Your die-cut components need to meet pharmaceutical cleanliness standards and hold tolerance across thousands of units. They also need to come with the documentation your QA team requires. Colvin Friedman has cut parts for regulated industries for 75+ years, and Josh Rodman, our VP, stays available directly throughout your project at (707) 769-4488.
Tell us what you’re building. We’ll match the material, method, and documentation requirements.
| Segment | Applications | Materials |
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| Drug Delivery Device Components |
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| Secondary Packaging |
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| Cold Chain Packaging |
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| Prototype and Clinical Trial Parts |
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| Sterile Barrier Components |
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Qualifying a new die cutting supplier comes down to one core question: can they hold your tolerances and give you what you need for the audit trail? Here’s where we stand:
We process in a controlled environment, monitor temperature and humidity throughout production, use powder-free handling, and clean dies between material changes.
Rotary: ±0.005" / Flatbed: ±0.010", maintained from first prototype through full-volume production.
We provide complete documentation for every order, including process records, dimensional reports, material certifications, and batch traceability.
Prototype units are available within days using production-equivalent tooling to support reliable validation data.
You work directly with Josh, our VP, without account manager layers. Technical questions receive same-day answers.
We support R&D quantities through full production, scaling up to 40,000 units/hour while maintaining qualification continuity.
We give you fast prototyping and rigorous production control, with documentation at every stage.
01
We review your tolerances, material specifications, and regulatory requirements. We confirm process feasibility and recommend rotary or flatbed cutting based on your material and production volume.
02
We evaluate your pharma-grade material for cutting behavior, assess delamination risk and dimensional stability, and identify any conditioning required before cutting begins.
03
We cut initial parts using production-equivalent tooling and ship them for fit-and-function validation. The same tooling parameters carry forward to full production.
04
We generate first-article inspection reports and dimensional data. Material certifications are provided before production proceeds for QA review and approval.
05
We run production with continuous QMS monitoring and in-process dimensional checks. Batch documentation is compiled throughout the run and included in your audit file.
Contamination and dimensional failure happen at the material-die interface, not in spec sheets. These are the specific protocols we run during production for each pharmaceutical material type:
| Material Type | Our Production Protocols | What This Protects |
|---|---|---|
| Barrier Films and Foils (up to .015″) | We maintain temperature at 68–72°F and humidity at 45–55% RH throughout processing. We use powder-free handling and calibrate cutting pressure based on material thickness. |
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| Foam Materials (up to 0.5″) | We acclimate materials for a minimum of 24 hours before cutting. We apply progressive cutting pressure and run density and compression tests per batch. |
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| Multi-Layer Materials (up to 0.5″) | We verify layer adhesion before cutting, clean dies between material changes, and inspect cut edges under magnification. |
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| Temperature-Sensitive Materials | We monitor material temperature throughout production, apply defined cooling periods between cuts, and document environmental conditions for each batch. |
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| Engineering Plastics (up to 0.5″) | We verify material grade and orientation before cutting. We adjust cutting speed for material thickness and perform dimensional checks throughout the run. For reactive materials, we implement inert gas environments during cutting when required. |
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| Protective Films (up to .015″) | We use static elimination throughout processing, clean cutting surfaces regularly, and use non-contact handling to prevent surface damage. |
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| Capability | Rotary Die Cutting | Flatbed Die Cutting |
|---|---|---|
| Maximum Width | 16″ (we slit from larger jumbos) | 40″ |
| Maximum Thickness | 0.015″ (material-dependent) | 0.5″ (material-dependent) |
| Tolerance | ±0.005″ | ±0.010″ |
| Max Production Rate | 40,000 units/hour | 2,000–4,000 parts/hour |
| Average Lead Time | 3 weeks | 3 weeks |
| Best Pharma Applications | Thin barrier films and drug delivery substrates | Thicker foam inserts and multi-layer constructions |
Not sure which process fits your part? Call Josh directly at (707) 769-4488.
Yes. We produce die-cut components for manufacturers in FDA-regulated environments. We maintain process documentation and batch-level traceability on every order, giving your QA team what it needs for regulatory submissions.
We provide first-article inspection reports and dimensional data with every order. We also provide material certifications and batch traceability records. If your project requires a specific documentation format, we discuss that during your specification review.
We have prototypes ready within days of design approval. We cut them with production-equivalent tooling and parameters, so your validation data holds when you move to full production.
Yes. We work with barrier films and pharmaceutical-grade foils. We also cut engineering plastics and temperature-sensitive materials. We confirm cutting feasibility for your specific material before production begins.
We monitor cutting environment temperature and humidity throughout production. We use powder-free handling and clean dies between material changes. We also run static elimination during protective film processing.
Pharmaceutical die cutting with Colvin Friedman is the right fit for manufacturers who:
Or call Josh at (707) 769-4488