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

 

INTRODUCTION
  1. The films which generally delivers both environmental and physical protection of the product inside the package are considered to be good for packaging medicare products.
  2. Need rigidity and sufficient barrier properties.
  3. Most important requirements are their barrier properties.

Dr. Subhas C. Shit
Dy. Director
CIPET Ahmedabad

 

SURFACE PROPERTIES
  • SEALING
  • STERILIZATION
  • VACUUM METALISATION
  • PRINTING
  • ELECTRICAL PROPERTIES
  • CO-EFFICIENT OF FRICTION

CHECKING OF SURFACE PROPERTIES WITH NEW FILMS

  • When new films are designed based on blending they undergo change.
  • Therefore any newly designed film which is proposed for this applications must undergo check of such properties.

ENVIRONMENTAL PROTECTION

  • Environmental protection keeps desirable components inside the package and keep undesirable components out.
  • This often requires some level of barrier to substances such as moisture, oxygen, chemicals and aromas.

PHYSICAL & THERMAL DEMANDS TO PRODUCE PACKAGE

  • The physical protection is achieved through use of sufficiently rigid or protective package structure that can withstand physical and thermal demands while producing package.
  • But still meet better surface properties for appealing

SEALING

Heat sealing capability is usually specified by

  • Seal strength
  • Hot tack strength
  • Seal initiation temperature

* (Strength of hot seal after cooling for 0.1 sec.)
100% hot tack strength is important in vertical form fill and seal equipment while contents are dropped into bags while seal is still hot.

ADDITION OF TOPAS ON PE IMPROVES THE PROPERTIES

CHARACTERISTICS OF COC (TOPAS)

TOPAS is a trade name of COC (Cyclic Olefin copolymer).

  • High transparency and gloss
  • Excellent moisture and aroma barrier
  • Variable glass transition temperatures from 65 °C to 178 °C
  • High stiffness and strength
  • Easy to extrude and thermoform
  • Compatibility with polyfins
  • Excellent biocompatibility and inertness
  • Resists hydrolysis, polar organics, acids and alkalis
PROPERTIES OF TOPAS
Property Unit Test Method 9506F-04 8007F-04 8007F-400 6013F-04
Density kg/m3 ISO 1183 1020 1020 1020 1020
Melt Volume Rate (MVR)

 

* at 230°C, 2.16 kg load

* at 190°C, 2.16 kg load

 

cm3/10 min

 

ISO 1133

 

6.0

1.0

 

12.0

2.0

 

11.0

2.0

 

1.0

-

Melt Flow Rate

* at 230°C, 2.16 kg load

* at 190°C, 2.16 kg load

g/10 min *  

5.5

0.9

 

11.0

1.9

 

10.1

1.8

 

0.9

0.1

Water absorption (23°C - sat) % ISO 62 0.01 0.01 0.01 0.01
Thermal Properties            
Glass transition temperature ((10°/min) °C ISO 11357 -1, -2, -3 65 78 78 138
Test specimen production (film)            
Type of extrusion     cast cast cast cast
Thickness of specimen µm   70 70 70 70

 

Mechanical Properties (film)
Tensile modulus            
- machine direction

- transverse direction

MPa ISO-527-3 1700

2000
2200

1800
2100

1700
2400

2250
Tensile strength at break            
- machine direction

- transverse direction

MPa ISO-527-3 55

55
57

50
55

50
55

45
Elongation at break            
- machine direction

- transverse direction

% ISO-527-3 2.9

3.6
2.9

3.0
3.4

3.4
2.4

2.2
Elmendorf tear strength            
- machine direction

- transverse direction

% ISO-6383-2 230

240
225

230
-

-
9

9
Dart Drop Impact Strength, F50   ISO-7765-1 <36 <36 - <36

 

Optical Properties (film)
Gloss 60° % ISO 2813 >100 >100 >100** >100
Haze % ISO 14782 <1 <1 <2** <1
Barrier Properties (film)
Water vapor permeability (38°C, 90% RH) g-100 µm/(m2-day) ISO 15106-3 0.8 0.8 0.8 1.3
Oxygen permeability (23°C, 50% RH) cm2-100 µm/((m3-day-bar) ASTM D3985 170.0 200.0 - 280

* Calculated from ISO 1133 MVR using a melt density of 0.92

** Haze level will depend on processing conditions.

The above values are representative values and not guaranteed values for quality or design purpose

 

EFFECTS

  • TOPAS (COC) which is added maintain high modulus of 65 to 78oC.

  • This adds significant seal strength at temperature, where PE has low strength and modulus.

  • When COC is blended with PE it broadened the seal temperature range.

  • Fig. shows a typical case where the seal range of pure LLDPE is extended and seal strength is also noticeably higher.

SEALING SHOULD BE AT OPTIMUM MODULUS

 

  1. TOPAS (a specified grade seals itself as a seal initiation temperature 105oC (defined as seal temperature where 8.8 N seal strength is achieved.

  2. Seal strength of the TOPAS-TOPAS seal is similar to that of LDPE-LLDPE.

  3. It also has good hot tack strength.

  4. High modulus of TOPAS means the seal may not be as tough as that of other materials, although seal will be hermetic.

  5. Therefore blending is required with PE.

 

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