Inside Our Cleanroom: How ISO Class 7 Ensures Sterile Blister Packaging

When a single dust particle can compromise an entire batch of cardiac implants, standard manufacturing won’t cut it. Our ISO Class 7 cleanroom isn’t just a “clean space”—it’s a precision ecosystem where medical-grade blister packaging achieves near-zero contamination. Here’s what happens behind the airlocked doors.

1. The Airflow Armor

Unlike typical factories, our cleanroom enforces:

• Vertical laminar flow: 0.3-micron particles removed at 99.99% efficiency

• Positive pressure zones: +15 Pa differential prevents external air ingress

• Real-time particle counters: Alarms trigger at >352,000 particles/m³ (ISO threshold)

Result: Sterile blister foils produced with ≤5 CFU (colony-forming units) per tray – 10× below FDA limits.

2. Gowning: Your First Line of Defense

Every technician undergoes NASA-grade protocols:

• 30-minute air showers before entry

• Sterile gloves changed every 45 minutes during blister sealing film handling

• No makeup/skin exposure policies to prevent microbial shedding

Data Point: Routine swab tests show our aseptic thermoforming areas average <1 viable microorganism per 10 cm².

3. Material Decontamination Gateways

Raw materials face 3-stage purification:

1. Gamma irradiation: For high-barrier aluminum foils used in implant packaging

2. Non-ethanol vapor wipe-down: For PETG blister sheets (alcohol residues cause clouding)

3. Double-bag transfer systems: With interlock pass-through chambers

4. Monitoring: Where AI Meets Asepsis

Smart systems prevent human error:

• IoT sensors halt production if humidity exceeds 45% (prevents blister delamination)

• Blockchain logging tracks every material batch from sterilization to sealing

• Viable air samplers detect microbes before colonies form

Why ISO 14644-1 Class 7 Matters for You

For ophthalmic drug blister packs or surgical tool trays, this standard ensures:

• Zero endotoxin risks: Critical for injectables

• Consistent seal integrity: No particulates weaken blister heat seals

• Audit-ready compliance: Full traceability for FDA/EU GMP inspections

While others claim “clean manufacturing,” we prove it with particle-per-cubic-meter accountability. Because when packaging protects lives, every micron counts.