When a major pharmaceutical company had 500,000 sterile blister packs recalled last year due to non-compliant sealing, the $2.3M loss could have been prevented with one thorough pre-production review. For medical device and drug manufacturers, FDA approval isn't just paperwork—it's a critical safeguard. Use this actionable checklist to ensure your medical-grade blister packaging meets every requirement.  

1. Material Compliance: Start with the Basics

- USP Class VI certification for plastics contacting drugs (essential for PVC-free blister foils)  

- 21 CFR 177.1630 approval for PETG/PVC in direct food/drug contact  

- Documented resin history proving no recycled content in primary blister packaging 

Red Flag: Using non-approved colorants that migrate into drug products  

2. Critical Seal Integrity Tests 

Your blister sealing films must pass:  

- ASTM D3078 bubble leak testing (≤0.5mL/min leakage rate)  

-ISO 11607 validation for sterile barrier systems  

- Peel strength verification (minimum 1N/15mm for child-resistant blisters)  

3. Labeling Pitfalls That Trigger Rejections

- Missing "Rx Only" markings on prescription drug blisters  

- Incorrect NDC number formatting (must match FDA database)  

- Non-compliant Braille requirements for Schedule II-V drugs  

Pro Tip: RFID-enabled blister cards help automate tracking compliance  

4. Stability & Aging Validation 

- 40°C/75% RH accelerated aging tests for 90-day equivalent  

- Photostability reports if using clear blister packaging for light-sensitive drugs  

- Extractables/leachables data for novel high-barrier blister materials  

5. Submission-Ready Documentation

Ensure your blister packaging manufacturer provides:  

- DMF Type III references for materials  

- Process validation reports (IQ/OQ/PQ)  

- Full migration study results  

Non-compliance costs more than just FDA rejection—it erodes patient trust. Partner with ISO 13485-certified blister suppliers who speak FDA's language fluently.