KRAIBURG TPE offers
innovation and superior support
for medical and
pharmaceutical TPE applications

Aditya Purandare
Managing Director
Kraiburg TPE Pvt. Ltd |
About KRAIBURG TPE
Founded in 2001, KRAIBURG TPE is a
global manufacturer of custom thermoplastic elastomers
offering a wide product portfolio for applications in
the automotive, industrial and consumer goods
industries, including the strictly regulated medical
sector. With production sites in Germany, the USA and
Malaysia, KRAIBURG TPE, as a competence leader offers
global customer orientation, customized product
solutions and reliable service.
Minimizing risk in medical and
pharma material selection
When selecting any materials for
medical device and pharma packaging applications, the
primary focus should be on the choosing the right
materials to accomplish the application requirement,
complemented by reducing the risk to a minimal. Risk
mitigation is a crucial aspect in KRAIBURG TPE’s
thermoplastic elastomers, in
addition to offering many advantages over traditional
soft materials such as PVC and silicone rubbers.
KRAIBURG TPE’s material solutions for the medical
device and pharmaceutical market are marketed under
the THERMOLAST® M and THERMOLAST® H brand names. |
THERMOLAST® M – comply with high
medical standards
THERMOLAST® M TPEs comply with VDI-2017
which includes change management control, full material
traceability, and a dedicated production line and quality
control system for manufacturing medical TPEs.
Additionally, these products meet ISO 10993-5 standards
and representative compound tests for ISO 10993-4, -6, -10
and -11, USP 87/88, USP Class VI, in addition to having
Drug Master File listing. That’s not all - THERMOLAST® M
TPEs carry a 24-month supply guarantee (in the event of
any forced change in raw material specifications or even
changes in customer’s product design) to ensure a
continued supply of the approved TPE product, should a new
end product approval be necessary. All THERMOLAST® M TPEs
are produced at our manufacturing facility in Germany.

THERMOLAST® H for medical device and
pharma packaging applications
THERMOLAST® H TPEs focuses on the
healthcare as well as medical device and pharmaceutical
packaging applications in the Asia-Pacific region. Most of
these TPEs are tested as per ISO 10993-5 and GB/T 16886.5
and comply to the EU No 10/2011, US FDA CFR21 and
GB4806.6. These TPEs are produced on a designated
production line at our manufacturing facility in Malaysia
using controlled GMP procedures. This line of medical
grade TPEs caters primarily to the APAC market
requirements.
All KRAIBURG TPE medical TPE series are
sterilizable via autoclave/steam, EtO or gamma radiation.
The choice of sterilization depends on the part numbers
produced, the intended device use, and access to the
sterilization equipment. Besides this, our medical TPEs
are resistant to most cleaning and disinfecting liquids
that contain typical chemicals such as hydrogen peroxide,
ethanol, chlorinated solutions and sodium hydroxide, and
others. |