Cleanroom & Sterile Barrier Packaging

From molded parts to sealed pouches, we support sterile medical manufacturing with ISO-certified cleanrooms, validated sealing methods, and full compliance documentation; ready for downstream sterilization.

ISO Class 7 Cleanrooms

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Our three ISO Class 7 cleanrooms are purpose-built for sterile barrier packaging. With impulse and rotary sealers and strict environmental controls to reduce particulates and microbial levels, we support critical applications where cleanliness and compliance are non-negotiable.

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Key Capabilities:

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  • Certified ISO Class 7 environments (3 rooms)
  • Impulse and rotary (band) sealing systems
  • Standard Tyvek/LDPE and custom pouch formats
  • Environmental controls for particle and microbe reduction

‍ISO Class 8 Cleanrooms

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We operate nine ISO Class 8 cleanrooms dedicated to clean molding and assembly. Designed for regulatory compliance, consistency, and cleanliness, these controlled spaces are optimized for regulated medical builds and downstream packaging.

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Key Capabilities:

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  • Nine Class 8 cleanrooms for molding and assembly
  • Controlled environments for cleanliness and quality
  • Ideal for low-particulate production and clean handling
  • Supports compliance with strict medical manufacturing standards

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Certified. Controlled. Clean. Every Step of the Way.

We don’t cut corners when it comes to cleanliness. As an American-made, employee-owned partner, our ISO-certified environments and quality systems deliver the exceptional standards that meet regulatory demands and your internal benchmarks, striving to be on time, every time.

3 ISO Class 7 Cleanrooms

Dedicated to final barrier packaging with validated workflows.

9 ISO Class 8 Cleanrooms

Used for molding and sub-assembly in low-particulate environments.

100% Seal Integrity Testing

Performed on every sterile packaging run to confirm process control.

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Contract Sterilization Support

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We streamline your path to sterilization with end-to-end support, from part manufacturing and assembly to packaging and direct drop-shipment to your sterilization partner. Our ISO-aligned workflows are backed by validated part cleansing protocols and in-line seal integrity testing, giving you confidence in every production run.

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Key Capabilities:

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  • Sterilization-ready packaging workflows
  • Peel and burst testing for seal integrity
  • Direct coordination with sterilization partners
  • Validated part cleansing processes

Our Certifications
& Registrations

Sterile-Ready from the First Step to the Final Seal

Ready to experience the exceptional standards that make P1 the first choice for cleanroom manufacturing? From sterile molding to final packaging, we deliver the precision and compliance your critical applications demand.