Medical plastic injection molding and manufacturing for precision medical devices, laboratory components, and healthcare products

ISO 13485 Certified Medical Plastic Injection Molding, blow molding & Manufacturing

Hi-Rel Plastics & Molding Corp. provides medical plastic injection molding, clean room injection molding manufacturing, medical blow molding & other plastic molding services, custom plastic and metal parts manufacturing, tooling, assembly, and secondary manufacturing services for medical device, healthcare, pharmaceutical, diagnostic, laboratory, and life science applications throughout California and across the United States.

As an ISO 13485 certified medical manufacturer, Hi-Rel Plastics & Molding supports medical OEMs and other quality-critical manufacturers requiring precision, repeatability, contamination control, traceability, and reliable manufacturing processes.

Our medical manufacturing capabilities include medical device injection molding, plastic injection molding, medical cleanroom injection molding, liquid silicone rubber (LSR) injection molding, plastic blow molding, thermoforming and vacuum forming, rotational molding, mold and tool manufacturing, custom plastic and metal parts manufacturing, cleanroom assembly, ultrasonic welding, and a broad range of secondary services.

From initial part evaluation and DFM through prototyping, tooling, molding, cleanroom manufacturing, assembly, secondary operations, and production, Hi-Rel Plastics & Molding provides comprehensive medical contract manufacturing services from its California manufacturing facility.

ISO 13485 Certified Medical Device Manufacturing

Medical components require manufacturing processes built around quality, consistency, documentation, and risk management.

Hi-Rel Plastics & Molding operates under an ISO 13485 certified quality management system supporting medical device and healthcare manufacturing programs where controlled processes and consistent product quality are critical.

Our quality-focused manufacturing approach supports customers producing medical devices, diagnostics, laboratory equipment, pharmaceutical products, healthcare products, and other precision applications.

Combined with extensive molding, tooling, machining, assembly, and secondary-service capabilities, our quality system enables Hi-Rel Plastics & Molding to support customers from early product development through ongoing production.

Cleanroom Manufacturing

Controlled production environments designed to meet strict cleanliness and contamination standards.

Medical-Grade Materials

Experience with resins suited for biocompatibility, sterilization, and regulatory compliance.

Precision & Consistency

Tight-tolerance molding ensures reliable, repeatable parts for critical medical applications.

Quality-Driven Processes

Strict quality control ensures every component meets performance and industry standards.

ISO 13485 Certified | ISO Class 7 & Class 8 Cleanrooms | 40+ Years Experience | California Manufacturing | Prototype to Production

Hi-Rel Plastics & Molding offers controlled cleanroom manufacturing environments for medical products and components requiring enhanced contamination control.

Our cleanroom capabilities include:

  • Class 10,000 / ISO Class 7 cleanroom environments
  • Class 100,000 / ISO Class 8 cleanroom environments
  • Medical cleanroom injection molding
  • Cleanroom component handling
  • Cleanroom assembly
  • Cleanroom ultrasonic welding
  • Cleanroom secondary operations
  • Controlled manufacturing and packaging operations based on project requirements

These capabilities allow Hi-Rel Plastics & Molding to support medical device components requiring controlled manufacturing environments from molding through downstream assembly operations.

For applications specifically requiring injection molding in controlled environments, learn more about our medical device injection molding capabilities.

Medical Plastic Injection Molding

Hi-Rel Plastics & Molding provides custom plastic injection molding for medical device components requiring precision, dimensional consistency, complex geometries, repeatability, and medical-grade or engineering-grade thermoplastics.

Our medical plastic injection molding services can support applications such as:

  • Diagnostic equipment components
  • Laboratory equipment components
  • Medical device housings
  • Surgical device components
  • Fluid-management components
  • Connector components
  • Medical equipment enclosures
  • Instrument housings
  • Caps and closures
  • Tubing connectors
  • Valve components
  • Pharmaceutical device components• Disposable medical components
  • Medical equipment handles and controls
  • Custom tight-tolerance plastic components

Hi-Rel Plastics & Molding can support projects from early product development and prototyping through tooling and scalable production.

