PT Bio Farma ( Persero )

Jl. Pasteur 28 Bandung

Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.22
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.22 1-2 (B) CA AS SP

Tgl
Monitoring GP2.22 1-2 GP2.22 1-2 GP2.22 1-2 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP CA Limit CA AS Limit AS SP Limit SP
1/28/2021 0 14 0 5 4 10 4 5 4 50121 Formulasi Validasi Aseptic Fill Uniject
2/4/2021 0 6 0 5 4 10 4 5 4 5150473 Distribusi FAB
2/8/2021 0 0 0 5 4 10 4 5 4 5150465-5150466 Distribusi FAB
2/9/2021 0 0 2 5 4 10 4 5 4 0119 Distribusi TAM
2/12/2021 0 7 0 5 4 10 4 5 4 5150465 112-RA-EM-2021 Formulasi 3 FPVP
2/13/2021 0 2 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 3 FPVP
2/13/2021 0 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 3 FPVP
2/15/2021 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 3 FPVP
2/18/2021 0 9 2 5 4 10 4 5 4 0319 112-RA-EM-2021 Formulasi 3 FPVP
2/19/2021 0 4 1 5 4 10 4 5 4 5150465 112-RA-EM-2021 Formulasi 3 FPVP
2/20/2021 0 0 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 3 FPVP
2/20/2021 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 3 FPVP
2/22/2021 0 0 0 5 4 10 4 5 4 0519 112-RA-EM-2021 Formulasi 3 FPVP
2/23/2021 0 2 0 5 4 10 4 5 4 5150473 112-RA-EM-2021 Formulasi 3 FPVP
2/25/2021 0 2 0 5 4 10 4 5 4 0619 112-RA-EM-2021 Formulasi 3 FPVP
2/27/2021 0 0 0 5 4 10 4 5 4 00621 112-RA-EM-2021 Formulasi 3 FPVP
2/27/2021 1 5 4 10 4 5 4 00621 112-RA-EM-2021 Formulasi 3 FPVP
3/3/2021 0 0 0 5 4 10 4 5 4 5150469 112-RA-EM-2021 Formulasi 3 FPVP

Average 0 3 0
SD 0 4 1
Ave + 3 SD 0 16 2

Trend Hasil Mikrobiologi Kelas B GP2.22 1-2

Bagian FPVP
Pemantauan Lingkungan
15
No.#.100K-SIS-EM
14
13
12
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.22
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.22 1-2 (B) CA AS SP

Tgl
Monitoring GP2.22 1-2 GP2.22 1-2 GP2.22 1-2 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP CA Limit CA AS Limit AS SP Limit SP
Trend Hasil Mikrobiologi Kelas B GP2.22 1-2
Bagian FPVP
15
14
13
12
11
10
9
8
7
6
5
4
3
2
1
0
2/4/2021

2/8/2021

2/9/2021

2/20/2021

2/22/2021

3/3/2021
1/28/2021

2/12/2021

2/13/2021

2/13/2021

2/15/2021

2/18/2021

2/19/2021

2/20/2021

2/23/2021

2/25/2021

2/27/2021

2/27/2021
Tanggal Uji

GP2.22 1-2 CA GP2.22 1-2 SP Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA

Action Limit AS Action Limit SP GP2.22 1-2 AS

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian: FPVP
AS 10 7 cfu/m3 No ID Ruang: GP2.21

SP 5 3 cfu/plates/4
jam
FD 5 3 cfu/glove

GP2.19 I-7
(B) CA AS SP
Tgl
Monitoring GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP
1/25/2021 0 0 0 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/26/2021 0 2 3 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/27/2021 0 3 2 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/29/2021 0 6 0 0 0 5 4 10 4 5 4 20121 112-RA-EM-2021 Formulasi 2 FPVP
1/30/2021 0 0 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/1/2021 0 4 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/2/2021 0 0 2 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/3/2021 0 8 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/4/2021 0 4 2 3 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/5/2021 0 0 0 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 2 FPVP
2/10/2021 0 4 2 1 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 2 FPVP
2/11/2021 0 0 0 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/12/2021 0 3 0 2 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/13/2021 0 3 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/17/2021 0 1 1 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/18/2021 0 1 0 0 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/19/2021 0 0 1 0 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/20/2021 0 3 1 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/22/2021 0 0 0 0 5 4 10 4 5 4 00421 112-RA-EM-2021 Formulasi 2 FPVP
2/24/2021 0 0 0 0 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/25/2021 0 6 1 2 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
2/26/2021 0 1 1 1 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
2/27/2021 0 0 0 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
3/1/2021 0 0 0 0 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP
3/2/2021 0 1 1 0 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP
3/3/2021 0 1 0 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian: FPVP
AS 10 7 cfu/m3 No ID Ruang: GP2.21

SP 5 3 cfu/plates/4
jam
FD 5 3 cfu/glove

GP2.19 I-7
(B) CA AS SP
Tgl
Monitoring GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP
3/5/2021 0 2 2 0 5 4 10 4 5 4 00720 112-RA-EM-2021 Formulasi 2 FPVP

