PT. KIMIA FARMA (Persero) Tbk.

AHU B1 Doc. #: AHUB1-103

Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 1 of 47
LAPORAN KUALIFIKASI INSTALASI

REVISION HISTORY:
SEJARAH PERUBAHAN:
REVISION # DATE DESCRIPTION BY
PERUBAHAN # TANGGAL DESKRIPSI DIBUAT OLEH
New submission
1 30/05/2018 M Winadewi
Pengajuan Baru

Prepared By Name/Company Signature Date

Dibuat Oleh Nama/Perusahaan Tanda Tangan Tanggal
Validation Representative (PT
GKT)
Perwakilan Validasi

Document Review Name/Company Signature Date

Pengkajian Dokumen Nama/Perusahaan Tanda Tangan Tanggal
Quality System Assistant
Manager
Asisten Manager Pemastian
Mutu
Maintenance Assistant Manager
Asisten Manager Teknik &
Pemeliharaan
Consultant
Konsultan

Document Approval Name/Company Signature Date

Pengesahan Dokumen Nama/Perusahaan Tanda Tangan Tanggal
Quality System Assistant
Manager
Asisten Manager Pemastian
Mutu
Maintenance Assistant Manager
Asisten Manager Teknik &
Pemeliharaan
Consultant
Konsultan

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 2 of 47
LAPORAN KUALIFIKASI INSTALASI

TABLE OF CONTENTS

1 PURPOSE.............................................................................................................................................................3
2 SCOPE..................................................................................................................................................................3
3 REFERENCE DOCUMENTS...................................................................................................................................5
4 PRE- QUALIFICATION REQUIREMENTS................................................................................................................6
5 SIGNATURE IDENTIFICATION & VERIFICATION OF TRAINING.............................................................................9
6 VERIFICATION OF DOCUMENTATION................................................................................................................11
7 INSTRUMENT VERIFICATION.............................................................................................................................15
8 VERIFICATION OF FILTERS.................................................................................................................................22
9 CRITICAL COMPONENT VERIFICATION..............................................................................................................27
10 HEPA FILTER INTEGRITY TESTING......................................................................................................................35
11 PROCEDURE VERIFICATION...............................................................................................................................40
12 IQ VARIANCE REPORT.......................................................................................................................................42
13 VARIANCE REPORT FORM ATTACHMENT NO: …………………….................................................................43
14 LIST OF ATTACHMENTS.....................................................................................................................................46

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 3 of 47
LAPORAN KUALIFIKASI INSTALASI

1 PURPOSE

The purpose of this Installation Qualification (hereon known as IQ) is to prove and document that the AHU B1 system
properly installed and lead to the predetermined specification. That is to ensure that:
o all critical aspects or acceptance criteria for intended use are incorporated in the installed equipment
o the equipment is fit for the intended purpose.

Tujuan dokumen Kualifikasi Instalasi (KI) ini untuk membuktikan dan mendokumentasikan dimana Sistem Tata Udara B1
(AHU B1) telah terinstal sesuai dengan spesifikasi yang telah ditentukan sebelumnya. Untuk memastikan dimana AHU B1:
 Telah mengakomodasi seluruh kriteria penerimaan spesifikasi pada komponen AHU B1 yang telah terinstal
 Peralatan yang terinstal sesuai dengan tujuan yang telah disesuaikan sebelumnya

2 SCOPE

The Client intends to introduce a new HVAC system AHU B1 as shown in the diagram below:
Sistem Tata Udara B1 (AHUB1) yang baru dapat dilihat melalui diagram berikut:

Figure 1 –Process Flow Diagram

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 4 of 47
LAPORAN KUALIFIKASI INSTALASI

VALIDATION REQUIREMENTS - The scope of Equipment Qualification and this IQ:

 Excludes Electrical System, Chilled Water System and Hot Water System
 Air Handling Unit and air distribution system are the GMP direct system and in the scope of Equipment
Qualification

KRITERIA VALIDASI – Ruang Lingkup Kualifikasi Peralatan dan yang termasuk KI berikut ini:
 Tidak Termasuk – Sistem Eletrikal, Sistem Air Dingin , dan Sistem Air Panas
 Sistem tata udara dan distribusinya termasuk ke dalam kategori CPOB yang ‘berdampak langsung’, maka dari itu
termasuk ke dalam ruang lingkup Kualifikasi Peralatan.

A summary of the Validation Plan (extract from AHU0-008):

Kesimpulan daripada Rencana Validasi yaitu (dikutip dari dokumen AHU-008):

Sub- Process IMPACT ASSESSMENT VALIDATION REQUIREMENTS

system
AHU D1 Air Handling Unit System D1 Direct Impact Test & Commissioning
Sistem Tata Udara D1 Berdampak Langsung IQ & OQ
Pengujian, Komisioning, KI & KO
AHU D2 Air Handling Unit System D2 Direct Impact Test & Commissioning
Sistem Tata Udara D2 Berdampak Langsung IQ & OQ
Pengujian, Komisioning, KI & KO
AHU D3 Air Handling Unit System D3 Direct Impact Test & Commissioning
Sistem Tata Udara D3 Berdampak Langsung IQ & OQ
Pengujian, Komisioning, KI & KO
AHU C1 Air Handling Unit System C1 Direct Impact Test & Commissioning
Sistem Tata Udara C1 Berdampak Langsung IQ & OQ
Pengujian, Komisioning, KI & KO
AHU C2 Air Handling Unit System C2 Direct Impact Test & Commissioning
Sistem Tata Udara C2 Berdampak Langsung IQ & OQ
Pengujian, Komisioning, KI & KO
AHU C3 Air Handling Unit System C3 Direct Impact Test & Commissioning
Sistem Tata Udara C3 Berdampak Langsung IQ & OQ
Pengujian, Komisioning, KI & KO
AHU B1 Air Handling Unit System B1 Direct Impact Test & Commissioning
Sistem Tata Udara B1 Berdampak Langsung IQ & OQ
Pengujian, Komisioning, KI & KO
CHWS Chilled Water System Indirect Test & Commissioning
Sistem Air Dingin Tidak berdampak Pengujian dan Komisioning
Langsung
HWS Hot Water System Indirect Test & Commissioning
Sistem Air Panas Tidak berdampak Pengujian dan Komisioning
Langsung
BAS Building Automated (Control) Complex System GAMP Compliance
System Dampak Langsung, Standar GAMP
Sistem Otomatisasi Bangunan (BAS) Sistem Komplex

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 5 of 47
LAPORAN KUALIFIKASI INSTALASI

3 REFERENCE DOCUMENTS
REFERENSI DOKUMEN

No Document Number Document Name

3.1
N/A URS Kimia Farma
HVAC Air Flow Schematic Diagram AHU INJ-B1
3.2 KF.AC.09
Serves Room in GMP Class B
3.3
AHUB1-101 Quality Risk Assessment
3.4
AHU0-003 CQA & CPP

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 6 of 47
LAPORAN KUALIFIKASI INSTALASI

4 PRE- QUALIFICATION REQUIREMENTS

KRITERIA PRE-KUALIFIKASI

The following pre-qualification activities should be completed.

Anyone who signs or initials for the execution of this Protocol must fill in the data requested below. The purpose of this
table is to trace signatures & initials back to the individual and confirm that they have received training in review and
execute testing Protocol.

The training verification must be completed prior to the individual being involved in the execution of the testing.

Berikut ini adalah aktivitas pre-kualifikasi yang perlu dilengkapi

Peserta pegujian yang menandatangani atau menuliskan inisial dalam protocol ini harus mengisi data tabel dibawah ini.
Tujuannya adalah untuk merekan tanda tangan dan inisial penguji validasi dan mengkonfirmasi bahwa penguji validasi
telah mendapatkan training untuk mengkaji dan melakukan pengujian yang ada di protocol ini.

Verifikasi training harus di selesaikan sebelum penguji validasi tersebut melakukan pengujian KI ini.

Training Record of persons executing Validation Protocol

Dokumen Pendukung Training Penguji
Training Record –
Name of Tester Title of Tester Title/Location Initial/Date
Nama Penguji Jabatan Penguji Dokumen Pendukung- Inisial/Tanggal
Judul/Lokasi

Megani Winadewi Validation Folder 1 MW/02.04.18

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 7 of 47
LAPORAN KUALIFIKASI INSTALASI

Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached inventory printouts, YES

etc): All Acceptance Criteria
YA
achieved?
Halaman yang dilampirkan (jumlah halaman yang terlampir):

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 8 of 47
LAPORAN KUALIFIKASI INSTALASI

The following documents form the basis of the design (only include documents that are relevant to define the set of
critical aspects or acceptance criteria):

Dokumen berikut ini adalah dasar pendukung desain yang akan di verifikasi instalasinya (hanya dokumen yang
bersangkutan yang menjabarkan mengena aspek kritis atau kriteria penerimaan)

Document Documentation Documentation Complete Initial/Date

[Type] [Title/Number/Version Location [ Y/N ] Inisial/Tanggal
Tipe Dokumen No./Date] Lokasi Dokumen Selesai Y/T
Judul/Nomor/Versi/Tanggal
Design Qualification Design Qualification /AHU C2-
Folder 3C Y MW/02.04.18
Kualifikasi Desain 102/1/20.12.2017

Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached inventory printouts, All Acceptance Criteria YES
etc): achieved? YA
Halaman yang dilampirkan (jumlah halaman yang terlampir):

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 9 of 47
LAPORAN KUALIFIKASI INSTALASI

5 SIGNATURE IDENTIFICATION & VERIFICATION OF TRAINING

Anyone who signs or initials for the execution of this Protocol must fill in the data requested below. The purpose of this
table is to trace signatures & initials back to the individual and confirm that they have received training in review and
execute IQ Protocol.