Medical Cleanroom Injection Molding

For medical products requiring additional contamination control, Hi-Rel Plastics & Molding provides medical cleanroom injection molding within controlled ISO Class 7 and ISO Class 8 environments.

Cleanroom molding can be appropriate for medical, diagnostic, pharmaceutical, laboratory, and other applications where airborne particles and environmental contamination must be carefully controlled during manufacturing.

Our cleanroom manufacturing capabilities can be combined with cleanroom assembly and ultrasonic welding, helping customers consolidate multiple manufacturing operations with a single supplier.

Liquid Silicone Rubber (LSR) Injection Molding for Medical Components

Medical LSR injection molding provides an effective manufacturing solution for flexible components requiring excellent temperature resistance, chemical resistance, elasticity, and dimensional consistency.

Hi-Rel Plastics & Molding provides liquid silicone rubber injection molding for medical and other demanding applications.

Potential medical LSR components include:

  • Seals and gaskets
  • Flexible valve components
  • Diaphragms
  • Medical device seals
  • Flexible connectors
  • Soft-touch components
  • Protective components
  • Silicone overmolded components
  • Custom flexible medical components

Our LSR capabilities can complement thermoplastic injection molding when medical products require combinations of rigid and flexible materials.

Medical Blow Molding

Hi-Rel Plastics & Molding provides custom plastic blow molding services for medical, pharmaceutical, diagnostic, laboratory, and healthcare applications requiring hollow plastic components.

Our capabilities include extrusion blow molding (EBM), injection blow molding (IBM), and injection stretch blow molding (ISBM).

Potential applications include:

  • Medical fluid bottles
  • Pharmaceutical containers
  • Diagnostic solution bottles
  • Specimen containers
  • Laboratory bottles
  • Disinfectant containers
  • Healthcare packaging
  • Fluid-handling containers
  • Custom hollow medical components

Hi-Rel Plastics & Molding’s blow molding capabilities support products ranging from small containers to larger hollow plastic components.

Medical Thermoforming & Vacuum Forming

Hi-Rel Plastics & Molding provides custom thermoforming and vacuum forming services for medical and healthcare components requiring lightweight formed plastic parts.

Potential applications include:

  • Medical equipment housings
  • Equipment covers
  • Medical device trays
  • Protective packaging
  • Component handling trays
  • Equipment panels
  • Laboratory equipment components
  • Diagnostic equipment enclosures
  • Custom formed medical plastic components

Thermoforming and vacuum forming can provide cost-effective alternatives for larger plastic components, protective packaging, equipment covers, and lower-volume applications.

Medical Rotational Molding

For larger hollow plastic components, Hi-Rel Plastics & Molding offers custom rotational molding services.

Potential healthcare and medical applications include:

  • Medical equipment housings
  • Large equipment enclosures
  • Healthcare storage containers
  • Durable transport containers
  • Medical waste containers
  • Fluid-management components
  • Equipment carts and housings
  • Custom large hollow plastic components

Having injection molding, LSR molding, blow molding, thermoforming, vacuum forming, and rotational molding capabilities allows Hi-Rel Plastics & Molding to help customers evaluate an appropriate process based on part geometry, material, quantities, tooling requirements, performance, and cost objectives.

Medical Mold & Tool Manufacturing

Reliable production begins with reliable tooling.

Hi-Rel Plastics & Molding provides custom medical mold and tool manufacturing services supporting injection molding, LSR molding, blow molding, thermoforming, vacuum forming, rotational molding, and other manufacturing processes.

Our tooling support can include:

  • Design for Manufacturability (DFM)
  • Mold Flow analysis when applicable
  • Mold and tooling design
  • Prototype tooling
  • Production tooling
  • Mold sampling
  • Mold modification
  • Mold repair
  • Mold maintenance
  • Existing mold evaluation
  • Mold transfer programs

Integrated tooling and molding capabilities allow customers to work with Hi-Rel Plastics & Molding from product development through production.