Average 0 2 1 0 0
SD 0 2 1 1 0
Ave + 3 SD 0 9 3 3 0

Trend Hasil Mikrobiologi Kelas B GP2.21 I-3

Bagian FPVP
10
9
8
7
6
5
4
3
2
1
0
1/26/2021

1/29/2021

2/2/2021

2/3/2021

2/4/2021

2/5/2021

2/11/2021

2/13/2021

2/18/2021

2/26/2021

3/1/2021

3/3/2021
1/25/2021

1/27/2021

1/30/2021

2/1/2021

2/10/2021

2/12/2021

2/17/2021

2/19/2021

2/20/2021

2/22/2021

2/24/2021

2/25/2021

2/27/2021

3/2/2021

3/5/2021
Pemantauan Lingkungan Tanggal Uji
No.#.100K-SIS-EM
GP2.19 I-7 CA Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA
Action Limit AS Action Limit SP GP2.19 I-7 AS GP2.19 I-7 SP 1 GP2.19 I-7 SP 2
 10
9
PT Bio Farma ( Persero
8 )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan
7
6
Spesifikasi Action limit Satuan
5
CA 5 3 cfu/plates Nama Bagian: FPVP
AS 4 10 7 cfu/m3 No ID Ruang: GP2.21
3 cfu/plates/4
SP 5 3
2 jam
FD 1 5 3 cfu/glove
0 GP2.19 I-7
CA AS SP
1/26/2021

1/29/2021

2/2/2021

2/3/2021

2/4/2021

2/5/2021

2/11/2021

2/13/2021

2/18/2021

2/26/2021

3/1/2021

3/3/2021
1/25/2021

1/27/2021

1/30/2021

2/1/2021

2/10/2021

2/12/2021

2/17/2021

2/19/2021

2/20/2021

2/22/2021

2/24/2021

2/25/2021

2/27/2021

3/2/2021

3/5/2021
(B)
Tgl
Monitoring GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 GP2.19 I-7 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP

Tanggal Uji
GP2.19 I-7 CA Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA
Action Limit AS Action Limit SP GP2.19 I-7 AS GP2.19 I-7 SP 1 GP2.19 I-7 SP 2
GP2.19 I-7 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian: FPVP
AS 10 7 cfu/m3 No ID Ruang: GP2.21

SP 5 3 cfu/plates/4
jam
FD 5 3 cfu/glove

GP2.19 I-8
(B) CA AS SP
Tgl
Monitoring GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP
1/25/2021 0 0 0 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/26/2021 0 0 0 1 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/27/2021 0 3 1 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/29/2021 0 2 0 0 0 5 4 10 4 5 4 20121 112-RA-EM-2021 Formulasi 2 FPVP
1/30/2021 0 0 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/1/2021 0 6 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/2/2021 0 0 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/3/2021 0 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/4/2021 0 0 1 4 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/5/2021 0 0 2 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 2 FPVP
2/10/2021 0 8 1 2 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 2 FPVP
2/11/2021 0 0 0 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/12/2021 0 0 0 1 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/13/2021 0 4 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/17/2021 0 0 1 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/18/2021 0 2 0 0 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/19/2021 0 2 1 1 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/20/2021 0 7 1 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/22/2021 0 0 2 0 5 4 10 4 5 4 00421 112-RA-EM-2021 Formulasi 2 FPVP
2/24/2021 0 0 0 0 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/25/2021 0 2 2 0 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
2/26/2021 0 0 4 3 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
2/27/2021 0 10 0 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
3/1/2021 0 0 2 0 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP
3/2/2021 0 0 0 2 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP
3/3/2021 0 1 0 0 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian: FPVP
AS 10 7 cfu/m3 No ID Ruang: GP2.21

SP 5 3 cfu/plates/4
jam
FD 5 3 cfu/glove

GP2.19 I-8
(B) CA AS SP
Tgl
Monitoring GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP
3/5/2021 0 0 0 5 4 10 4 5 4 00720 112-RA-EM-2021 Formulasi 2 FPVP

Average 0 2 1 1 0
SD 0 3 1 1 0
Ave + 3 SD 0 10 4 4 0

Trend Hasil Mikrobiologi Kelas B GP2.21 I-3

Bagian FPVP
10
9
8
7
6
5
4
3
2
1
0
1/26/2021

1/29/2021

2/2/2021

2/3/2021

2/4/2021

2/5/2021

2/11/2021

2/13/2021

2/18/2021

2/26/2021

3/1/2021

3/3/2021
1/25/2021

1/27/2021

1/30/2021

2/1/2021

2/10/2021

2/12/2021

2/17/2021

2/19/2021

2/20/2021

2/22/2021

2/24/2021

2/25/2021

2/27/2021

3/2/2021

3/5/2021
Pemantauan Lingkungan Tanggal Uji
No.#.100K-SIS-EM
GP2.19 I-8 CA Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA
Action Limit AS Action Limit SP GP2.19 I-8 AS GP2.19 I-8 SP 1 GP2.19 I-8 SP 2
 10
9
PT Bio Farma ( Persero
8 )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan
7 Partikel
6
Spesifikasi Action limit Satuan
5
CA 5 3 cfu/plates Nama Bagian: FPVP
AS 4 10 7 cfu/m3 No ID Ruang: GP2.21
3 cfu/plates/4
SP 5 3
2 jam
FD 1 5 3 cfu/glove
0 GP2.19 I-8
CA AS SP
1/26/2021

