Capabilities · Capability 04
Medical Plastic Injection Molding
20+ years
Experience serving medical applications
ISO 13485
Certified quality management system
Laminar flow
ISO Class 7
Dedicated laminar-flow molding environment
Cleanroom
Assembly, bonding and packaging operations
150 T
Dedicated hybrid molding machine with 3-axis robot
10 years
Production data retention
Our ISO 13485 Environment
ISO 13485 certified, PPI has been supporting medical device and healthcare product manufacturers for more than 20 years, producing plastic components that meet demanding requirements for quality, traceability and process control. Our Orléat facility includes a dedicated injection molding machine operating under an ISO Class 7 laminar-flow environment, together with a cleanroom for assembly, bonding, ultrasonic welding and packaging operations. These capabilities enable us to tailor the manufacturing environment to the specific requirements of each medical application.
Medical Manufacturing Expertise
More Than Injection Molding
Medical manufacturing requirements extend well beyond the injection molding process itself.
Medical device manufacturers must demonstrate control over their manufacturing processes, maintain material traceability and ensure product conformity throughout the production lifecycle.
With experience in the medical sector and an ISO 13485-certified quality management system, PPI incorporates these requirements into all of its manufacturing processes and customer projects.
This gives our customers access to a manufacturing partner already familiar with the quality, traceability and process-control expectations of the medical industry.
Quality Management System
ISO 13485-Certified Quality Management System
PPI is ISO 13485 certified.
This certification demonstrates the implementation of a quality management system specifically structured around the requirements associated with medical device manufacturing and medical components.
Medical tooling is stored in a dedicated, temperature-controlled area separate from the production floor and protected by fire-rated compartmentation. This dedicated environment helps protect molds over time and supports reliable tooling management throughout the life of the production program. Our quality system is regularly audited to maintain the level of control expected for medical manufacturing projects. For our customers, working within an established ISO 13485 framework helps streamline project development and reduce manufacturing and qualification risks.
Key Elements of Our Medical Quality System
Controlled Manufacturing Environments
Production Capabilities Matched to Application Requirements
Laminar flowISO Class 7
Dedicated Injection Molding Under ISO Class 7 Laminar Flow
For applications requiring enhanced particulate control, PPI operates a dedicated injection molding machine within an ISO Class 7 laminar-flow environment.
Controlled airflow and air renewal help minimize airborne particles within the production area.
This is not a sterile environment. It is a controlled manufacturing area designed to meet the particulate cleanliness requirements associated with selected medical and healthcare applications.
Our dedicated 150-metric-ton horizontal hybrid injection molding machine is equipped with a 3-axis robot, automating part handling while minimizing unnecessary manual intervention.
Qualifiedmedical molding
Not Every Medical Application Requires Laminar-Flow Production
Depending on the product, its intended use and defined manufacturing requirements, medical components can also be produced on other qualified injection molding machines within our production facility. This flexibility enables PPI to select the most appropriate manufacturing environment for each application while maintaining process control, production repeatability and part conformity.
Process Qualification
Qualified Processes for Consistent, Repeatable Production
In medical manufacturing, producing one conforming part is not enough. The manufacturing process must demonstrate its ability to deliver consistent results over time.
This is why our production equipment and processes undergo defined qualification activities.
These qualifications assess
Testing under different production conditions helps verify process robustness and supports reliable manufacturing over time.
This approach reduces production risk and helps secure our customers’ medical projects.
ERP
Automated batch tracking
10 years
of data archiving
Scope of Tracing
Raw materials • Process parameters • Product batches • Retained samples
Traceability
End-to-End Material and Production Batch Traceability
Traceability is a fundamental requirement in medical manufacturing.
Our quality management system, supported by our ERP, provides automated tracking and traceability of raw materials, manufacturing parameters and production lots throughout the manufacturing process. Each production stage is documented to enable information to be retrieved whenever required. Production data is retained for 10 years in accordance with the requirements applicable to the projects concerned. Representative samples can also be retained to support production history and follow-up.
From Component to Finished Product
Beyond Medical Component Manufacturing
Material Selection
Material Selection for Medical Injection Molding
Material selection is a critical step in the development of a medical component or healthcare product.
Our teams support customers in identifying materials suited to their application while considering relevant medical-sector requirements.
Key selection criteria may include:
Selection Criteria
Medical Components & Applications
Plastic Components for Medical and Healthcare Applications
Our manufacturing capabilities support a range of plastic components for medical and healthcare applications. Each project is reviewed individually to ensure that product requirements are aligned with the selected manufacturing process and production environment. Our experience includes projects involving:
Measurement Equipment
Medical & Healthcare Products
Packaged Products Ready for Distribution (blister packaging, individual pouches and application-specific packaging)
High-Value Technical Components
Cleanroom Assembly & Packaging
From Molded Component to Packaged Product
Beyond plastic component manufacturing, PPI can perform assembly, bonding, ultrasonic welding and packaging operations. Depending on project requirements, our capabilities include blister packaging, individual bagging, application-specific packaging, sales-unit preparation and preparation prior to sterilization. This enables us to deliver components or assembled products ready to enter the customer’s downstream logistics, sterilization or distribution process.
Why PPI
Why Choose PPI for Your Medical Injection Molding Program?
Our Other Capabilities
More PPI Capabilities
Frequently Asked Questions About Medical Injection Molding
FAQ
What is medical plastic injection molding?
Medical plastic injection molding is the manufacture of plastic components for medical and healthcare applications under enhanced requirements for quality, traceability and process control.
What does ISO 13485 certification mean?
ISO 13485 certification confirms that PPI operates a quality management system specifically structured around requirements applicable to medical device manufacturing and related components. For customers, this provides an established quality framework for managing medical manufacturing projects.
Is your production environment sterile?
No. Our dedicated medical injection molding machine operates under an ISO Class 7 laminar-flow environment designed to limit particulate contamination in the production area. It is a controlled environment, not a sterile manufacturing environment.
What operations can you perform in your cleanroom?
Our cleanroom capabilities include assembly, bonding, ultrasonic welding and packaging operations.
How do you ensure production traceability?
Our quality management system and ERP track raw materials, process parameters and manufactured lots throughout production. Production data is retained for 10 years, providing long-term access to the manufacturing history associated with each project.
Why work with an ISO 13485-certified injection molding supplier?
Working with an injection molding partner that already operates within an ISO 13485-certified quality framework can help reduce project risk and streamline the development and industrialization of medical components. It also means that requirements related to process control, documentation and traceability are already integrated into the supplier’s quality management system.
PPI
Let’s Discuss Your Project
Developing a Plastic Component?
Our team can support you from design through industrialization.
Your contact
Céline JEANNIN
Sales Manager