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compounding world | november 2012 www.compoundingworld.com 10
news
BYK starts
American
expansion
BYK Additives & Instru-
ments has begun construc-
tion of a new three-storey
production building on
newly acquired grounds at
its site in Wallingford,
Connecticut, USA. It is
investing E36 million in the
facility which is due to be
completed in 2014.
This investment in
Wallingford underlines once
again our aspiration to grow
on the North American
market and to produce as
many products as possible
locally, said Dr Roland
Peter, president of BYK
Additives & Instruments.
BYK produces a range of
additives including wetting
and dispersing agents for
masterbatches, plus
modifers for plastics.
www.byk.com
IPC meets ISO medical standard
Innovative Polymer Com-
pounds (IPC) of Kilbeggan in
County Westmeath, Ireland,
has achieved the ISO 13485
quality standard for medical
manufacturing.
IPC focuses on producing
compounds for medical device
manufacturers at its plant
which was established in 2008.
It says that achieving ISO
13485 will help it to grow its
European customer base.
Compounding is carried out
using a Leistritz ZSE 27 Maxx
twin-screw extruder in a Class
100,000 clean room (pictured).
pounded at the plant include
polyamides, TPEs, TPUs and
fuoropolymers.
The ISO 13485 standard is
primarily aimed at medical
device manufacturers, but a
growing number of compound-
ers and masterbatch makers
that supply such companies
are implementing the standard
themselves. Other examples
include Clariant, PolyOne,
Teknor Apex and Elasto. For
more information, see the
article on clean compounding
which starts on page 15.
www.ipcpolymers.ie
TPEs compounder Star
Thermoplastic Alloys &
Rubbers has opened its a new
process development labora-
tory at its headquarters in
Broadview, Illinois, USA. The
new purpose-built 8,000 ft
2
(740 m
2
) facility is equipped
with four extruders with
outputs ranging from 60 to 500
lbs/hr (27 to 230 kg/hr).
It is the ffth laboratory at
Star adds new extrusion lab
the site the others are used
for wet chemistry, polymer
research and characterisation,
physical testing and sample
production.
Stars R&D manager, Dr
Prakash Sanjeevaiah said: The
addition of this new lab gives
us and those customers we
serve a greater capability for
providing more samples and in
larger quantities. We are now
offering as many as 200
extrusion grade samples, argu-
ably the most in the industry.
Star reports that it has
achieved a 50% year-on-year
increase in sales. In addition to
the new lab, it has expanded
its sales and service offce
space and increased its
number of employees in
production, sales and service.
www.starthermoplastics.com
The line is fed by K-Tron
gravimetric dosing units, while
pelletizing is carried out at the
plant using a Gala underwater
system or an Automatik strand
pelletizer. Materials com-
ICL Industrial Products is
ending the sale of Tris(1,3-
dichloro-2-propyl)phosphate
(TDCP or Tris) fame
retardants for home furnishing
applications, including chairs,
sofas and nursery products,
with effect from 1 January
2013. At the same time, it is
expanding production of its
Fyrol HF-5 polymeric fame
retardant for fexible polyure-
thane foam applications at its
ICL advances with TDCP replacement
Gallipolis Ferry plant in West
Virginia, USA.
By expanding the produc-
tion of Fyrol HF-5, ICL-IP is
positioned to serve the
changing needs of the uphol-
stered furniture industry, said
Greg Symes, ICL-IPs global
business manager for polyure-
thane products.
The company is also
developing a new fame
retardant to replace TDCP in
automotive and other trans-
portation industry applications.
It plans to have this available
in 2013, which will allow
customers in transport-related
segments adequate time to
qualify the replacement
through the Production Part
Approval Process system.
ICL-IP says that it will cease
all production of TDCP by the
end of 2015.
www.icl-group.com
www.compoundingworld.com
news
Toray is to establish a new PA
and PBT compounding plant at
its Indonesia Toray Synthetics
(ITS) subsidiary, located at
Tangerang, Banten Province,
Indonesia. It is investing
approximately 600 million
(E6 million) in the 6,000
tonnes/year facility which is
expected to start production in
November 2013.
ITS already polymerizes
nylon and polyester at the
Tangerang site, as well as
producing flament yarns using
these materials. Toray claims
that its new resin compound-
ing plant will be the frst to be
established by an engineering
plastics manufacturer in
Indonesia.
