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 TyvekÒ
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
Dependent |
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 TyvekÒ 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 | | | | |
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.