Peserta yang menandatangani atau mencantumkan inisial dalam protocol ini, harus mengisi data tabel dibawah ini.
Tujuannya adalah untuk merekan tanda tangan dan inisial penguji validasi dan mengkonfirmasi bahwa penguji validasi
telah mendapatkan training untuk mengkaji dan melakukan pengujian yang ada di protocol ini.

The training verification must be completed prior to the individual being involved in the execution of the IQ.
Verifikasi training harus di selesaikan sebelum penguji validasi tersebut melakukan pengujian KI ini.

Training Record of persons executing Validation Protocol

Dokumen Pendukung Training Peserta Pengujian Validasi
Verification of Training.
(Initial/Date of QA
Title / Company Name Representative)
5.1 Name Initial/Date
Jabatan/ Nama Verifikasi Training
Test # Nama Inisial/Tanggal
Perusahaan (Inisial/Tanggal dari
Perwakilan Pihak
Pemastian Mutu)

5.1.1 Megani Winadewi Validation Manager/ GKT MW/02.04.18

5.1.2

5.1.3

5.1.4

5.1.5

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 10 of 47
LAPORAN KUALIFIKASI INSTALASI

Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached inventory All Acceptance Criteria YES
printouts, etc): achieved? YA
Halaman yang dilampirkan (jumlah halaman yang
terlampir):

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 11 of 47
LAPORAN KUALIFIKASI INSTALASI

6 VERIFICATION OF DOCUMENTATION
VERIFIKASI DOKUMENTASI
1.1 Objective
To verify that relevant documentation exists, are accurate, and reflect the installed equipment/system:
o Specification, Scope and design of the equipment – ie defining the acceptance criteria:
o User Requirement Specification
o Functional Specification & related documents
o Relevant drawings like P&ID, schematics, isometrics, layouts, etc

Tujuan
Melakukan verifikasi terhadap dokumen pendukung instalasi

Spesifikasi, ruang lingkup dan desain peralatan telah dijabarkan dalam dokumen berikut ini:
 URS
 Spesifikasi Fungsi dan dokumen pendukungnya
 Gambar seperti P&ID, skematik, isometric, layout, dll.

1.2 Method
Collect and review copies of all documentation pertaining to the equipment. Examine whether the available
documents are as listed in result section.

Metode:
Kompulkan dan kaji seluruh dokumen yang ditujukan untuk peralatan tersebut. Pastikan bahwa dokumen yang
tersedia semua telah di jabarkan

1.3 Acceptance Criteria

All documents must be available in current status.

Kriteria Penerimaan
Seluruh dokumen tersedia dalam versi terbaru

1.4 Results
Hasil

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 12 of 47
LAPORAN KUALIFIKASI INSTALASI

Revision No. / Issue Acceptable[

Document Initials/ Data
6.1 Document Title Date Y / N]
Reference
Test # Judul Dokumen Nomor Perubahan/ Diterima
Nomor Versi Inisial/Tanggal
Tanggal Pengesahan (Y/T)

6.1.1 User Requirement Spec Y MW/02.04.18

Critical Quality Attributes

6.1.2 & Critical Process 1/15.02.2018 AHU0-003 Y MW/02.04.18
Parameters
Criticality Assessment &
6.1.3 1/14.11.2017 AHU0-008 Y MW/02.04.18
Validation Plan

6.1.4 Quality Risk Assessment 2/14.03.2018 AHUB1-101 Y MW/02.04.18

6.1.5 Design Qualification 1/20.12.2017 AHUB1-102 Y MW/02.04.18

Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached inventory All Acceptance Criteria achieved? YES
printouts, etc): YA
Halaman yang dilampirkan (jumlah halaman yang
terlampir):

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 13 of 47
LAPORAN KUALIFIKASI INSTALASI

1.5 Verification of Drawings

The accuracy of drawings are field checked:

o Field-check the system against the current drawings by high-lighting each critical component, instrumentation, etc
to reflect the “as built” status of the equipment/system
o Red lined Drawings – include observations that do not conform to field installation details.

Verifikasi Gambar

Gambar harus sesuai dengan kondisi lapangan secara akurat, cara pengujian adalah sebagai berikut:
 Pengecekan lapangan antara barang yang terinstal dengan gambar terakhir yang dipegang saat KI. Telusuri
gambar dan beri warna pada gambar untuk seluruh komponen, instrumen kritis, dimana memastikan bahwa
gambar telah ditelusuri dan telah merefleksikan kondisi terakhir ‘as built’
o Beri warna gambar dan beri keterangan Diterima/Ditolak (Pass/Fail)

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 14 of 47
LAPORAN KUALIFIKASI INSTALASI

Document No./Revision No. / Acceptable

Initials/Date
6.2 Document Title Issue Date Document Location [Y / N]
Inisial/
Test # Judul Dokumen Nomor Dokumen/Nomor Lokasi Dokumen Diterima
Tanggal
Revisi/Tanggal Pengesahan Y/T
HVAC Air Flow
Schematic Diagram
KF.AC.03/N/A/29.03.18
6.2.1 AHU INJ-B1 Serves Folder 1 Y MW/02.04.18
Room in GMP
Class B

Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached inventory printouts, etc): All Acceptance YES
Halaman yang dilampirkan (jumlah halaman yang terlampir): Criteria achieved? YA

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 PT. KIMIA FARMA (Persero) Tbk.
AHU B1 Doc. #: AHUB1-103
Jakarta Timur, Java, Indonesia
PROJECT: HVAC RENOVATION STERILE INJECTION
Project # 246/KF/PRJ/XII/2016
SUBJECT: INSTALLATION QUALIFICATION REPORT
Page No. Page 15 of 47
LAPORAN KUALIFIKASI INSTALASI

7 INSTRUMENT VERIFICATION
VERIFIKASI INSTRUMEN
Objective
To verify the lists of instruments included in the system are as specified and calibrated
Method
Visually check whether instruments installed do confirm with the specified requirement specifications listed in the
“Specified” column. Record the information in the result section.

Acceptance Criteria
All installed instruments listed must be tagged and in conformance to the specifications listed in the specified
column.

Result

Tujuan
Untuk melakukan verifikasi terhadap daftar instrument yang telah terpasang sesuai dengan spesifikasi dan status
kalibrasinya

Metode
Lakukan pengecekan secara visual apakah instrument telah terpasang atau tidak, konfirmasi spesifikasinya pada tabel
dibawah

Kriteria Penerimaan
Seluruh insrumen yang telah terpasang harus di beri label dan pada instrument terdapt informasi sesuai dengan data yang
dijabarkan pada tabel dibawah

Hasil

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 CERTIFICATE/
MATERIAL SERIAL DATASHEET ACTUAL/PROJECT PASS
7.1 INITIAL/ DATE

TOTAL
LOCATION DESCRIPTION ID TAG MANUFACTUR NUMBER NO FOLDER NO. (Y/N)
TES MODEL/ TYPE INISIAL/
LOKASI DESKRIPSI NOMOR ID PRODUSEN NOMOR NOMOR HASIL AKTUAL/NO. DITERIM
T# TANGGAL
MATERIAL SERIAL SERTIFIKAT/DATA FOLDER A (Y/T)
SHEET
Mezz +6500 Air Product & SDx.B1.01 SDx.B1.01 /
7.1.1 Smoke Detector 1 SDx.B1.01 SL-2000 N/A Y MW/2.4.18
RFU.INJ.B1 Control (Datasheet) Folder 2A
AVD-NC.B1.1 AVD-NC.B1.1 /
AVD-NC.B1.1 Belimo NM24A N/A Y MW/2.4.18
(Datasheet) Folder 2A
Mezz +6500 Volume Damper
AVD-NC.B1.2 AVD-NC.B1.2 /
7.1.2 RFU.INJ.B1 Actuator 3 AVD-NC.B1.2 Belimo NM24A N/A Y MW/2.4.18
(Datasheet) Folder 2A
AVD-NC.B1.3 AVD-NC.B1. /
AVD-NC.B1.3 Belimo NM24A N/A Y MW/2.4.18
(Datasheet) Folder 2A 3
Vx.B1.01
Dwyer
Vx.B1.01 AVU-3A 8482 AVU-3A Vx.B1.01/ Folder 2A Y MW/2.4.18
Mezz +6500 Velocity Sensor Intrument
(Datasheet)
7.1.3 AHU INJ.B1 & Transmitter 2
Vx.B1.02
Dwyer Vx.B1.02
Vx.B1.02 AVU-3A 8407 AVU-3A Y MW/2.4.18
Intrument / Folder 2A
(Datasheet)
0454.G-
101487301 Tx.B1.01
Mezz +6500 Temperature Tx.B1.01 Azbil TY78X3 Sert/01/18 Y MW/2.4.18
1115 / Folder 2A
7.1.4 AHU INJ.B1 transmitter 2 (Sertificate)
1010436010 0446.G- Tx.B1.02
Tx.B1.02 Azbil TY7830D0400 Y MW/2.4.18
85 Sert/03/18 / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.01
PDi. B1.01 Magnehelic W35AABR FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
Mezz +6500 Pressure 09/GKT/KIMIA
Dwyer PDi. B1.02
7.1.5 AHU INJ.B1 Differential 3 PDi. B1.02 Magnehelic W04ABBKK FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.03
PDi. B1.03 Magnehelic W48AAAR FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A