The Japanese-headquar-
tered company says that
Indonesias annual demand for
engineering plastics is
expected to grow at around 9%
per annum from 21,000 tonnes
in 2011 to 45,000 tonnes in
2020. This growth is being
driven by the expansion of
Indonesia economy and in
particular increased produc-
tion of vehicles and electrical
and electronic products in the
country.
Indonesias automobile
production is estimated to
grow from 840,000 units in
2011 to more than 2 million
units in 2020, making it a
major automobile production
base in the region alongside
Thailand. In addition, the grow-
ing wealth of the countrys
huge population of 240 million
people is encouraging
increased local manufacture of
electrical and electronic
products.
www.toray.com
Toray invests in
Indonesian plant
RePin Masterbatches of India
has formed a joint venture with
Al Ahli Holding Group (AAHG)
to manufacture masterbatches
in the United Arab Emirates
(UAE) for the Middle East and
African markets. Called
AlwanRePin, the JV is 51%
owned by AAHG and 49%
owned by RePin.
AAHG is a large group with
interests in a broad range of
markets including real estate,
construction, engineering and
retail malls. Its existing
plastics activities are focused
on fexible packaging and bags
which are produced by its Al
Ahli Plastic Industries
subsidiary. Its plant at
Fujairah, UAE, includes a
fve-layer blown flm line for
making barrier flms.
RePin is part of RP
Industries and produces a
range of black, white, colour
and additive masterbatches at
its two plants in northern
India. It has also recently
opened an offce in Colombia
to grow sales in Latin America.
www.alwanrepin.com
Indian and UAE groups
form masterbatch JV
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news
combines high-end perfor-
mance and a low environmen-
tal footprint, thats a winning
proposition for players and
planet.
Merquinsa, a Spanish
subsidiary of Lubrizol, supplies
Pearlthane ECO grades of TPU
with a bio-based content of 32
to 46% and with 82 to 95 Shore
A hardness. The materials has
been developed for the sports
and recreation market and is
claimed to deliver excellent
abrasion resistance and cold
exibility combined with
improved hydrolysis resistance
and good adhesion to other
non-TPU shoe components.
S www.merquinsa.com
Nike saves
weight with
bio-based TPU
Nike has selected a bio-based
thermoplastic polyurethane
from Merquinsa for the sole
plate of its new light-weight GS
football boot. The Pearlthane
ECO TPU grade has a lower
density then its petroleum-
based counterparts, helping to
deliver a 15% overall weight
saving compared to traditional
sole plate designs.
The Nike GS is the lightest
and fastest football boot weve
ever made and really denes a
new era in how we create,
design and produce elite
football boots, said Andy
Caine, global design director
for Nike Football. When you
can deliver a boot that
Nike is using bio-based TPU
from Merquinsa in its new
GS football boot
Evonik has commissioned a
new compounding line at its
plant in Caojing, Shanghai,
China. This second line triples
the German companys existing
production capacity for
polyamide compounds in China.
The turn-key compounding
line was supplied from
Germany and will support the
rapid growth in demand that
Evonik is experiencing in Asia
and particularly China from
markets such as automotive,
sports and electronics.
S www.evonik.com
Evonik commissions
compounding line
Clean compounding lines and plants
are being commissioned to meet the
increasingly stringent demands
of the medical, pharmaceutical,
electronics and food sectors.
Jennifer Markarian reports
www.compoundingworld.com November 2012 | COMPOUNDING WORLD 15
Clean compounding | processing feature
Compounding plants are generally busy and efcient
facilities, but they are not well known for being
particularly clean. However, an emerging trend in the
compounding industry is changing this stereotype, and
a growing number of companies are now operating
clean compounding facilities.
Although the processes used in clean compounding
have been used for at least 15 years in applications like
optical-quality compounds and medical compounds, the
last ve years have seen an increase in demand for
clean compounding and the emergence of new and
more exacting customer stipulations in a broader range
of applications.
One driver for the clean-compounding trend is the
growing industry focus on medical compounding, which
has stringent requirements for eliminating contamina-
tion. Another driver is the need for compounding
high-purity materials that will be used in a cleanroom
or used to produce cleanroom devices or equipment.
The electronics market, for example, has cleanliness
requirements that include specications for outgassing,
non-volatiles, and ionics content, comments Lai Chang
Fong, technical director for Engineered Materials Asia
at PolyOne.
In addition, the trend to smaller, thinner parts makes
aws more apparent and creates a need for reduced
contamination. Electronics and medical devices are
good examples of this requirement, but it is also seen in
automotive and lighting as innovation produces smaller,
thinner part designs, notes Susan Brate, general
manager for manufacturing and supply chain at Sabic
Innovative Plastics.
