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About Pexco
Medical and Life Science Solutions
Custom Medical-Grade Extrusion and Molding: USP Class VI, FDA, and ISO 10993-5 Compliant
When health, safety, and quality of life are at stake, Pexco delivers. From ISO 10993-5 certified tubing and heat shrink for medical devices to extruded shapes and precision-machined parts for lab, diagnostic, and pharmaceutical equipment, our components are there when you need them—engineered for reliability, compliance, and care.
Market Challenges
The Medical and Life Science industries face enormous regulatory pressure. Purity, sterilizability, and chemical and bio compatibility are all critical requirements for materials used in these spaces.
Top Challenges
- Achieving tight tolerances and precision in custom components
- Miniaturizing components while maintaining structural integrity and manufacturability
- Selecting reliable, inert materials that withstand cleaning agents, sterilization, and long-term flexing
- Maintaining proper certifications and material traceability for compliance
- Delivering consistent quality for life saving applications
- Securing reliable material supply and global sourcing continuity to mitigate disruptions
Pexco Solutions
Pexco’s products and capabilities help solve these challenges by combining materials expertise with advanced manufacturing.
Products for Medical and Life Science Applications
Our Capabilities
Plastic extrusion
Injection and compression molding
Precision CNC machining
Secondary operations (bonding, drilling, finishing)
Assembly and kitting
Material selection and engineering support
Materials Expertise
Every application starts with the right material. Pexco’s extensive expertise helps match polymers to demanding market requirements.
Common Medical and Life Sciences Polymers
PEEK
High strength-to-weight ratio, excellent chemical resistance, and good machinability
Fluoropolymers (PTFE, FEP, PFA)
Low friction, excellent chemical resistance, and low leachability
PEI (Ultem®)
Excellent biocompatibility, dimensional stability, and strength
PEI (Nylon®)
Excellent flexibility, biocompatibility, and strength
Polyolefin
Durable, flexible, and easily heat sealable
Silicone
Flexible, non-reactive, and heat resistant
EDPM
Excellent resistance to cleaning chemicals, steam, and polar media used in sanitary environments
TPV/TPE
lightweight, colorable, and cost-efficient
Compliance and Certifications
Pexco Medical and Life Science products comply with the following standards:
- USP Class VI
- USFDA C.F.R. 177.1330
- ISO 9001
Medical and Life Science Case Studies
Why Pexco?
Domestic Manufacturing Footprint
U.S. based operations and production for critical Medical and Life Science parts
Materials Expertise
Maintains decades of polymer engineering knowledge
Custom Engineering and Design
Offers engineering support from concept to prototype to production
Integrated Capabilities
Provides extrusion, molding, machining, and assembly services through a single point of contact
Scalability
Capable of supporting prototype quantities through full-scale productions runs
Frequently Asked Questions
What certifications cover Pexco’s medical-grade extrusion and molding?
Pexco produces medical-grade components compliant with USP Class VI and USFDA C.F.R. 177.1330 under an ISO 9001 quality system, using biocompatible materials suitable for medical devices and life-science applications.
Which Pexco products meet USP Class VI requirements?
Pexco runs a USP Class VI-compliant medical program spanning its medical-grade fluoropolymer tubing, Insultab® medical-grade heat shrink, and biocompatible PEEK and fluoropolymer (PTFE, FEP, PFA) molded and machined components for fluid-contact and device applications.
Can Pexco manufacture PEEK components for implantable medical devices?
Yes — Pexco machines and molds medical-grade PEEK and biocompatible fluoropolymers for demanding medical-device applications under its ISO 9001 / USP Class VI medical program. For implantable use specifically, confirm the implant-grade resin and validation requirements with Pexco, since those depend on the device and its regulatory pathway.
What sterilization methods are compatible with Pexco's medical polymers?
Compatibility depends on the polymer. Pexco’s medical-grade materials support common methods such as autoclave (steam), gamma, and E-beam — for example, Insultab® HS-714 medical-grade heat shrink is validated for E-beam, gamma, and autoclave sterilization. Confirm the validated method for your specific material with Pexco.
Does Pexco support prototype quantities for medical device development?
Yes — Pexco scales from prototype quantities through full-scale production runs in U.S.-based operations, supporting medical device development from early design iterations to launch.