Dwyer Magnesense II PDx.B1-01 PDx.B1.01

PDx.B1.01 018671 Y MW/2.4.18
Intrument MS2 W103 (Datasheet) / Folder 2A
Mezz +6500 Pressure
Dwyer Magnesense II PDx.B1-02 PDx.B1.02
7.1.6 AHU INJ.B1 Differential 3 PDx.B1.02 01867P Y MW/2.4.18
Intrument MS2 W101 (Datasheet) / Folder 2A
Dwyer Magnesense II PDx.B1-03 PDx.B1.03
PDx.B1.03 01867R Y MW/2.4.18
Intrument MS2 W101 (Datasheet) / Folder 2A

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 CERTIFICATE/
MATERIAL SERIAL DATASHEET ACTUAL/PROJECT PASS
7.1 INITIAL/ DATE

TOTAL
LOCATION DESCRIPTION ID TAG MANUFACTUR NUMBER NO FOLDER NO. (Y/N)
TES MODEL/ TYPE INISIAL/
LOKASI DESKRIPSI NOMOR ID PRODUSEN NOMOR NOMOR HASIL AKTUAL/NO. DITERIM
T# TANGGAL
MATERIAL SERIAL SERTIFIKAT/DATA FOLDER A (Y/T)
SHEET
Mezz +3000
Temperature &
ST-041 101-5289- 0440.G.Sert/01/ DTx.B1.01
7.1.7 Humidity 1 DTx.B1.01 Azbil HTY7803D4400 Y MW/2.4.18
R.Personal Air 0115 18 (Sertificate) / Folder 2A
Transmitter
lock-8
Mezz +3000
ST-041 Pressure Sensor Px.B1.ST.041. Dwyer MS2 W101 Px.B1.ST.041.1
7.1.8 1 N/A N/A Y MW/2.4.18
R.Personal Air & Transmitter 1 Intrument Magnesense II / Folder 2A
lock-8
ST-041 Human 060/GKT/KIMIA
HMI. B1.01
7.1.9 R.Personal Air Machine 1 HMI. B1.01 Mitsubishi GT2103PMBD 17X-0134 FARMA- Y MW/2.4.18
/ Folder 2A
lock-8 Interface MEP/IX/17
Mezz +3000 Temperature &
101-4046- DTx.B1.02
7.1.10 ST-040 R. Humidity 1 DTx.B1.02 Azbil HTY7803D4400 N/A Y MW/2.4.18
01115 / Folder 2A
Locker B-ON Transmitter
Mezz +3000 Pressure 09/GKT/KIMIA
Dwyer PDi. B1.04
7.1.11 FFU ST-040 R. Differential 1 PDi. B1.04 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
Locker B-ON Indicator
Mezz +3000 Px.B1.ST.040. Dwyer MS2 W101 Px.B1.ST.040.1
Pressure Sensor N/A N/A Y MW/2.4.18
ST-040 R. 1 Intrument Magnesense II / Folder 2A
7.1.12 & Transmitter 2
Locker B-ON Px.B1.ST.040. Dwyer MS2 W101 Px.B1.ST.040.2
N/A N/A Y MW/2.4.18
2 Intrument Magnesense II / Folder 2A
060/GKT/
Human
ST-040 R. KIMIAFARMA- HMI. B1.02
7.1.13 Machine 1 HMI. B1.02 Mitsubishi GT2103PMBD 176-1320 MEP/IX/17
Y MW/2.4.18
Locker B-ON / Folder 2A
Interface (Datasheet)
Mezz +3000
Temperature &
ST-039 101-4592- 0433.G.Sert/01/ DTx.B1.03
7.1.14 Humidity 1 DTx.B1.03 Azbil HTY7803D4400 Y MW/2.4.18
R.Personal Air 01115 18 (Sertificate) / Folder 2A
Transmitter
Lock-9
Mezz +3000
ST-039 Pressure Sensor Px.B1.ST.039. Dwyer MS2 Px.B1.ST.039.1
7.1.15 1 N/A N/A Y MW/2.4.18
R.Personal Air & Transmitter 1 Intrument Magnesense II / Folder 2A
Lock-9
060/GKT/
ST-039 Human
KIMIAFARMA- HMI. B1.03
7.1.16 R.Personal Air Machine 1 HMI. B1.03 Mitsubishi GT2103PMBD 179-0922 MEP/IX/17
Y MW/2.4.18
/ Folder 2A
Lock-9 Interface (Datasheet)

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 CERTIFICATE/
MATERIAL SERIAL DATASHEET ACTUAL/PROJECT PASS
7.1 INITIAL/ DATE

TOTAL
LOCATION DESCRIPTION ID TAG MANUFACTUR NUMBER NO FOLDER NO. (Y/N)
TES MODEL/ TYPE INISIAL/
LOKASI DESKRIPSI NOMOR ID PRODUSEN NOMOR NOMOR HASIL AKTUAL/NO. DITERIM
T# TANGGAL
MATERIAL SERIAL SERTIFIKAT/DATA FOLDER A (Y/T)
SHEET
Mezz +3000
Pressure 09/GKT/KIMIA
FFU ST-039 Dwyer PDi. B1.05
7.1.17 Differential 1 PDi. B1.05 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
R.Personal Air Intrument (DATASHEET) / Folder 2A
Indicator
Lock-9
Mezz +3000 Temperature &
101-4269- 0406.G.Sert/01/ DTx.B1.04
7.1.18 ST-038 R. Humidity 1 DTx.B1.04 Azbil HTY7803D4400 Y MW/2.4.18
01115 18 (Sertificate) / Folder 2A
Simpan Alat Transmitter
060/GKT/
Human
ST-038 R. KIMIAFARMA- HMI. B1.04
7.1.19 Machine 1 HMI. B1.04 Mitsubishi GT2103PMBD 179-0927 MEP/IX/17
Y MW/2.4.18
Simpan Alat / Folder 2A
Interface (Datasheet)
Mezz +3000
Pressure Sensor Px.B1.ST.038. Dwyer MS2 Px.B1.ST.038.1
7.1.20 ST-038 R. 1 N/A N/A Y MW/2.4.18
& Transmitter 1 Intrument Magnesense II / Folder 2A
Simpan Alat
09/GKT/KIMIA
Mezz +3000 Pressure Dwyer PDi. B1.06
PDi. B1.06 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
FFU ST-038 R. Differential Intrument (DATASHEET) / Folder 2A
7.1.21 2
Simpan Alat Indicator Dwyer
09/GKT/KIMIA
PDi. B1.07
PDi. B1.07 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
Mezz +3000
Temperature &
ST-037 101-5290- 0442.G.Sert/01/ DTx.B1.05
7.1.22 Humidity 1 DTx.B1.05 Azbil HTY7803D4400 Y MW/2.4.18
R.Cooling LAF 01115 18 (Sertificate) / Folder 2A
Transmitter
Staging 3
060/GKT/
ST-037 Human
KIMIAFARMA- HMI. B1.05
7.1.23 R.Cooling LAF Machine 1 HMI. B1.05 Mitsubishi GT2103PMBD 179-0917 MEP/IX/17
Y MW/2.4.18
/ Folder 2A
Staging 3 Interface (Datasheet)
Mezz +3000
ST-037 Pressure Sensor Px.B1.ST.037. Dwyer MS2 0603.G.Sert/01/ Px.B1.ST.037.1
7.1.24 1 O101FT Y MW/2.4.18
R.Cooling LAF & Transmitter 1 Intrument Magnesense II 18 (Sertificate) / Folder 2A
Staging 3
Mezz +3000 09/GKT/KIMIA
Pressure Dwyer PDi. B1.08
FFU ST-037 PDi. B1.08 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Differential Intrument (DATASHEET) / Folder 2A
7.1.25 R.Cooling LAF 2
Indicator Dwyer
09/GKT/KIMIA
PDi. B1.09
Staging 3 PDi. B1.09 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
7.1.26 Mezz +3000 Temperature & 1 DTx.B1.06 Azbil HTY7803D4400 101-4158- 0401.G.Sert/01/ DTx.B1.06 Y MW/2.4.18
ST-048 Humidity 01115 18 (Sertificate) / Folder 2A

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 CERTIFICATE/
MATERIAL SERIAL DATASHEET ACTUAL/PROJECT PASS
7.1 INITIAL/ DATE

TOTAL
LOCATION DESCRIPTION ID TAG MANUFACTUR NUMBER NO FOLDER NO. (Y/N)
TES MODEL/ TYPE INISIAL/
LOKASI DESKRIPSI NOMOR ID PRODUSEN NOMOR NOMOR HASIL AKTUAL/NO. DITERIM
T# TANGGAL
MATERIAL SERIAL SERTIFIKAT/DATA FOLDER A (Y/T)
SHEET