Yet another aspect is the increase in restrictions on
the types of additives going into certain products and the
accompanying requirement to avoid cross-contamination
with the restricted additives, for example heavy-metal
containing colours or phthalate-based plasticizers.
Customer and OEM demands for more stringent
and formalized manufacturing methods, process
control, and dedicated facilities have denitely in-
creased over time, notes Will Taber, business manager
for emerging technologies at RTP Company.
Medical, food, and electronics applications are key
markets, but others can benet as well. If you carry the
Keep it clean
compounding world | november 2012 www.compoundingworld.com 16
processing feature | Clean compounding
PolyOne sees
growing
demand for
high-purity
materials used
in cleanrooms
in the electron-
ics sector
RTPs Ultra
Clean Com-
pounding
Center is
designed to
minimize
environmental
pollutants
clean-compounding model into other applications, youll
be way ahead on compliance, points out Doug Borgs-
dorf, president of Plastics Color Corporation (PCC).
From dedicated lines to complete plants
Some compounders have chosen to dedicate specifc
lines or sections of their plant to clean compounding,
which helps efforts to more tightly control incoming raw
materials and reduce contamination. PCC, for example,
runs a 7,000 ft
2
(650 m
2
) plant within a plant at its North
Carolina facility, in which the dedicated clean compound-
ing lines produce only FDA-approved materials.
Teknor Apexs Vinyl Division also runs dedicated,
high-purity facilities for the production of medical
compounds in. In 2008, the company further separated
production of medical-grade PVC compounds contain-
ing phthalate plasticizers from that of medical com-
pounds plasticized with non-phthalate alternatives at
two of its plants in the United States.
RTP established an Ultra Clean Compounding Center
(UCC) in 2009 at its headquarters site in Winona,
Minnesota, USA. It is a 3,300 ft
2
(300 m
2
), self-contained,
controlled manufacturing environment that is designed
to minimize and control the presence of environmental
pollutants such as dust, aerosol particles, and chemical
vapours.
Particles can come in the form of airborne dust from
outside a plant or from materials used within the plant.
It is important to control not only the contaminants in
the air, but also those on material processing and
handling equipment, says Taber.
To control contaminants, the UCC has dedicated
extruders and auxiliary equipment, positive pressure
ventilation, high-speed interlocking doors to control
access, and deionised, fltered cooling water. The UCC
also physically separates the feeding and compounding
lines, which is critical in reducing the potential for
cross-contamination due to airborne particles that can
be generated in weighing, mixing, metering, and
feeding. Compounding, cooling, pelletizing, classifying,
and packaging all take place within the contained
environment.
Operators, who have been specifcally trained to
work in the UCC, follow good manufacturing practices
for operating and maintaining the equipment, such as a
complete extruder tear-down and clean-out between
every run. The UCC is used to produce compounds to
meet strict cleanliness specifcations that cannot be
met in standard facilities.
For example, compounds produced in the facility can
meet requirements such as those for outgassing,
particle generation, and ionic purity (i.e., no anions or
cations that can contaminate a cleanroom) that are
demanded by applications such as some electronics
packaging. RTP also produces compounds in the UCC
for applications in food handling, medical products, and
some industrial applications where customers are
concerned with visible contaminants affecting the
perceived quality of their goods.
Clean compounding can also encompass an entire
plant. In 2010, PCC built a clean compounding facility in
California that is dedicated to medical compounds and
runs under the FDAs current good manufacturing
processes (cGMP) quality system guidelines. For
example, in this facility, air and water are fltered, and
water baths are drained and UV-sterilized between
runs. All PCCs facilities have ISO-9001 certifcation.
Teknor Apex has a clean-compounding plant at St.
Albans in Vermont that runs its Medalist range of
thermoplastic elastomers (TPEs) used in medical
devices. The plant is certifed under the ISO-13485
standard for quality management in medical manufac-
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All prices are correct at the time of publication but may be subject to change.
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PVC FORMULATION 2012 - CONFERENCE
PROCEEDINGS
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Clean compounding | processing feature
Leistritz says
compounders
can learn about
best practises
from pharma-
ceutical
manufacturers
turing, while companys Oldbury plant in the UK is in the
process of being certifed to the same standard. The
companys TPE plant in Singapore runs with the same
processes and quality management as the other two
plants and has ISO-9000 certifcation.
ISO-13485 is a requirement for medical-device
manufacturers, not compounders, but Teknor sought
the certifcation to provide its medical-device customers
with an extra dimension of quality assurance. The
comprehensive implementation program required for
ISO-13485 certifcation has focused our entire St.