1/29/2021

2/2/2021

2/3/2021

2/4/2021

2/5/2021

2/11/2021

2/13/2021

2/18/2021

2/26/2021

3/1/2021

3/3/2021
1/25/2021

1/27/2021

1/30/2021

2/1/2021

2/10/2021

2/12/2021

2/17/2021

2/19/2021

2/20/2021

2/22/2021

2/24/2021

2/25/2021

2/27/2021

3/2/2021

3/5/2021
(B)
Tgl
Monitoring GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 GP2.19 I-8 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP

Tanggal Uji
GP2.19 I-8 CA Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA
Action Limit AS Action Limit SP GP2.19 I-8 AS GP2.19 I-8 SP 1 GP2.19 I-8 SP 2
GP2.19 I-8 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian: FPVP
AS 10 7 cfu/m3 No ID Ruang: GP2.21

SP 5 3 cfu/plates/4
jam
FD 5 3 cfu/glove

GP2.19 I-9
(B) CA AS SP
Tgl
Monitoring GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP
1/25/2021 0 0 0 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/26/2021 0 1 0 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/27/2021 0 4 0 0 5 4 10 4 5 4 30121 112-RA-EM-2021 Formulasi 2 FPVP
1/29/2021 0 0 0 0 0 5 4 10 4 5 4 20121 112-RA-EM-2021 Formulasi 2 FPVP
1/30/2021 0 0 0 1 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/1/2021 0 0 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/2/2021 0 0 0 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/3/2021 0 8 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/4/2021 0 0 2 0 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 2 FPVP
2/5/2021 0 0 1 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 2 FPVP
2/10/2021 0 9 0 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 2 FPVP
2/11/2021 0 2 0 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/12/2021 0 1 0 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/13/2021 0 0 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/17/2021 0 0 1 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 2 FPVP
2/18/2021 0 4 3 0 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/19/2021 0 1 1 5 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/20/2021 0 5 1 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/22/2021 0 5 0 0 5 4 10 4 5 4 00421 112-RA-EM-2021 Formulasi 2 FPVP
2/24/2021 0 0 0 0 5 4 10 4 5 4 00521 112-RA-EM-2021 Formulasi 2 FPVP
2/25/2021 0 2 1 0 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
2/26/2021 0 1 0 2 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
2/27/2021 0 7 1 5 4 10 4 5 4 00721 112-RA-EM-2021 Formulasi 2 FPVP
3/1/2021 0 0 1 0 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP
3/2/2021 0 0 0 0 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP
3/3/2021 0 5 1 5 4 10 4 5 4 00821 112-RA-EM-2021 Formulasi 2 FPVP

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian: FPVP
AS 10 7 cfu/m3 No ID Ruang: GP2.21

SP 5 3 cfu/plates/4
jam
FD 5 3 cfu/glove

GP2.19 I-9
(B) CA AS SP
Tgl
Monitoring GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP
3/5/2021 0 0 1 0 5 4 10 4 5 4 00720 112-RA-EM-2021 Formulasi 2 FPVP

Average 0 2 1 0 0
SD 0 3 1 1 0
Ave + 3 SD 0 10 3 4 0

Trend Hasil Mikrobiologi Kelas B GP2.21 I-3

Bagian FPVP
10
9
8
7
6
5
4
3
2
1
0
1/26/2021

1/29/2021

2/2/2021

2/3/2021

2/4/2021

2/5/2021

2/11/2021

2/13/2021

2/18/2021

2/26/2021

3/1/2021

3/3/2021
1/25/2021

1/27/2021

1/30/2021

2/1/2021

2/10/2021

2/12/2021

2/17/2021

2/19/2021

2/20/2021

2/22/2021

2/24/2021

2/25/2021

2/27/2021

3/2/2021

3/5/2021
Pemantauan Lingkungan Tanggal Uji
No.#.100K-SIS-EM
GP2.19 I-9 CA Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA
Action Limit AS Action Limit SP GP2.19 I-9 AS GP2.19 I-9 SP 1 GP2.19 I-9 SP 2
 10
9
PT Bio Farma ( Persero
8 )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan
7 Partikel
6
Spesifikasi Action limit Satuan
5
CA 5 3 cfu/plates Nama Bagian: FPVP
AS 4 10 7 cfu/m3 No ID Ruang: GP2.21
3 cfu/plates/4
SP 5 3
2 jam
FD 1 5 3 cfu/glove
0 GP2.19 I-9
CA AS SP
1/26/2021

