HTI Plastics is dedicated to manufacturing high quality injection molded products, providing timely deliveries and creating an atmosphere of continuous improvements where all employees strive to keep both internal and external customers satisfied.
HTI Plastics understands that in today’s world you are looking for a company that is knowledgeable within your industry, provides excellent service and high standards of quality products. Our team will work with you from inception throughout the lifetime of your project.
Quality is built into our customers’ products and processes at HTI Plastics.
Our quality assurance is integrated into all processes that guarantee the final product you receive is built to your specifications. Products are made here at HTI Plastics by continuously monitoring the manufacturing and assembly process from beginning to end, using documented First Article Inspection, In Process and Final Inspection Procedures. Our modern injection molding machines are configured to your project's specifications and monitored to maximize quality and efficiency. The result is a process that is reliable and repeatable. We institute these rigorous standards for the pharmaceutical industry and all industries that we serve.
At HTI Plastics details matter, we are
• ISO 13485:2003 registered
• ISO 9001:2008 certified
• 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.
Maintaining exacting tolerances is a critical component of quality control—from cavity to cavity, first shot to final run. Scientific molding, a state-of-the-art in-mold monitoring process mastered by HTI, determines optimal fill speed, pack time, and pressure—eliminating guesswork and dramatically improving precision repeatability and efficient runtime. At HTI Plastics, you can be assured that we take every step carefully, precisely and with the end result in mind. Let us show you how we can do it for you.
CAPA is a concept within Good Manufacturing Practices and allows us to have a systematic investigation of discrepancies in an attempt to prevent their recurrence or to prevent occurrence.
Clean Assembly Environment
Our facilities meet the requirements of 21 CFR 820.70 of the Quality System (QS) Regulation to minimize contaminants; assure order handling procedures and prevent mix-ups. Our modern facilities are designed to have sufficient space and adequate lighting for manufacturing, secondary operations, assembly, storage and allow for proper cleaning, maintenance and other necessary operations.
First Article Inspection Reports
A First Article Inspection (FAI) establishes accountability that your products have been manufactured to your specifications. Every critical design characteristic called out on the part drawing is verified and recorded. We perform FAIs for all new part orders, and we can also provide FAI data after any process change when required. Providing this valuable service earns a higher level of trust from our customers and strengthens our relationships with them.
Nonconforming Material Control System
Every Quality Assurance Program must have a system that directs your nonconforming material control. This system prevents defective material from being processed, consumed, or shipped. When documenting this system consider these processes:
Receiving Inspection
Process Defects
Product Defects
Finished Goods Containment
Returned Material
In process product specific containment
Our Quality department provides customized inspection services to meet your specific requirements.
Real Time Process Monitoring
Real time availability of every detail involved in the entire manufacturing operation is crucial to delivering product our customers expect. A component of our ERP System is Real Time Process Monitoring. We are able to gather manufacturing data and statistics from our presses and deliver it in real time for accurate production reporting and analysis, and allows us to compare what products are being made with our customers’ specifications. We have instantaneous feedback on critical parameters such as total parts created, production time, down time, scrap, rejects, parts remaining to be produced, and cavitation changes. Thus, eliminating unnecessary waste and downtime as production and maintenance issues are identified before they become a problem.
CMM: Coordinate measurement machines
We use coordinate measurement machines (CMM) to verify tolerance measurement. With CMM analyzing high precision parts is easy and quick, and provides consistent accuracy. The machine uses an X-Y-Z grid to determine its position on a work area. The probe is used to touch different spots on the part being measured. The machine then uses the X,Y,Z coordinates of each of these points to determine size and position. The software makes the setup of qualifying probes and aligning parts easy. And once the program for your part is created, setting up and running an accurate quality analysis is a matter of a few keystrokes on the computer.
Our quality assurance is integrated into all processes that guarantee the final product you receive is built to your specifications. Products are made here at HTI Plastics by continuously monitoring the manufacturing and assembly process from beginning to end, using documented First Article Inspection, In Process and Final Inspection Procedures. Our modern injection molding machines are configured to your project's specifications and monitored to maximize quality and efficiency. The result is a process that is reliable and repeatable. We institute these rigorous standards for the pharmaceutical industry and all industries that we serve.
A First Article Inspection (FAI) establishes accountability that your products have been manufactured to your specifications. Every critical design characteristic called out on the part drawing is verified and recorded. We perform FAIs for all new part orders, and we can also provide FAI data after any process change when required. Providing this valuable service earns a higher level of trust from our customers and strengthens our relationships with them.
