Automated injection molding cell in a bright controlled manufacturing environment

Medical & Healthcare

Medical injection molding built around controlled production

Infinity coordinates cleanroom molding, inspection, and assembly around the quality and handling requirements of medical and healthcare programs.

Cleanroom platform 4 all-electric presses

55 to 110 tons

Medical quality system ISO 13485

Process discipline and traceability

Coordinated scope Molding and assembly

One connected program path

A connected production path protects medical program requirements

Material identity, environmental control, molding parameters, inspection evidence, and downstream handling are coordinated as parts move from resin receipt to shipment.

  1. 01

    Incoming material

    Resin identity and incoming requirements are checked before production release.

  2. 02

    Cleanroom molding

    All-electric presses and robotics support controlled, repeatable processing.

  3. 03

    Inspection evidence

    On-site measurement links dimensional results back to the program.

  4. 04

    Assembly and marking

    White-room operations consolidate handling beyond the molding cycle.

  5. 05

    Program management + validation

    A dedicated program manager coordinates requirements, production records, customer communication, and IQ/OQ/PQ protocol support.

One assigned point of contact

A dedicated program manager coordinates communication among the customer, Infinity teams, and approved outside suppliers while keeping validation activity connected to the program plan.

IQ
Installation qualification
OQ
Operational qualification
PQ
Performance qualification
How Infinity works

Precision molding supports diverse medical device applications

Infinity's experience spans disposable and durable component programs where geometry, material behavior, repeatability, and controlled handling all influence manufacturing strategy.

Drug delivery

Surgical pump components

Repeatable molded features for components used in fluid-management and delivery systems.

Monitoring

Cardiac monitor assemblies

Molded components and coordinated assembly for monitoring equipment programs.

Optical

Scanning product components

Geometry-aware processing and inspection for optical scanning applications.

Orthopedic and surgical

Components for demanding use environments

Material and tooling strategies aligned to functional, handling, and program requirements.

Application examples describe Infinity's manufacturing experience; final material, validation, handling, and regulatory requirements are defined program by program.

Class 8 controls extend beyond the molding cycle

Environmental discipline combines facility controls, entry protocols, all-electric molding, robotics, and downstream handling within a dedicated medical operation.

Cleanroom technician examining molded medical components beside automated inspection equipment
Controlled handling Assembly + inspection
Environment status
50 sec. Complete cleanroom air exchange
  • On-site particle-count monitoring
  • Controlled airlocks and gowning protocols
  • Automated part handling at every press
See cleanroom molding and assembly
Press technology All-electric

Repeatable motion and precise process control.

Automation Integrated robotics

Consistent part handling with less contact.

High-heat option Configured equipment

One cleanroom press supports advanced resin processing.

Quality evidence stays connected to each production decision

Move through the evidence layers to see how material, process, dimensional, and release controls support a medical manufacturing program.

Incoming assurance

Confirm material identity before the process begins

Infinity's incoming inspection process includes FTIR scanning on every resin lot, adding objective material evidence before molding parameters are put to work.

  • Resin-lot verification
  • Material handling requirements
  • Program-specific documentation
Review resin expertise

Assembly and marking keep sensitive handling consolidated

Infinity supports controlled assembly and pad printing for molded medical components, with inspection and lot records supporting the program.

One coordinated workflow Molded part Finished requirement

Assembly + subassembly

Bring multiple parts and controlled work instructions into one repeatable operation.

Marking + identification

Coordinate pad printing and program-specific identification requirements.

ISO 13485 supports disciplined medical production controls

The quality framework connects requirements, validation, measurement, traceability, and corrective action across the life of a medical manufacturing program.

Certified system ISO 13485

Medical device quality management

View certifications

Requirement control

Translate prints, specifications, and acceptance criteria into the program plan.

Validation evidence

Document how tooling, process parameters, and part response support release.

Traceable execution

Keep material, production, inspection, and lot information connected.

Continuous response

Use measured results and corrective action to strengthen ongoing performance.

Specialized medical production connects to shared technical support

Infinity's dedicated medical facility is supported by engineering, tooling, metrology, and program resources located within one coordinated campus.

Build a medical molding brief around the program requirements

Share what is known today. Infinity can help connect the part, material, production environment, validation plan, and downstream work into a practical next step.

Start a medical project review
Program input
  • Part drawing or current design
  • Material and performance requirements
  • Annual volume and launch timing
  • Cleanroom and validation needs
  • Assembly, marking, and inspection requirements