Medical Device Assembly & Packaging FAQs
What package design services does J-Pac offer?
Medical Tray Carton
Packaging carton for a sterile device package. E-flute designs can eliminate the need for shipper boxes in some circumstances.
J-Pac offers a turnkey ISO/FDA compliant medical device package design and validation process that can be integrated into your technical files.
- We start with documenting customer requirements for their medical device package, which includes usability issues and aseptic transfer requirements, as well as labeling preferences.
- Next, we document the packaging system requirements that consider storage and transportation conditions, cleanliness, bioburden, and expected environmental stresses and constraints. Sterility methods and material compatibility are also assessed at this time.
- Based on these inputs, we design both the medical device sterile barrier system that will prevent microbial contamination and the protective packaging that will protect both the product and the sterile barrier system during shipment.
- Next, we manufacture prototypes under worse-case manufacturing conditions and test the feasibility of these designs in our in-house lab to ensure a high probability they will pass simulated distribution testing.
- Once the customer approves the medical device packaging prototypes, we can test usability with our panel of surgical nurses to ensure we meet the requirements for usability.
- All of this medical device package design work will be conducted under an ISO 13485 quality system including requirements specifications, test protocols, validation plans, and test reports and these are provided to the customer for their technical files. We also manage all outside testing services.
Do orthopedic implants need to be double packaged?
Double barrier thermoformed trays that nest into each other. Each tray will be sealed with Tyvek.
There is no regulatory requirement for double packaging orthopedic implants but there are several factors and requirements of ISO 11607-1 that influence the decision. Section 6.2.2 requires that the medical device package allow the product to be presented in an aseptic manner. While this does not require a double package design, some surgeons prefer to have a “belt and suspenders” approach where the inner package prevents any unnecessary contact while sitting in the sterile field. Additionally, many circulation nurses prefer the ability to transfer the device to the sterile field without waiting for someone in the field to take it out of the package. A double package design can facilitate this - often called “dumping,” “throwing,” or “dropping,” by OR nurses. Additionally, the standard section 6.1.1 requires that the package protect the safety of the user and patient. Some medical device implants have sharp features that may make a double package design desired. Lastly, the issue may come down to surgeon preference.
Packaging & Package Validation
How long does a medical device package design and validation take from start to finish?
Package Sealing Line
Shuttle sealer packaging line. Sealing packages in class 8 cleanroom.
Package Design (Phase 1): 13 Weeks
- Package System Requirements
- Sterile Barrier Design
- Protective Package Design
- Verification Testing
- Sterile Presentation Test
Sealing and Manufacturing Process Development (Phase 2 - 3): 16 Weeks
- Thermoforming & Sealing Tooling
- Thermoforming IQ/OQ
- Sealing IQ/OQ
- Device Assembly IQ/OQ
- Label Development
- Build OQ-Low for Transit Test
Transit Testing and Seal Testing (Phase 4 - 6): 13 Weeks
- Expose to Worst-Case Sterilization
- Transit Simulation
- Accelerated Aging Testing
- Real-Time Aging Testing
- Seal Testing
Sterilization Validation: 8 Weeks
These are typical lead times, but they can be significantly reduced by selecting an outsourcing partner well versed in all aspects of the process as well as having vertically integrated packaging and manufacturing processes.
Should the medical device packaging performance qualification (distribution simulation) be done at the same time as the product stability study?
Package Seal Test
Pull test of a medical package seal to evaluate the strength and integrity of the seal.
No. ISO 11607-1 Section 6.4.4 indicates that stability testing and performance testing are separate entities.
Performance testing is testing how the packaging system responds to shipping and handling stresses. The performance test must demonstrate that expected shipping stresses do not compromise the sterile barrier.
How do you validate medical device packaging?
Pre-validated, Double Barrier Packaging
Pre-validated nested double barrier packaging with custom urethane insert.
Packaging validation is complex. There are several processes that must be completed
- The manufacturing process to produce the packaging’s sterile barrier system must be validated. This requires an Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to be conducted on the manufacturing equipment.
