Glossary Term
Aseptic Processing
Definition
Aseptic Processing refers to a manufacturing technique in which sterile products are assembled and packaged in a sterile environment to prevent contamination by microorganisms. It is commonly used for medical devices, pharmaceuticals, and biologics that must remain free of pathogens to ensure patient safety.
Relevance to the MedTech Industry
Aseptic Processing is critical for ensuring the sterility and safety of medical devices and drugs, particularly those that come into direct contact with internal body tissues or sterile environments. It supports compliance with regulatory standards and prevents infection-related complications, ensuring the integrity of products from production to patient use.
Additional Information & Related Terms
Sterility Assurance Level (SAL) Ensures a product meets defined sterility standards through aseptic processing.
ISO 13485 Specifies quality management systems for sterile device manufacturing.
Cleanroom Classification Defines environmental controls critical for aseptic processing.
Packaging Validation Confirms that sterile packaging systems maintain sterility throughout the product’s lifecycle.