Medical-Grade & Engineering Plastic Materials

Material selection can have a significant impact on the performance, manufacturability, chemical resistance, dimensional stability, temperature resistance, and durability of medical plastic components.

Hi-Rel Plastics & Molding processes a broad selection of commodity, engineering, and high-performance thermoplastics.

Learn more about thermoplastic injection molding material selection for demanding applications.

Materials may include:

  • Polycarbonate (PC)
  • Polypropylene (PP)
  • Polyethylene (PE)
  • ABS
  • Acetal / POM
  • Nylon / Polyamide
  • PEEK
  • PEI / ULTEM®
  • PPS
  • PPSU
  • PES
  • PBT
  • PVDF
  • LCP
  • TPE
  • TPU
  • Acrylic / PMMA
  • Liquid Silicone Rubber (LSR)
  • Glass-filled engineering thermoplastics
  • Customer-specified medical and engineering materials

Material selection should be based on the specific performance, regulatory, chemical, thermal, mechanical, and manufacturing requirements of each application.

Custom Plastic & Metal Medical Parts Manufacturing

Medical manufacturing programs frequently involve more than a single molded component.

Hi-Rel Plastics & Molding provides custom plastic and metal parts manufacturing to support individual medical components as well as more complex assemblies.

Combining molded plastic components, machined components, metal parts, tooling, and secondary manufacturing with one supplier can help medical device OEMs reduce supply-chain complexity and improve coordination between manufacturing operations.

Medical Cleanroom Assembly

Hi-Rel Plastics & Molding offers cleanroom assembly services for medical components and products requiring controlled handling after molding.

Depending on the project, our assembly capabilities can support:

  • Plastic component assembly
  • Multi-component medical assemblies
  • Mechanical assembly
  • Component insertion
  • Bonding operations
  • Ultrasonic welding
  • Cleanroom handling
  • Secondary manufacturing operations
  • Customer-specific assembly requirements

Combining cleanroom molding and cleanroom assembly can reduce the number of outside suppliers involved in a medical manufacturing program and simplify component handling between production steps.

Hi-Rel Plastics & Molding provides ultrasonic welding and value-added secondary manufacturing services to transform molded components into more complete products and assemblies.

Secondary capabilities may include:

  • Ultrasonic welding
  • Ultrasonic insertion
  • Heat staking
  • Heat insertion
  • Adhesive bonding
  • Mechanical assembly
  • Pad printing
  • Label application
  • Painting and coating
  • Trimming and deflashing
  • CNC machining
  • Leak testing
  • Heat sealing
  • Custom packaging
  • Component inspection
  • Customer-specific secondary operations

These capabilities allow customers to consolidate molding and downstream manufacturing operations with Hi-Rel Plastics & Molding.

Medical Applications We Support

Our broad manufacturing capabilities can support components used throughout the medical and healthcare industry, including:

  • Medical devices
  • Diagnostic equipment
  • Laboratory equipment
  • Pharmaceutical products and packaging
  • Surgical equipment
  • Patient-care equipment
  • Fluid-management systems
  • Drug-delivery components
  • Medical electronics
  • Medical equipment housings
  • Healthcare products
  • Medical packaging
  • Laboratory consumables
  • Life science equipment
  • Custom medical device components

Each application has different functional, quality, material, cleanliness, and manufacturing requirements. Hi-Rel Plastics & Molding evaluates each project individually to determine the appropriate manufacturing approach.

From Medical Product Development to Production

Hi-Rel Plastics & Molding can support customers throughout the medical manufacturing lifecycle.

A typical program may include:

Part Evaluation → DFM → Material Selection → Prototyping → Tool Design → Mold Manufacturing → Mold Sampling → Cleanroom Molding → Inspection → Secondary Operations → Cleanroom Assembly → Packaging

Providing multiple services through one manufacturing organization can reduce supplier complexity and simplify project coordination.

Why Medical Device Companies Choose Hi-Rel Plastics & Molding ?

ISO 13485 Certified

Our ISO 13485 quality management system supports manufacturing for medical device and other quality-critical applications.

