시설
공장, 유틸리티 및 시설 설계/적격성평가.
시설
2026년 8월 24일
Airlock Design — Personnel and Material Flow in Aseptic Facilities
How airlocks are designed to control contamination risk for personnel and material entry into aseptic areas.
4
시설
2026년 8월 24일
Cleanroom Classification — ISO 14644-1 vs EU GMP Grade Comparison
How ISO 14644-1 classes map to EU GMP Grades A-D for pharmaceutical cleanroom design.
시설
2026년 8월 24일
Compressed Air System — Quality Requirements per ISO 8573-1
Air purity classes under ISO 8573-1 and how they apply to compressed air used in pharma processes.
1
시설
2026년 8월 24일
Environmental Monitoring Program — Design for Grade A/B Areas
How to design a risk-based environmental monitoring program for the most critical cleanroom grades.
2
시설
2026년 8월 24일
Facility Design — Unidirectional Flow for Aseptic Processing
Design principles behind unidirectional airflow in Grade A aseptic processing zones.
시설
2026년 8월 24일
Facility Qualification — DQ/IQ/OQ/PQ Lifecycle Overview
How the four qualification stages fit together across a facility project lifecycle.
시설
2026년 8월 24일
HVAC System — Qualification Approach for Pharma Manufacturing
DQ/IQ/OQ/PQ scope for an HVAC system serving classified manufacturing areas.
시설
2026년 8월 24일
Pest Control Program — Requirements for GMP Facilities
What a GMP-compliant pest control program needs to cover, from monitoring to documentation.
시설
2026년 8월 24일
Warehouse Storage Conditions — Temperature Mapping Study Approach
How temperature mapping studies establish reliable storage zones in a pharmaceutical warehouse.
2
시설
2026년 8월 24일
Water for Injection (WFI) System — Qualification Requirements
Qualification stages for a WFI generation and distribution system, including the phased sampling approach.