- Packaging performance testing must be completed. This includes manufacturing and sterilizing under worst-case conditions and subjecting the packaging system to simulated distribution testing.
- A stability study must be completed and is typically done with both accelerated and real-time aging studies.
- Both the performance testing and stability study require tests for seal integrity and seal strength as well as an evaluation of product protection.
What medical device testing has to be done under worst-case conditions?
Automated Packaging Line
Automated packaging line that seals medical foam into a four-sided sterile package.
ISO 11607-1 Section 6.3.4 states, “Performance testing shall be conducted on the worst-case sterile barrier system produced at the specified process limits of forming and sealing and after exposure to all the specified sterilization processes.”
The Performance Test includes the simulated distribution test and is a separate test from the sterile barrier stability study. In practice, the most typical “worst-case” manufacturing conditions are related to variables affecting seal strength. However, there is no formal definition provided by the standard. It is up to the manufacturer to define “worst-case” manufacturing conductions.
Are microbial challenges required for medical device packaging validation?
Pouch card packaging for spinal implants
3D printed prototypes of spinal implants packaged on an HDPE die cut card.
There is no universally accepted method of demonstrating microbial barrier properties, although there are efforts to address this that may eventually be incorporated into the standard. The part 1 standard section 5.2.2 indicates only that the microbial barrier requirement can be demonstrated by showing the material is impermeable. Annex C requires that impermeable materials for sterile barrier systems shall be tested for air permeance in accordance with ISO 5636-5. Other tests are noted in Annex B. In practice, demonstrating a sufficient microbial barrier is performed on the material itself by the raw material supplier and their test reports can be referenced in the MDM’s technical file.
Do I need to include an IFU (Instructions For Use) when testing?
Universal Orthopedic Nail Package
A thermoformed package for multiple SKU’s of orthopedic nails. The package has adjustable foam blocks to accommodate various sized nails.
The IFU is required for the package performance test because it may impact the integrity or strength of the sterile barrier during shipping and handling. For example, an IFU with sharp edges may cause tears.
How do I determine sample size?
Styrene Medical Tray
Thermoformed tray made from styrene plastic.
There is no single standard for sample size selection. When determining the right sample size for your product, the most important factor to consider is risk. ISO 11607-1 section 4.3 indicates that sample sizes must be based on some statistical rationale and references sampling plans in ISO 2859-1 and ISO 186.
Is cleaning validation required for orthopedic implants?
Orthopedic screw package exploded view
Injection molded vial for orthopedic screw packaging. The vial has an adjustable length to fit multiple length screws or plates.
If the orthopedic implant is cleaned prior to packaging, the cleaning process must be validated to ensure a high probability that the cleaning specifications are met (FDA CGMP). There have been numerous recalls in orthopedics caused by cleaning processed getting out of control, which left patient harming contaminants on the product. A cleaning validation should be evaluated starting with a product and process FMEA that shows possible sources of contamination and their impact and severity.
What tests are used for a cleaning validation?
Tyvek clear film peel pouch. The clear film allows visibility to the device while the Tyvek enables Eto sterilization.
Typically, testing covers three areas:
- Cytotoxicity: a test for overall safety, measuring if the device material or residuals are cytotoxic.
- Bacterial Endotoxin: a test of harmful endotoxin contamination, which is typically introduced by water and can be very dangerous to patients.
- Bioburden: a test of fungal or bacterial contamination.
How does J-Pac perform a cleaning validation?
Pre-validated medical device package with double barrier
Pre-validated sterile package, including nested rigid trays and flexible urethane inserts that allow multiple components to share the same package.
J-Pac uses approved protocols for all validations, including cleaning. The medical device cleaning validation is designed to show that contaminants that come in contact with the product during manufacturing and packaging are safely removed. These contaminants include organic residues (such as oil), inorganic residues (such as leftover particulates from processing), and microbiological contaminants (such as bioburden from inadequate operator hygiene controls).