R.Corridor B Transmitter

060/GKT/
Human
ST-048 KIMIAFARMA- HMI. B1.06
7.1.27 Machine 1 HMI. B1.06 Mitsubishi GT2103PMBD 179-0913 MEP/IX/17
Y MW/2.4.18
R.Corridor B / Folder 2A
Interface (Datasheet)
Mezz +3000
Pressure Sensor Px.B1.ST.048. Dwyer MS2 W101 Px.B1.ST.048.1
7.1.28 FFU ST-048 1 N/A N/A Y MW/2.4.18
& Transmitter 1 Intrument Magnesense II / Folder 2A
R.Corridor B
09/GKT/KIMIA
Dwyer PDi. B1.10
PDi. B1.10 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.11
PDi. B1.11 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Mezz +3000 Pressure Dwyer PDi. B1.13
PDi. B1.13 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
FFU ST-048 Differential Intrument (DATASHEET) / Folder 2A
7.1.29 6
R.Corridor B Indicator Dwyer
09/GKT/KIMIA
PDi. B1.14
PDi. B1.14 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.15
PDi. B1.15 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.16
PDi. B1.16 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
Mezz +3000 Temperature &
101-5284- 0436.G.Sert/01/ DTx. B1.07
7.1.30 ST-048 Humidity 1 DTx. B1.07 Azbil HTY7803D4400 Y MW/2.4.18
01115 18 (Sertificate) / Folder 2A
R.Corridor B Transmitter
060/GKT/
Human
ST-036 R. KIMIAFARMA- HMI. B1.07
7.1.31 Machine 1 HMI. B1.07 Mitsubishi GT2103PMBD 179-0929 MEP/IX/17
Y MW/2.4.18
Filling B / Folder 2A
Interface (Datasheet)
Mezz +3000
Pressure Sensor Px.B1.ST.036. Dwyer MS2 W101 0604.G.Sert/01/ Px.B1.ST.036.1
7.1.32 ST-036 R. 1 01D163 Y MW/2.4.18
& Transmitter 1 Intrument Magnesense II 18 / Folder 2A
Filling B
7.1.33 Mezz +3000 Pressure 5 PDi. B1.17 Dwyer Magnehelic N/A 09/GKT/KIMIA PDi. B1.17 Y MW/2.4.18
FFU ST-036 R. Differential Intrument FARMA-M EP/I/17 / Folder 2A
(DATASHEET)

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 CERTIFICATE/
MATERIAL SERIAL DATASHEET ACTUAL/PROJECT PASS
7.1 INITIAL/ DATE

TOTAL
LOCATION DESCRIPTION ID TAG MANUFACTUR NUMBER NO FOLDER NO. (Y/N)
TES MODEL/ TYPE INISIAL/
LOKASI DESKRIPSI NOMOR ID PRODUSEN NOMOR NOMOR HASIL AKTUAL/NO. DITERIM
T# TANGGAL
MATERIAL SERIAL SERTIFIKAT/DATA FOLDER A (Y/T)
SHEET
09/GKT/KIMIA
Dwyer PDi. B1.18
PDi. B1.18 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.19
PDi. B1.19 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Filling B Indicator Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.20
PDi. B1.20 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A
09/GKT/KIMIA
Dwyer PDi. B1.21
PDi. B1.21 Magnehelic N/A FARMA-MEP/I/17 Y MW/2.4.18
Intrument (DATASHEET) / Folder 2A

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
Pages attached (page count of any attached inventory YES Comments: None
printouts, etc): YA Catatan: Tidak Ada
Halaman yang dilampirkan (jumlah halaman yang
terlampir):

All Acceptance Criteria achieved?

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427692701.docx
8 VERIFICATION OF FILTERS
VERIFIKASI FILTER

Objective
To document any filter used by the equipment associated with the equipment that may come into contact with the
product.

Method
Record the filter details and verify that a Preventive Maintenance (PM) schedule is in place for periodic
replacement of the filter elements.

Acceptance Criteria
All filters used in the equipment and in contact with the product are documented and they are in compliance with
the SOP or PM schedule.

Result

Tujuan
Mendokumentasikan seluruh filter dalam sistem peralatan yang kontak dengan udara

Metode
Catat detil filter dan verifikasi apakah Pemeliharaan untuk penggantian filter telah dijadwalkan

Kriteria Penerimaan
Semua filter telah didokumentasikan dan telah dijadwalkan PM

Hasil

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 ACTUAL /
COMPONENTS & SERIAL PM SCHEDULE PASS
8.1 INITIAL DATE

TOTAL
LOCATION SIZE NUMBER HASIL AKTUAL/ [Y / N]
TEST LOCATION ID TAG BRAND TYPE/ MODEL INISIAL
KOMPONEN & UKURAN NOMOR JADWAL DITERIMA
NO. TANGGAL
LOKASI SERIAL PEMELIHARAA (Y/T)
N
Every 6
Mezz +6500 Prefilter RFU- MW/2/4/1
8.1.1 1 PF.RF.B1.R.1 Camfil G4 594x594x46mm N/A Month or max Y
RFU-INJ.B1 INJ.B1 8
250 Pa
Every 6
Mezz +6500 Prefilter AHU- MW/2/4/1
8.1.2 1 PF.AHU.B1.R.1 Camfil G4 594x594x46mm N/A Month or max Y
AHU-INJ.B1 INJ.B1 8
250 Pa
Every 1 year
002451091 MW/2/4/1
MDF.AHU.B1.R.1 Camfil F7 592x287x296mm or Max 400 Y
Mezz +6500 Medium Filter 72 8
Pa
8.1.3 AHU-INJ.B1 AHU-INJ.B1 2
592x287x296mm Every 1 year
004695091 MW/2/4/1
MDF.AHU.B1.R.2 Camfil F7 or Max 400 Y
72 8
Pa
592x287x296mm Every 1 year
002484111 MW/2/4/1
MDF.AHU.B1.S.1 Camfil F9 or Max 400 Y
Mezz +6500 Medium Filter 72 8
Pa
8.1.4 AHU-INJ.B1 AHU-INJ.B1 2
592x287x296mm Every 1 year
002394101 MW/2/4/1
MDF.AHU.B1.S.2 Camfil F9 or Max 400 Y
72 8
Pa
Every 1 year
Mezz +6500 HEPA Filter AHU- MW/2/4/1
8.1.5 1 HF.AHU.B1.S.1 Camfil H13 610X610X292 623510 or Max 600 Y
AHU-INJ.B1 INJ.B1 8
Pa
FFU ST-041 Every 1 year
HEPA Filter MW/2/4/1
8.1.6 R.Personal Air 1 H14.ST.041.B1.S.1 AAF H14 605x605x69mm 000007 or Max 600 Y
FFU.ST.041.B1.S.1 8
lock-8 Pa
H14 Every 1 year
FFU ST-040 R. HEPA Filter MW/2/4/1
8.1.7 1 H14.ST.040.B1.S.1 AAF 605x1215x69mm 000002 or Max 600 Y
Locker B-ON FFU.ST.040.B1.S.1 8
Pa
FFU ST-039 H14 Every 1 year
HEPA Filter MW/2/4/1
8.1.8 R.Personal Air 1 H14.ST.039.B1.S.1 AAF 605x605x69mm 000008 or Max 600 Y
FFU.ST.039.B1.S.1 8
Lock-9 Pa
H14 Every 1 year
FFU ST-038 R. HEPA Filter MW/2/4/1
8.1.9 H14.ST.038.B1.S.1 AAF 605x1215x69mm 000003 or Max 600 Y
Simpan Alat FFU.ST.038.B1.S.1 8
Pa
2
H14 Every 1 year
FFU ST-038 R. HEPA Filter MW/2/4/1
8.1.10 H14.ST.038.B1.S.2 AAF 605x1215x69mm 000047 or Max 600 Y
Simpan Alat FFU.ST.038.B1.S.2 8
Pa

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 ACTUAL /
COMPONENTS & SERIAL PM SCHEDULE PASS
8.1 INITIAL DATE

TOTAL
LOCATION SIZE NUMBER HASIL AKTUAL/ [Y / N]
TEST LOCATION ID TAG BRAND TYPE/ MODEL INISIAL
KOMPONEN & UKURAN NOMOR JADWAL DITERIMA
NO. TANGGAL
LOKASI SERIAL PEMELIHARAA (Y/T)
N
FFU ST-037 H14 Every 1 year
HEPA Filter MW/2/4/1
8.1.11 R.Cooling LAF H14.ST.037.B1.S.1 AAF 605x1215x69mm 000043 or Max 600 Y
FFU.ST.037.B1.S.1 8
Staging 3 Pa
2
FFU ST-037 H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.12 R.Cooling LAF H14.ST.037.B1.S.2 AAF 000041 or Max 600 Y
FFU.ST.037.B1.S.2 8
Staging 3 Pa
H14 605x1215x69mm Every 1 year
FFU ST-048 HEPA Filter MW/2/4/1
8.1.13 H14.ST.048.B1.S.1 AAF 000048 or Max 600 Y
R.Corridor B FFU.ST.048.B1.S.1 8
Pa
FFU ST-048 H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.14 R.Corridor B H14.ST.048.B1.S.2 AAF 000036 or Max 600 Y
FFU.ST.048.B1.S.2 8
Pa
FFU ST-048 H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.15 R.Corridor B H14.ST.048.B1.S.3 AAF 000037 or Max 600 Y
FFU.ST.048.B1.S.3 8
Pa
6
FFU ST-048 H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.16 R.Corridor B H14.ST.048.B1.S.4 AAF 000044 or Max 600 Y
FFU.ST.048.B1.S.4 8
Pa
FFU ST-048 H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.17 R.Corridor B H14.ST.048.B1.S.5 AAF 000045 or Max 600 Y
FFU.ST.048.B1.S.5 8
Pa
FFU ST-048 H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.18 R.Corridor B H14.ST.048.B1.S.6 AAF 000042 or Max 600 Y
FFU.ST.048.B1.S.6 8
Pa
5 H14 605x1215x69mm Every 1 year
FFU ST-036 R. HEPA Filter MW/2/4/1
8.1.19 H14.ST.036.B1.S.1 AAF 000040 or Max 600 Y
Filling B FFU.ST.036.B1.S.1 8
Pa
FFU ST-036 R. H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.20 Filling B H14.ST.036.B1.S.2 AAF 000039 or Max 600 Y
FFU.ST.036.B1.S.2 8
Pa
FFU ST-036 R. H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.21 Filling B H14.ST.036.B1.S.3 AAF 000038 or Max 600 Y
FFU.ST.036.B1.S.3 8
Pa
FFU ST-036 R. H14 605x1215x69mm Every 1 year
HEPA Filter MW/2/4/1
8.1.22 Filling B H14.ST.036.B1.S.4 AAF 000035 or Max 600 Y
FFU.ST.036.B1.S.4 8
Pa
8.1.23 FFU ST-036 R. HEPA Filter H14.ST.036.B1.S.5 AAF H14 605x1215x69mm 000034 Every 1 year Y MW/2/4/1
Filling B FFU.ST.036.B1.S.5 or Max 600 8

