Injection Molding Machines for Cleanrooms – ISO 14644 and ISO 13485 2025

Introduction to Cleanroom Injection Molding Machines

Growing demand for disposable medical devices, premium cosmetics, and medical electronics is driving more manufacturers to install injection molding machines in cleanrooms. These environments control particle counts, microclimate parameters, and full quality traceability compliant with ISO 13485 and GMP. Any deviation can result in batch rejection, so planning a cleanroom cell requires exceptional care.

This article explains how to select injection molding machines, molds, and automation for ISO 7–ISO 5 zones. We cover the history of technology development, drive configurations, key parameters, and validation requirements. This guide helps project teams streamline commissioning and maintain audit compliance.

Cleanroom operation transforms the entire production workflow: from raw material intake and mold preparation to final packaging. Materials pass through airlocks, operators work in cleanroom suits, and every entry and exit is logged. That's why a cleanroom injection molding machine is more than just equipment—it's an integral part of the quality chain that enforces procedural discipline.

Companies that consistently implement cleanroom projects gain access to new markets: they can bid on medical tenders, supply premium cosmetic brands, and deliver components for FDA-certified devices. The high entry barrier protects margins but demands deep standards knowledge and staff training investments.

What is a Cleanroom Injection Molding Machine?

A cleanroom injection molding machine is an injection molding machine modified for controlled atmospheres. It features mold area enclosures with laminar flow shields, sealed hydraulic systems, and lubricants approved for medical product contact. The machine integrates with HVAC systems, particle monitoring, and data logging compliant with FDA 21 CFR Part 11.

The injection process is fundamentally the same as standard operations, but every step must be documented and validated via IQ/OQ/PQ. The injection molding machine sends process data to MES/MOM systems, which assign serial numbers to each part and link them to material batches, machine settings, and visual inspection results.

Operator zones are separated from the machine's technical areas. Outside the cleanroom are hydraulic power units, power supplies, and material feeders. Sealed pass-throughs run through the wall, keeping the interior free of unnecessary components. This simplifies cleanliness maintenance and shortens disinfection times.

Cleanroom injection molding machines also feature advanced software functions: bioburden counters, GMP event logging, electronic signatures, and parameter locks. Operators log in via RFID cards, and every setting change requires authorization and a reason entered in the HMI. The system automatically generates reports for auditors.

History of Cleanroom Injection Molding Development

Cleanroom injection molding began in the 1980s when syringe manufacturers started dedicating high-cleanliness zones. These were mainly modified hydraulic injection molding machines that generated significant heat and contamination. The breakthrough came in the 2000s with the widespread adoption of all-electric injection molding machines, which naturally reduce oileaks and provide quiet operation.

The next phase involved IT system integration. With the MDR regulation and updated ISO 13485:2016 standards, manufacturers had to ensure full traceability and process validation. Modern cleanroom cells integrate the injection molding machine, robots, optical inspection, and packaging in a single stream, minimizing manual interventions.

The last decade has been the era of digitalization and advanced automation. Processors deploy digital twins of cleanrooms to simulate airflow and analyze equipment impact on cleanliness. Injection molding machines generate massive data volumes fed into data warehouses and analyzed by AI algorithms. This simplifies audits and enables predictive downtime decisions rather than ad hoc reactions.

Types of Injection Molding Machines for Cleanrooms

Cleanrooms primarily use three machine types: all-electric, hydraulic with closed circuits, and hybrid. All-electric injection molding machines dominate in ISO 7 and cleaner classes, where cleanliness and precision matter most. Hydraulic machines are still used for high clamping forces (e.g., medical bag blow molding) but require extra enclosures, filtration, and leak monitoring. Hybrids combine the best of both—high injection dynamics and energy efficiency.

Selection depends on part size, quality requirements, and budget. Automation compatibility is also key, including pick-and-place robots, vision systems, and integrated antiseptic bag packaging.

The market now offers two-platen injection molding machines in cleanroom versions, which fit compactly into limited spaces due to their design. For micro-molding, benchtop machines mount directly on medical device assembly lines. Every solution requires careful consideration of service access, as dirty repairs are not allowed in cleanrooms.

External drive unit mounting is another key criterion. Hybrid injection molding machines allow relocating pumps and oil reservoirs outside the clean zone, simplifying maintenance and reducing heat emissions. All-electric machines offer the best energy efficiency and low noise but demand high-quality power supplies and proper control cabinet cooling.

Class II/III Medical Devices

Producing implants, infusion pump components, or in vitro kits requires all-electric injection molding machines with 50–220 tons of clamping force. Molds feature pressure and temperature sensors, and cavities often run multi-cavity (32–64 cavities). Injection molding machines must maintain shot volume and screw speed repeatability to meet tolerances of ±0,01 mm.

