Medical Device Qualified Supplier Directory
Qualifications: ISO 13485, ISO 9001, FDA Registered, CGMP Certified, Supplier to Medical Manufacturers, Exhibitor in at least 2 MD&M and/or MEDTEC shows
Markets Supplied: Worldwide
HTI Plastics is a global contract manufacturer for the medical device, pharmaceutical, industrial, outdoor recreation and packaging industries. Capabilities include design, development engineering, prototyping, thermoplastic injection molding, complex assembly and secondary operations. HTI adheres to systematic molding methodologies and practices continuous process improvement in its FDA registered, ISO 13485:2016 certified facility with Class I and II clean area assembly rooms.
Here at HTI Plastics, we have a state-of-the-art injection molding manufacturing facility with 23 injection molding machines that range from 50 to 950 ton. These presses offer outstanding precision, high quality, dynamic responses and the fastest dry cycle times in the industry. We also utilize a computerized material distribution system and have on-site silo storage of resin.
Beyond custom manufacturing
We are dedicated to improving productivity through automation. The presses are operated in an automatic mode to the greatest extent possible. Parts are removed from the injection mold by robotics or conveyor systems. The result is a reliable, efficient, and cost effective system to improve our contract manufacturing processes.
From prototyping and tooling, to finishing, assembly, and packaging, HTI does it
all. Our secondary applications include:
- Insert Molding
- Over Molding
- Clean Assembly Environment
- Ultrasonic Welding
- Automated Videoscope Measuring
- Hot Stamping
- Bar Coding
- PAD Printing
At HTI Plastics details matter, we are:
- ISO 13485:2016 registered
- ISO 9001:2015 registered
- USDA/FDA approved and registered facility
- Compliant with Good Manufacturing Practices (cGMP) Compliance 21 CFR 820
- Corrective and Preventive Action (CAPA) System
- Clean assembly environment for FDA/GMP product lines
- NSF certified by Cook and Thurber
At HTI Plastics, we’ve instituted many processes and reports to ensure you get the quality you’ve come to expect. With Process Control, you can be assured that changes won’t be made without thorough review of the entire procedure/process.
- Documented Inspection Plans and Work Instructions
- Internal Auditing
- Non-Conforming Material Control
- Document Control System
- Gauge Calibration Program
- Control Plans, PFMEA and Risk Analysis
- CMM Optical Measurement Systems
Designing for Manufacturability
Our expertise and know-how is from years of creating products using a wide range of materials, design requirements and manufacturing challenges. Our engineers fully support the customer during every phase of every project.
We pride ourselves on our extreme attention to your specifications and project details, and deliver a design that is moldable, which is what you should expect from an experience contract manufacturer like us.
Whether designing parts or tooling, we utilize the most advanced software and tools, including:
- CAD Platform is Solid Works 3D
- Translation Software: IGES, STEP, DWG, DXF
- Mold flow analysis
- SLA / SLS Models
- Process Development
- Rapid Prototyping
Founded in 1985, HTI traces its humble beginnings to the design and manufacture of one of the first vaginal applicators. The expertise acquired from producing over 300 million applicators a year brings us opportunities to develop and produce other custom medical devices.
We will be your single source partner using our proven in-depth process that consists of these components:
- Product development
- Project Management
- Process Development
- Injection Molding
The acquisition in 1995 by PCE, Inc. expanded our capabilities significantly. Besides thermoplastic injection molding, HTI has blow molding and profile extrusion capabilities. Both facilities are ISO 9001 registered. With multiple processing capabilities, HTI Plastics is the single source for all your contract manufacturing needs.
For more information contact HTI Plastics