KK HVAC QC at OP Desember 2023 - Edit (Viable Belum Masuk)

No Day 1 Day 2
No Ruangan Kelas
Ruangan TSA TDA TSA TDA
1 Positive Control Room 3011 C
2 Inactivation Room 3012 D

3 Changing Room ruang identifikasi 3013 C
4 Buffer Room ruang identifikasi 3014 C
5 Microbial Limit Room 3015 C
6 Prepare ruang uji non steril 3016 D

7 Buffer Room ruang uji non steril 3017 C
8 Changing Room ruang uji non steril 3018 C
9 Sterility Room 3019 B
10 Prepare ruang uji sterilitas 3020 D

11 Buffer Room 1 ruang uji sterilitas 3021 C
12 Changing Room 2 ruang uji sterilitas 3022 B
13 Air Lock ruang uji sterilitas 3023 B
14 Cultivating Room 3024 D
15 Prepare Media 3025 D

16 Utensils Washing Room 3026 D
17 Changing Room In Out 3037 D
18 Buffer Room In Out 3038 D
19 Changing Room 1 ruang uji sterilitas 3039 C
20 Airlock 3040 D
21 Corridor N/A D
rata rata per hari #DIV/0! #DIV/0! #DIV/0! #DIV/0!

Day 3 Summary Batas
Kelas Hasil
TSA TDA D1 D2 D3 Keberterimaan
0 0 0 B 10 0
0 0 0 C 100 0
0 0 0 D 200 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
#DIV/0! #DIV/0!
No Day 1 Day 2
No Ruangan Kelas




20 Airlock 3040 D
21 Corridor N/A D

Day 3 Summary Batas
Kelas Hasil
0 0 0 B 5 0
0 0 0 C 50 0
0 0 0 D 100 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
#DIV/0! #DIV/0!
0
No Day 1 Day 2
No Ruangan Kelas




20 Airlock 3040 D
21 Corridor N/A D

Day 3 Summary Batas
Kelas Hasil
0 0 0 B 5 0
0 0 0 C 25 0
0 0 0 D 50 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
0 0 0
#DIV/0! #DIV/0!
0
Titik Hari Rata Rata Harian
No Ruangan No Ruangan Kelas
Sampel 1 2 3 1 2
1 47.10 56.10 57.00
2 53.70 57.20 57.50
3 55.60 58.00 57.10
4 54.20 56.30 56.90
1 55.70 55.70 56.00
2 54.80 54.80 55.90
1 60.00 60.00 60.10
2 58.60 58.60 59.60
1 57.00 57.60 57.60
2 57.70 57.00 57.00
1 56.00 56.00 56.50
2 56.60 56.50 56.40
3 54.90 59.00 59.10
4 54.90 58.10 58.70
1 58.80 56.40 56.90
2 57.80 57.90 57.40
1 56.10 56.90 56.40
2 55.90 55.90 59.10
1 56.30 56.40 61.40
2 55.60 55.90 61.00
1 63.30 60.30 60.30
2 61.30 61.00 61.00
3 60.90 60.40 60.40
4 61.00 59.60 59.40
1 58.10 58.10 59.10
10 Prepare ruang uji sterilitas 3020 D 2 59.00 59.10 59.20
3 58.00 59.00 59.10
1 60.00 56.40 56.40
2 60.50 59.00 58.10
1 60.90 60.40 59.10
2 30.40 60.50 59.40
1 61.40 60.50 59.40
2 61.30 59.60 59.60
1 53.10 53.10 53.40
2 54.80 54.80 54.80
3 54.60 56.10 56.10
4 55.30 56.00 57.00
5 56.00 56.00 58.00
6 56.20 57.10 57.50
7 55.90 58.10 58.10
8 55.80 59.22 59.10
1 58.30 54.00 56.00
2 59.00 56.00 59.10
3 60.00 56.00 58.20
4 61.00 55.90 58.40
5 58.10 55.40 58.40

6 59.00 55.20 56.10
1 57.50 57.00 55.40
2 56.90 58.00 56.00
3 56.00 58.10 57.40
4 57.00 57.90 57.00
5 57.60 57.80 58.00
6 57.00 57.90 57.50
1 58.60 58.40 57.60
2 58.60 58.40 58.40
1 59.60 59.40 57.50
2 57.40 59.00 57.00
1 59.00 59.40 59.10
2 59.50 58.40 59.00
1 57.60 54.20 59.40
20 Airlock 3040 D
2 59.60 59.10 58.40
1 57.70 56.10 55.40
2 55.10 57.20 55.60
3 57.20 57.00 56.00
21 Corridor N/A D
4 54.90 56.00 55.90
5 58.80 56.40 55.00
6 53.70 57.00 58.10
Air lock (2038)
12.0
10.0
8.0
6.0
4.0
2.0
0.0
1 2 3
RH
Concentrated solution
room (2041)
12.0
10.0
8.0
6.0
4.0
2.0
0.0
1 2 3
RH
Air lock (2009)

