What Is MDI Filling and Why Is It Critical in Pharmaceutical Manufacturing?

MDI (Metered Dose Inhaler) filling refers to the precision-controlled process of filling pressurized inhaler containers with exact doses of active pharmaceutical ingredients and propellant gases. This technology is widely used in the production of asthma and respiratory treatment products.

In the pharmaceutical industry, especially in respiratory care, MDI devices must deliver consistent, metered doses for both safety and regulatory compliance. Therefore, the MDI filling process is subject to stringent validation, sterile handling, and high-precision requirements.

How Does the MDI Filling Process Work?

The MDI filling process consists of several tightly controlled steps that ensure accurate dosing, sterility, and pressure balance:

1. Can preparation and purging: Containers are cleaned and purged of air.

2. Valve insertion: Metering valves are precisely crimped onto the canister.

3. Filling with API and propellant: Liquids are injected under pressure using cold or pressure-fill technology.

4. Crimping and sealing: Ensures no leakage and maintains pressure integrity.

5. Leak and weight testing: Each unit is checked for fill volume, pressure, and container integrity.

Sora Machine’s MDI filling systems are fully automated and compatible with pharmaceutical-grade cleanroom standards.

What Makes MDI Filling Systems Unique Compared to Other Liquid Filling Machines?

While traditional liquid filling systems focus on volume-based filling, MDI systems are specifically engineered to handle:

• Highly volatile and pressurized gases (HFA, CFC-free propellants)

• Precise micro-dosing of active ingredients

• Sterile and particle-free filling environments

• Pharmaceutical validation and documentation requirements (GMP)

MDI filling machines must maintain ±1% or better dose accuracy and meet all requirements set by health authorities such as the FDA or EMA.

What Are the Key Features of Sora Machine’s MDI Filling Systems?

Sora Machine’s MDI filling systems are designed to meet the demanding specifications of pharmaceutical production. Core features include:

• Precision filling heads for accurate API and propellant dosing

• Crimping and valve insertion units with micron-level accuracy

• Integrated leak testers to ensure container integrity

• Modular design for easy scalability and maintenance

• Full compliance with cGMP and 21 CFR Part 11 standards

• Data logging and electronic batch recording capabilities

The systems are suitable for both clinical batch production and full-scale commercial manufacturing.

How Is Product Safety Ensured During MDI Filling?

Safety and sterility are central to the MDI filling process. Sora Machine integrates multiple safety layers into its solutions:

• HEPA-filtered enclosures to maintain cleanroom conditions

• Explosion-proof construction for safe handling of propellants

• Automatic rejection units for weight, seal, and leakage control

• Fail-safe mechanisms for pressure surges and mechanical misalignments

• User access control and audit trails for traceability

Additionally, all components that come into contact with the product are made of FDA-approved materials and are fully cleanable or autoclavable.

What Are the Advantages of Using Automated MDI Filling Lines?

Automated MDI filling lines increase efficiency, reduce operator error, and ensure regulatory compliance. Some specific benefits include:

• Higher throughput with consistent quality

• Reduced risk of contamination and dosage variation

• Automated data capture and electronic documentation

• Cost-effective production for both small and large batches

• Real-time monitoring and remote access

Automation also ensures long-term scalability, enabling manufacturers to adapt quickly to market demands and regulatory changes.

What Should Be Considered When Choosing an MDI Filling Machine?

When selecting an MDI filling solution, the following criteria are crucial:

• Dosage precision range: µL to mL-level accuracy

• Production capacity: Batches per hour / units per minute

• Cleanroom compatibility: ISO Class 5 or better?

• Propellant compatibility: HFA-134a, HFA-227, others?

• Regulatory compliance: cGMP, FDA, EU Annex 1

• Integration options: With leak testers, checkweighers, and serialization systems

Sora Machine provides both turnkey and customized MDI solutions depending on production scale and regulatory needs.

How Does Sora Machine Support MDI Manufacturers After Installation?

Beyond machine delivery, Sora Machine offers extensive technical support and lifecycle services for MDI systems:

• Installation and commissioning with IQ/OQ documentation

• Training of technical and production staff

• Preventive maintenance and calibration services

• Remote troubleshooting and software updates

• Spare parts availability and validation support

This long-term support ensures system uptime, regulatory compliance, and production efficiency for pharmaceutical clients.