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 ACTUAL /
COMPONENTS & SERIAL PM SCHEDULE PASS
8.1 INITIAL DATE

TOTAL
LOCATION SIZE NUMBER HASIL AKTUAL/ [Y / N]
TEST LOCATION ID TAG BRAND TYPE/ MODEL INISIAL
KOMPONEN & UKURAN NOMOR JADWAL DITERIMA
NO. TANGGAL
LOKASI SERIAL PEMELIHARAA (Y/T)
N

Pa

Every 6
Mezz +6500 Prefilter EFU- MW/2/4/1
8.1.24 1 PF.EF.B1.E.1 Camfil G4 610x610x292mm N/A month or Max Y
EFU-INJ.B1 INJ.B1 8
250 Pa

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PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached inventory All Acceptance Criteria YES
printouts, etc): achieved? YA
Halaman yang dilampirkan (jumlah halaman yang
terlampir):

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427692701.docx
9 CRITICAL COMPONENT VERIFICATION
VERIFIKASI KOMPONEN KRITIS
Objective
To verify that the equipment and component meet the criteria specified in the relevant documentation – Name-Plate
verification.

Method
Visually examine all equipment components as listed in the tables below. Confirm that all specified requirements listed in
specified column in result section have been met. Record the information in the result section.

Acceptance Criteria
Equipment installed must be in conformance to specifications as listed in the “Specified” in the “Actual” section.

Result

Tujuan
Untuk melakukan verifikasi terhadap peralatan dan komponen bahwa telah memenuhi kriteria spesifikasi. Contoh
verifikasi plat mesin

Metode
Lakukan pengecekan secara visual terhadap semua peralatan dan komponen yang terpasang sudah sesuai tabel dibawah
ini. Pastikan seluruh spesifikasi penerimaan yang terdaftar telah sesuai dengan barang yang terpasang.

Kriteria Penerimaan
Peralatan yang terpasang harus sesuai dengan spesifikasi yang dicantumkan pada kolom “Spesifikasi” dan ditulis hasilnya
dalam kolom “Aktual”

Hasil

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 SPECIFICATION ACTUAL /
MATERIAL
SPESIFIKASI Project Folder PASS (Y/N) INITIAL/ DATE
LOCATION DESCRIPTION ID TAG
SERIAL NUMBER No. DITERIMA INISIAL/
LOKASI DESKRIPSI NOMOR ID MANUFACTURER MODEL/TYPE
NOMOR SERI AKTUAL/ NO. (Y/T) TANGGAL
MATERIAL PRODUSEN MODEL/TIPE
FOLDER
Mezz +6500 RFU- 13AA100L GL1608/05-2016- MF.EF.B1
9.1.1 Motor Fan Unit MF.EF.B1 Elektra Y MW/2.4.18
INJ.B1.1 ELEKTRA 04-0233 / Folder 2A
Mezz +6500 RFU- RFU-INJ.B1.01
9.1.2 Return Fan Unit RFU-INJ.B1.01 Robatherm RM06/06 98025MV Y MW/2.4.18
INJ.B1.1 / Folder 2A
Mezz +6500 RFU- GL1605/01- MF.RF.B1
9.1.3 Motor Fan Unit MF.RF.B1 Elektra 13AA801-2 Y MW/2.4.18
INJ.B1.1 2016/01-0232 / Folder 2A
Mezz +6500 RFU- Automatic Volume AVD-NC.B1.3
9.1.4 AVD-NC.B1.3 Belimo NM24A N/A Y MW/2.4.18
INJ.B1.1 Damper / Folder 2A
Mezz +6500 RFU- PT.Gedong Alumunium Seal VD.03.B1.FA.1
9.1.5 Volume Damper VD.03.B1.FA.1 N/A Y MW/2.4.18
INJ.B1.1 Karya Teknika Damper / Folder 2A
Mezz +6500 RFU- Automatic Volume AVD-NC.B1.2
9.1.6 AVD-NC.B1.2 Belimo NM24A N/A Y MW/2.4.18
INJ.B1.1 Damper / Folder 2A
Mezz +6500 RFU- VD.05.B1.FFA. PT.Gedong Alumunium Seal VD.05.B1.FFA.2
9.1.7 Volume Damper N/A Y MW/2.4.18
INJ.B1.1 2 Karya Teknika Damper / Folder 2A
Mezz +6500 RFU- Automatic Volume PT.Gedong Alumunium Seal VD.02.B1.R.1
9.1.8 VD.02.B1.R.1 N/A Y MW/2.4.18
INJ.B1.1 Damper Karya Teknika Damper / Folder 2A
Mezz +6500 AHU- AVD-NO.B1.1
9.1.9 Volume Damper AVD-NO.B1.1 Belimo NM24A N/A Y MW/2.4.18
INJ.B1 / Folder 2A
Mezz +6500 AHU- AHU-INJ-B1
9.1.10 Air Handling Unit AHU-INJ-B1 Robatherm RM0609 98025.7 Y MW/2.4.18
INJ.B1 / Folder 2A
Mezz +6500 AHU- Control Valve CVM B1-01
9.1.11 CVM B1-01 Honeywell ML7420A8088-E TJ171-50205 Y MW/2.4.18
INJ.B1 Modulation / Folder 2A
Mezz +6500 AHU- Speed Control SCO B1-01
9.1.12 SCO B1-01 Danfoss FC102 017624G127 Y MW/2.4.18
INJ.B1 (On/Off Status) / Folder 2A
Mezz +6500 AHU- Speed Control SCM B1-01
9.1.13 SCM B1-01 Danfoss FC102 017624G127 Y MW/2.4.18
INJ.B1 Modulation / Folder 2A
Mezz +6500 AHU- Control Valve CVM B1-02
9.1.14 CVM B1-02 Honeywell ML7420A8088-E TJ171-61018 Y MW/2.4.18
INJ.B1 Modulation / Folder 2A
Mezz +6500 AHU- Speed Control SCO B1-02
9.1.15 SCO B1-02 Danfoss FC102 143224 6127 Y MW/2.4.18
INJ.B1 (On/Off Status) / Folder 2A

Mezz +6500 AHU- Speed Control SCM B1-02

9.1.16 SCM B1-02 Danfoss FC102 1432246127 Y MW/2.4.18
INJ.B1 Modulation / Folder 2A

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 MATERIAL SPECIFICATION ACTUAL /
SPESIFIKASI Project Folder PASS (Y/N) INITIAL/ DATE
LOCATION DESCRIPTION ID TAG
SERIAL NUMBER No. DITERIMA INISIAL/
LOKASI DESKRIPSI NOMOR ID MANUFACTURER MODEL/TYPE
NOMOR SERI AKTUAL/ NO. (Y/T) TANGGAL
MATERIAL PRODUSEN MODEL/TIPE
FOLDER
Mezz +6500 AHU- EFU-INJ.B1.01
9.1.17 Exhaust Fan Unit EFU-INJ.B1.01 Ziehlabegg RH31C.1R/SM12 31435946 Y MW/2.4.18
INJ.B1 / Folder 2A

