Frequently Asked Questions

Yes! We are also working on remote video access.

Yes. Here are three very helpful actions: 1. Write the quote number on the outside of your package(s). 2. When possible, place your package(s) on a pallet. Use added protection such as sheeting, corner boards, banding, and stretch wrap. Have samples delivered via small parcel or less-than-truckload shipping, such as UPS, FedEx, or DHL. Please use over-pack shippers and cushioning. 3. Clearly indicate whether samples are arriving in over-packs and should be removed from over-packs prior to testing. This helps the lab intake technician accurately record receiving information and prepare for testing.

Unfortunately, no. The Intended Users for a device are different than the Intended Users who open and dispense the product/device.

Yes! Standard Usability Evaluations are excluded from being able to provide your own end users.

Only clients who use PCL/PCM as their contract packager can purchase our prevalidated CompliancePack packaging.

Yes, but the simulated product/device must be size and weight representative.

PCL can act as extra fire power for your existing team and author your protocols.

PCL does not have production minimums! We can accommodate annual volumes as low as one finished good annually.

Yes! PCL has single- and dual-barrier film-to-Tyvek pouch options and one dual-barrier tray option. Many of our prevalidated packaging options come with carton boxes and shippers. Request a quote for more information..

An ASTM Guidance document will be balloted in 2024. In the meantime, we've used the following standards to author our usability plans:

• ISO 11607-01 Section 7
• FDA1757
• IEC 62366
• AMMI/ANSI HE75

Contact us, request a quote, email, or call and we’ll connect you with a sales engineer who will help with the information you need..

Contact us, request a quote, email, or call and we’ll connect you with a sales engineer who will assist with your medical device packaging project.

Burst strength testing is performed by internally pressuring a package until it bursts.

Chamber duration depends on the temperature of your chamber and your shelf-life claim. For example, a product that claims a shelf life of 55°C for one year would require 40 days in the chamber.

We have two labs located in the greater Grand Rapids, MI area and a sales office in Boulder, CO.

1 to 3 per user. Having a sample size on the higher end is preferred.

Clients of PCM can shave months off their project timeline when they use CompliancePack. A typical timeline for CPack + PCL contract packaging launch if clients have samples ready is three to four months.

PCL partners with many medical device sealing manufacturers and would be happy to help procure a sealer for your sealer validation.

Yes, we are. See Packaging Compliance Labs ISTA Certificate here.

ASTM D4169 and ISTA 3A are both acceptable standards for medical device transit validations per ISO 11607. The decision about which to use depends on how you will be shipping your product once it is for sale. We can give feedback about what we typically see, but would ask that you rely on your regulatory consultant.

You tell us. We can discard the samples or return them to you for further evaluation. Sample disposition is discussed in the return shipment instruction that your operations supervisor will provide.

PCL is a medical-focused lab. We also support the pharmaceutical and diagnostics industries.

The TPS is our way of ensuring that your team and ours are accurately interpreting the details of your study. You review and agree or clarify before we begin your packaging testing.

The test measure is the maximum pressure detected before the package fails. These test methods provide rapid means of evaluating tendencies for package failure when the package is exposed to a pressure differential.

Formative studies should be performed before a design freeze. Summative studies should be conducted after sealing validation.

See Packaging Compliance Labs ISO certificate here

Packaging Compliance Labs, LLC, C/O [Work Order #] 4334 Brockton Dr SE Suite E Kentwood, MI 49512

DC 13 AL1 is most common for sterile medical device packaging. With that said, there can be caveats so you should ask your regulatory consultant or packaging engineer for additional information.

A PCL engineer will review the quoted test plan, protocols and other supporting information and draft the TPS. As soon as everything is aligned, you sign off and we get started.

The 15 users requirements are directly tied to requirements of IEC 62366 and AMMI/ANSI HE75.