Clean molded parts

Custom clean injection molding for pharma and life science applications

Compatibility: Universal
Customization level: Customized

Clean molded parts at a glance

Clean molded parts tailored to your needs

Future-ready

Flexible adaptation to evolving biotech innovation needs
Sterility by design

Each part is molded in ISO 5 or ISO 7 cleanroom conditions, ensuring low bioburden and readiness for sterilization
Scalable production

Seamless scale-up from early-stage prototyping to large-scale manufacturing
Regulatory compliance

Production and documentation aligned with GMP and ISO standards
Process engineering

Expertise in material selection, mold design, and manufacturing processes
End-to-end management

Complete in-house control from mold design and validation to production, assembly, packaging, and documentation
Full traceability

Integrated processes ensure transparency, reproducibility, and regulatory readiness
Experienced partner

Extensive expertise in cleanroom injection molding for pharmaceutical and biotech applications

Application

Diverse application range

For medical devices

Custom-molded components for diagnostic and therapeutic devices, designed to meet strict biocompatibility and dimensional accuracy requirements.
For pharmaceutical packaging

Injection-molded parts engineered for aseptic packaging solutions, ensuring product integrity and compatibility with sterilization processes. Suitable for primary and secondary packaging in GMP environments.
For microfluidic

Precision-molded microstructures enable controlled fluid handling for analytical, diagnostic, or research applications. Designed for high accuracy, optical clarity, and reliable performance in complex micro-scale systems.

Process

How it works

1

Requirement definition

The process begins with a technical discussion to define your product’s functional, material, and regulatory requirements. Early collaboration ensures feasibility and alignment with your manufacturing and sterilization needs.
2

Design and prototyping

Our engineering team develops a custom design using 3D modeling and rapid prototyping. Prototypes are tested for performance, material compatibility, and cleanroom suitability before the mold design is finalized.
3

Numerical simulation

Mold flow and thermal simulations are performed to predict material behavior, optimize part geometry, and prevent potential molding or performance issues before production.
4

Mold design and validation

Molds are designed and validated in-house to ensure precision, durability, and reproducibility. Dimensional accuracy and surface quality are verified under controlled conditions.
5

Clean injection molding

Parts are produced in ISO 7 and ISO 5 cleanrooms using medical-grade polymers. Strict process control ensures consistent quality and contamination-free manufacturing of product-contacting components.
6

Assembly and finishing

Post-molding operations such as assembly, trimming, or welding are performed in clean environments. Each step follows documented procedures to maintain sterility assurance and traceability.
7

Packaging and release

Final parts are clean-packaged and ready for sterilization or direct integration into manufacturing processes. Every batch undergoes quality control, documentation review, and qualified person (QP) release.

Product highlights

Transforming your requirements into solutions

Sterility assurance

Every component is manufactured in controlled cleanroom environments – ISO 7 or ISO 5 – to ensure contamination-free production. From material handling to demolding, each step is managed to maintain a low bioburden. Parts are supplied clean and sterilized.
Scalability and compliance

Our injection molding capabilities cover the entire product lifecycle, from early-stage prototyping to large-scale commercial manufacturing. Processes and documentation are designed in accordance with GMP and ISO standards, ensuring consistency, reproducibility, and seamless scale-up as product volumes increase or regulations evolve.
End-to-end management

We manage all critical stages internally – from mold design and validation to supplier and material selection, production, assembly, packaging, and documentation. This integrated approach guarantees full traceability, process integrity, and regulatory readiness, giving our partners reliable oversight across the entire manufacturing chain.

Technical specifications

Process

In-house parts and mold design, manufacturing, and validation
Design optimization

Via numerical simulation

Used equipment

High-precision molding using electrical injection machines under ISO 7 laminar flows
Production volume

Flexibility, from prototypes to large-scale runs
Cleanroom finishing

Washing, inspection, and packaging in ISO 7- or ISO 5-certified cleanrooms
Supply chain

Strong supplier network

Qualification and validation

Metrology laboratory for mold qualifications (IQ/OQ/PQ) and parts validation
Certification

ISO 15378

FAQs

All parts are produced in ISO 7 or ISO 5 cleanroom environments, ensuring strict contamination control and low bioburden levels. The process is designed for sterility assurance, with components delivered clean and ready for sterilization or direct integration into aseptic manufacturing systems.
Yes. Our facilities are equipped to handle all stages – from rapid prototyping and pilot runs to industrial-scale production. This scalability ensures consistent quality and regulatory compliance while enabling efficient transitions from development to commercial manufacturing.
All operations, including mold design, validation, production, and packaging, are performed in-house. This end-to-end control provides complete traceability, consistent quality, and documentation aligned with GMP, ISO, and regulatory requirements for pharmaceutical and biotech applications.