HANDBOOK CLEANROOM ENGINEERING
Konsep, Desain, Konstruksi, dan Validasi Cleanroom
Penulis
Machfud
PT Rijomac Sembilan Sembilan
LAMPIRAN
LAMPIRAN A
CHECKLIST SURVEY CLEANROOM
Informasi Umum
Nama Proyek :
Lokasi :
Customer :
PIC Customer :
Tanggal Survey :
Surveyor :
Data Ruangan
Jenis Ruangan :
Panjang :
Lebar :
Tinggi :
Volume :
Jumlah Ruangan :
Kebutuhan Proses
□ Produksi Farmasi
□ Laboratorium
□ BSL-2
□ Cytotoxic
□ Ruang Isolasi
□ Dry Room
□ Lainnya : __________
Parameter Target
ISO Class :
Temperatur :
RH :
Pressure :
ACH :
Existing Building
□ Bangunan Baru
□ Bangunan Existing
□ Renovasi
Catatan :
Kebutuhan HVAC
□ AHU
□ FCU
□ Split Duct
□ Exhaust System
□ Fresh Air
□ Dehumidifier
Catatan :
LAMPIRAN B
CHECKLIST COMMISSIONING CLEANROOM
HVAC System
□ AHU Running
□ Fan Rotation Benar
□ Motor Ampere Normal
□ Filter Terpasang
□ Damper Berfungsi
□ Diffuser Terpasang
Pressure System
□ Pressure Monitor Aktif
□ Pressure Sesuai Desain
□ Alarm Berfungsi
Monitoring
□ Temperatur
□ RH
□ Pressure
□ Alarm
Dokumentasi
□ Foto
□ Data Pengukuran
□ Laporan
□ Berita Acara
LAMPIRAN C
CHECKLIST TAB
Supply Air
No | Ruangan | Design | Actual | Status |
Return Air
No | Ruangan | Design | Actual | Status |
Exhaust Air
No | Ruangan | Design | Actual | Status |
Pressure
Area | Design | Actual |
LAMPIRAN D
FORM PENGUKURAN DIFFERENTIAL PRESSURE
No | Area 1 | Area 2 | Design (Pa) | Actual (Pa) |
Tanggal :
Operator :
Alat Ukur :
Nomor Kalibrasi :
LAMPIRAN E
FORM PENGUKURAN AIRFLOW
No | Diffuser | Design CMH | Actual CMH |
Total Supply Air
________ CMH
Total Return Air
________ CMH
Total Exhaust Air
________ CMH
LAMPIRAN F
FORM MONITORING TEMPERATUR DAN RH
Tanggal | Jam | Temperatur (°C) | RH (%) | Keterangan |
LAMPIRAN G
CONTOH URS CLEANROOM
User Requirement Specification
Nama Proyek
Cleanroom Produksi Farmasi
Target Lingkungan
ISO Class 7
Temperatur :
22–24°C
RH :
45–60%
Pressure :
+15 Pa
ACH :
Minimum 20 ACH
Sistem Yang Dibutuhkan
□ Sandwich Panel
□ HVAC Cleanroom
□ HEPA Filter
□ Airlock
□ Pass Box
□ Monitoring Pressure
LAMPIRAN H
CONTOH LAYOUT PRESSURE CASCADE
Positive Pressure Cleanroom
Production : +20 Pa
↓
Preparation : +15 Pa
↓
Gowning : +10 Pa
↓
Corridor : +5 Pa
↓
General Area : 0 Pa
Negative Pressure Isolation Room
General Area : 0 Pa
↓
Anteroom : -2.5 Pa
↓
Isolation Room : -5 Pa
↓
Toilet : -10 Pa