1/29/2021

2/2/2021

2/3/2021

2/4/2021

2/5/2021

2/11/2021

2/13/2021

2/18/2021

2/26/2021

3/1/2021

3/3/2021
1/25/2021

1/27/2021

1/30/2021

2/1/2021

2/10/2021

2/12/2021

2/17/2021

2/19/2021

2/20/2021

2/22/2021

2/24/2021

2/25/2021

2/27/2021

3/2/2021

3/5/2021
(B)
Tgl
Monitoring GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 GP2.19 I-9 Spesifikasi Action Spesifikasi Action Spesifikasi Action No Batch Nama Proses
CA AS SP 1 SP 2 SP 3 CA Limit CA AS Limit AS SP Limit SP

Tanggal Uji
GP2.19 I-9 CA Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA
Action Limit AS Action Limit SP GP2.19 I-9 AS GP2.19 I-9 SP 1 GP2.19 I-9 SP 2
GP2.19 I-9 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.20 I-3 (B) CA AS SP

Tgl
No Batch Nama Proses
Monitoring GP2.20 I-3 GP2.20 I-3 GP2.20 I-3 GP2.20 I-3 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP
2/4/2021 0 4 2 5 4 10 4 5 4 9910121 112-RA-EM-2021 Filling Ampul 2
2/5/2021 0 3 0 4 5 4 10 4 5 4 9910221 112-RA-EM-2021 Filling Ampul 2
2/9/2021 0 4 2 5 4 10 4 5 4 9910321 112-RA-EM-2021 Filling Ampul 2
2/10/2021 0 0 2 5 4 10 4 5 4 9910421 112-RA-EM-2021 Filling Ampul 2
2/12/2021 0 9 5 5 4 10 4 5 4 9910521 112-RA-EM-2021 Filling Ampul 2
2/16/2021 0 0 0 5 4 10 4 5 4 9910621 112-RA-EM-2021 Filling Ampul 2
2/17/2021 0 0 1 5 4 10 4 5 4 9910721 112-RA-EM-2021 Filling Ampul 2
2/17/2021 0 0 0 5 4 10 4 5 4 9910821 112-RA-EM-2021 Filling Ampul 2
3/5/2021 0 2 2 5 4 10 4 5 4 9910921 112-RA-EM-2021 Filling Ampul 2
3/16/2021 5 4 10 4 5 4 9911021 112-RA-EM-2021 Filling Ampul 2

Average 0 2 2 4
SD 0 3 2 0
Ave + 3 SD 0 11 6 0

Trend Hasil Mikrobiologi Kelas B GP2.20 I-3

Bagian FPVP
20
18
16
14
12
10
Pemantauan8Lingkungan
6
No.#.100K-SIS-EM
4
2
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
Trend Hasil Mikrobiologi Kelas B GP2.20 I-3
FD 5 3 cfu/glove Bagian FPVP
20
18 GP2.20 I-3 (B) CA AS SP
Tgl 16
No Batch Nama Proses
14 GP2.20 I-3
Monitoring GP2.20 I-3 GP2.20 I-3 GP2.20 I-3 Spesifikasi Action Spesifikasi Action Spesifikasi Action
12 CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP
10
8
6
4
2
0
2/4/2021

2/9/2021

2/10/2021

2/12/2021

2/16/2021

2/17/2021

2/17/2021

3/5/2021

3/16/2021
2/5/2021

Tanggal Uji
GP2.20 I-3 CA GP2.20 I-3 SP 2 Spesifikasi CA Spesifikasi AS Spesifikasi SP
Action Limit CA Action Limit AS Action Limit SP GP2.20 I-3 AS GP2.20 I-3 SP 1

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.20 I-4 (B) CA AS SP

Tgl
No Batch Nama Proses
Monitoring GP2.20 I-4 GP2.20 I-4 GP2.20 I-4 GP2.20 I-4 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP
2/4/2021 0 4 4 5 4 10 4 5 4 9910121 112-RA-EM-2021 Filling Ampul 2
2/5/2021 0 2 3 1 5 4 10 4 5 4 9910221 112-RA-EM-2021 Filling Ampul 2
2/9/2021 0 3 0 5 4 10 4 5 4 9910321 112-RA-EM-2021 Filling Ampul 2
2/10/2021 0 6 0 5 4 10 4 5 4 9910421 112-RA-EM-2021 Filling Ampul 2
2/12/2021 0 2 3 5 4 10 4 5 4 9910521 112-RA-EM-2021 Filling Ampul 2
2/16/2021 0 0 0 5 4 10 4 5 4 9910621 112-RA-EM-2021 Filling Ampul 2
2/17/2021 0 0 0 5 4 10 4 5 4 9910721 112-RA-EM-2021 Filling Ampul 2
2/17/2021 0 0 0 5 4 10 4 5 4 9910821 112-RA-EM-2021 Filling Ampul 2
3/5/2021 0 4 4 5 4 10 4 5 4 9910921 112-RA-EM-2021 Filling Ampul 2
3/16/2021 5 4 10 4 5 4 9911021 112-RA-EM-2021 Filling Ampul 2

