Medical Primary Packagingn

Medical Primary Packaging


Primary Packaging is the first-level of medical product packaging which contains the actual product. The best way to determine the style and features that will best protect and enhance your product is to work with an experienced packaging engineer or carton designer. A poor fit between the product and the packaging will often result in damage, the cost of which usually exceeds any cost savings gained by using less than ideal packaging.

Typical Medical Pouch Materials and Properties

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
CORNER PEEL POUCH
SQUARE PEEL POUCH
HEADER POUCH
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

POUCH STYLES

Chevron Peel Pouch

Most commonly used for sterile medical products that don’t 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.

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.

Squared Sealed (No-Peel, Tear) 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.

Chevron Peel 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.

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 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 and 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.

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.