12.0
10.0
8.0
6.0
4.0
2.0
0.0
1 2 3
8.0
6.0
4.0
2.0
0.0
1 2 3
RH
Buffer room (man)

(2012)
50
48
46
44
42
40
38
36
1
RH alert min
alert max action min
action max
Air lock (2014)

52
51
50
49
48
47
46
45
44
43
42
1
RH alert min
action max
Air lock (2021)

52
51
50
49
48
47
46
45
44
43
1
RH alert min
action max
45
44
43
1
RH alert min
action max
Utensils staging room

(2036)
56
54
52
50
48
46
44
42
40
1
RH alert min
action max
In process control
room (2028)
56
54
52
50
48
46
44
42
40
1
RH alert min
action max
Dies Storage room

(2030)
54
52
50
48
46
44
42
40
1
RH alert min
action max
The waste granule
crushing room (2024)
56
54
52
50
48
46
44
42
40
1
RH alert min
action max
Rata Rata Harian Batas
Rata-Rata Kelas Minimal Maksimal
3 Keberterimaan
B 30.4 63.3
C ≤ 75% 47.1 61.4
55.6
D 53.1 61
55.5
59.5
57.3
56.9
57.5
56.7
57.8
60.7
58.7
58.4
55.1
60.3
56.1
57.4
57.4
57.2
58.3
58.3
59.1
58.1
56.3
Cleanin Weighin
g outer g room
package (2061)
room
12.0
(2037)
10.0
80.0
75.0 8.0
70.0
65.0 6.0
60.0
55.0 4.0
50.0
45.0 2.0
40.0 0.0
1 2 3 1 2 3
RH RH
ution Diluted Material supply

solution room (2003)
room 12.0
(2043) 10.0
60.0 8.0
55.0
6.0
50.0
45.0 4.0
40.0
2.0
35.0
30.0 0.0
3 1 2 3 1 2 3
RH RH
Cleanin Changing room

g outer (man) (2011)
packag 50
e room 48
(2008) 46
80.0 44
42
70.0 40
1
60.0
50.0 RRH
alert min
40.0
1 2 3 alert max
50
e room 48
(2008) 46
80.0 44
42
70.0 40
1
60.0
50.0 RRH
alert min
40.0
1 2 3 alert max
action min
RH action max
an) Changi Changing

ng room out
room in (man) (2013)
(man)
(2015) 55
50
50
45
48
40
46 1
44
RH
42
alert min
lert min 40 alert max
ction min 1
action min
RH max
alert
actionmin
min
max action max
4) Changin
g room Changing
(women room in
) (2017) (women)
(2020)
51
50 50
49
48 46
47
46 42
1
45
44
RH
43
alert min 42 alert min
action min 1 alert max
action min
RH max
alert
actionmin
min
max
action max
Changin Laundry
g room rooom (2023)
out
(women 51
50
) (2019) 49
48
48 47
47.5 46
47 45
46.5 44
46 43
1
45.5
45
44.5 RH
44 alert min
1 alert max
RH max
alert
actionmin
min
max action min
action max
46.5 44
46 43
1
45.5
45
44.5 RH
44 alert min
1 alert max
RH max
alert
actionmin
min
max action min
action max
g room Utensil Waste

s room
Washin (2033)
g room 55
(2035) 50
45
52 40
35
48 1
44 RH
alert min
40
alert min 1 alert max
action min action min
RH max
alert
actionmin action max
min
max
ntrol Janito Preform

8) rial temporary
washi storage
ng room
room (2031)
(2027 56
) 54
52
55 50
50 48
45 46
40 44
alert min 1 42
action min 40
RH
alert
action 1
min
max
room Cap
storag Class C
e corridor
room 60
(2029 55
) 50
55 45
50 40
45 1
40
1 RH
alert min alert min
action min ac-
RH
alert
action alert max
max
min
tion
max action min
action max
Filling Stagting room

