Advancing non-destructive analysis of 3D printed medicines

Area of Science:

• Pharmaceutical manufacturing
• Additive manufacturing
• Quality control

Background:

• Pharmaceutical 3D printing (3DP) enables personalized medicine production.
• Existing quality control (QC) for large-scale manufacturing conflicts with 3DP's on-demand capabilities.
• Regulatory bodies like the FDA and MHRA are addressing 3DP for point-of-care (PoC) manufacturing.

Purpose of the Study:

• To review recent advancements in non-destructive analytical techniques for pharmaceutical 3DP.
• To propose quality control systems compatible with pharmaceutical 3DP workflows.
• To discuss challenges in integrating analytical tools into 3DP.

Main Methods:

• Literature review focusing on non-destructive analysis for pharmaceutical 3DP.
• Analysis of current regulatory documents from FDA and MHRA.
• Synthesis of research on process analytical technology (PAT) and non-destructive tools.

Main Results:

• Growing recognition of process analytical technology (PAT) and non-destructive tools for pharmaceutical 3DP.
• Identification of regulatory pathways and challenges for PoC manufacturing.
• Emerging non-destructive analytical methods suitable for 3DP.

Conclusions:

• Non-destructive analysis and PAT are crucial for pharmaceutical 3DP quality control.
• Plausible QC systems can be developed to complement 3DP workflows.
• Integration of analytical tools into 3DP remains a key challenge.