute
amounts of potential leachables can result in
allergic or sensitization reactions. Sensitization
tests are described in ISO 10993-10.
Irritation – These tests estimate the irritation
potential of medical devices, materials and/or
their extracts, using appropriate sites for implant
tissue such as skin, eye and mucous membrane
in a suitable model. The test(s) performed
should be appropriate for the route (skin, eye,
mucosa) and duration of exposure or contact to
determine irritant effects of devices, materials
and potential leachables. Irritation tests are
described in ISO 10993-10.
Intracutaneous Reactivity – These tests assess
the localized reaction of tissue to medical device
extracts. These test are applicable where
determination of irritation by dermal or mucosal
tests are inappropriate (e.g. medical devices
having access to the blood path). These tests
may also be useful where extractables are
hydrophobic. Intracutaneous reactivity tests are
described in ISO 10993-10.
Systemic Toxicity (acute Toxicity) – These tests
estimate the potential harmful effects of either
single or multiple exposures, during a period of
less than 24 h, to medical devices, materials
and/or their extracts in an animal model. These
tests are appropriate where contact allows
potential absorption of toxic leachables and
degradation products.
Pyrogenicity tests are included to detect
material-mediated pyrogenic reactions of
extracts of medical devices or materials. No
single test can differentiate pyrogenic reactions
that are material-mediated from those due to
endotoxin contamination. Systemic toxicity tests
are described in ISO 10993-11.
Medical Devices used for Drug Delivery with
Patient and/or Drug Contact
If the medical device will be used for drug
delivery, all of the same requirements for patient
contact and duration must be considered, plus
there are additional factors that the designer
must consider.
The drug delivery device must be evaluated to
ensure that the stability and bioavailability of the
drug has not been adversely changed. This is
done once drug toxicity is known and has been
approved for use. Drug delivery evaluations are
done on a case by case basis and include testing
for drug/plastic interaction and plastic/drug
leachability.
To reduce plastic selection errors, and therefore
speed the development process, it is a good idea
to work with a plastics supplier with medical
device experience early in the development
process to add color and/or other value-added
features into the plastics. Key services to look
for include material selection experience across
a wide range of resins, suggestions based on
successful experience, in-house testing of
specific colors and plastics, and the ability to
hold a formulation fixed.
III. Plastic Formulation Selection,
Control and Change Management
Selecting raw materials for medical devices
includes screening them for the ability to pass
ISO 10993 biologic testing. The FDA and EU
place a high demand for information on
colorants used in plastic formulations and
requires a deep understanding of what color
additives will pass the required biologic tests
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and perhaps more importantly which ones may
fail. Regulatory bodies have expressed renewed
concern over color additives in plastics over
fears that they may leach out and have adverse
patient reaction or interactions with drug
formulations which alter the drug.
Pre-testing plastics, carriers, pigments and dyes
help to ensure the resulting colored plastic
compound has the ability to pass required
biologic testing on the finished molded and
assembled device. Pre-tested color compounds
should include taking pigments and dyes
through ISO 10993 biocompatibility testing at
an independent lab for part 5, in vitro
cytotoxicity, part 10, irritation and delayed type
hypersensitivity, and part 11, systemic toxicity
[5].
In addition to obtaining a statement of
biocompatibility design engineers should ask
questions to help ensure global availability and
high commercial viability by checking to make
sure large demand exists for these products.
Using pre-tested plastic compounds does not
relieve the OEM from testing the finished
molded and assembled device, as is likely
required by the regulatory body. Using pre-
tested raw materials helps to demonstrate to the
regulatory body a pattern of concern for safety
that was taken during product development. It
will also help to ensure that when testing does
take place, which is usually at the end of the
development, there won’t be any setbacks or
redesign issues which can delay the product
launch schedule.
Color Control for Medical Devices
Good color specifications create boundaries
within a color space that indicate the exact color
desired by OEM’s for medical devices, but are
not too tight to cause excessive rejections.
Numeric color measurement plays an important
role in color control for the plastics compounder
and the molder. By establishing tolerances for
acceptable color, OEMs can help processors,
from raw material to finished parts, achieve
consistent color quality across multiple lots and
manufacturing sites around the world.
Color control tolerances are often driven by the
application. For example, color used to identify
different sizes and types of medical instruments
usually do not have to be as stringent since color
is being used to differentiate one instrument
from another using various colors. Devices
incorporating various polymers of the same
color can require tighter tolerances to maintain
color harmony and devices incorporating brand
colors are often driven by corporate guidelines
using ink on paper.