ISO Class 7 & ISO Class 8 Cleanroom Environments

Hi-Rel Plastics & Molding offers both Class 10,000 / ISO Class 7 and Class 100,000 / ISO Class 8 cleanroom environments to support medical manufacturing requirements.

Multiple Medical Plastic Molding Technologies

Customers can access plastic injection molding, LSR injection molding, blow molding, thermoforming and vacuum forming, and rotational molding through one manufacturing partner.

Medical Cleanroom Injection Molding

Our controlled cleanroom capabilities support precision medical components requiring enhanced contamination control during molding and handling.

Medical Cleanroom Assembly

Molded components can proceed into cleanroom assembly and other downstream operations, reducing unnecessary transfers between suppliers.

Liquid Silicone Rubber Injection Molding

LSR molding provides additional manufacturing options for flexible medical components, seals, gaskets, diaphragms, and other silicone products.

Mold & Tool Manufacturing

Integrated tooling capabilities support medical products from prototype and product development through production tooling and ongoing manufacturing.

Custom Plastic & Metal Components

Hi-Rel Plastics & Molding’s capabilities extend beyond molding to support custom plastic and metal components for more comprehensive medical manufacturing programs.

Assembly & Secondary Operations

Cleanroom assembly, ultrasonic welding, joining, finishing, machining, inspection, and other secondary operations help customers source more complete manufacturing solutions.

Prototype Through Production

Hi-Rel Plastics & Molding can support early product development, prototypes, tooling, production ramp-up, and ongoing manufacturing programs.

Medical Device Manufacturing in California

California is home to a major medical device, biotechnology, pharmaceutical, diagnostics, and life science manufacturing ecosystem.

Working with a California medical plastics manufacturer can provide advantages for OEMs requiring responsive engineering communication, tooling support, production coordination, quality management, and domestic supply-chain support.

Located in Riverside, California, Hi-Rel Plastics & Molding supports customers throughout Southern California, Los Angeles, Orange County, San Diego, the Inland Empire, Northern California, and across the United States.

Our California location combined with ISO 13485 certification, ISO Class 7 and ISO Class 8 cleanroom environments, and diverse manufacturing capabilities makes Hi-Rel Plastics & Molding a valuable manufacturing resource for medical device companies seeking U.S.-based production.

One Manufacturing Partner for Complex Medical Programs

Instead of managing separate suppliers for tooling, injection molding, LSR molding, blow molding, thermoforming, rotational molding, machining, cleanroom assembly, and secondary operations, customers can consolidate multiple manufacturing requirements with Hi-Rel Plastics & Molding.

This broad manufacturing capability is particularly valuable for medical products containing multiple components manufactured through different processes.

Whether your project requires a precision injection molded medical device component, LSR seal, blow molded medical container, thermoformed equipment housing, rotationally molded enclosure, custom tooling, cleanroom assembly, ultrasonic welding, or a combination of plastic and metal components, Hi-Rel Plastics & Molding can evaluate your requirements and recommend an appropriate manufacturing approach.

Request a Quote for Medical Plastic Molding & Manufacturing

Looking for an ISO 13485 certified medical plastics manufacturer, medical device injection molding company, cleanroom injection molding manufacturer, or medical contract manufacturer in California or the USA?

Hi-Rel Plastics & Molding can support your project from part evaluation, DFM, and prototyping through tooling, cleanroom molding, production, secondary operations, and cleanroom assembly.

Submit your drawings, 3D CAD files, material requirements, expected production quantities, cleanliness requirements, and applicable specifications for review.

Contact Hi-Rel Plastics & Molding to discuss your next medical device molding, cleanroom manufacturing, tooling, assembly, or contract manufacturing project.

Cleanroom Manufacturing

Controlled production environments designed to meet strict cleanliness and contamination standards.

Medical-Grade Materials

Experience with resins suited for biocompatibility, sterilization, and regulatory compliance.

Precision & Consistency

Tight-tolerance molding ensures reliable, repeatable parts for critical medical applications.

Quality-Driven Processes

Strict quality control ensures every component meets performance and industry standards.