Albans operation on processes and procedures that
maximize the safety and reliability of the compounds we
supply to medical device manufacturers, said Paul
Burke, now vice-president of manufacturing at Teknor
Apex, in a press statement last year.
In a recent interview with Compounding World,
Burke noted that, from the perspective of the com-
pounders customers, one of the most important
aspects of ISO-13485 is the management of change,
which gives assurance that a change in the process or
materials will not affect the end product. Testing of
incoming materials, as well as the more standard
testing of the fnished compound, is important in
maintaining tight process control. In addition, quality-
control checks during the production run of properties
like viscosity and durometer allow increased control
over the process and product quality, adds Burke.
Clariant has also implemented ISO 13485 standards
at selected plants in Asia, Europe and America. These
include its facilities in Malm, Sweden, as well as in
Lewiston, Maine, USA, and in Singapore. These three
locations have dedicated lines for medical materials
and can produce harmonised products in all three
regions, according to Steve Duckworth, Clariants head
of Global Segment Medical & Pharmaceutical.
The three plants produce Clariants Mevopur lines of
colour masterbatches and performance compounds for
the medical and pharmaceutical markets. All Mevopur
grades are manufactured using raw materials that
comply with USP parts 87 and 88 (Class VI devices) and/
or ISO 10993 and are produced on segregated com-
pounding lines to reduce the risk of cross contamination
The IS0 13485 standard includes evaluation of risk
potential within the manufacturing process and
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compounding world | november 2012 www.compoundingworld.com 20
processing feature | Clean compounding
establishing controls to address this. For Clariant, this
covers the formulation of a masterbatch, incoming raw
materials, production processes and the fnished
product. Duckworth says that implementing ISO 13485
has taught the company lessons that are also useful in
other markets such as packaging and toys. It is much
more rigorous that ISO 9001, he adds.
Equipment design
In addition to dedicating and segregating extrusion lines,
equipment designed to minimize contamination risks
and allow easy cleaning and maintenance is critical in
clean compounding. When we moved to clean com-
pounding, not one piece of equipment didnt get modifed
in some way, notes Borgsdorf. While some technology
is available today, further advances in equipment and
process designs are needed, say compounders.
One aspect to consider is the design of the extruder
and the materials of construction used. It is important
to avoid materials that degrade over time and might add
contaminants, notes Sabics Brate. In addition, melt
fltration is a common method of reducing contaminants
in the material.
A key to clean compounding is that there is nothing
left behind when you change from one product to
another, which can involve designing equipment to
avoid hang-up points. Newer designs of both dosing
equipment and extruders that allow easier cleaning for
faster changeovers in general compounding applica-
tions also help to achieve the thorough cleaning needed
for clean compounding.
Cleaning and maintenance procedures also need to
be modifed to take into account all possible contamina-
tion risks. Cleaning a pelletizer, for example, usually
involves blowing out the pellets with air. This procedure
doesnt work in clean compounding, because it
introduces the risk of blowing a pellet somewhere it
shouldnt be, notes Borgsdorf.
When following cGMP guidelines in compounding,
equipment must be cleaned at appropriate intervals and
detailed, written procedures must be followed, noted
Charlie Martin, president of the US operations of
Leistritz, in a presentation explaining the use of
twin-screw extruders in the pharmaceutical industry at
the recent SPE Color and Additives Division conference
(CAD RETEC). cGMP guidelines also require inspections
Cleanroom compounding
Some clean compounding operations that
cater for the most demanding applica-
tions are carried out in cleanrooms.
Examples include the production of
compounds for medical applications,
including polymers containing an active
pharmaceutical ingredient for human
use, implants for the human body, and
some drug-eluting devices (For more
details, see the medical compounding
article in Compounding World, June 2012
http://bit.ly/MedCompounds).
Cleanrooms can be classifed by the
ISO system, which ranges from the most
stringent, ISO 1, to the least stringent, ISO
9, or by a similar FDA cGMP classifcation.
Biomedical compounds typically must be
compounded in at least an ISO 8 clean-
room, which is equivalent to a class
100,000 cGMP cleanroom.
Foster, for example, produces
compounds for implantable and highly-
regulated polymers in its class 10,000
cleanroom facility in Connecticut, USA.
The room features quartz epoxy seamless
foors, a dedicated fume and dust
collection system, interlock pass through,
gowning room, and temperature and
humidity controls.