An important first step in color control is a basic
understanding of color technology, color
measurement and methods available to control
color. Device color can be evaluated visually by
trained colorists or instrumentally with color
measuring devices and software. Visual
evaluation can be limiting because it can be
difficult to communicate or transfer color
information and is usually not a good choice for
consistent color control. A good practice is to
measure color instrumentally and incorporate
visual evaluation in the total color control
process.
The two most common color measuring
instruments are the colorimeter and the
spectrophotometer. Colorimeters are useful for
simple color difference measurements when
both the standard and the trial are made from the
same substrate, the same colorants and using one
illuminant. Spectrophotometers measure the
reflected or transmitted light at specific
wavelengths to provide color difference
measurements as well as take into account gloss
or texture.
Numerous measuring systems have been
developed over the years to quantify color
numerically using color measuring instruments.
These systems require the use of a defined color
space that is usually three dimensional and
provides a means for color specification or
identification and comparison. The most
popular are based on the CIE L*a*b* color
space. In the CIE L*a*b* color space, colors are
identified by their L*, a*, and b* values:
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Fig. 2 CIE L*a*b* Visual Difference Example
L* defines the lightness/darkness of a color
a* defines the redness/greenness of a color
b* defines the yellowness/blueness of a color
When a color is measured instrumentally using
the CIE L*a*b* color space, the resulting
numeric coordinates for L*, a*, and b* can be
used to identify a particular color and can also
be used as a quality control tool. In production,
numeric color values from current
manufacturing lots of medical devices can be
compared to stored standard values.
Numerous color difference equations have been
developed based on the CIE L*a*b* color space
that actually improve the correlation between
what is measured instrumentally and how it
corresponds to what is actually perceived by the
human eye. This is why visual evaluation
should always be a part of a good color control
program.
Fig. 2 illustrates a color control scenario with a
numeric limitation in CIE L*a*b* color space of
1.0 unit for L*, a*, and b* along with a color
representation of each. When setting up a color
control program, care should be taken not to
establish color acceptability limits beyond what
is necessary for your usage situation. Depending
on the color difference equation selected, it will
not be unusual to have different limits set for
each variable. It is common to have more color
rejects and returns as well as increased
production costs when using extremely tight
color tolerances.
Color control programs can be very detailed
depending on the color requirements of an
application. For help with setting up a color
control program, ASTM International has
several methods and standard practices for
evaluating color and for establishing color
tolerances and color differences based on visual
evaluations and from instrumental color
measurements [c]. Color measuring instrument
manufacturers can also help with establishing
color controls with the purchase of hardware and
software.
Finally, it is important that standards, measuring
requirements and established tolerances are
communicated and understood throughout your
supply chain for any color control program to be
successful. A good color control program will
also help make the regulatory approval process
easier and less time consuming.
Sterilization Techniques Effect on Color
An issue to be aware of during medical device
development is the effect sterilization may have
on the color of plastic components. The most
commonly used sterilization techniques are
autoclave, ethylene oxide gas (EtO) and
radiation sterilization by either gamma or E-
beam radiation. Each sterilization technique has
an effect on plastic materials that may adversely
affect the color and physical properties. It is
recommended to check color in the finished
CLAB Color Space diagram
CIE L*a*b* Color Space Diagram
Copyright © RTP Company Page 8 of 13
assembled state before and after sterilization to
determine the visual and physical effects.
Autoclave - Typical reactions to autoclave may
include hydrolysis, warp and part
distortion/deformation, however, color is usually
not affected.
EtO is often used for heat sensitive polymers
and usually does not cause significant color
change.
Gamma and E-Beam radiation sterilization can
cause cross linking of polymers, chain scission
and yellowing of colors. Although not the
subject of this paper, there are techniques that
knowledgeable color suppliers use to stabilize
colors against radiation.
IV. Formulation Change Control
It is a common practice for plastic compounders
to use resin and pigment equivalents that can be
interchanged based on price and availability.
The key test criteria are typically physical
properties and the ability to match the color
target. Unless you specifically request that the
formulation be held fixed and the compounder
has the ability to track and trace the formulation
in every production lot, you will not have a
secure formula and you may introduce
significant risk to your device and invalidate
your biologic testing.
Once you have selected the color for your device
and have taken it through required biologic, drug
interaction or leachability testing, you must lock
the formulation so that no changes can take
place. This is best accomplished by requesting it
at the beginning of color development.
Otherwise, by not locking your plastic
formulation you will put your device at risk
because all of your test data was performed on a
specific formulation and you may have an
uncontrolled plastic formulation which allows
the supplier to change ingredients.
Measuring Change Using Fourier Transform
Infrared Spectroscopy (FTIR)
Using FTIR test results on a pigment sample
helps us to demonstrate subtle differences in
chemical composition and drive home the need
for formulation control. FTIR is a common
failure analysis technique that provides
information about the chemical bonding or
molecular structure of materials, whether
organic or inorganic. It is used to identify
known and unknown substances present in a
specimen.