Average 0 2 2 1
SD 0 2 2 0
Ave + 3 SD 0 9 7 0

Trend Hasil Mikrobiologi Kelas B GP2.20 I-3

Bagian FPVP
20
18
16
14
12
10
Pemantauan8Lingkungan
6
No.#.100K-SIS-EM
4
2
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
Trend Hasil Mikrobiologi Kelas B GP2.20 I-3
FD 5 3 cfu/glove Bagian FPVP
20
18 GP2.20 I-4 (B) CA AS SP
Tgl 16
No Batch Nama Proses
14 GP2.20 I-4
Monitoring GP2.20 I-4 GP2.20 I-4 GP2.20 I-4 Spesifikasi Action Spesifikasi Action Spesifikasi Action
12 CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP
10
8
6
4
2
0
2/4/2021

2/9/2021

2/10/2021

2/12/2021

2/16/2021

2/17/2021

2/17/2021

3/5/2021

3/16/2021
2/5/2021

Tanggal Uji
GP2.20 I-4 CA GP2.20 I-4 SP 2 Spesifikasi CA Spesifikasi AS Spesifikasi SP
Action Limit CA Action Limit AS Action Limit SP GP2.20 I-4 AS GP2.20 I-4 SP 1

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.20 I-8 (B) CA AS SP

Tgl
No Batch Nama Proses
Monitoring GP2.20 I-8 GP2.20 I-8 GP2.20 I-8 GP2.20 I-8 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP
2/4/2021 0 2 4 5 4 10 4 5 4 9910121 112-RA-EM-2021 Filling Ampul 2
2/5/2021 0 7 0 3 5 4 10 4 5 4 9910221 112-RA-EM-2021 Filling Ampul 2
2/9/2021 0 4 2 5 4 10 4 5 4 9910321 112-RA-EM-2021 Filling Ampul 2
2/10/2021 0 4 3 5 4 10 4 5 4 9910421 112-RA-EM-2021 Filling Ampul 2
2/12/2021 0 6 4 5 4 10 4 5 4 9910521 112-RA-EM-2021 Filling Ampul 2
2/16/2021 0 0 3 5 4 10 4 5 4 9910621 112-RA-EM-2021 Filling Ampul 2
2/17/2021 0 0 2 5 4 10 4 5 4 9910721 112-RA-EM-2021 Filling Ampul 2
2/17/2021 0 0 0 5 4 10 4 5 4 9910821 112-RA-EM-2021 Filling Ampul 2
3/5/2021 0 2 1 5 4 10 4 5 4 9910921 112-RA-EM-2021 Filling Ampul 2
3/16/2021 5 4 10 4 5 4 9911021 112-RA-EM-2021 Filling Ampul 2

Average 0 3 2 3
SD 0 3 2 0
Ave + 3 SD 0 11 7 0

Trend Hasil Mikrobiologi Kelas B GP2.20 I-3

Bagian FPVP
20
18
16
14
12
10
Pemantauan8Lingkungan
6
No.#.100K-SIS-EM
4
2
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
Trend Hasil Mikrobiologi Kelas B GP2.20 I-3
FD 5 3 cfu/glove Bagian FPVP
20
18 GP2.20 I-8 (B) CA AS SP
Tgl 16
No Batch Nama Proses
14 GP2.20 I-8
Monitoring GP2.20 I-8 GP2.20 I-8 GP2.20 I-8 Spesifikasi Action Spesifikasi Action Spesifikasi Action
12 CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP
10
8
6
4
2
0
2/4/2021

2/9/2021

2/10/2021

2/12/2021

2/16/2021

2/17/2021

2/17/2021

3/5/2021

3/16/2021
2/5/2021

Tanggal Uji
GP2.20 I-8 CA GP2.20 I-8 SP 2 Spesifikasi CA Spesifikasi AS Spesifikasi SP
Action Limit CA Action Limit AS Action Limit SP GP2.20 I-8 AS GP2.20 I-8 SP 1

