Planning packaging for your first validation build

A first validation build is where packaging stops being a design and becomes a specification. The parts you build with, the settings you seal at and the lots you test all end up in the records that support your shelf-life and sterility claims. A build planned well runs once. A build planned in a hurry can run twice.

This article is for teams planning that first build: what to settle first, which tests to expect, how much to order, and what to ask your component suppliers for. It describes common practice. Your own test plan, written with your test lab or packaging consultant, sets the details.

Who does what

The device maker validates the sterile barrier system to ISO 11607-1 and -2. If a contract manufacturer seals and sterilizes the packages, it usually validates the sealing process on its own equipment, for the device maker's system.

ISO 11607-1 covers the materials and the design of the sterile barrier system: whether the package protects the device and keeps it sterile through sterilization, shipping and storage, and can be opened aseptically. ISO 11607-2 covers validation of the processes that form, seal and assemble the package.

We supply components, samples and documents that support that work. We don't validate your package or claim compliance on your behalf. Keeping that line clear helps everyone: your records show who is responsible for each step, and your auditor sees it too.

What to freeze before the build

Validation tests a specific package made in a specific way. Anything that changes afterward can mean retesting, so settle these before you order parts for the build:

• Material and grade. For example heat-seal coated Tyvek® 1073B for the lid, or the paper grade and film for a pouch.
• Material source. The same grade from a different manufacturer is a different material for validation purposes.
• Thickness or gauge. Card thickness, film gauge and laminate construction.
• Spec and revision. The outline, features and print for each component, at the revision you will produce.
• Die and cutting process. Parts for the build should be cut the way production parts will be, on the same die and process.
• Sealing process. The sealer, tooling and the sealing window you intend to run.
• Sterilization method and cycle. Including any resterilization you want to allow.

A change to any of these after validation is a change to a validated system. Ask every supplier how, and how far ahead, they will tell you before a material, source or process changes. We give advance written notice of any change that affects a part you have approved, and wait for your written approval where the change affects your validated specification.

Typical tests and their standards

Most first validations include tests like these. Your plan decides which apply and in what order.

Packages are normally tested after sterilization, often after the maximum exposure you intend to allow, and then after aging and distribution. Accelerated aging lets you support a shelf-life claim before real-time data is complete. Real-time aging still has to confirm it, so start the real-time samples at the same time.

On the process side, ISO 11607-2 validation typically runs as installation, operational and performance qualification. Operational qualification usually seals packages at the edges of the sealing window, as well as at nominal settings, and tests them. That is one reason a build needs more components than the number of finished packages in the test plan.

Worst case and sample quantities

You rarely validate every size and configuration separately. Instead, the test plan picks a worst case that the rest of the family can be shown to follow: often the largest or heaviest device, the package with the least clearance, the longest seal, or the sealing settings at the edge of the window. The device maker sets the worst-case rationale and the sample sizes, usually from a statistical basis such as a stated confidence and reliability for each test.

Once the plan sets the number of test packages, work out the component order from it:

• Test packages for each test, at each aging time point, including real-time pulls.
• Sealing set-up and qualification. Packages sealed while setting up the sealer and at the edges of the window.
• Retests. A spare set for any test that has to be repeated, so a failed sample doesn't stop the build.
• Retained samples for your records, if your quality system calls for them.

Decide how lots should appear in the build. Parts from one material lot keep the build simple to trace. If your plan calls for more than one lot, say so when you order.

What to order from us, and when

For a tray system, the build usually needs die-cut lids and any cards or film parts that go inside. For a pouch system, it needs the pouches or rollstock, plus any cards. We cut lids, cards, film parts and sheets in our ISO Class 8 cleanroom, with no minimum order on the parts we cut, so you can order what the test plan needs rather than a year of stock. We supply rollstock, pouches and header bags from qualified manufacturers.

When you order, tell us the order is for a validation build, give the spec revision for each part, and tell us the date the build starts. Order at least 3–4 weeks before the build, and allow time for a first-article check on the parts before you seal. We cut validation lots on the production die and process, and a first-article inspection report is available on request.

Documents to ask for

Whoever supplies your components, ask for the documents your validation records will need, and ask early:

• A certificate of conformance for each lot of parts used in the build
• Lot numbers on the parts and labels, so each test package can be traced to its component lots
• Lot records that link the parts to the material lots they were cut from
• The material maker's data and statements for porous and sealant materials, such as microbial barrier data and ISO 11607-1 material statements
• The supplier's quality certificate, and what it covers
• How the supplier will tell you before any change to material, source, process or site

Record the component lot numbers in your test report. If a result is questioned later, those numbers are how you show what was tested. For parts we cut, each shipment comes with a packing list and a certificate of conformance stating the part number, spec revision, lot, quantity and ship date. Our lot records cover the material lot, cutting date, die, inspection results and operator, and the lot number is on every bag and carton. For supplied items, our certificate of conformance records the manufacturer's lot number.

Next steps

If you are still designing the parts, read what to put on a die-cut spec and prototype to production. When the design is frozen, send your specs and test plan quantities through the engineering quote form, and tell us the build date.