The procedure works on the fact that bonds and
groups of bonds vibrate at characteristic
frequencies. A molecule that is exposed to
infrared rays absorbs infrared energy at
frequencies which are characteristic to that
molecule. During FTIR analysis, a spot on the
specimen is subjected to a modulated IR beam.
The specimen's transmittance and reflectance of
the infrared rays at different frequencies is
translated into an IR absorption plot consisting
of reverse peaks. The resulting FTIR spectral
pattern is then analyzed and matched with
known signatures of identified substances in the
FTIR library.
RTP Company used the FTIR analysis technique
to examine two chemical equivalents to
reinforce the need for formulation control and
“no material substitution” services. For this
example, your medical device is colored using
pigment white 6 with a CAS registry number of
13463-67-7, color index number 77891 and its
generic chemical name is titanium dioxide. The
commercial chemical composition of titanium
dioxide can vary due to the variety of surface
treatments used to improve durability, dispersion
and processing performance. RTP Company
tested the same pigment white 6 with CAS
registry number 13463-67-7 from two different
suppliers shown in figure 3 [6].
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Formulation Change Management
Having made excellent raw material choices that
have passed your fit, form, and biologic testing
requirements, you’ve made sure the formulas for
your plastic compounds are controlled. But what
happens when change occurs? These changes
typically fall into the following categories:
The OEM changes the location of where the
medical device will be produced or adds
another manufacturing or assembly area.
A supplier has a force majeure situation
occur (such as fire or act of God which
cannot be controlled).
A supplier goes out of business.
The resin, pigment or colorant becomes
discontinued.
The resin, pigment or colorant supplier goes
out of business or has a force majeure
situation
In all these supply disruptions, communication
and the ability to supply from multiple locations
or even globally are key attributes of a quality
medical plastics compounder with a strong
supply chain. Screening questions which can be
asked of the plastic compounder up front will
help to ensure that you develop long term
relationships with a supplier that has the ability
to successfully supply to the medical device
industry.
Does the medical plastics supplier have:
A commitment to the medical industry and
a track record of success?
Multiple manufacturing plants in case one
site experiences force majeure?
A global foot print to accommodate your
growth into other areas of the world?
A solid financial background to reduce the
risk of bankruptcy?
A quality system in place to help you
respond to supply chain issues of
discontinuation and force majeure by
offering change management services?
Change Notification: If a raw material is going
to be discontinued, the change notification
system needs to be capable of determining
where a particular ingredient has been used and
search of all formulations globally for the
purpose of notifying customers of a change and
provide options to pre-order a sufficient
quantity, or evaluate a replacement material.
Change Options: If a raw material has
experienced force majeure or been discontinued,
there may be an option to make a large purchase
to provide more time to qualify new materials or
will there be a need to begin testing new raw
materials right away.
V. Special Effects and Value-Added
Options
Medical devices that have moved from
institutions or doctor’s office into the home
experience new “consumer cross-over” demands
for appealing special effect colors and
ergonomics. Special effect colors that have the
ability to pass ISO 10993 biologic testing are
Metallic Special effects colors available from RTP Company
Fig. 3 FTIR scan demonstrates the differences that can be
found in equivalent pigments from different suppliers.
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available for use in medical devices. Devices
moving from metal to plastic and using high
strength-to-weight ratio plastics can be colored
with a metallic color effect with low or no knit
line to provide a similar look. Additional special
effects including granite, marble, sparkle,
fragrance, glow in the dark, and camouflage may
be an appealing design consideration for in-
home medical devices.
Antimicrobial: Value-Added, Masterbatch,
and Precolor Technology
Two popular antimicrobial chemistries
considered for use in medical devices are silane-
based and silver technologies. These
technologies can produce up to a 99% kill rate of
some microorganisms on surfaces including
fungi, and algae depending on polymer
formulation and loading. For medical devices,
efficacy testing is necessary to substantiate any
claim by the OEM. Guidelines for the use of
antimicrobials in medical devices are provided
by the FDA and can be found on their website
[d].
Antimicrobials can be provided in compounds
that incorporate colorants and other necessary
additives as a total package for the molder.
Masterbatches are also available that are
concentrations of the antimicrobial additive
compounded into a carrier resin that is metered
into the molding process at predetermined
levels. Masterbatch (concentrates) carriers can
be unique to specific applications or universal
for use in various polymers. Masterbatches can
also incorporate other additives, fillers, or
colorants necessary for the manufacture of a
device.
VI. Summary and Conclusions Increased regulatory scrutiny placed on colored
plastics from Europe, Japan, United States, and
other countries to pass biologic testing makes
appropriate material and color selection a critical
skill when developing new medical devices.