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.15 I-7 (B) CA AS SP

Tgl
No Batch Nama Proses
Monitoring GP2.15 I-7 GP2.15 I-7 GP2.15 I-7 GP2.15 I-7 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP
2/1/2021 0 0 1 2 5 4 10 4 5 4 00121 112-RA-EM-2021 Formulasi 1 FPV
2/3/2021 0 0 2 2 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 1 FPV
2/8/2021 0 0 0 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 1 FPV
2/9/2021 0 0 1 1 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 1 FPV
2/10/2021 0 8 0 5 4 10 4 5 4 00221 112-RA-EM-2021 Formulasi 1 FPV
2/11/2021 0 0 0 0 5 4 10 4 5 4 00321 112-RA-EM-2021 Formulasi 1 FPV
2/16/2021 0 0 0 0 5 4 10 4 5 4 00421 112-RA-EM-2021 Formulasi 1 FPV
2/17/2021 0 0 0 1 5 4 10 4 5 4 00421 112-RA-EM-2021 Formulasi 1 FPV
2/18/2021 0 0 1 5 4 10 4 5 4 00421 112-RA-EM-2021 Formulasi 1 FPV
2/23/2021 0 0 2 0 5 4 10 4 5 4 00621 112-RA-EM-2021 Formulasi 1 FPV
2/24/2021 0 1 1 0 5 4 10 4 5 4 00621 112-RA-EM-2021 Formulasi 1 FPV
2/25/2021 0 3 1 5 4 10 4 5 4 00621 112-RA-EM-2021 Formulasi 1 FPV
3/1/2021 0 0 0 0 5 4 10 4 5 4 00421 112-RA-EM-2021 Formulasi 1 FPV
3/3/2021 0 0 1 0 5 4 10 4 5 4 00921 112-RA-EM-2021 Formulasi 1 FPV
3/4/2021 0 0 0 1 5 4 10 4 5 4 00921 112-RA-EM-2021 Formulasi 1 FPV
3/5/2021 0 2 0 5 4 10 4 5 4 00921 112-RA-EM-2021 Formulasi 1 FPV
3/16/2021 5 4 10 4 5 4 5150467 112-RA-EM-2021 Formulasi 1 FPV

Average 0 1 1 1
SD 0 2 1 0
Ave + 3 SD 0 7 3 0

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.20
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.15 I-7 (B) CA AS SP

Tgl
No Batch Nama Proses
Monitoring GP2.15 I-7 GP2.15 I-7 GP2.15 I-7 GP2.15 I-7 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 CA Limit CA AS Limit AS SP Limit SP

Trend Hasil Mikrobiologi Kelas B GP2.20 I-3

Bagian FPVP
20
18
16
14
12
10
8
6
4
2
0
2/1/2021

2/3/2021

2/8/2021

2/9/2021

2/10/2021

2/11/2021

2/16/2021

2/17/2021

2/18/2021

2/23/2021

2/24/2021

2/25/2021

3/1/2021

3/3/2021

3/4/2021

3/5/2021

3/16/2021
Tanggal Uji
GP2.15 I-7 CA GP2.15 I-7 SP 2 Spesifikasi CA Spesifikasi AS Spesifikasi SP
Action Limit CA Action Limit AS Action Limit SP GP2.15 I-7 AS GP2.15 I-7 SP 1

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.21
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.21 I-3 (B) CA AS SP

Tgl
No Batch
Monitoring GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 SP 3 SP 4 CA Limit CA AS Limit AS SP Limit SP
2/8/2021 2 0 0 0 0 5 3 10 7 5 3 3650121
2/10/2021 0 2 0 0 0 0 5 3 10 7 5 3 3650221
2/12/2021 0 6 1 0 0 1 5 3 10 7 5 3 3650321
2/16/2021 0 0 0 0 0 0 5 3 10 7 5 3 3650421
2/17/2021 0 0 2 0 1 0 5 3 10 7 5 3 3650521
2/18/2021 0 0 2 2 1 0 5 3 10 7 5 3 3650621
2/19/2021 0 0 0 1 0 0 5 3 10 7 5 3 3650721
2/22/2021 0 0 0 0 0 0 5 3 10 7 5 3 3650821
2/23/2021 0 0 3 0 1 0 5 3 10 7 5 3 3650921
2/24/2021 0 0 1 3 0 0 5 3 10 7 5 3 3651021
2/25/2021 0 0 0 0 0 0 5 3 10 7 5 3 3651121
2/26/2021 0 1 1 3 0 6 5 3 10 7 5 3 3651221
3/1/2021 0 0 0 0 0 1 5 3 10 7 5 3 3651321
3/2/2021 0 0 0 2 0 0 5 3 10 7 5 3 3651421
3/3/2021 0 1 1 0 1 0 5 3 10 7 5 3 3651521
3/4/2021 0 0 5 0 0 0 5 3 10 7 5 3 3651621
3/5/2021 0 0 0 0 1 0 5 3 10 7 5 3 3651721
3/10/2021 0 4 0 1 5 3 10 7 5 3 50121
3/10/2021 0 0 0 5 3 10 7 5 3 50121
3/10/2021 0 0 1 5 3 10 7 5 3 50121
3/10/2021 0 0 0 5 3 10 7 5 3 50121
3/15/2021 5 3 10 7 5 3 3651821
Average 0 1 1 1 0 0
SD 0 2 1 1 0 1
Ave + 3 SD 0 5 5 4 2 5

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.21
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.21 I-3 (B) CA AS SP

Tgl
No Batch
Monitoring GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 GP2.21 I-3 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 SP 3 SP 4 CA Limit CA AS Limit AS SP Limit SP

