Core Requirement
350°C-rated HEPA filters are required only in dry-heat depyrogenation/sterilization hot-air recirculation systems. High-temperature zones must use all-inorganic ceramic adhesives, 304/316 stainless steel frames, and H13/H14 glass-fiber minipleat filters — ensuring zero outgassing, zero fiber shedding, and ISO Class 5 (Grade A) clean air delivery per GMP/FDA standards.
Key Applications
1. Tunnel Depyrogenation Ovens
For ampoules, vials, cartridges, and pre-filled syringes. 350°C laminar airflow destroys endotoxins and spores while maintaining ISO 5 cleanliness. Mandatory: H14 for sterile injectables, H13 for large-volume infusions; 304SS frame + stainless separators + ceramic sealant.
2. Static Dry-Heat Sterilization Chambers
For tools, caps, molds, and metal fixtures. Operates at 320–350°C for 60–120 min. Filters installed at fan discharge and laminar hood terminals to prevent recontamination.
3. Isolator-Integrated Depyrogenation Modules
For high-potency biologics and cytotoxic products. Compact 350°C filters inside closed isolators enable in-situ depyrogenation with zero organic outgassing.
4. QC Laboratory Ovens
For glassware used in endotoxin testing. 350°C filters prevent false-positive LAL test results by eliminating airborne particulates.
5. API Aseptic Dryers
For sterile peptides and high-purity APIs. Hot air passes through 350°C HEPA before contacting the product — all-inorganic construction is critical to avoid impurity leaching.
6. Aesthetic Device Glass Lines
For hyaluronic acid cartridges and filler vials. Same standards as injectables — 330–350°C with H14 filtration.
Post time: Jul-21-2026