NAMA ALAT MEREK TIPE PEMBACAAN LOKASI

Incubator I Sanyo MIR-I5I 0.1 °C Laboratorium

Incubator II Sanyo MIR-I5I 0.1 °C Laboratorium
Thermometer GEA N/A Laboratorium
Thermometer GEA N/A Laboratorium
Laminar Air Flow Horizontal N/A Laboratorium
Thermometer GEA N/A Laboratorium
Thermometer GEA N/A Laboratorium
pH Meter Digital I Sun Care PH-009(1)A Laboratorium
Autoclave GEA YX-280D (24 L) Laboratorium
Autoclave HIRYAMA HL36e (50 L) Laboratorium
Termometer batang WSS No. F512 Laboratorium
Viscometer LABO NDJ-8S Laboratorium
Detector-HPLC Shimadzu SPD-6AV Laboratorium
Recorder HPLC Penelson 900 Series Laboratorium
Oven Mammert Memmert N/A Laboratorium
TDS Meter BNQ TDS-3 Laboratorium
Mikropipet Huawei 14070138 Laboratorium
Mikroskop N/A N/A Laboratorium
Microwave Maxii N/A Laboratorium
Oven Kirin Kirin N/A Laboratorium
Spectrophotometer Hitachi U-2000 Laboratorium
Spectrophotometer Shimadzu N/A Laboratorium
Thermocontrol Autonics N/A Laboratorium
Termometer Dinding I GEA Laboratorium
Termometer Dinding II GEA Laboratorium
Timbangan Digital CHQ DJ1002C Laboratorium

Thermometer Digital Sun Care 303C T = 0,1 °C, RH = 1% Lab. Mikro

Thermometer Digital Sun Care 303C T = 0,1 °C, RH = 1% Lab. Fis-Kim

Thermometer Digital Sun Care 303C T = 0,1 °C, RH = 1% R. Retained Sample

Termohygrometer Electronik Corona GL 86

Termohygrometer Electronik Corona GL 86
Furnace Gallankamp Muffle Furnace
Termohygrometer Electronik Corona GL 86
Timbangan R. Mikrobiologi
Bimetal Thermometer WSS F.512 R. Lab
Show Case Modena R. Lab
Mikropipet Huawei 14070138 R. Lab
Timbangan Pocket ION Scale EPS 05 R. Preparrasi
Incubator III Sanyo MIR-551 R. Preparrasi
Autoclave GEA YX-280D (241) R. Preparasi
TDS Meter BNQ TDS-3 R. Lab
Spectrophotometer Hitachi U-2000 R. Lab
Thermometer Gelas WSS No. F512 R. Lab

Thermohygrometer Digital Corona GL-89 T = 0,1 °C, RH = 1% Produksi

Thermohygrometer Digital Carona GL-89 T = 0,1 °C, RH = 1% Produksi

Timbangan Pocket ION Scale EPS 05 Produksi

Pressure gauge A MC 1.6/SN.813342 Produksi
Pressure gauge B Wipro - Produksi
Pressure gauce RO MEC - Produksi
Schuh EN 837-1/ SC
Vacuum gauge Freeze Dryer R. Ekstraksi
Technology 250
Timbangan Digital DJ-series Produksi
Timbangan 75 kg Produksi
Timbangan 300 kg Produksi

Thermohygrometer Digital Corona GL-89 T = 0,1 °C, RH = 1% Produksi

Thermohygrometer Digital Sun Care 303C T = 0,1 °C, RH = 1% Produksi

Max : 500 gram, d =

Timbangan Pocket Camry EHA251 Produksi
0,1 g
Thermohygrometer Digital Corona GL-89 R. Timbang
Stopwatch Butterfly BT02 1/100 Second Produksi
Max : 500 gram, d =
Timbangan Pocket Camry EHA251 Produksi
0,1 g
Stopwatch Butterfly BT02 1/100 Second Produksi

