MEDICAL APPLICATONS WITH TOPAS® COC

Primary pharmaceutical packaging
New options for primary pharmaceutical packaging

Biocompatibility

The combination of high transparency, greater shatter resistance thanglass and superior barrier to moisture makes TOPAS® COC particularly

Primary pharmaceutical packaging is subject to regulations concerning the finished part. However, criteria for the use of plastics in theseapplications are specified in the national pharmacopoeias and by theresponsible authorities.*

attractive for prefillable primary pharmaceutical packaging. The material also has high purity and excellent biocompatibility.
Examples of applications are prefillable syringes and vials and a wide
variety of prefillable contain-ers which can be used, for example, as
compo-nents of injection systems.
Injection molding and injection blow molding/injection stretch blow
molding are typical manufacturing processes for this kind of pharma
packaging.

For this reason, a number of TOPAS® COC grades have been studied ina biocompatibility test program. The TOPAS® COC grades studied meetthe requirements of US Pharmacopoeia XXIII Class VI and ISO 10993.
Certificates are available on request.

Furthermore, TOPAS® COC is used increasingly for pharmaceutical blister packaging because of its high transparency, biocompatibility andexcellent moisture barrier.
Barrier for long life
The moisture barrier helps to extend the shelf life of pharmaceuticals and solutions stored in prefill-able primary packaging. It keeps
the moisture away from the contents or keeps the concentration ofready-prepared solutions constant.
With its remarkable property profile compared with known plastics,
TOPAS® COC offers new options for these applications.

Prefillable syringes Schott TopPac TM, manufactured by Schott GlasExtraction tests and chemical characterizations corresponding to theUS, EU and Japanese pharmacopoeia protocols have been carried out
successfully on certain TOPAS® COC grades.
In addition, an FDA Drug Master File (Number 12132) and an FDA Device
Master File (Number 1043) have been established.
The monomers used for the manufacturing of the above mentioned
product are listed in the EU-Directive 2002/72/EC, and in the newedition of the German "Bedarfsgegenständeverordnung" of December
23rd, 1997. The FDA Regulation Number is 21 CFR 177.1520.
Blister packaging film made with TOPAS* It is not possible to obtain a general approval for plastics in medical applications. However, TOPAS Advanced Polymers supports manufacturers and users of such products
through biocompatibility studies and the compilation of Drug Master Files/Device Master Files for the selected product grades. These FDA documents contain confidential information on the formulations and production process and the toxicological data. With the agreement of TOPAS Advanced Polymers, the FDA authorities may examine the documents
for a particular customer.

Diagnostic articles
Innovations in diagnostic applications
The possibility of varying the glass transition temperature over a broad
range gives access to materials whose softening point is sufficiently
high to withstand steam sterilization. Where the article is sterilized
more than once, ETO or gamma sterilization is recommended.

TOPAS® COC grades developed specifically for applications in diagnostics have excellent light transmission in the near UV region as well as
high transparency in the visible region.
Excellent resistance to aqueous and polar organic media, good biocompatibility and the ability to reproduce fine structures, makes
TOPAS® COC the material of choice for innovative applicationsin the area of diagnostic articles.
Examples of applications are microtiter plates for high throughput
screening, microstructured cuvettes and test tubes for clinical analysis,
and containers for spectroscopic monitoring of biochemical reactions.
Injection molding and injection blow molding/in-jection stretch blow
molding are typical manufac-turing processes for these diagnostic
articles.
Sterilizability
Plastics used in medicine and diagnostics often have to be sterilizable.
TOPAS® COC grades can withstand high-energy radiation (gamma rays
and electron beams) and ethylene oxide.

