Accelerated & Real-Time Aging
Life Science Outsourcing has proven expertise in packaging design and validation and works closely with clients to implement primary and secondary package design solutions.
Package Design Expertise
Life Science Outsourcing’s primary objective is to have your medical device arrive safely and intact at its final destination. Our team has experience designing a variety of custom medical device packages, including low-volume plastic packaging and low-cost tooling as well as high-volume plastic packaging.
We partner with clients to develop successful packaging configurations and test durability and integrity prior to making any final determinations on tooling and production quantities. We will then provide you with documentary evidence of compliance.
Our in-house packaging validation capabilities are aligned with the industry’s most comprehensive regulatory requirement, ISO 11607 – “Packaging for Terminally Sterilized Medical Devices.
Accelerated Aging Calculator
This calculator generates a table of values for calculations based upon ASTM F1980, Accelerated Aging of Sterile Medical Device Packages.
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.
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 Tyvek 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.
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.
Pouch Styles
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
|
Medical Secondary Packaging
Secondary packaging, or protective packaging, protects the primary sterile barrier and the medical device contents from damage.
Folding Cartons
Folding cartons provide excellent secondary protection for individually packaged sterile products as well as multiple unit packs. For multiple unit packs, the carton can be designed as a dispenser carton by including a perforated area into the carton. The user exposes the product for easy removal by their customer using the perforated section.
There are many styles of folding cartons, and numerous specialized features can be added to these design styles. Although some simple styles can be ordered off the shelf, most folding cartons used for medical products are custom designed to fit the product and to incorporate the specialized features which enhance the product presentation.
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 carton and the inner package/product will often result in damage, the cost of which usually exceeds any cost savings gained by using less than ideal off-the-shelf cartons.
Shipping Containers
The shipping container is a corrugated box, which has sufficient strength to be used for shipping, sterilization, and storage of medical devices or any other medical product.
Corrugated fiberboard is made up of two separate components, the linerboard and the medium. The linerboard is the flat facing and the medium is the fluted paper glued between the liners.
There are many flute profiles used in the construction of corrugated board. The arched flutes create a very rigid and strong medium. The flutes also act as a cushion against minor impact. The most common configurations include B-Flute, C-Flute, E-Flute and Double Wall constructions. The type of corrugation used in the construction of a shipping container is determined by the physical size, weight, and fragility of the product(s) going inside the box.
The type of flute is only part of the equation in determining the strength and durability of the container. Since different grades of material can be used for both the linerboard and the medium, burst strength ratings are also important. Simply put, burst strength is a standardized test method used by all corrugated manufacturers to rate the penetration resistance of the container wall. The higher the rating, the stronger the box. A 200-pound test is a commonly used material but may not be adequate for delicate products or heavy products.
The most widely used style of shipping container is the Regular Slotted Container (RSC). The RSC can be used in conjunction with inner-packing materials including corrugated inserts, bubble wrap, and rigid or soft foam inserts to further protect the product.
Shipping containers and folding cartons are defined first by style, second by the inside dimensions Length x Width x Depth, third by the material (flute style and pound test for corrugated) and finally if the carton is printed or plain
Documentation Support
Developing manufacturing documentation and a quality system that is compliant, efficient, and easy to maintain as you grow can be a burdensome effort which, if done improperly, can lead to significant consequences and challenges.
Partnering with the Life Science Outsourcing team provides access to manufacturing documentation and a quality system that has been audited by the FDA and is reviewed and audited over 50 times a year by our customers.
Because we are building from this extensively audited quality system, the manufacturing documentation that we develop is efficient and easy to use while exceeding industry and regulatory standards. Our quality and process engineers can build customized manufacturing documentation that meets your specific needs and allows your company to tap into existing documentation and processes.
Manufacturing Documentation Services:
- Development of customized documentation
- Process development
- Implementation and adoption into practice
- Training of personnel – including ISO 13485, FDA QSR (GMPs), Corrective Actions
- Continuous Improvement/Gap Assessments – including ISO 13485, FDA QSR (GMPs)
Front-end Design Assistance
Life Science Outsourcing’s product and package design and engineering support services provide guidance on design, details, and development. This includes comprehensive consultation services.
- Design for manufacturability analysis
- Consult on parts design
- Consult on material selection
- Sterile package design
- Shelf and shipping box design and configuration
Shelf and Shipping Box Design and Configuration
Through our extensive work with startups, Life Science Outsourcing’s engineering teams have regularly manufactured products for the customer’s clinical trials. For clinical trial production, our experts provide label designing, tooling and fixture designing, risk analysis, failure mode effect analysis (FMEA), product inspections, and process validations.
Through our comprehensive suite of solutions, Life Science Outsourcing coordinates support services such as sterilization validations and package testing and validations. In addition, our engineers can assist you in defining and developing assembly processes, writing product and packaging specifications, and creating validation protocols and reports.
Let’s work together
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