The key components of the validation are:
- Process FMEA to determine possible sources of contaminants, including suppliers that touch the device
- Benchmarking non-cleaned parts
- Establishing acceptance criteria
- Grouping of samples by material type/family, cleaning process
- Identification of worst-case conditions to test
- Establishing a statistically rationale sample size
- Establishing the cleaning process steps and parameters
- Post cleaning testing
- Establishing Alert and Action Levels
- Establishing post validation sampling plan and change control plan
Does J-Pac perform post-thermoforming customization of medical grade trays?
Catheter Tray Package
A surgical catheter packaged in a thermoformed tray. The tray was designed with a clear lid that snaps into place. The customer wanted the tray to be pouched.
Thermoformed medical device packaging trays are customized to incorporate various types of venting to support lyopholization processes and/or Eto processing of resorbable polymers. Additionally, reverse flanges can be provided for large trays that are designed to accommodate heavy materials.
What is ISO 11607?
Automated Blister Manufacturing
High volume blister manufacturing line. Film is thermoformed and sealed with a foil lidding material. Multiple blister wells are vacuum tested real-time with the line running at 20M units per year.
ISO 11607 is the standard for packaging terminally sterilized medical devices and is comprised of two parts.
ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems, and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
ISO 11607-2:2006 specifies requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems and packaging systems.
Part 1 addresses Materials and Design while Part 2 addresses Packaging Process Validation. These are both required to satisfy the Essential Requirements of the European Directives to achieve CE Marking. Additionally, this guidance document is recognized by the FDA and used for premarket review submissions.
Shelf Life Testing
What is the determining factor in determining a medical device's shelf life?
Packaged surgical kits stacked after Tyvek sealing. Thermoformed rigid trays containing surgical procedure devices.
The FDA defines medical device shelf life as, “the term or period during which a device remains suitable for its intended use.” Fitness for use can be impacted by both maintaining sterility of the medical device package and ensuring the device performs as specified after aging. A risk-based approach should be used to determine the potential impact of using a device that may no longer be fit for use. Some medical devices will experience degradation over time and the risk of that degradation to the device’s fitness for use must be assessed when determining specifications and tolerances for manufacturing and components.
A stability study must be conducted on the sterile barrier system. Packaging samples (not containing the product) typically undergo both accelerated and real-time testing to establish the shelf life of the seal. Accelerated testing is allowed for market launch but must be followed up by real-time data. Accelerated aging should follow ASTM F1980, which details the Arrhenius equation that is commonly used. This equation is based on the principle that every 10°C increase in temperature doubles the reaction rate. Both accelerated and real-time aging should be done on medical device packages that have undergone worst-case sterilization.
Stability testing can take many avenues including material strength testing as well as visual inspection and functional testing. The medical device stability tests should be conducted on a packaged product that underwent worst-case sterilization and simulated distribution.
Can the product shelf life testing be done at the same time as the stability study for the sterile barrier?
Tray Shuttle Sealing
A heat sealer is used to seal Tyvek lid stock to PETG trays.
The medical device package shelf life testing and the stability study should be done separately. The FDA defines shelf life as the term or period during which a device remains suitable for its intended use. Fitness for use can be impacted by both maintaining sterility of the package and the post-aging performance characteristics of the medical device. These are two separate items and should be tested separately. The temperatures that are appropriate for sterile barrier system (SBS) materials may not be applicable to device materials. This may jeopardize the otherwise successful stability study on the SBS. When device assembly is completed and the product is packed within the SBS during stability studies, they often interfere with many of the tests that are conducted on the SBS at each aging interval. Medical devices often have a functional shelf life, which is much less than that of the SBS. These device limitations would unnecessarily shorten the dating claims for future products using the same SBS materials.
MDMs that include devices in their SBS stability studies often end up linking that particular device with the specific SBS used. They then feel it is necessary to repeat the stability study on the same SBS materials if a different device is packaged in it. This is not true. It is much better to keep SBS stability studies independent from any specific device.
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