A TECHNO-ECONOMIC NEWS MAGAZINE FOR MEDICAL PLASTICS AND PHARMACEUTICAL INDUSTRY
Our 16th Year of Publication
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Cover Story

Development of High Surface Quality Packaging Film For Medical Products

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STERILIZATION

Table - 1.
Sterilization of TOPAS:

TOPAS  

121°C

Hot Steam

134°C

 

143°C

ETO High Energy Gamma Radiation Electrons
8007 - - -
6003 - -

Can be sterilized by common methods.

  • Gamma radiation
  • E-beam/beta beam irradiation

  • Ethylene oxide

  • Steam

STERILIZATION EFFECTS

  • It is relatively stable to gamma radiation at a dosage 5 M rad.

  • Tensile strength, izod impact strength and other mechanical properties show no change after exposure and 12 months aging.

  • It shows yellow slightly immediately after exposure but this fades over several days to nearly the initial colour.

ADVANTAGES CAN BE TRANSFERRED TO NEW MATERIALS

  • It can be steam sterilized at 121oC for 20 minutes.

  • Procedure for sterilization calls venting the steam with dry air above 120oC. Drying should last about 60 minutes depending on the size and thickness to gain the desired clarity before cooling to room temperature.

  • e-beam causes to yellow slightly. The colour fades to the original. The intensity of the colour shift is proportional to dosage.

  • TOPAS is unaffected by ethylene oxide sterilization and the temperature involves 60oC.

  • All these advantages of new material can be transferred to PE by blending.

VACUUM METALISING

  • TOPAS based film out performs polyolefin in decorating and other secondary operations on medicare products.

  • It delivers a clean hard surface, high stiffness and thermal stability.

  • When metallized cast or blown films with TOPAS skin yield barrier equal or superior to metallized OPP applications for packing items which are to be protected from different kinds of vapours, gases and moisture.

  • Low shrinkage.

  • No pre-treatment before metallization (colour or flame).

PRINTING

  • Since film has to be carefully dried in an oven to drive off the ink solvent, without thermal stability of the film, this is not possible.

  • TOPAS provide a supervisory printing surface by improving flatness, increasing temperature resistance and providing glossy high quality surface.

  • TOPAS when added with PE it reduces elongation under tension and in turn improve print registration.

ELECTRICAL PROPERTIES

  • It has high surface charge retention capacity.

  • Dissipation factor (low) holds steady with temperature.

CO-EFFICIENT OF FRICTION

  • Medium slip film is useful for vertical form fill seal operations.

  • Slip additives are not needed when TOPAS is used and avoid migration problem.

MEDICAL PACKAGING

  1. It fulfills the criteria of medicare device or medicine.

  2. Bio-compatibility.

  3. Protection against external influences.

  4. Optimum Shelf life.

  5. Clear identified condition.

  6. Easy handling and disposing.

BLISTER PACKS

  1. Used for blister packs (clear)

  • Easy and

  • Safe for patient use

  • Help patients comply with dosage recommendations

  1. Easy identification and quality control, protection from moisture

  2. TOPAS films used in pharmaceutical blister packs usually have thin PP or HDPE outer layer and interior layer of pure COC or COC blended with PE.

MEDICAL TRAY
  • For Medical Tray, COC is combined with other layer of PET or SBC for clear deep draw and outstanding moisture barrier.

  • COC significantly improves thermoformity and film stiffness.

FORMING WEBS FOR MEDICAL DEVICE PACKING

  • Improved barrier performance due to decreased corner thinning and opportunities of down gauging while maintains tactile stiffness in formed package.

  • Clarity and high gloss enticingly display health beauty and medical products in many types of formed packages.

PHARMACEUTICAL BLISTER

Description : TOPAS as moisture barrier in multilayer coextruded or laminated films.

Advantages :
  • Excellent moisture barrier
  • Good thermoformability
  • High purity
  • Halogen free
  • High clarity

Materials: TOPAS 8007F-04

Customer : Alcan Pharmaceutical Packaging
Klockner Pentaplast, Tekni-Plex

STERILIZABLE BLISTER

Description : Steam sterilizable thermoformed blister pack

Advantage :
  • No shrinkage or distortion of blister film
  • High moisture barrier
  • Excellent forming
  • Polyolefin solution
  • Contact clarity

    Materials: TOPAS 6013F-04

    Customer : Not disclosed

MEDICAL FORMING WEB

Description : Forming webs for medical device packaging made from TOPAS/PE blends

Advantage:

  • Good forming
  • Limited shrink back
  • Excellent stiffness
  • Downgauging
  • Easy tear

Material: TOPS 8007F-04, 8007F-400

Customer: Not disclosed

MEDICAL TRAY

Description : Clear Thermoformable barrier film with deep draw capability

Advantage:

  • Excellent clarity
  • High moisture barrier
  • Retains barrier and optics in deep draw
  • Good formability

Material: TOPAS 8007F-04

Customer: Tekni-Plex

Ref. : Conference on Indian Medical Devices & Plastics Disposable Industry 2009

28th February 2009

 

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