For more than 30 years, Jamestown Plastics has been a trusted partner in medical packaging, offering advanced ISO Class 7 and 8 cleanroom manufacturing, ISO 13485:2016 certification, and precision thermoforming. Our solutions are designed to meet the most rigorous demands of the healthcare industry. Read on to learn how our cleanroom capabilities enhance medical packaging.
How Cleanroom Manufacturing Elevates Medical Packaging
Before a medical device reaches a patient, its packaging must protect it from contamination, preserve sterility, and comply with FDA and ISO standards. Whether it’s pharmaceutical trays, surgical kits, or clamshell packaging, maintaining a controlled environment during production is essential.
Particulate exposure is one of the biggest risks in medical packaging. Even microscopic contaminants can compromise the integrity of a product. Our ISO-certified cleanrooms are engineered to reduce these risks, using HEPA filtration, precise air exchange systems, and stringent handling protocols. These safeguards create an environment where medical packaging remains pristine and compliant with strict regulatory requirements.
Cleanroom Capabilities That Set a Higher Standard
ISO Class 7 and 8 Cleanrooms
Different medical applications require different levels of particulate control.
- ISO Class 7 cleanrooms provide enhanced contamination control, making them ideal for sterile barrier packaging and precision-formed medical trays.
- ISO Class 8 cleanrooms support applications with lower sterility demands while maintaining a carefully regulated environment.
This flexibility allows us to tailor our cleanroom processes to specific customer needs, ensuring every product meets industry standards.
In-House Design & Tooling for Total Control
Managing every stage of production under one roof gives us the ability to move from concept to final product with greater efficiency. Our in-house capabilities allow for:
- Shorter lead times for accelerated project completion
- Uncompromising precision and consistency across all production runs
- Custom design flexibility to meet unique medical packaging requirements
Precision Thermoforming for Medical Packaging
With expertise in both light-gauge and heavy-gauge thermoforming, we create a range of medical packaging solutions, including:
- Sterile Medical Device Packaging: Custom unit dose trays, clamshells, and pharmaceutical packaging
- Medical Trays: Single-use and reusable options for surgical kits, lab storage, and procedure setups
- Secure Storage & Transport Packaging: Lock boxes, medical carts, and returnable totes designed for healthcare environments
Material Versatility for Medical Applications
Selecting the right materials is just as important as the manufacturing process itself. We use FDA-compliant, medical-grade plastics to deliver strength, durability, and sterility. Some of the most commonly used materials include:
- PETG & APET: Transparent and impact-resistant, ideal for sterile barrier packaging
- HIPS & PVC: Lightweight and cost-effective for disposable medical trays
- ABS & Polycarbonate: High-strength options for reusable storage and medical equipment enclosures
- Autoclavable Polysulfone: Heat-resistant materials designed for sterilization processes
For specialized applications, we also offer anti-static films, oxygen barrier layers, and sustainable material options that align with evolving environmental standards.
Commitment to Quality: ISO 13485:2016 Certification
The healthcare industry demands precision and reliability. Our ISO 13485:2016 certification reinforces our dedication to quality management, regulatory compliance, and continuous improvement. Every stage of production—from material selection to final inspection—meets stringent standards to ensure consistent performance.
With manufacturing facilities in New York, Pennsylvania, and Texas, we provide redundant production capacity to strengthen supply chains and minimize disruptions. Customers benefit from reliable service and on-time delivery, even when demand fluctuates.
Applying Cross-Industry Expertise to Medical Packaging
Experience across multiple industries provides fresh perspectives on medical packaging challenges. Techniques from automotive, electronics, and industrial manufacturing have allowed us to refine processes, enhance durability, and improve efficiency. These insights have resulted in:
- Streamlined production workflows that reduce waste and improve speed
- Enhanced protective designs for delicate medical instruments
- Sustainable solutions that incorporate recyclable and reusable materials
Applying expertise from diverse industries allows us to develop smarter, more adaptable packaging solutions that meet the evolving needs of the healthcare sector.
A Trusted Partner for Medical Packaging Solutions
Cleanroom manufacturing is an essential part of medical packaging, offering sterility, compliance, and protection where it matters most. Jamestown Plastics brings decades of experience, advanced manufacturing technology, and rigorous quality controls to every project.
From custom medical device packaging to secure transport solutions, our team is ready to collaborate and bring your vision to life. Let’s discuss how our cleanroom capabilities can support your medical packaging needs – contact us today!