Mezz +6500 AHU- GL1608/05-2016- MF.EF.B1

9.1.18 Motor Fan Unit MF.EF.B1 Elektra 13AA100L Elektra Y MW/2.4.18
INJ.B1 04-0233 / Folder 2A
Mezz+3000
Control Valve CVM B1-03
9.1.19 ST-041 R.Personal CVM B1-03 Honeywell ML7420A8088-E TJ171-50153 Y MW/2.4.18
Modulation / Folder 2A
Air lock-8
Mezz+3000 ST-
X1(S)0540H.0500 HC-B1-01
9.1.20 041 R.Personal Air Heating Coil HC-B1-01 Saiver M123-26 Y MW/2.4.18
W / Folder 2A
lock-8
Mezz+3000 ST-
VD.ST.041.B1. PT.Gedong Alumunium Seal VD.ST.041.B1.S.1
9.1.21 041 R.Personal Air Volume Damper N/A Y MW/2.4.18
S.1 Karya Teknika Damper / Folder 2A
lock-8
FFU.ST.041.B1.S.
ST-041 R.Personal FFU.ST.041.B1 FFU-SS-MGS500 171800129C-(5-
9.1.22 Fan Filter Unit AAF 1 Y MW/2.4.18
Air lock-8 .S.1 RELISA 7 5)V-00007
/ Folder 2A
LRD.ST.041.B1.R.
ST-041 R.Personal LRD.ST.041.B1 PT.Gedong Alumunium Seal
9.1.23 Low Return Duct N/A 1 Y MW/2.4.18
Air lock-8 .R.1 Karya Teknika Damper
/ Folder 2A
Mezz+3000 ST-
VD.ST.041.B1. PT.Gedong Alumunium Seal VD.ST.041.B1.R.1
9.1.24 041 R.Personal Air Volume Damper N/A Y MW/2.4.18
R.1 Karya Teknika Damper / Folder 2A
lock-8
Mezz+3000
Control Valve CVM B1-04
9.1.25 ST-040 R. Locker CVM B1-04 Honeywell ML7420A8088-E TJ171-61010 Y MW/2.4.18
Modulation / Folder 2A
B-ON
Mezz+3000
X1(S)0540HH.050 HC-B1-02
9.1.26 ST-040 R. Locker Heating Coil HC-B1-02 Saiver M123-27 Y MW/2.4.18
0W / Folder 2A
B-ON
Mezz+3000
VD.ST.040.B1. PT.Gedong Alumunium Seal VD.ST.040.B1.S.1
9.1.27 ST-040 R. Locker Volume Damper N/A Y MW/2.4.18
S.1 Karya Teknika Damper / Folder 2A
B-ON
FFU.ST.040.B1.S.
ST-040 R. Locker FFU.ST.040.B1 FFU-SS-MGS500 171800176-(5-5)V-
9.1.28 Fan Filter Unit AAF 1 Y MW/2.4.18
B-ON .S.1 RELISA 7 00013
/ Folder 2A
ERD.ST.040.B1.E.
ST-040 R. Locker Exhaust Return ERD.ST.040.B1 PT.Gedong Alumunium Seal
9.1.29 N/A 1 Y MW/2.4.18
B-ON Duct .E.1 Karya Teknika Damper
/ Folder 2A
This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 MATERIAL SPECIFICATION ACTUAL /
SPESIFIKASI Project Folder PASS (Y/N) INITIAL/ DATE
LOCATION DESCRIPTION ID TAG
SERIAL NUMBER No. DITERIMA INISIAL/
LOKASI DESKRIPSI NOMOR ID MANUFACTURER MODEL/TYPE
NOMOR SERI AKTUAL/ NO. (Y/T) TANGGAL
MATERIAL PRODUSEN MODEL/TIPE
FOLDER
Mezz+3000
VD.ST.040.B1. PT.Gedong Alumunium Seal VD.ST.040.B1.E.1
9.1.30 ST-040 R. Locker Volume Damper N/A Y MW/2.4.18
E.1 Karya Teknika Damper / Folder 2A
B-ON
Mezz+3000
Control Valve CVM B1-05
9.1.31 ST-039 R.Personal CVM B1-05 Honeywell ML7420A8088-E TJ171-61006 Y MW/2.4.18
Modulation / Folder 2A
Air Lock-9
Mezz+3000
X1(S)0540HH.050 HC-B1-03
9.1.32 ST-039 R.Personal Heating Coil HC-B1-03 Saiver M123-28 Y MW/2.4.18
0W / Folder 2A
Air Lock-9
Mezz+3000
VD.ST.039.B1. PT.Gedong Alumunium Seal VD.ST.039.B1.S.1
9.1.33 ST-039 R.Personal Volume Damper N/A Y MW/2.4.18
S.1 Karya Teknika Damper / Folder 2A
Air Lock-9
FFU.ST.039.B1.S.
ST-039 R.Personal FFU.ST.039.B1 FFU-SS-MGS500 171800001C-(5-
9.1.34 Fan Filter Unit AAF 1 Y MW/2.4.18
Air Lock-9 .S.1 RELISA 7 5)V-00010
/ Folder 2A
ERD.ST.039.B1.E.
ST-039 R.Personal Exhaust Return ERD.ST.039.B1 PT.Gedong Alumunium Seal
9.1.35 N/A 1 Y MW/2.4.18
Air Lock-9 Duct .E.1 Karya Teknika Damper
/ Folder 2A
Mezz+3000
VD.ST.039.B1. PT.Gedong Alumunium Seal VD.ST.039.B1.E.1
9.1.36 ST-039 R.Personal Volume Damper N/A Y MW/2.4.18
E.1 Karya Teknika Damper / Folder 2A
Air Lock-9
Mezz+3000
Control Valve CVM B1-06
9.1.37 ST-038 R. Simpan CVM B1-06 Honeywell ML7420A8088-E TJ171-50151 Y MW/2.4.18
Modulation / Folder 2A
Alat
Mezz+3000
X1(S)0540HH.050 HC-B1-04
9.1.38 ST-038 R. Simpan Heating Coil HC-B1-04 Saiver M123-29 Y MW/2.4.18
0W / Folder 2A
Alat
Mezz+3000
VD.ST.038.B1. PT.Gedong Alumunium Seal VD.ST.038.B1.S.1
9.1.39 ST-038 R. Simpan Volume Damper N/A Y MW/2.4.18
S.1 Karya Teknika Damper / Folder 2A
Alat
FFU.ST.038.B1.S.
ST-038 R. Simpan FFU.ST.038.B1 FFU-SS-MGS500 171800010C-(5-
9.1.40 Fan Filter Unit AAF 1 Y MW/2.4.18
Alat .S.1 RELISA 7 5)V-000014
/ Folder 2A
FFU.ST.038.B1.S.
ST-038 R. Simpan FFU.ST.038.B1 FFU-SS-MGS500 171800012C-(5-
9.1.41 Fan Filter Unit AAF 2 Y MW/2.4.18
Alat .S.2 RELISA 7 5)V-000015
/ Folder 2A
LRD.ST.038.B1.R.
ST-038 R. Simpan LRD.ST.038.B1 PT.Gedong Alumunium Seal
9.1.42 Low Return Duct N/A 1 Y MW/2.4.18
Alat .R.1 Karya Teknika Damper
/ Folder 2A
This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 MATERIAL SPECIFICATION ACTUAL /
SPESIFIKASI Project Folder PASS (Y/N) INITIAL/ DATE
LOCATION DESCRIPTION ID TAG
SERIAL NUMBER No. DITERIMA INISIAL/
LOKASI DESKRIPSI NOMOR ID MANUFACTURER MODEL/TYPE
NOMOR SERI AKTUAL/ NO. (Y/T) TANGGAL
MATERIAL PRODUSEN MODEL/TIPE
FOLDER
Mezz+3000
VD.ST.038.B1. PT.Gedong Alumunium Seal VD.ST.038.B1.R.1
9.1.43 ST-038 R. Simpan Volume Damper N/A Y MW/2.4.18
R.1 Karya Teknika Damper / Folder 2A
Alat
Mezz+3000
Control Valve CVM B1-07
9.1.44 ST-037 R.Cooling CVM B1-07 Honeywell ML7420A8088-E TJ171-61065 Y MW/2.4.18
Modulation / Folder 2A
LAF Staging 3
Mezz+3000
X1(S)0540HH.050 HC-B1-05
9.1.45 ST-037 R.Cooling Heating Coil HC-B1-05 Saiver M123-30 Y MW/2.4.18
0W / Folder 2A
LAF Staging 3
Mezz+3000
VD.ST.037.B1. PT.Gedong Alumunium Seal VD.ST.037.B1.S.1
9.1.46 ST-037 R.Cooling Volume Damper N/A Y MW/2.4.18
S.1 Karya Teknika Damper / Folder 2A
LAF Staging 3
FFU.ST.037.B1.S.
ST-037 R.Cooling FFU.ST.037.B1 FFU-SS-MGS500 17180025C-(5-5)V-
9.1.47 Fan Filter Unit AAF 1 Y MW/2.4.18
LAF Staging 3 .S.1 RELISA 7 00007
/ Folder 2A
FFU.ST.037.B1.S.
ST-038 R. Simpan FFU.ST.037.B1 FFU-SS-MGS500 171800023C-(5-
9.1.48 Fan Filter Unit AAF 2 Y MW/2.4.18
Alat .S.2 RELISA 7 5)V-00002
/ Folder 2A
LRD.ST.037.B1.R.
ST-037 R.Cooling LRD.ST.037.B1 PT.Gedong Alumunium Seal
9.1.49 Low Return Duct N/A 1 Y MW/2.4.18
LAF Staging 3 .R.1 Karya Teknika Damper
/ Folder 2A
Mezz+3000
Control Valve CVM B1-08
9.1.50 ST-048 R.Corridor CVM B1-08 Honeywell ML7420A8088-E TJ171-61070 Y MW/2.4.18
Modulation / Folder 2A
B
Mezz+3000
X1(S)0540HH.035 HC-B1-06
9.1.51 ST-048 R.Corridor Heating Coil HC-B1-06 Saiver M123-31 Y MW/2.4.18
00W / Folder 2A
B
Mezz+3000
VD.ST.048.B1. PT.Gedong Alumunium Seal VD.ST.048.B1.S.1
9.1.52 ST-048 R.Corridor Volume Damper N/A Y MW/2.4.18
S.1 Karya Teknika Damper / Folder 2A
B
FFU.ST.048.B1.S.
ST-048 R.Corridor FFU.ST.048.B1 FFU-SS-MGS500 171800011C-(5-
9.1.53 Fan Filter Unit AAF 1 Y MW/2.4.18
B .S.1 RELISA 7 5)V-00010
/ Folder 2A
FFU.ST.048.B1.S.
ST-048 R.Corridor FFU.ST.048.B1 FFU-SS-MGS500 171800015C-(5-
9.1.54 Fan Filter Unit AAF 2 Y MW/2.4.18
B .S.2 RELISA 7 5)V-000011
/ Folder 2A
FFU.ST.048.B1.S.
ST-048 R.Corridor FFU.ST.048.B1 FFU-SS-MGS500 171800005C-(5-
9.1.55 Fan Filter Unit AAF 3 Y MW/2.4.18
B .S.3 RELISA 7 5)V-000012
/ Folder 2A
This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 MATERIAL SPECIFICATION ACTUAL /
SPESIFIKASI Project Folder PASS (Y/N) INITIAL/ DATE
LOCATION DESCRIPTION ID TAG
SERIAL NUMBER No. DITERIMA INISIAL/
LOKASI DESKRIPSI NOMOR ID MANUFACTURER MODEL/TYPE
NOMOR SERI AKTUAL/ NO. (Y/T) TANGGAL
MATERIAL PRODUSEN MODEL/TIPE
FOLDER
FFU.ST.048.B1.S.
ST-048 R.Corridor FFU.ST.048.B1 FFU-SS-MGS500 17180018C-(5-5)V-
9.1.56 Fan Filter Unit AAF 4 Y MW/2.4.18
B .S.4 RELISA 7 000004
/ Folder 2A
FFU.ST.048.B1.S.
ST-048 R.Corridor FFU.ST.048.B1 FFU-SS-MGS500 171800196C-(5-
9.1.57 Fan Filter Unit AAF 5 Y MW/2.4.18
B .S.5 RELISA 7 5)V-000005
/ Folder 2A
FFU.ST.048.B1.S.
ST-048 R.Corridor FFU.ST.048.B1 FFU-SS-MGS500 171800198C-(5-
9.1.58 Fan Filter Unit AAF 6 Y MW/2.4.18
B .S.6 RELISA 7 5)V-000006
/ Folder 2A
LRD.ST.048.B1.R.
ST-048 R.Corridor LRD.ST.048.B1 PT.Gedong Alumunium Seal
9.1.59 Low Return Duct N/A 1 Y MW/2.4.18
B .R.1 Karya Teknika Damper
/ Folder 2A
ST-048 R.Corridor VD.ST.048.B1. PT.Gedong Alumunium Seal VD.ST.048.B1.R.1
9.1.60 Volume Damper N/A Y MW/2.4.18
B R.1 Karya Teknika Damper / Folder 2A
Mezz+3000 Control Valve CVM B1-09
9.1.61 CVM B1-09 Honeywell ML7420A8088-E TJ171-61068 Y MW/2.4.18
ST-036 R. Filling B Modulation / Folder 2A
Mezz+3000 X1(S)0540HH.050 HC-B1-07
9.1.62 Heating Coil HC-B1-07 Saiver M123-32 Y MW/2.4.18
ST-036 R. Filling B 0W / Folder 2A
Mezz+3000 VD.ST.036.B1. PT.Gedong Alumunium Seal VD.ST.036.B1.S.1
9.1.63 Volume Damper N/A Y MW/2.4.18
ST-036 R. Filling B S.1 Karya Teknika Damper / Folder 2A
FFU.ST.036.B1.S.
FFU.ST.036.B1 FFU-SS-MGS500 171800020C-(5-
9.1.64 ST-036 R. Filling B Fan Filter Unit AAF 1 Y MW/2.4.18
.S.1 RELISA 7 5)V-00003
/ Folder 2A
FFU.ST.036.B1.S.
FFU.ST.036.B1 FFU-SS-MGS500 171800022C-(5-
9.1.65 ST-036 R. Filling B Fan Filter Unit AAF 2 Y MW/2.4.18
.S.2 RELISA 7 5)V-00022
/ Folder 2A
FFU.ST.036.B1.S.
FFU.ST.036.B1 FFU-SS-MGS500 17180015SC-(5-
9.1.66 ST-036 R. Filling B Fan Filter Unit AAF 3 Y MW/2.4.18
.S.3 RELISA 7 5)V-000046
/ Folder 2A
FFU.ST.036.B1.S.
FFU.ST.036.B1 FFU-SS-MGS500 171800008C-(5-
9.1.67 ST-036 R. Filling B Fan Filter Unit AAF 4 Y MW/2.4.18
.S.4 RELISA 7 5)V-000047
/ Folder 2A
FFU.ST.036.B1.S.
FFU.ST.036.B1 FFU-SS-MGS500 171800044C-(5-
9.1.68 ST-036 R. Filling B Fan Filter Unit AAF 5 Y MW/2.4.18
.S.5 RELISA 7 5)V-00048
/ Folder 2A
LRD.ST.036.B1.R.
LRD.ST.036.B1 PT.Gedong Alumunium Seal
9.1.69 ST-036 R. Filling B Low Return Duct N/A 1 Y MW/2.4.18
.R.1 Karya Teknika Damper
/ Folder 2A
This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 MATERIAL SPECIFICATION ACTUAL /
SPESIFIKASI Project Folder PASS (Y/N) INITIAL/ DATE
LOCATION DESCRIPTION ID TAG
SERIAL NUMBER No. DITERIMA INISIAL/
LOKASI DESKRIPSI NOMOR ID MANUFACTURER MODEL/TYPE
NOMOR SERI AKTUAL/ NO. (Y/T) TANGGAL
MATERIAL PRODUSEN MODEL/TIPE
FOLDER
Mezz+3000 VD.ST.036.B1. PT.Gedong Alumunium Seal VD.ST.036.B1.R.1
9.1.70 Volume Damper N/A Y MW/2.4.18
ST-036 R. Filling B R.1 Karya Teknika Damper / Folder 2A