Microtiter plates manufactured from TOPAS® COC

UV light transmission

Chemical resistance of TOPAS® COC
MediumTransmission [%]100

Quartz glass (Fused Silica)

80
TOPAS 8007X10®

60PS

PC

4020PMMA

0200(2 mm plaques)

240

280

320

360

400

MediumHydrochloric acid 36%+n-Pentane-

Sulfuric acid 40%+

Heptane-Sodium hydroxide 50%+

Toluene-Dimethyl sulfoxide+

Hexane-Acetonitrile+

Benzene-Ethanol+

Oleic acid-

Isopropanol+

Wavelength [nm]TOPAS® COC
121 °CHot steam
134 °CETO

High-energy radiation
GammaElectrons

143 °C

8007---+++5013---+++6013+--+++6015++++++TOPAS Advanced Polymers
A member of Polyplastics Group

Physical properties of TOPAS® COC grades
Property

Unit

Test method

8007

6013

6015

5013

Melt volume rate MVR at 260 °C, 2.16 kg

ml/10 minISO 1133

3214448

Melt volume rate MVR at HDT +115 °C, 2.16 kg

ml/10 minISO 1133265

24Density

g/cm3

ISO 1183

1.02

1.02

1.02

1.02

Water absorption (24 h immersion in water at 23 °C)%

ISO 62< 0.01< 0.01< 0.01< 0.01

Water vapor permeability
at 23 °C and 85% relative humidity

g · mm/m2 · dDIN 53 122

0.023

0.035

0.035

0.030

Mold shrinkage (Shrinkage is dependent
on processing conditions and part design)%–

0.1 - 0.5

0.4 - 0.7

0.4 - 0.7

0.4 - 0.7

Mechanical properties, measured under standard conditions, ISO 291 – 23/50
Tensile strength [5 mm/min]MPa

ISO 527, Part 1 and 2636360

46

Elongation at break [5 mm/min]%

ISO 527, Part 1 and 210*)

2.7

2.5

1.7

Tensile modulus [1 mm/min]MPa

ISO 527, Part 1 and 2

2600

2900

3000

3200

Impact strength (Charpy)

kJ/m2

ISO 179/1eU

20151513

Notched impact strength (Charpy)

kJ/m2

ISO 179/1eA

2.6

1.8

1.6

1.6

Ball indentation hardness, 30-sec-value

N/mm2

ISO 2039 part 1,
applied load 961N

130184

184

184°C

ISO 75 , Part 1 and 2

75

130

150

130

K-1ISO 11359, Part 1
and 2

Thermal properties
Heat deflection temperature HDT/B (0.45 MPa)
Coeffizient of linear thermal expansion

0.7 · 10-4 0.6 · 10-4 0.6 · 10-4 0.6 · 10-4*) Yield strain: 4.5%applications. A special quality control program has been set up tosecure purity and constancy of product properties.

TOPAS Advanced Polymers GmbH

Polyplastics USA, Inc.

Polyplastics Co., Ltd.

Am Prime Parc 965479 Raunheim, Germany
Phone: +49 (0)1805 1 86727
eMail: info@topas.com

27240 Haggerty Road, Suite E-20
Farmington Hills, MI 48331, USA
Phone: +1-248-479-8928
eMail: info@topas-us.com

JR Shinagawa East Building, 13F
18-1 Konan 2 - Chome, Minato-Ku
Tokyo, 108-8280, Japan
Phone: +81 3 6711 8615

www.topas.com

www.topas.com

www.polyplastics.com

All data are based on studies on test specimens and indicate guide values which may fall within the usual variation latitude for the material properties. The values are of only limited applicability tofinished parts. Colorants and other additives can cause significant changes to the material properties. The values given should not be used to define maximum or minimum values or specifications.
Determination of the suitability of the material for a particular application and the type of use are the sole responsibility of the user. The information given in this publication is not to be understood as arecommendation for a particular application. The user is responsible for satisfying himself that the finished parts are suitable for the application and meet its requirementsThe materials are not intended
for use in the form of implants in the human body.To the best of our knowledge, the information given in this publication is correct. However, we take no responsibility of any type for the correctness andcompleteness of the information. It is the sole responsibility of the user to check whether existing patents will be infringed by the use of the material in an application.

TB003_2019.09_E

Special TOPAS® COC grades are available for use in medical and diagnostic applications. They conform to specifications for quality anduniformity that have been developed specifically for these sensitive