Compounding of polymer blends with
active pharmaceutical ingredients must
be performed under cGMP standards and
must follow 21CFR Parts 210 and 211,
explains Tony Listro, managing director
at Foster Delivery Science.
For example, any part in contact with
the drug materials, including screws and
barrels, must be either dedicated to that
drug or undergo a validated cleaning
protocol before use in other applications.
In addition, the equipment must use
FDA-approved lubricants, and the
product-contact parts must be non-reac-
tive and non-absorptive.
Foster develops and produces compounds
under clean conditions in Connecticut
ENTEK Extruders
A Division of ENTEK Manufacturing
PO Box 39, 200 Hansard Avenue
Lebanon, Oregon, USA, 97355
Tel: 541-259-1068 Fax: 541-259- 8018 www.entekextruders.com
ENTEK_LarryKeith_CW_A4_051812_x1a.indd 1 5/18/12 3:23 PM
processing feature | Clean compounding
for cleanliness and records of both cleaning and
inspection. Martin noted the compounding industry can
benet from auditing and selectively implementing
practices of pharmaceutical manufacturing companies.
Limiting human interaction with the product through
automation is another way to reduce contamination. At
PCCs clean compounding facilities, operators are
involved in blending, but extrusion through pelletizing and
packaging are all automatic, says Borgsdorf. Automation
can also be applied to process data acquisition. RTP, for
example, notes that its automated data acquisition
system allows detailed monitoring and traceability.
The human component
Automation, however, cannot replace the need for
operators that are highly trained and understand the
value of running a clean compounding plant. The
methods that you use to run processes and having
trained and disciplined managers and operators are
even more important than equipment modications,
comments Burke.
Operators need to understand the specications
and the impact of correctly following procedures on
product quality. With our operating teams, an in-depth
FMEA (failure modes/effect analysis) is a good tool. This
type of risk analysis increases understanding of the
procedures, the potential points of failure, and the risk
mitigation points, adds Brate.
It comes down to the people in the end, says
Borgsdorf. You need to value your employees and their
input. As our operators got to know the system in the new
clean compounding plant, they suggested modications
to make it even better. We couldnt have been successful
without management listening to the operators and giving
them the ability to operate as was needed. Listening to
customers is another critical aspect for success. The
industry needs to change its old mentality that would not
want customers to come into a manufacturing plant.
Several times a month, we now have customers coming
to perform audits, and we gladly listen to their sugges-
tions to help make our process better and even involve
them in long-range planning, says Borgsdorf.
More information
Doug Borgsdorf of PCC will be speaking about human
factors at the Thermoplastics Concentrates 2013
conference which takes place on 29-31 January at the
Fort Lauderdale Marriott Coral Springs Golf Resort in
Florida, USA, on 29-31 January. He will join an impres-
sive line-up of speakers featuring experts from
throughout the masterbatch supply chain. For full
details, visit http://bit.ly/TC2013.
Click on the links for more information:
S www.polyone.com
S www.sabic-ip.com
S www.rtpcompany.com
S www.plasticscolor.com
S www.teknorapex.com
S www.leistritz-extrusion.com
S www.fostercomp.com
Clean com-
pounding
depends on
highly trained
operators that
understand the
value of
product quality
Pi pes i n
I nf rast r uct ure
2013
Market trends, new products and technical developments
in plastic pipes for infrastructure applications
Click here
for details on
attending, sponsoring
or speaking at
the conference.
Contact: Giulia Esposito
ge@amiplastics.com
9-11 April 2013, Hotel Nikko,
Dsseldorf, Germany
Organised by Applied Market Information Ltd. (AMI)
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KMIsproductrangeincludes
LamellarMIOX
LamellarMica
AcicularWollastonite
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Krntner
Montanindustrie
Schloss1
A9400Wolfsberg,AUSTRIA
Tel:+43(4352)545350
Fax:+43(4352)54535135
miox@kmi.at
www.kmi.at
Krntner Montanindustrie (KMI),
located in Austria, is the market leader
inMicaceousIronOxide(MIOX).
KMI, as a specialist in micronization of
high aspect ratio (HAR) minerals,
extended their product portfolio to
Mica (Muscovite, Phlogopite) and
Wollastonite.
KMIsMICAPhlogopite
Polyamide is often reinforced by glass
fiberwhichleadstotheproblemofani
sotropic shrinkage and therewith the
riskofwarpage.Glassspheresareoften
used to avoid that effect but with a
negative impact on mechanical proper
tiesandheatdistortiontemperature.