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached All Acceptance Criteria YES
inventory printouts, etc): achieved? YA
Halaman yang dilampirkan (jumlah halaman yang
terlampir):

This document & attachments are the LEGAL Intellectual Property of Gedong Karya Teknika and has been issued to
PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
10 HEPA FILTER INTEGRITY TESTING
TES INTEGRITAS FILTER HEPA

Objective : To verify that the HEPA filter is in good condition without any leakage.
Procedure: Perform integrity test to each HEPA filter to check the aerosol penetration. Record and attach the test result
Use additional sheet(s), if necessary, and attach to this protocol-report.
Acceptance Criteria : Aerosol penetration is not more than (NMT) 0.01% for each HEPA filter area.

Tujuan : Untuk melakukan verifikasi filter HEPA bahwa dalam keadaan baik dan tidak bocor
Prosedur: Lakukan tes integritas pada setiap filter HEPA menggunakan aerosol, dan lakukan pengecekan
kebocorannya. Rekam hasil sesuai pengetesan dan lampirkan hasil uji

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PT. Kimia Farma. Do not to be distributed to other parties without authorization from Gedong Karya Teknika
427692701.docx
 Total Acceptance
Criteria Met? (Y,N)
10.1 Filter IDE Specification Actual Result Initials &Date
(Kriteria VRF#.
TEST # (Nomor ID) (Spesifikasi) (Hasil Aktual) (Inisial/Tanggal)
Penerimaan Telah
Sesuai? Y/T)
1 Aerosol penetration is not more than (NMT)
H-14.ST.041.B1.S.1
10.1.1 0.01% N/A N/A N/A N/A
R. PERSONAL AIR LOCK-8
Kebocoran aerosol tidak lebih dari 0.01%
1 Aerosol penetration is not more than (NMT)
H-14.ST.040.B1.S.1
10.1.2 0.01% N/A N/A N/A N/A
R. LOCKER B-ON
Kebocoran aerosol tidak lebih dari 0.01%
1 Aerosol penetration is not more than (NMT)
H-14.ST.039.B1.S.1
10.1.3 0.01% N/A N/A N/A N/A
R. PERSONAL AIR LOCK-9
Kebocoran aerosol tidak lebih dari 0.01%
2 Aerosol penetration is not more than (NMT)
H-14.ST.038.B1.S.1
10.1.4 0.01% N/A N/A N/A N/A
R. SIMPAN ALAT
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.038.B1.S.2
10.1.5 0.01% N/A N/A N/A N/A
R. SIMPAN ALAT
Kebocoran aerosol tidak lebih dari 0.01%
2 Aerosol penetration is not more than (NMT)
H-14.ST.037.B1.S.1
10.1.6 0.01% N/A N/A N/A N/A
R. COOLING LAF STAGING -3
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.037.B1.S.2
10.1.7 0.01% N/A N/A N/A N/A
R. COOLING LAF STAGING -3
Kebocoran aerosol tidak lebih dari 0.01%
10.1.8 H-14.ST.048.B1.S.1 6 Aerosol penetration is not more than (NMT) N/A N/A N/A N/A
R. CORRIDOR – B 0.01%
Kebocoran aerosol tidak lebih dari 0.01%

