Primary Packaging
Typical Medical Pouch Materials
and Properties
|
Pouch Type
Materials
|
UNCOATED
TYVEK
to
FILM
|
COATED TYVEK
to
FILM
|
UNCOATED
PAPER
to
FILM
|
COATED PAPER
to
FILM
|
FILM
to
FILM
|
LAMINATE
to
LAMINATE
|
|
CHEVRON PEEL
POUCH
|
X
|
X
|
X
|
X
|
X
|
X
|
|
CORNER PEEL POUCH
|
X
|
X
|
X
|
X
|
X
|
X
|
|
SQUARE SEALED
POUCH
|
n/a
|
n/a
|
n/a
|
n/a
|
X
|
X
|
|
HEADER POUCH
|
X
|
X
|
n/a
|
n/a
|
n/a
|
n/a
|
|
MATERIAL
PROPERTIES
|
1,
2. 3, 6,7, & 11
|
1,
2, 5, 7 & 11
|
1,
2, 3, 4, 6, 7 & 11
|
1,
2, 5, 7 & 11
|
2,
5, 8, & 10
|
2,
3, 5, 9 & 12
|
|
Key to Material Properties:
|
| Sterilization
Method: |
| 1) EtO |
| 2) Radiation |
| 3) Autoclave (long
cycle) |
| 4) Autoclave (short
cycle) |
|
| Peel
Quality: |
| 5) Clean Peel |
| 6) May
have fiber tear when peeled |
|
| Barrier
Qualities: |
| 7) Sterile Barrier
but Gas Permeable |
| 8) Medium Gas/Moisture
Barrier |
| 9) High Gas/Moisture
Barrier |
| 4) Autoclave (short
cycle) |
|
| Visibility:
|
| 10) Both Sides |
| 11) One Side (Both
sides for Header Pouch) |
| 12) Opaque |
|
Pouch Styles
| Chevron
Peel Pouch: |
|
| Most commonly used for sterile
medical products that do not require the rigidity or other protective
characteristics of a thermoformed tray. The most popular materials
used in this pouch construction are a TyvekŇ back and a clear
film face. Some barrier materials and clear films are now available
with special heat-seal coatings that provide peel type seals.
These pouches are generally referred to as "film to film" or
"foil to foil" pouches and are not suitable for gas sterilization
since both sides of the pouch are comprised of non-porous materials. |
| Corner Peel Pouch: |
|
| Same construction as a chevron pouch with
a different seal configuration. Corner peel pouches are used
when it is desirable for the product fit close to the top seal
of the pouch or for bulky products. |
| Square Sealed Pouch: |
|
| This style is commonly used for multi-layer
laminate barrier materials. The heat seal is permanent and cannot
be peeled apart. Therefore, a tear notch is typically provided
in the heat seal near the top of the pouch to facilitate opening. |
| Header Style Pouch: |
|
| Two layers of clear thermoplastic film form
the pouch and a strip of breathable material (usually Tyvek)
is sealed along the topside of the pouch. The strip is peeled
off to gain access to the pouch contents. Clear construction
allows the product to be seen from both sides. Most commonly
used on bulky items and for large items such as a procedure
kit. These pouches can be manufactured from heavier thermoplastic
films that offer better resistance to stress cracking and puncture.
|
Standard Method of Dimensioning
Pouches
All pouches, regardless of style, are defined by their outside
dimensions.
The
"A" dimension is the opening or width and is always listed
first.
The "B" dimension is the length and is always listed second.
Example: 4"
x 8". The 4" dimension is the width and the 8"
dimension is the length of the pouch.
