Depyrogenation Tunnels /Dry Heat Sterilizer (DHS) are critical for ensuring the sterilization and endotoxin removal of glass vials in sterile and aseptic pharmaceutical manufacturing. PrimeGMP provides complete qualification services to verify that Depyrogenation Tunnels/ DHS systems consistently achieve required temperature profiles and endotoxin reduction levels, ensuring full compliance with global regulatory standards.

Our DHS / Tunnel Qualification Scope

1. Design Qualification (DQ)

• Review of URS, OEM documentation, and P&IDs
• Assessment of conveyor system, heating zones, laminar airflow system
• Verification of temperature uniformity design, ramp-up capability
• Compliance check with ISO 20857, EU Annex 1, and USFDA expectations

2. Installation Qualification (IQ)

• Verification of mechanical installation (conveyors, fans, HEPA filters)
• Calibration of temperature sensors, thermocouples, control systems
• Inspection of heating zones, cooling zones, and air handling units
• Verification of safety devices, interlocks, alarms
• Documentation checks (material certificates, FAT/SAT reports)

3. Operational Qualification (OQ)

• Temperature distribution mapping (empty load)
• Conveyor speed verification across all heating zones
• HEPA filter integrity testing
• Airflow pattern checks & pressure differentials
• Alarm and interlock functionality testing
• Hot air recirculation and flow balance verification

4. Performance Qualification (PQ)

• Loaded temperature mapping using calibrated thermocouples
• Depyrogenation cycle validation at worst-case load positions
• Lethality (Fh value) determination
• Endotoxin challenge studies using Endotoxin Indicators (EIs)
• Verification of ≥ 3-log reduction or validated SAL as required
• Qualification of vial loading/unloading patterns

Documentation Provided

• DQ / IQ / OQ / PQ Protocols & Reports
• Temperature mapping reports (empty & loaded)
• Endotoxin Indicator (EI) test reports
• HEPA integrity test reports
• Conveyor speed & cycle reproducibility reports
• Validation summary with CAPA recommendations
• SOPs for operation, maintenance, and requalification

Standards & Guidelines Followed

• ISO 20857 – Dry Heat Sterilization / Depyrogenation
• EU GMP Annex 1 (Aseptic Processing)
• EU GMP Annex 15 (Qualification & Validation)
• WHO TRS 961 / 1019
• USFDA 21 CFR 210/211
• ISPE Baseline Guide – Sterilization & Depyrogenation

Why Choose PrimeGMP for DHS Qualification?

• Expertise in all DHS tunnel types (hot air tunnels, dry heat depyrogenators)
• Use of high-accuracy thermocouples & traceable instruments
• Detailed Lethality (Fh) calculations
• Complete cycle development support
• Clear, audit-ready documentation
• Ability to troubleshoot temperature non-uniformity and airflow issues