Lytzen ISO Class 5 (Class 100) Depyrogenation Oven

ISO Class 5 at High Temperatures

ISO 14644-1 Class 5 (Class 100) Certified: Maintains Class 5 air cleanliness throughout the entire cycle.

Up to 280 °C Airflow Integrity: Delivers unidirectional HEPA-filtered airflow at temperatures up to 280 °C, enabled by Lytzen’s unique chamber construction and filter suspension system.

Continuous Clean Air Protection: HEPA filtration remains stable and effective during heating, sterilizing, and cooling phases.


Validated Depyrogenation & Sterilization
Dry Heat up to 280 °C: Validated for both sterilization and ≥3-log reduction of endotoxins.

Exceptional Uniformity: Ensures reliable and consistent processing of glassware and components.

High Load Capacity: Designed to support both small and large-scale pharmaceutical operations.

Technical Specifications
Cleanroom Classification: ISO 14644-1 Class 5 (Class 100) maintained throughout the cycle

Operating Temperature: Up to 280 °C continuous operation

Airflow Type: Unidirectional laminar airflow

Filtration: HEPA H14 filters with advanced suspension system
Chamber Material: AISI 316L stainless steel interior
Controls: Siemens HMI interface
Validation: GMP-compliant; supports IQ/OQ/PQ and CFR 21 Part 11 compliance


Applications
Pharmaceutical: Vial, ampoule, and glassware depyrogenation


Biotech: Sterile preparation of components before aseptic fill

Sterile manufacturing: Endotoxin removal for GMP environments
Laboratory: Pilot-scale sterilization and dry heat validation

Benefits
True ISO Class 5 at 280 °C – unmatched cleanroom integrity during high-heat operation

Regulatory Confidence – supports global GMP and FDA requirements

Superior Engineering – long filter life and low maintenance through innovative construction

Process Consistency – validated, repeatable depyrogenation cycles

Scalable Solutions – available for lab, pilot, and full production use