Typical Thermoformed
Tray Materials and Properties
|
Materials
Properties
|
PVC
|
PETG
|
STYRENE
|
POLY
CARBONATE
|
|
O2 Permeation Rate *
|
150
|
4
|
310
|
300
|
|
N2 Permeation Rate *
|
65
|
1
|
50
|
50
|
|
CO2 Permeation Rate *
|
20-30
|
16
|
1,050
|
1,000
|
|
MVTR **
|
4
|
1.7
|
4
|
11
|
|
Transparent
|
Yes
|
Yes
|
No
|
Yes
|
|
Color – Opaque
|
Yes
|
Yes
|
Yes
|
Yes
|
|
EtO Compatible
|
Yes
|
Yes
|
Yes
|
Yes
|
|
Radiation Compatible
|
No
|
Yes
|
Yes
|
Grade
Dependant
|
|
Autoclave Compatible
|
No
|
No
|
No
|
Yes
|
|
Relative Material Cost
|
Low
|
Medium
|
Low
|
High
|
|
Accepted in Europe
|
No
|
Yes
|
Yes
|
Yes
|
|
* Permeation
Rate measured in cc/Mil/100 In2 per 24 hour period
** Moisture
Vapor Transmission Rate measured in
grams
loss/24hr/100 In2/Mil at 95°
F
|
Typical Tray Styles
| Standard Tray With Undercuts: |
|
| This style tray is designed to be enclosed in a Peel Pouch
or a Header Pouch which provides the sterile barrier. It does
not have molded flanges for a heat-sealed lid. Typically used
for catheters and other long-narrow devices. Some kit trays
are also designed in this style. |
 |
| Tray With Molded Lid: |
|
| This style tray is designed to be enclosed in
a Peel Pouch or a Header Pouch which provides the sterile barrier.
It does not have molded flanges for a heat-sealed lid. Typically
used for catheters and other long-narrow devices. Some kit trays
are also designed in this style. |
| Tray With Heat Sealed Lid: |
|
| This style tray has an integral heat-seal flange molded around
the perimeter of the tray. The lidded tray may be used as a
single sterile barrier or may be placed in a Peel or Header
Pouch to provide a double sterile barrier. Typical lid stock
is coated TyvekŇ but coated papers, nonporous foil laminates
and other flexible films can also be used. |
 |
| Dual Sterile Barrier – Inner & Outer
Tray: |
|
| Two trays designed to nest together. The product is placed
in the inner tray and then a lid is heat-sealed in place. The
sealed inner tray is placed inside the outer tray and a lid
is heat-sealed to the outer tray. This type of packaging is
generally reserved for medical products such as orthopedic implants
and surgical instruments. |
 |
Typical Tray Lid Stock Materials
and Properties
|
Materials
Properties
|
Coated
Paper
|
Coated
Tyvek®
|
Clear
Film
|
Foil
Laminates
|
|
EtO Sterilization
|
Yes
|
Yes
|
No
|
No
|
|
Radiation
|
Yes
|
Yes
|
Yes
|
Yes
|
|
Autoclave
|
No
|
*Yes
|
No
|
Yes
|
|
Gas Barrier Qualities
|
None
|
None
|
Medium
|
High
|
| *
Requires a special coating |
Die Cut Backer Cards
Die cut backer cards are often used for
the packaging of clinical trial products, low volume products or
for products that require immobilization when pouches are the desired
method of packaging versus a thermoformed tray. The product is mounted
to the plastic card via features die cut into the card. After it
is mounted to the backer card, the product is loaded into a chevron
peel pouch, corner peel pouch or header bag. Backer cards generally
do not provide as much rigidity or overall protection as a thermoformed
tray. They are usually used as a temporary packaging alternative
until the product design has stabilized and final packaging can
be designed.
High-density polyethylene is the preferred
material for die cut backer cards because it does not generate particulate
like paperboard (chipboard) does. High impact polystyrene is also
used. These plastic materials will withstand radiation sterilization,
as well as EtO and hydrogen peroxide/gas plasma sterilization processes.
They will not withstand the high temperatures of dry heat or steam
sterilization.
Backer Card Examples:
Backer cards can be complex or simple,
depending upon the requirements of the product. Cards can be designed
to hold catheters in a straight condition or fiber optic devices
in a coiled position. These cards are always custom designed to
fit each product specifically.
|
