What are MDI Filling Machines and What is Their Purpose?
MDI (Metered Dose Inhaler) filling machines are devices used in the treatment of respiratory diseases such as asthma, COPD, and similar conditions, designed to deliver specific doses of medication. The production of these devices is a process that requires high precision within a pharma filling system infrastructure. Sora Machine enhances production processes in this field, making them more efficient and safer with its MDI filling machine and MDI filling system solutions.
What Stages Does a Pharma Filling System Include?
In addition to the filling of liquid medications, a pharma filling system also integrates crucial steps such as gas filling, valve insertion, crimping, and leak testing. Sora Machine automates all these stages, increasing production capacity and minimizing human error. MDI filling system solutions ensure that every stage is controlled with precision.
How is Precise Dosage Achieved with an MDI Filling Machine?
MDI filling machines are capable of precisely filling liquids and gases. Each device must dispense the correct amount of medication and propellant gas. Sora Machine’s MDI filling machines are equipped with servo motors that provide dosage accuracy at the microliter level. This ensures accurate dosage with every use.
How Does a Pharma Filling Machine Work and Why is it Important?
Pharma filling machines operate in compliance with the high reliability and hygiene requirements of pharmaceutical production processes. In MDI production, every stage is automatically controlled to ensure accurate liquid and gas filling. Sora Machine’s pharma filling system solutions guarantee quality by performing liquid and gas filling under full control.
How is an MDI Filling System Automated?
An MDI filling system integrates multi-step processes in the production line such as liquid filling, gas filling, crimping, leak testing, and labeling. This automation makes production lines more efficient and guarantees that each product fully complies with quality requirements.
Why are Crimping and Leak Testing Important in MDI Filling Machines?
Crimping is a critical step for MDI filling machines. Errors in this process can lead to the device leaking air or the valve being loose. Sora Machine uses servo motors for the crimping process, ensuring consistent crimping. Simultaneously, each product within the pharma filling system undergoes a leak test at vacuum test stations.
How is Propellant Gas Filling Done in MDI Filling Systems?
Propellant gases used in MDI filling machines are sensitive components that must be filled correctly. Environmentally friendly gases like HFA-134a and HFA-227 are filled in closed systems with Sora Machine’s MDI filling system solutions. During this process, pressure and temperature are continuously monitored, and safety measures are implemented.
Ensuring GMP and FDA Compliance in Pharma Filling Systems and MDI Production
Sora Machine designs all its pharma filling machine and MDI filling system solutions to be compliant with GMP and FDA standards. The stainless steel contact surfaces used in these systems and the 21 CFR Part 11 compliant software infrastructure guarantee quality and traceability. This prevents any quality issues from arising during the production process.
How is Validation Performed on the Production Line with an MDI Filling Machine?
MDI filling machine solutions also include the validation process for each product. All machines undergo IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) tests and are delivered in accordance with industry standards. Sora Machine applies a meticulous production and inspection process to ensure these validations.