Thermometer Digital Sun Care 303C T = 0,1 °C, RH = 1% Produksi

Timbangan Henherr 0.01 Kg, Max : 150 Kg Ruang Timbang

 DJ-series / SN.Ex
Timbangan Excellent 0.01 Kg R. IPC
006960
Termohygrometer Electronik Corona GL 86
Termohygrometer Electronik Corona GL 86
Termohygrometer Electronik Corona GL 86
Digital Termohygrometer 1 No. 15009047 R. Timbang
Vacuum Gauge Filling Kapsul R. Pengolahan
Pressure Gauge Filling Kapsul R. Pengolahan
Termocontrol V-1 Filling Sachet R. Pengolahan
Termocontrol V-2 Filling Sachet R. Pengolahan
Termocontrol H-1 Filling Sachet R. Pengolahan
Termocontrol H-1 Filling Sachet R. Pengolahan
Timbangan Digital Henherr XK3190-A12+E SN. HH0012344444 R. Produksi
Timbangan Digital Excellent Scale R. Produksi
Top Pan Balance Excellent DJ-Series SN. EX 006960 R. IPC
Termomerter Ruang GEA R. Produksi
Digital Thermohygrometer 2 Corona GL - 89 R. Produksi
Themocontrol Cold Storage Unit 2 Ekstraksi
Themocontrol Cold Storage Unit 3 Ekstraksi
Themocontrol Cold Storage Unit 4 Ekstraksi
Themocontrol Cold Storage Unit 5 Ekstraksi
Agitator Inverter R. Ekstraksi
Termocontrol Ekstraktor R. Ekstraksi
Pump Sirkulasi Ekstraktor R. Ekstraksi
Pump Sirkulasi Evaporator R. Ekstraksi
Vacuuum gauge Evaporartor R. Ekstraksi
Termocontrol Evaporrator R. Ekstraksi
Termocontrol VBD R. Ekstraksi
Inverrter VBD R. Ekstraksi
Pressure Gauge R. Ekstraksi
Digital Thermohygrometer 3 AZ-HT-02 G. Ekstrak

Thermometer Digital Sun Care 303C T = 0,1 °C, RH = 1% Gudang Bahan Awal

Thermometer Digital Sun Care 303C T = 0,1 °C, RH = 1% Gudang Produk Jadi

Timbangan Excellent Excellent 0.005 Kg, Max : 75 Kg Gudang Bahan Awal

Timbangan Excellent 0.01 Kg Gudang Obat Jadi

Termohygrometer Electronik Corona GL 86
Termohygrometer Electronik Corona GL 86
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Magnehelic Drwyer 0-700 Pa AHU Plant
Pressure Gauge Austrralia
 INTERNAL / TEMPEL
NO.IDENTITAS KALIBRASI REKALIBRASI KONDISI
EKSTERNAL IDENTITAS
AU-QC-001 7/1/2016 Internal
AU-QC-002
AU-QC-002 12/3/2016 Internal
AU-QC-002 12/3/2016 Internal
AU-QC-003 7/1/2016 Internal
AU-QC-003 12/3/2016 Internal
AU-QC-004 12/3/2016 Internal
AU-QC-004
AU-QC-005 7/1/2016 Internal
AU-QC-006
AU-QC-007 7/1/2016 Internal
AU-QC-008
AU-QC-009
AU-QC-010
AU-QC-011
AU-QC-012 7/1/2016 Internal
4/2/2016 Internal
AU-QC-013
AU-QC-014
AU-QC-015
AU-QC- 7/1/2016 Internal
AU-QC-016
AU-QC-017
AU-QC-018 14-Mar-16 Internal 14-Mar-17 Done
AU-QC-019 14-Mar-16 Internal 14-Mar-17 Done
AU-QC-020 Internal