Additional considerations for branding and
consumer preference must all blend together
with the required fit, form, and biologic testing
to create a functional and attractive medical
device. Understanding the biologic testing needs
of your device is essential to good base resin and
color pigment selection.
Once color has been selected, it is important to
control the raw material formulation and not
allow any changes to the formulation because it
has the potential to invalidate biologic testing
results.
Selecting a color compounder with a long
history of success in the medical device market
is critical as they will have important services
such as pretested ISO 10993 resin and pigment
selections, resin and color advice based on
experience, formulation control, and change
management services. A suggested check list for
screening suppliers is included in the
appendix[e].
Copyright © RTP Company Page 11 of 13
Biography
Josh Blackmore is the Global Healthcare
Manager at RTP Company and holds a Bachelor
of Science in Medical Technology from the
Michigan State University and an International
MBA from the University of Notre Dame. He
has over 18 years of experience in the medical
plastics industry and is the co-author of two
additional white papers “Effects of Static on
Plastics Used in Drug Delivery Devices” and
“Effect of Gamma Sterilization on Select TPE
Materials.”
Mike Chappell is the Color and Additive
Marketing Specialist for RTP Company. He has
been with the company for 25 years. During
which he managed the Color Lab at RTP
Company’s South Boston Virginia facility.
About RTP Company
RTP Company is a global compounder of
custom engineered thermoplastics. Private
ownership allows the company to be
independent and unbiased in its selection of
resins and additives while its materials experts
formulate thousands of compounds each year
that meet specific end-use application
requirements.
Thermoplastic compounds can be tailored to
provide multiple property enhancements in a
single material. RTP Company’s customization
capabilities include color, conductivity,
elastomeric, flame retardance, high temperature,
structural, and wear resistant performance.
Headquartered in Winona, Minnesota, RTP
Company operates 12 additional full-service
manufacturing facilities located throughout
North America, Europe, and Asia. Each facility
has complete make-to-order manufacturing,
color lab, product development, and technical
service onsite.
Copyright © RTP Company Page 12 of 13
VII. References
[1] Hanson, Scott & Turner, Rachel. “Where Color Meets Clarity.” Medical Device & Diagnostic
Industry, July 2010.
[2] VanAuken, Brad. "Color & Brand Identity." Branding Strategy Insider. 26 July 2007. Web. 03 Feb.
2011. http://www.brandingstrategyinsider.com/2007/07/color-brand-ide.html .
[3] CCICOLOR - Institute for Color Research
[4] University of Loyola, Maryland study
[5] Blackmore, Josh. “Biocompatible Colors for Healthcare Applications”, RTP Company, May 2011.
[6] Podhajny, Richard M. "Phthalo Green: How Can You Tell If It's Always the Same?" Paper, Film &
Foil Converter Magazine. 01 July 2003. Web. 03 Feb. 2011. http://pffc-
online.com/materials/paper_phthalo_green_tell/.
VIII. Appendix
Additional Resources:
[a] 510(k) Memorandum - #G95-1 table 1 Initial Evaluation Tests for Consideration: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080742.htm
US FDA: Device Advice: Comprehensive Regulatory Assistance
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/default.htm
[b] European medical device guideline for the classification of medical devices:
http://ec.europa.eu/consumers/sectors/medical-devices/files/meddev/2_4_1_rev_9_classification_en.pdf
[c] ASTM International: http://www.astm.org/index.shtml
[d] US FDA: Antimicrobials in Medical Devices:
www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm071380.htm
Copyright © RTP Company Page 13 of 13
Selection Check List for Evaluation of
Color Compounders for Medical Devices
Experience and expertise of the organization
o Past history of success in medical devices
o Years of experience in the medical industry
o Products that have been ISO 10993 tested
o Color experience, membership in the Color Marketing Group
o Industry manager responsive to the needs of the medical industry
Knowledge of the organization and support staff
o USA and European regulatory environment.
o Database of known biocompatible resins and additives including color pigments
o Ability to work with any resins system or resins currently commercially available
o Product stewardship department for reporting regulatory compliance
History of the organization
o Years of service
o Technical leadership
o Financial stability
Manufacturing capabilities
o Location of manufacturing plants. Global or regional.
o Capable to handle small to large lot sizes
o Ability to supply precolor and masterbatch
o IT infrastructure and security of data and confidentiality
o Accessibility/flexibility
Quality and change management
o Quality system in place to handle fixed formulations
o Color consistency from plant-to-plant and region-to-region
o System in place to notify of any changes efficiently
o Quality assurance on a physical and appearance level
o Physical audit and outcome of audit
o Quality policy
- APPENDIX E -