Trend Hasil Mikrobiologi Kelas B GP2.21 I-3

Bagian FPVP

10
9
8
7
6
5
4
3
2
1
0

2/26/2021

3/5/2021

3/10/2021
2/8/2021

2/10/2021

2/12/2021

2/16/2021

2/17/2021

2/18/2021

2/19/2021

2/22/2021

2/23/2021

2/24/2021

2/25/2021

3/1/2021

3/2/2021

3/3/2021

3/4/2021

3/10/2021

3/10/2021

3/10/2021
Tanggal Uji

GP2.21 I-3 CA GP2.21 I-3 SP 4 Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA

Action Limit AS Action Limit SP GP2.21 I-3 AS GP2.21 I-3 SP 1 GP2.21 I-3 SP 2 GP2.21 I-3 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Nama Proses

112-RA-EM-2021 Filling Uniject FPVP

112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP

Pemantauan Lingkungan
No.#.100K-SIS-EM
 PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Nama Proses

Hasil Mikrobiologi Kelas B GP2.21 I-3

FPVP
2/26/2021

3/5/2021

3/10/2021
2/23/2021

2/24/2021

2/25/2021

3/1/2021

3/2/2021

3/3/2021

3/4/2021

3/10/2021

3/10/2021

3/10/2021

3/15/2021

Tanggal Uji

Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA

GP2.21 I-3 AS GP2.21 I-3 SP 1 GP2.21 I-3 SP 2 GP2.21 I-3 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.21
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.21 I-4 (B) CA AS SP

Tgl
No Batch
Monitoring GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 SP 3 SP 4 CA Limit CA AS Limit AS SP Limit SP
2/8/2021 0 0 0 0 0 0 5 3 10 7 5 3 3650121
2/10/2021 0 2 0 0 0 0 5 3 10 7 5 3 3650221
2/12/2021 0 3 2 0 1 0 5 3 10 7 5 3 3650321
2/16/2021 0 0 4 0 0 0 5 3 10 7 5 3 3650421
2/17/2021 0 0 1 0 2 0 5 3 10 7 5 3 3650521
2/18/2021 0 0 1 0 0 0 5 3 10 7 5 3 3650621
2/19/2021 0 0 1 2 2 0 5 3 10 7 5 3 3650721
2/22/2021 0 0 0 0 0 0 5 3 10 7 5 3 3650821
2/23/2021 0 0 0 1 0 0 5 3 10 7 5 3 3650921
2/24/2021 0 0 0 0 0 0 5 3 10 7 5 3 3651021
2/25/2021 0 0 0 0 2 0 5 3 10 7 5 3 3651121
2/26/2021 0 7 2 0 2 1 5 3 10 7 5 3 3651221
3/1/2021 0 0 0 0 0 1 5 3 10 7 5 3 3651321
3/2/2021 0 0 0 1 0 0 5 3 10 7 5 3 3651421
3/3/2021 0 4 0 0 1 2 5 3 10 7 5 3 3651521
3/4/2021 0 0 2 0 3 0 5 3 10 7 5 3 3651621
3/5/2021 0 0 1 1 0 2 5 3 10 7 5 3 3651721
3/10/2021 0 0 0 0 0 0 5 3 10 7 5 3 50121
3/10/2021 1 0 0 5 3 10 7 5 3 50121
3/15/2021 5 3 10 7 5 3 3651821
Average 0 1 1 0 1 0
SD 0 2 1 1 1 1
Ave + 3 SD 0 7 4 2 4 2

Trend Hasil Mikrobiologi Kelas B GP2.21 I-3

Pemantauan Lingkungan Bagian FPVP
No.#.100K-SIS-EM
10
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.21
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.21 I-4 (B) CA AS SP

Tgl
No Batch
Monitoring GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 GP2.21 I-4 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 SP 3 SP 4 CA Limit CA AS Limit AS SP Limit SP
Trend Hasil Mikrobiologi Kelas B GP2.21 I-3
Bagian FPVP

10
9
8
7
6
5
4
3
2
1
0

3/2/2021

3/5/2021
2/8/2021

2/12/2021

2/24/2021

2/25/2021

3/1/2021

3/3/2021

3/4/2021
2/10/2021

2/16/2021

2/17/2021

2/18/2021

2/19/2021

2/22/2021

2/23/2021

2/26/2021

3/10/2021

3/10/2021
Tanggal Uji

GP2.21 I-4 CA GP2.21 I-4 SP 4 Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA

Action Limit AS Action Limit SP GP2.21 I-4 AS GP2.21 I-4 SP 1 GP2.21 I-4 SP 2 GP2.21 I-4 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
 PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Nama Proses

112-RA-EM-2021 Filling Uniject FPVP

112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP

Hasil Mikrobiologi Kelas B GP2.21 I-3

FPVPPemantauan Lingkungan
No.#.100K-SIS-EM
 PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Nama Proses