AU-QC-021 11-Apr-16 11-Apr-17 Done

Internal

AU-QC-022 11-Apr-16 11-Apr-17 Done

Internal

AU-QC-023 11-Apr-16 11-Apr-17 Done

Internal
AU-QC-023 31/10/2016 Internal
AU-QC-024 31/10/2016 Internal
AU-QC-024 5/10/2016 Internal
AU-QC-025 31/10/2016 Internal
AU-QC-O24
AU-QC- 8/1/2016 Eksternal
AU-QC- 16/1/2016 Eksternal
AU-QC- 4/2/2016 Eksternal
AU-QC- 7/1/2016 Eksternal
AU-QC- 7/1/2016 Eksternal
AU-QC- 7/1/2016 Eksternal
AU-QC- 7/2/2016 Eksternal
AU-QC- 7/1/2016 Eksternal
AU-QC- 7/1/2016 Eksternal

AU-PR-001 11-Apr-16 11-Apr-17 Done

Internal

AU-PR-002 11-Apr-16 11-Apr-17 Done

Internal
AU-PR-003 7/1/2016 Internal
AU-PR-004
AU-PR-005
AU-PR-006

AU-PR-007

AU-PR-008
AU-PR-009
AU-PR-010

AU-PR-012 11-Apr-16 11-Apr-17 Done

Internal

AU-PR-013 Jan-16 Jan-17 Done

Internal

AU-PR-014 Done

AU-PR-015 11-Apr-16 Internal 11-Apr-17 Done

AU-PR-016 Done

AU-PR-017 Done

AU-PR-018

AU-PR-019 11-Apr-16 11-Apr-17 Done

Internal

AU-PR-020 7/1/2016
Internal
AU-PR-021 7/1/2016
Internal
AU-PR-024 31/10/2016 Internal
AU-PR-025 31/10/2016 Internal
AU-PR-026 31/10/2016 Internal
AU-PR- 18/1/2016 Eksternal
AU-PR-
AU-PR-
AU-PR-
AU-PR-
AU-PR-
AU-PR-
AU-PR- 7/1/2016 Eksternal
AU-PR- 7/1/2016 Eksternal
AU-PR- 7/1/2016 Eksternal
AU-PR- 7/1/2016 Eksternal
AU-PR- 7/1/2016 Eksternal
AU-EK-002
AU-EK-003
AU-EK-004
AU-EK-005
AU-EK-
AU-EK-
AU-EK-
AU-EK-
AU-EK-
AU-EK-
AU-EK-
AU-EK-
AU-EK-
AU-EK- 7/1/2016 Eksternal

AU-PI-001 11-Apr-16 11-Apr-17 Done

Internal

AU-PI-002 11-Apr-16 11-Apr-17 Done

Internal

AU-PI-003

AU-PI-004
AU-PI-003 31/10/2016
AU-PI-004 31/10/2016
AU-TK-001 6/4/2015 Internal
AU-TK-002 6/4/2015 Internal
AU-TK-003 6/4/2015 Internal
AU-TK-004 6/4/2015 Internal
AU-TK-005 6/4/2015 Internal
AU-TK-006 6/4/2015 Internal
AU-TK-007 6/4/2015 Internal
AU-TK-008 6/4/2015 Internal
AU-TK-009 6/4/2015 Internal
AU-TK-008 6/4/2015 Internal
8/1/2016 Eksternal
NO NAMA ALAT MERK/ TIPE LOKASI

