ASTM F2394: Particulate Testing for Medical Devices Essentials Training by Tonex
Designed for quality, regulatory, and manufacturing teams, this course demystifies ASTM F2394 and shows how particulate characterization underpins safe, compliant medical devices. Participants learn how to plan statistically sound studies, select media and extraction conditions, and interpret particle size, count, and morphology data for risk decisions.
Because particle data now flows from networked counters, microscopes, and LIMS, the course highlights cybersecurity implications—protecting data integrity, audit trails, and access controls. You will see how secure-by-design practices reduce tampering risk, safeguard electronic records, and maintain chain of custody. The result is trustworthy evidence that stands up to regulators and customers.
Learning Objectives
- Explain the scope and intent of ASTM F2394 for medical devices
- Select suitable extraction media, conditions, and test assemblies
- Apply particle counting and sizing principles to real samples
- Build defensible sampling plans and acceptance criteria
- Use particulate results to drive risk-based decisions and CAPA
- Strengthen data integrity and cybersecurity controls across instrument, LIMS, and reports
Audience
- Quality Assurance and QC Engineers
- Regulatory Affairs Specialists
- Manufacturing and Process Engineers
- R&D and Product Development Scientists
- Test Laboratory Managers and Technicians
- Cybersecurity Professionals
Course Modules
Module 1 – Standard Fundamentals
- Scope and terminology
- Device categories and risk
- Cleanliness limits rationale
- Extraction principles overview
- Validation and verification
- Documentation expectations
Module 2 – Test Methods
- Dry vs wet extraction
- Agitation and sonication use
- Filters and membranes selection
- Particle counting workflows
- Microscopy confirmation steps
- Avoiding method bias
Module 3 – Instrumentation Basics
- Liquid particle counters
- Optical and SEM imaging
- Weighing and gravimetry
- Calibration and traceability
- Environmental controls
- Maintenance scheduling
Module 4 – Data Integrity
- Sampling plan design
- Statistical confidence basics
- Control charts application
- LIMS configuration essentials
- ALCOA plus principles
- Secure audit trails
Module 5 – Risk and Compliance
- Linking to ISO 13485
- Interface with ISO 10993
- GMP and 21 CFR Part 11
- Nonconformance handling
- CAPA trigger criteria
- Supplier quality controls
Module 6 – Process Control
- Cleanroom practices alignment
- Packaging particulate control
- Assembly handling rules
- In-process checkpoints
- Trend analysis reviews
- Continuous improvement
Ready to elevate particulate testing from a checkbox to a competitive advantage? Enroll in ASTM F2394 Essentials by Tonex to master practical methods, protect data integrity and cybersecurity, and deliver devices that meet regulatory expectations with confidence.