Advantages include integration with liquid silicone (LSR) dosing systems or metal component overmolding. Cleanrooms host six-axis robots for filter installation, with all data feeding into eDHR (electronic Device History Record) systems.

Medical devices also demand strict material control. Pellets enter the cleanroom in sterile bags, dry in enclosed dryers, and convey via vacuum. The system monitors material air exposure time and temperature to prevent degradation. The injection molding machine automatically blocks batch starts if material conditions are not met.

Premium Cosmetics and Personal Care

Prestige cosmetic brands demand high gloss, no streaks, and sterile packaging. Injection molding machines with 150–300 tons produce pump closures, airless inserts, and decorative elements. Maintaining ISO 7–8 cleanliness while achieving throughput of tens of thousands of parts per hour is critical.

Cells feature IML (In-Mold Labeling) robots and gasket assembly stations. Vision systems 100% check gloss and color. Data aggregates into reports for cosmetic brands requiring full supply chain transparency.

Personalization is key in beauty. Cleanroom packaging stations are modular—the injection molding machine passes mold number and batch data to printers applying unique codes to packaging. MES systems integrate e-commerce orders for short runs and fast marketing campaigns.

Diagnostics and Medical Electronics

Facilities producing diagnostic cassettes, microfluidics, or sensor housings mainly use all-electric injection molding machines with 80–180 tons. Molds have conformal cooling channels, and injection occurs in ISO 6–7 zones. ESD control and electromagnetic shielding are essential, so cells include coating stations and resistance measurement.

Inline inkjet printers apply 2D codes to every part. MES systems monitor cleanroom temperature, humidity, and pressure, while the injection molding machine automatically adjusts parameters to ambient conditions for process stability.

For microfluidics, microchannel cleanliness is critical. Ionized air blasts and special robot grippers avoid functional surfaces. Mold flow sensor data archives with injection molding machine logs for full traceability.

Cleanroom Cell Construction and Key Components

A typical cell includes an injection molding machine, cleanroom enclosure (negative or positive pressure), robots, overhead conveyors, and packaging stations. The entire setup is in a cleanroom, but often only the mold area is ISO 6, with other equipment in ISO 8 to optimize investment costs.

Key elements include H14 HEPA filters, particle monitoring, differential pressure sensors, and integrated alarms. All material, hydraulic, and electricalines run under raised floors or in sealed ducts for easier disinfection.

Cleanroom cells also feature material and personnel airlocks. Material passes through UV-lit tunnels, operators go through washing and gowning zones. Each zone has terminals for GMP task confirmation. The flow layout ensures raw materials and finished products never cross.

Injection Unit in Cleanrooms

The injection unit is the heart of the system. Cleanroom versions use stainless steel enclosures, FDA seals, and servo drives minimizing particle emissions. Heating zones are insulated to avoid heating room air. A vapor extraction system removes volatiles from materials (e.g., PA12).

CIP (Cleaning in Place) capability is essential. Hopper sections, plastification zones, and nozzles must be easy to disassemble and disinfect. The injection molding machine tracks cycles since last cleaning and alerts operators for hygiene procedures.

The injection unit can include sensors monitoring air cleanliness near the mold area. If particle counts exceed limits, the controller stops the cycle, and HVAC ramps up airflow. This feedback loop is vital to minimize nonconforming parts.

Environment, HVAC, and Automation

The HVAC system maintains overpressure (10–20 Pa), temperature 20–22 °C and humidity 40–60%. Laminar airflow is directed vertically onto the mold area. Integration with the injection molding machine involves alarm synchronization – if the HEPA filter reaches end of life, the machine stops production. Additionally, hygienic operator panels are installed, which can be disinfected with alcohol.

Cell automation includes parts removal robots, conveyors to packaging stations, 2D/3D vision systems, and laser marking modules. All devices communicate via Ethernet/IP or Profinet with the master SCADA system. Environmental sensor data is archived to meet audit requirements.

AGV/AMR systems are increasingly used to deliver materials and remove finished products without disrupting airflow. Vehicle routes are designed to bypass the laminar flow zone. In the event of a cleanliness alarm, AGVs stop automatically, and injection molding machines switch to safe mode.

Key Technical Parameters

1. Cleanliness Class (ISO)

Defines the number of particles per unit volume. Typical classes for injection molding are ISO 7 for cosmetics, ISO 6 for diagnostics, and ISO 5 for critical medical devices. The injection molding machine and automation must maintain cleanliness even when the mold is open.

2. Clamping Force (t)

Selected as in standard processes, but accounting for additional enclosures and limited space. Two-platen machines are often chosen to save cleanroom floor space.

3. Particle Emission (particles/m³)

Manufacturers provide results from ISO 14644-14 tests. For cleanroom injection molding machines, emissions near the mold must be minimal. Specialow-particle materials and air filters are used.