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 Total Acceptance
Criteria Met? (Y,N)
10.1 Filter IDE Specification Actual Result Initials &Date
(Kriteria VRF#.
TEST # (Nomor ID) (Spesifikasi) (Hasil Aktual) (Inisial/Tanggal)
Penerimaan Telah
Sesuai? Y/T)
Aerosol penetration is not more than (NMT)
H-14.ST.048.B1.S.2 0.01%
10.1.9 N/A N/A N/A N/A
R. CORRIDOR – B Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.048.B1.S.3
10.1.10 0.01% N/A N/A N/A N/A
R. CORRIDOR – B
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.048.B1.S.4
10.1.11 0.01% N/A N/A N/A N/A
R. CORRIDOR – B
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.048.B1.S.5
10.1.12 0.01% N/A N/A N/A N/A
R. CORRIDOR – B
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.048.B1.S.6 0.01%
10.1.13 N/A N/A N/A N/A
R. CORRIDOR – B
Kebocoran aerosol tidak lebih dari 0.01%
5 Aerosol penetration is not more than (NMT)
H-14.ST.036.B1.S.1
10.1.14 0.01% N/A N/A N/A N/A
R.FILLING B
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.036.B1.S.2
10.1.15 0.01% N/A N/A N/A N/A
R.FILLING B
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.036.B1.S.3
10.1.16 0.01% N/A N/A N/A N/A
R.FILLING B
Kebocoran aerosol tidak lebih dari 0.01%
Aerosol penetration is not more than (NMT)
H-14.ST.036.B1.S.4
10.1.17 0.01% N/A N/A N/A N/A
R.FILLING B
Kebocoran aerosol tidak lebih dari 0.01%

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 Total Acceptance
Criteria Met? (Y,N)
10.1 Filter IDE Specification Actual Result Initials &Date
(Kriteria VRF#.
TEST # (Nomor ID) (Spesifikasi) (Hasil Aktual) (Inisial/Tanggal)
Penerimaan Telah
Sesuai? Y/T)
Aerosol penetration is not more than (NMT)
H-14.ST.036.B1.S.5
10.1.18 0.01% N/A N/A N/A N/A
R.FILLING B
Kebocoran aerosol tidak lebih dari 0.01%
1 Aerosol penetration is not more than (NMT)
HF.AHU.B1.S.1
10.1.19 0.01% N/A N/A N/A N/A
AHU-INJ.B1
Kebocoran aerosol tidak lebih dari 0.01%

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Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached All Acceptance Criteria achieved? YES
inventory printouts, etc): YA
Halaman yang dilampirkan (jumlah halaman yang
terlampir):

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11 PROCEDURE VERIFICATION
VERIFIKASI PROSEDUR
Objective :
To provide documented evidence that required Operation, Maintenance, Cleaning and
Calibration procedures associated with the system are approved, equipment logbooks are
available, and required preventative maintenance and calibration schedules (e.g. MERPs or
CMMS) have been created/updated.
Procedure :
1. Review the Operation, Maintenance, Cleaning and Calibration procedures and equipment
logbooks available for the system.
2. Record the document title, revision, version, issue date and approval status.
3. Confirm that the required preventative maintenance and calibration schedules (e.g. MERPs)
have been created/updated.
Acceptance Criteria :
4. Required Operation, Maintenance, Cleaning and Calibration procedures are available and
approved and equipment logbooks are available.
5. Required preventative maintenance and calibration schedules (e.g. MERPs or CMMS) have
been created/updated.

Tujuan :
Mendokumentasikan bukti prosedur operasional, pemeliharaan, pembersihan dan kalibrasi
peralatan. Memastikan logbook, jadwal pemeliharaan dan kalibrasi telah tersedia (contoh:
MERPs, CMMS, atau system pemeliharaan lainnya)
Prosedur :
6. Lakukan pengkajian terhadap prosedur operasional, pemeliharaan, pembersihan dan
kalibrasi. Pastikan logbook telah tersedia
7. Catat Judul, Nomor Perubahan, Versi, Tanggal Pengesahan dan Status
8. Konfirmasi bahwan jadwal pemeliharaan dan kalibrasi telah di input atau dibuat dalam
sistem (contoh: MERPs, CMMS, atau system pemeliharaan lainnya)
Kriteria Penerimaan :
9. Prosedur operasional, pemeliharaan, pembersihan dan kalibrasi telah tersedia dan telah
disahkan.
10. Log book tersedia
11. Jadwal pemeliharaan dan kalibrasi telah dibuat dalam system (contoh: MERPs, CMMS, atau
system pemeliharaan lainnya)

Approved Issued Date

Document Title Revision No. Version
No. (Yes/No) Tanggal
Judul Dokumen Nomor Perubahan Versi
Diterima (Y/T) Pengesahan

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 Approved Issued Date
Document Title Revision No. Version
No. (Yes/No) Tanggal
Judul Dokumen Nomor Perubahan Versi
Diterima (Y/T) Pengesahan

Preventive Maintenance and Calibration Documentation Tasks No.

Bukti dokumen jadwal pemeliharaan dan kalibrasi Nomor Pekerjaan
Logbook No.:
Nomor Logbook:
Comments: None
Catatan: Tidak Ada

Pages attached (page count of any attached inventory All Acceptance Criteria achieved? YES
printouts, etc): YA
Halaman yang dilampirkan (jumlah halaman yang
terlampir):

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12 IQ VARIANCE REPORT
LAPORAN DEVIASI KI

Report any protocol variances from the acceptance criteria or from protocol instructions that occur during execution in the
Variance Report Form.

Laporkan seluruh hasil yang deviasi dari kriteria penerimaan yang telah di instruksikan dalam protocol ini. Jabarkan deviasi
(VRF) pada tabel deviasi dibawah ini.

Test Section No. Test Page No.

Test# VRF # Status
Nomor Pengujian Nomor Lembar Pengujian
N/A N/A N/A N/A N/A

Comments:

Reviewed by Date

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13 VARIANCE REPORT FORM ATTACHMENT No: ……………………..
LAMPIRAN LAPORAN DEVIASI LAMPIRAN NOMOR:…………………….

Instructions:
• Use this form to document deviation from protocol
• Attach additional pages, if required to fully explain the issues.

Instruksi:
Gunakan lembar dibawah ini untuk mendokumentasikan deviasi pengujian protocol ini
Lampirkan tambahan lembar deviasi apabila diperlukan

VARIANCE
VRF #: Qualification Document Number: Qualification Document Title:
Nomor Dokumen Kualifikasi: Judul Dokumen Kualifikasi:
Rev #:
Proses Affected: Section: Step(s): Page:
Proses yang Terkena Dampak N/A Bagian: N/A Langkah- Halaman:N/A
langkah:N/A

DESCRIPTION OF VARIANCE
A Expected Results:
Hasil yAng Diinginkan
N/A

B Observed Results:
Hasil yang Didapatkan
N/A

Initiated by: Date:

Dibuat oleh: Tanggal

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RESOLUTION / EXPLANATION
A INVESTIGATION, VALIDATION IMPACT, PROPOSED CORRECTIVE & PREVENTATIVE ACTION INCLUDING
COMPLETION DATES
Hasil Investigasi Dampak Terhadap Validasi, Kegiatan Perbaikan dan Pemeliharaan yang Diajukan,
Termasuk Batas Waktunya
Investigation:
Hasil Investigasi:
N/A

Validation Impact:
Dampak Terhadap Validasi

Corrective Action: Target Date for Completion

Langkah Perbaikan: Batas Waktu:

Preventative Action: Target Date for Completion

Kegiatan Pemeliharaan Batas Waktu

Proposed by: Date:

Dibuat Oleh: Tanggal

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 B APPROVAL OF CORRECTIVE & PREVENTATIVE ACTION
Lembar Pengesahan untuk Langkah Perbaikan dan Pemeliharaan

Critical Variance Non-Critical Variance

Kategori Deviasi yang Kritis Kategori Deviasi yang Tidak Kritis

Proposal Accepted Proposal Rejected

Langkah Perbaikan dan Pemeliharaan Diterima Langkah Perbaikan dan Pemeliharaan Ditolak

Comments (if any):

Catatan (Apabila ada):

N/A

Approved by (System Owner): Date:

Disetujui oleh (Pengguna Sistem) Tanggal:

Approved by (Validation): Date:

Disetujui oleh (Validasi) Tanggal:

Approved by (Quality): Date:

Disetujui oleh (Pemastian Mutu) Tanggal

C CORRECTIVE & PREVENTATIVE ACTION FOLLOW UP / RESULTS

Langkah Perbaikan & Pemeliharaan Lanjutan / Hasilnya
Results:
Hasil:

N/A

Conclusion: Meets the Acceptance Criteria – Does not meet the Acceptance Criteria - Rejected
Kesimpulan Accepted
Sesuai dengan kriteria penerimaan Tidak sesuai dengan kriteria penerimaan dan ditolak
dan telah diterima

Action by: Date:

CLOSE OUT
Penutup
Approved by (Validation Manager): Date:
Disetujui oleh Validasi:
Approved by (System Owner): Date:
Disetujui oleh Pengguna Sistem:
Approved by (Quality): Date:
Disetujui oleh Pemastian Mutu

14 LIST OF ATTACHMENTS
LEMBAR LAMPIRAN

Appendix Document Title

No. Judul Dokumen
Lampiran

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Ke.

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