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.
Can I purchase PCL’s pre-validated packaging if I use a different contract manufacturer (CM) for my packaging?
Only clients who use PCL/PCM as their contract packager can purchase our prevalidated CompliancePack packaging.
Can PCL help with protocol authorship?
PCL can act as extra fire power for your existing team and author your protocols.
Does PCL have production minimums?
PCL does not have production minimums! We can accommodate annual volumes as low as one finished good annually.
Does PCL stock prevalidated packaging?
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..
How do I add PCL to my approved supplier list?
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..
How do I start working with PCL?
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.
How is burst strength testing performed?
Burst strength testing is performed by internally pressuring a package until it bursts.
How long will my samples stay in the accelerated aging chamber?
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.
How many locations does PCL have?
We have two labs located in the greater Grand Rapids, MI area and a sales office in Boulder, CO.
How much faster can I launch my device to market with PCL’s pre-validated packaging, CompliancePack?
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.
I need help purchasing a sealer. Can PCL help with this?
PCL partners with many medical device sealing manufacturers and would be happy to help procure a sealer for your sealer validation.
Is PCL ISTA Certified?
Yes, we are. See Packaging Compliance Labs ISTA Certificate here.
Should I use ASTM or ISTA for my transit simulation?
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.
What happens to my samples when testing is complete?
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.
What industries does PCL service?
PCL is a medical-focused lab. We also support the pharmaceutical and diagnostics industries.
What is a Test Parameter Sheet (TPS)?
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.
What kind of data does burst strength testing provide?
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.
Where can I find a copy of the PCL ISO 17025 certificate?
See Packaging Compliance Labs ISO certificate here
Where should I ship samples for testing?
Packaging Compliance Labs, LLC, C/O [Work Order #] 4334 Brockton Dr SE Suite E Kentwood, MI 49512
Which distribution channel is most common for ASTM D4169?
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.
Who drafts the Test Parameter Sheet?
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.
Still have questions? Reach out through our Contact Us page and we'll help you get the information you need.