The Packaging Challenge in Clinical Trial Supply
Clinical trial supply chains operate under some of the most demanding regulatory and logistical conditions in pharmaceutical distribution. Investigational medicinal products (IMPs) must be maintained within tightly defined temperature ranges throughout transit from manufacturer to investigator site, and in some protocols also on a return journey.
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For clinical operations managers, IMP couriers and CROs (contract research organisations), the packaging itself is a regulated component of the trial. It must perform, it must be documented, and it must not fail. A temperature excursion during IMP transit is not just a packaging problem, it can invalidate data, delay a trial, or require regulatory notification.
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Puffin Packaging’s Lunda TempChain range provides qualified TempChain packaging suited to the discipline of clinical trial supply: documented, practical, evaluation-ready and supported by a specialist team that understands how much pressure sits behind every shipment.
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Lunda TempChain for Clinical Trial & IMP Applications
Qualified packaging that gives clinical supply teams the data, documentation and confidence needed for regulated IMP distribution — without starting every validation exercise from scratch.
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Key Features for Clinical Trial Supply Teams:
🗹 Qualified Performance Data
Supports IMP packaging validation without in-house testing from scratch.
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🗹 Documented Temperature Maintenance
Full qualification reports available for regulatory submissions and investigator site audits.
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🗹 Multiple Size Configurations
Suitable for vials, syringes, prefilled devices and larger IMP batches.
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🗹 ISO 9001 & ISO 14001 Certified
Meets preferred supplier requirements for CROs and pharma sponsors
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🗹 UK-based Supply & Technical Support
Faster lead times, simpler ordering, no customs complications.
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Frequently Asked Questions
Does your packaging meet MHRA GDP guidelines for IMP distribution?
Yes. Lunda TempChain packaging is designed to support GDP-compliant distribution of investigational medicinal products. We provide qualification data packs that can be used to support your IMP packaging validation documentation. We recommend review by your Responsible Person (RP) for final compliance sign-off on your specific trial protocol.
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Can you supply documentation for our trial master file (TMF)?
Yes. We can provide qualification performance data and temperature range specifications suitable for inclusion in a trial master file. Contact our team to request a documentation pack tailored to your trial requirements.
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Do you supply direct to investigator sites, or through a CRO/IMP courier?
We can supply packaging directly to CROs, IMP distribution specialists, pharmaceutical sponsors, or directly to investigator sites, depending on your supply chain structure. We are flexible in our ordering model and can support both bulk depot supply and smaller individual site orders.
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What phase of clinical trial is your packaging suitable for?
Lunda TempChain packaging is suitable for IMP distribution across Phase I, II and III clinical trials. It is also used for post-approval studies and compassionate use programmes where GDP-compliant cold chain or TempChain is required. Contact us to discuss your specific protocol requirements
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Can we trial the packaging before committing to a volume order?
​Yes, and we strongly recommend it. Request a free sample and we will send the packaging along with qualification report so your clinical supply team can evaluate performance against your IMP specifications and trial protocol requirements before placing an order.