4. Temperature and Humidity

The HVAC system must maintain stability of ±1 °C and ±5% RH. The injection molding machine should compensate for changes affecting material shrinkage and viscosity (e.g., via adaptive reciprocating screw control).

5. Noise Level (dB)

In cleanrooms, levels below 70 dB are preferred to minimize turbulence and improve operator comfort. All-electric injection molding machines naturally meet these requirements.

6. Energy Consumption (kWh)

Energy use should be monitored, as cleanrooms have high operating costs. Energy meter data helps optimize production schedules and identify losses.

7. Traceability

The MES system assigns each part a batch number, injection parameters, visual test results, and environmental data. Only this complete data package meets ISO 13485 and FDA requirements.

8. Particle Monitoring (particles/m³)

Particle sensors are positioned at air inlets, above the mold, and in the packaging area. The injection molding machine uses this data to adjust settings and halt the process if limits are exceeded.

9. IQ/OQ/PQ Validations

Any mold or recipe change requires re-risk assessment. Documentation must reference machine serial numbers and test results, with data signed electronically.

Cleanroom Applications

Disposable Medical Devices

Syringes, infusion sets, catheter components – require production in ISO 7 and packaging in controlled atmospheres. Injection molding machines work with robots for sterile pouch packaging.

Microfluidics and Diagnostics

PCR test cartridges, lab-on-a-chip devices, sensor housings. Micro-tolerances and no cross-contamination are critical.

Durable Medical Equipment

Insulin pump components, ventilator housings, patient monitor parts. Chemical resistance and long-term documentation are required.

Cosmetics and Personal Care

Airless closures, applicators, and fragrance cartridges. Cleanliness enables "sterile ready" claims and extends product shelf life.

Medical Electronics

Sensor housings, wearables components, implant covers. ESD control and low humidity are required.

Pharma and Biotechnology

Vial stoppers, single-use bioreactor components, and dispenser parts are molded in cleanrooms. Injection molding machines must integrate with CIP/SIP systems and meet USP Class VI guidelines.

How to Select an Injection Molding Machine for Cleanrooms?

1. Regulatory Requirements Analysis

• Specify ISO classes, GMP, and industry standards (FDA, MDR).
• Define IQ/OQ/PQ validation scope and documentation requirements.
• Verify compliance with 21 CFR Part 11 and eDHR systems.

2. Technical Specification

• Select drive type (all-electric, hybrid, or servo-hydraulic).
• Specify required clamping force, shot volume, and platen size.
• Allow space for automation, packaging, and storage.

3. Cleanroom Integration

• Ensure compatibility with HVAC and BMS.
• Account for media pass-throughs, disinfection, and part entry/exit procedures.
• Enable CIP/SIP cleaning without disassembly.

4. Automation and Quality Control

• Robots for part removal and packaging, vision systems, leak testing.
• Integration with eDHR systems and electronic signatures.
• Scalability for AI/ML trend analysis.

5. Service Partner

• Experience with ISO 13485 audits and validations.
• 24/7 support and stock of critical spares.
• Operator training on cleanliness procedures and documentation.

6. Business Continuity Strategy

• Plan for mold and injection molding machine relocation in case of cleanroom failure.
• Stock spare HEPA filters, seals, and consumables.
• Procedures for rapid re-validation after production downtime.

Maintenance and Validations

Cleanroom cell maintenance covers both technical and documentation aspects. Injection molding machines undergo regular calibrations, alarm tests, and re-qualification validations. Procedures cover cleaning, HEPA filter changes, smoke tests, and particle measurements.

IQ/OQ/PQ systems require documentation of every step: from installation (IQ), operational parameter tests (OQ), to production confirmation (PQ). Tederic recommends electronic protocols that automatically pull data from the injection molding machine to reduce manual errors.

An effective maintenance program also includes microbiological monitoring. Injection molding machine surfaces are swabbed at regular intervals, with results fed into the quality system. Exceedances trigger immediate corrective actions and FMEA risk analysis updates.

Implement a CMMS with cleanroom module to remind about filter inspections, pressure sensor calibrations, and laminar flow hood sleeve changes. All work orders are linked to equipment reference numbers, simplifying audits and CAPA reports.

Summary

Injection molding machines operating in cleanrooms are the foundation of modern medical and cosmetics production. Success requires compliance with ISO 14644 and ISO 13485, well-designed automation, and consistent maintenance. Selecting the right injection molding machine, mold, and monitoring systems meets the strictest audit demands, while Tederic support speeds up and secures implementation.

Investing in such cells builds a long-term competitive edge. Companies can launch new product lines, respond to health crises, and ensure supply chain security for global brands. The key is a partner who understands both injection molding technology and medical regulations – that's why Tederic expertise is invaluable at every project stage.