1 Mesin Ekstraktor TOG-1000-00 Ruang Ekstraksi

2 Mesin Spinner Ruang Ekstraksi

3 Mesin Evaporator EVO-501 Ruang Ekstraksi
4 Mesin Spray Dryer Ruang Ekstraksi

5 Mesin VacuumBelt Wenxiong VBD Ruang Ekstraksi

6 Mesin Vacuum Ruang Ekstraksi

7 Mesin Freeze Dryer Ruang Pengolahan

8 Mesin Penggiling Ruang Pengolahan

9 Mesin Mixing V Ruang Pengolahan

10 Mesin Mixing UV Ruang Pengolahan

11 Mesin Filling Kapsul NJP 800 Ruang Pengolahan

12 Mesin Vacum Filling Kapsul Ruang Pengolahan

13 Mesin Polishing Kapsul Ruang Pengolahan

14 Mesin Filling Sachet W 110 D Ruang Pengolahan

15 Mesin Blister Ruang Pengolahan

16 Mesin Filling Botol Ruang Pengolahan

17 Sistem Boiler N/A PT. ROYAL

18 Sistem Pengolahan Air N/A PT. ROYAL
19 Sistem Compress Air N/A PT. ROYAL
20 Sistem Tata Udara N/A PT. ROYAL

21 Mesin Blister packing Ruang Pengolahan

22 Mesin Filling Powder & Capping Ruang Pengolahan

23 Mesin Labelling Ruang Pengolahan

24 Mesin Sealing Ruang Pengolahan

25 AHU UNIT 1
26 AHU UNIT 2
27 AHU UNIT 3
28 AHU UNIT 4
29 AHU UNIT 5
30 AHU UNIT 6
31 BOILER 1
32 BOILER 2
33 SPA
34 KOMPRESSOR
35 UNIT VACUUM
 TEMPEL
NO.IDENTITAS NO. PROTOKOL KUALIFIKASI
IDENTITAS

MU-EK-021 QA-OQ-LP-005
15/04/2016

MU-EK-020 QA-OQ-LP-006 25/04/2016

QA-OQ-PT-009

MU-EK-024 QA-OQ-LP-007
22/09/2016

QA-OQ-PT-008

QA-OQ-PT-016

QA-OQ-PT-004

MU-PR-003 QA-OQ-LP-002
28/09/2016

QA-OQ-PT-0

QA-OQ-PT-0

MU-PR-004 QA-OQ-LP-003
14/10/2016

MU-SPA-001 QA-OQ-LP-012 21/04/2016

MU-AHU-001 QA-OQ-LP-001 11/3/2016

QA-OQ-PT-010

QA-OQ-PT-011

QA-OQ-PT-013

QA-OQ-PT-0
 MASTER LIST DOKUMEN
CLEANING VALIDASI

NO NAMA ALAT LOKASI NO. PROTOKOL EF. PROTOKOL EF. REPORT

1 Mesin Ekstraktor Ruang Ekstraksi QA/CV/PT/001/00 2/12/2016
2 Mesin Spinner Ruang Ekstraksi QA/CV/PT/00/00
3 Mesin Evaporator Ruang Ekstraksi QA/CV/PT/002/00 2/12/2016
4 Mesin Spray Dryer Ruang Ekstraksi QA/CV/PT/004/00
5 Mesin VacuumBelt Ruang Ekstraksi QA/CV/PT/005/00
6 Mesin Freeze Dryer Ruang Pengolahan 2/12/2016
7 Mesin Mixing V Ruang Pengolahan QA/CV/PT/00/00
8 Mesin Filling Kapsul Ruang Pengolahan QA/CV/PT/007/00
9 Mesin Filling Sachet Ruang Pengolahan QA/CV/PT/006\/00
 MASTER LIST DOKUMEN
VALIDASI PROSES

NO NAMA SEDIAAN BENTUK SEDIAAN NO. PROTOKOL EF. PROTOKOL EF. REPORT
1 Ekstrak Vacuum Belt Dryer Serbuk QA/VP/PT/003/00 2/12/2016
2 Ekstrak Freeze Dryer Serbuk QA/VP/PT/001/00 2/12/2016
3 VipAlbumin Kapsul Kapsul QA/VP/PT/004/00 2/12/2016
4 VipAlbumin Plus Sachet QA/VP/PT/002/00 2/12/2016
5 VipAlbumin Dry Syrup Serbuk
6 Heparmin Kapsul
7 PinciOne Kapsul