Hasil Mikrobiologi Kelas B GP2.21 I-3

FPVP
3/2/2021

3/5/2021
2/24/2021

2/25/2021

3/1/2021

3/3/2021

3/4/2021
2/23/2021

2/26/2021

3/10/2021

3/10/2021

3/15/2021
Tanggal Uji

Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA

GP2.21 I-4 AS GP2.21 I-4 SP 1 GP2.21 I-4 SP 2 GP2.21 I-4 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.21
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.21 I-8 (B) CA AS SP

Tgl
No Batch
Monitoring GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 SP 3 SP 4 CA Limit CA AS Limit AS SP Limit SP
2/8/2021 0 0 1 3 0 0 5 3 10 7 5 3 3650121
2/10/2021 0 0 3 3 3 2 5 3 10 7 5 3 3650221
2/12/2021 0 9 2 1 2 0 5 3 10 7 5 3 3650321
2/16/2021 0 0 0 1 0 2 5 3 10 7 5 3 3650421
2/17/2021 0 0 3 2 2 1 5 3 10 7 5 3 3650521
2/18/2021 0 0 2 0 2 0 5 3 10 7 5 3 3650621
2/19/2021 0 0 2 3 2 2 5 3 10 7 5 3 3650721
2/22/2021 0 0 0 0 0 0 5 3 10 7 5 3 3650821
2/23/2021 0 0 4 3 1 0 5 3 10 7 5 3 3650921
2/24/2021 0 0 3 0 0 0 5 3 10 7 5 3 3651021
2/25/2021 0 0 1 0 5 1 5 3 10 7 5 3 3651121
2/26/2021 0 4 0 3 6 13 5 3 10 7 5 3 3651221
3/1/2021 0 0 2 1 0 1 5 3 10 7 5 3 3651321
3/2/2021 0 0 4 0 3 0 5 3 10 7 5 3 3651421
3/3/2021 0 3 3 3 1 2 5 3 10 7 5 3 3651521
3/4/2021 0 0 4 2 4 2 5 3 10 7 5 3 3651621
3/5/2021 0 0 0 5 5 3 5 3 10 7 5 3 3651721
3/10/2021 0 0 3 0 0 0 5 3 10 7 5 3 50121
3/10/2021 0 0 0 5 3 10 7 5 3 50121
3/15/2021 5 3 10 7 5 3 3651821
Average 0 1 2 2 2 2
SD 0 2 1 2 2 3
Ave + 3 SD 0 8 6 6 8 11

Trend Hasil Mikrobiologi Kelas B GP2.21 I-3

Pemantauan Lingkungan Bagian FPVP
No.#.100K-SIS-EM
10
PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Spesifikasi Action limit Satuan

CA 5 3 cfu/plates Nama Bagian : FPVP
AS 10 7 cfu/m3 No ID Ruangan : GP2.21
cfu/plates/4
SP 5 3
jam
FD 5 3 cfu/glove

GP2.21 I-8 (B) CA AS SP

Tgl
No Batch
Monitoring GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 GP2.21 I-8 Spesifikasi Action Spesifikasi Action Spesifikasi Action
CA AS SP 1 SP 2 SP 3 SP 4 CA Limit CA AS Limit AS SP Limit SP
Trend Hasil Mikrobiologi Kelas B GP2.21 I-3
Bagian FPVP

10
9
8
7
6
5
4
3
2
1
0

3/2/2021

3/5/2021
2/8/2021

2/12/2021

2/24/2021

2/25/2021

3/1/2021

3/3/2021

3/4/2021
2/10/2021

2/16/2021

2/17/2021

2/18/2021

2/19/2021

2/22/2021

2/23/2021

2/26/2021

3/10/2021

3/10/2021
Tanggal Uji

GP2.21 I-8 CA GP2.21 I-8 SP 4 Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA

Action Limit AS Action Limit SP GP2.21 I-8 AS GP2.21 I-8 SP 1 GP2.21 I-8 SP 2 GP2.21 I-8 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM
 PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Nama Proses

112-RA-EM-2021 Filling Uniject FPVP

112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP
112-RA-EM-2021 Filling Uniject FPVP

Hasil Mikrobiologi Kelas B GP2.21 I-3

FPVPPemantauan Lingkungan
No.#.100K-SIS-EM
 PT Bio Farma ( Persero )
Jl. Pasteur 28 Bandung
Trend Data Pemantauan Partikel

Nama Proses

Hasil Mikrobiologi Kelas B GP2.21 I-3

FPVP
3/2/2021

3/5/2021
2/24/2021

2/25/2021

3/1/2021

3/3/2021

3/4/2021
2/23/2021

2/26/2021

3/10/2021

3/10/2021

3/15/2021
Tanggal Uji

Spesifikasi CA Spesifikasi AS Spesifikasi SP Action Limit CA

GP2.21 I-8 AS GP2.21 I-8 SP 1 GP2.21 I-8 SP 2 GP2.21 I-8 SP 3

Pemantauan Lingkungan
No.#.100K-SIS-EM