Drug Delivery & Pharmaceutical Manufacturing
Precision Manufacturing for Drug Delivery Systems, Combination Products & Pharmaceutical Packaging
FDA Registered Facility
Class 8 Cleanroom Manufacturing
Why Pharmaceutical Companies Choose Natech
Applications We Support
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Drug Delivery Devices:
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Auto & Pen injectors
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Needle safety devices
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Pharmaceutical Packaging:
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Caps and Closures
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Dispensing systems
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Cartridge components
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Injectable Systems:
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Syringes
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Syringe components
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Core Manufacturing Capabilities
Hands-On Engineering
Optimize designs for manufacturability before tooling begins.
- Design for Injection Molding (DFIM)
- Material Selection
- Mold Flow Analysis
- Tooling Support
Injection Molding
Precision molding for complex diagnostic components.
- Precision Injection Molding
- Insert Molding
- Overmolding
- Microfeature Molding
Production
Integrated secondary operations to simplify your supply chain.
- Cleanroom Manufacturing
- Assembly
- Inspection
- Packaging
- Validation Support
Quality
Quality systems built for regulated diagnostic manufacturing.
- ISO 13485 Certified Quality System
- FDA-Registered Facility
- IQ/OQ/PQ Validation Support
- Process Validation & Documentation
- Full Lot Traceability
- Automated Inspection
Automation
Improving consistency, throughput, and repeatability.
- Vision Inspection
- Robotic Handling
- Automated Assembly
- In-Line Inspection
- Custom Automation
- Error Proofing
Specialized Materials & Product Enhancements
Selecting the right material is only part of the equation. Natech helps optimize pharmaceutical and drug delivery products through material expertise, integrated labeling, automation, and packaging solutions that improve product performance, traceability, and manufacturing efficiency.
Pharmaceutical-Grade Materials
We process a wide range of medical- and pharmaceutical-grade resins. Our engineers help customers select materials based on chemical compatibility, sterilization methods, regulatory requirements, and end-use performance.
- PP
- PE
- COC/COP
- PC
- ABS
- PEEK
- Ultem®
- and other engineered thermoplastics
Full Service Range
Drug Delivery
and Pharmaceutical Services
- Product Design Collaboration: Partner with our engineering team early to optimize product performance, manufacturability, cost, and regulatory readiness before production begins.
- Design for Manufacturing (DFM): Improve manufacturability, reduce production complexity, and optimize tooling, tolerances, and part geometry for efficient high-volume manufacturing.
- DFX Study: A holistic engineering approach that incorporates Design for Manufacturing, Assembly, Quality, Serviceability, Cost, and Supply Chain to reduce risk and accelerate commercialization.
- Material Selection: Select the optimal medical- and pharmaceutical-grade resin based on performance requirements, sterilization methods, chemical compatibility, and regulatory considerations.
- Mold Flow Analysis: Validate resin flow, gate locations, cooling performance, and potential molding challenges before tooling is built to reduce development risk and improve quality.
- Prototype Tooling: Rapidly produce prototype and bridge tooling to support product development, functional testing, verification, and early clinical builds.
- Production Tooling: Engineer and build high-performance production molds designed for repeatability, longevity, automation, and commercial-scale manufacturing.
- Precision Injection Molding: Manufacture tight-tolerance plastic components with exceptional consistency using scientific molding principles, advanced process controls, and automated production systems.
- Insert Molding: Integrate metal or plastic inserts directly into molded components to improve functionality, reduce assembly, and enhance product durability.
- Overmolding: Combine multiple materials or components into a single molded part to improve ergonomics, sealing, durability, and overall product performance.
- In-Mold Labeling (IML): Integrate durable, permanent labels directly into molded components, improving product identification, branding, traceability, and resistance to wear or sterilization processes.
- Automated Assembly: Reduce variation and improve throughput with automated assembly systems that deliver consistent, repeatable production for complex pharmaceutical and drug delivery products.
- Ultrasonic Welding: Create strong, clean, and repeatable bonds for plastic assemblies without adhesives, supporting leak integrity and product reliability.
- Laser Marking & Product Identification: Apply permanent, high-resolution identification, serialization, lot codes, and branding to components without compromising part integrity.
- Functional Testing & Inspection: Verify product performance through custom testing, dimensional inspection, visual verification, and quality assurance protocols tailored to your application.
- Cleanroom Manufacturing: Manufacture critical pharmaceutical and medical components in our ISO Class 8 cleanroom environment to support contamination control and regulatory requirements.
- IQ/OQ/PQ Validation: Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to ensure validated manufacturing processes and regulatory compliance.
- Production Transfer & Scale-Up: Transition existing products or manufacturing programs seamlessly while minimizing risk, maintaining quality, and reducing time to commercial production.
- Commercial Scale Manufacturing: From low-volume introductions to tens of millions of components annually, Natech provides the capacity, automation, and quality systems to support long-term production.
Pharamceutical Manufacturing FAQs
Yes. Natech holds ISO 15378 certification, which covers the manufacture of primary packaging materials for medicinal products in accordance with GMP principles. We are also ISO 13485 certified and inspected under 21 CFR 820.
Natech manufactures a range of drug delivery components including syringe barrels, plungers, closures, auto-injector components, drug delivery device housings, needle shields, and related components. We work with pharmaceutical companies and device manufacturers across the drug delivery supply chain.
ISO 15378 is a quality management standard specific to primary packaging materials for medicinal products, based on ISO 9001 and incorporating GMP guidelines. It means Natech’s manufacturing processes for pharmaceutical packaging meet the quality and documentation requirements of the pharmaceutical industry.
Yes. Combination products that integrate a drug or biologic with a device delivery mechanism require manufacturing capabilities that span both device and pharma quality systems. Natech’s certifications and manufacturing expertise support combination product programs.
Yes. We support IQ, OQ, and PQ for pharmaceutical manufacturing processes. Our team works with your quality and regulatory functions to develop and execute validation protocols that meet your submission requirements.
Material selection for pharmaceutical applications accounts for drug compatibility, extractables and leachables, sterilization method, and regulatory status. We work with materials including polypropylene, polyethylene, COC, and other resins with established pharmaceutical use histories.
Yes. Syringe component manufacturing at high volumes is a specific area of capability for Natech. Our automated production capabilities and validated processes allow us to maintain quality and consistency across high-volume pharmaceutical programs.
Yes. We operate a Class 8 cleanroom for pharmaceutical and drug delivery applications requiring controlled-environment manufacturing. This supports contamination control requirements for sensitive drug delivery components and primary packaging
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