room (storage
(2044) room) (2040)
anule Filling Stagting room
(2024) room (storage
(2044) room) (2040)
53 12.0
52
51 10.0
50
49 8.0
48
47 6.0
46
45 4.0
44
43 2.0
alert min 1
action min RH min
alert
action 0.0
1 2 3
min
max
RH
Hari Rata Rata Harian
No Ruangan No Ruangan Kelas Titik Sampel
1 2 3 1
1 21.9 21.8 21.5
2 23.2 20.9 21
1 Positive Control Room 3011 C 22.7
3 22.2 21.4 21.4
4 23.6 21.5 21
1 24.6 24 24
2 Inactivation Room 3012 D 24.4
2 24.2 24.2 23.8
1 23.9 23.9 24
3 Changing Room ruang identifikasi 3013 C 24.0
2 24 24 24
1 24 23.8 23.8
4 Buffer Room ruang identifikasi 3014 C 24.0
2 23.9 23.9 23.9
1 21.9 21 21.4
2 21.9 21.6 21.6
5 Microbial Limit Room 3015 C 21.8
3 21.7 20.9 20.9
4 21.7 21.4 21.4
1 23.8 23.5 23.5
6 Prepare ruang uji non steril 3016 D 23.9
2 24 23.4 23.7
1 22.5 22.5 22.7
7 Buffer Room ruang uji non steril 3017 C 22.2
2 21.9 21.5 21.9
1 23.2 23 22.5
8 Changing Room ruang uji non steril 3018 C 23.2
2 23.1 23.1 23
1 22 22 21.4
2 22.2 21.8 22
9 Sterility Room 3019 B 22.1
3 22 21.9 21.9
4 22 20.9 22
1 22.8 22.4 22.3
10 Prepare ruang uji sterilitas 3020 D 2 22.9 22.4 22.4 22.8
3 22.7 22.6 22.1
1 23.2 23 23
11 Buffer Room 1 ruang uji sterilitas 3021 C 23.1
2 23 23.4 22.4
1 20.4 20.9 20.9
12 Changing Room 2 ruang uji sterilitas 3022 B 20.5
2 20.6 20.7 20.7
1 20.4 21 21.1
13 Air Lock ruang uji sterilitas 3023 B 20.5
2 20.6 21 22
1 23.1 23.1 23.1
2 23.5 23.5 23.5
3 23.2 23.2 23.2
4 23.2 22.1 22.1
14 Cultivating Room 3024 D 23.1
5 23 23 23
6 23 22.4 22.4
7 22.9 22.6 22.1
8 22.8 21.9 21.4
1 21.9 24.6 23.4
2 22 24.5 23.1
3 20.3 23.6 23
15 Prepare Media 3025 D 21.6
4 21.4 24 23.6
15 Prepare Media 3025 D 21.6
5 22.1 23.5 22.4

6 22 23.6 23.1
1 22.7 22.3 22.4
2 22.4 22.4 21.6
3 22.4 22.4 22.5
16 Utensils Washing Room 3026 D 22.3
4 21.9 22.5 22.1
5 22.2 23 22.4
6 22 22.9 22.1
1 20.1 20.1 20.4
17 Changing Room In Out 3037 D 20.3
2 20.5 20.4 20.5
1 20.6 20.5 20.4
18 Buffer Room In Out 3038 D 20.7
2 20.7 20.6 20.6
1 23.1 22.4 20.4
19 Changing Room 1 ruang uji sterilitas 3039 C 23.1
2 23 22 20.6
1 21 23 21
20 Airlock 3040 D 21.2
2 21.4 23.1 21
1 23.5 23.4 23
2 23.5 23.5 23
3 23.4 23.5 23.6
21 Corridor N/A D 23.6
4 24.4 23 23.4
5 24 23.4 23.4
6 22.5 23.2 23.2
Rata Rata Harian Batas Keberterimaan
Rata-Rata Kelas Minimal Maksimal
2 3 (Celcius)
B 16 - 25 20.4 22.2
C 16 - 25 20.4 24
21.4 21.2 21.8
D 20 - 27 20.1 24.6
24.1 23.9 24.1
24.0 24.0 24.0
23.9 23.9 23.9
21.2 21.3 21.5
23.5 23.6 23.6
22.0 22.3 22.2
23.1 22.8 23.0
21.7 21.8 21.8
22.5 22.3 22.5
23.2 22.7 23.0
20.8 20.8 20.7
21.0 21.6 21.0
22.7 22.6 22.8
24.0 23.1 22.9

24.0 23.1 22.9
22.6 22.2 22.3
20.3 20.5 20.3
20.6 20.5 20.6
22.2 20.5 21.9
23.1 21.0 21.8
23.3 23.3 23.4

No Ruangan Air Flow Arah Flow Kelas
1 Inactivation Room ß Corridor D vs D

Changing Room ruang
2 identifikasi
à Corridor C vs D
3 Prepare ruang uji non steril à Corridor D vs D
Changing Room ruang uji

4 non steril
à Corridor C vs D
5 Prepare ruang uji sterilitas à Corridor D vs D
6 Cultivating Room à Corridor D vs D

7 Prepare Media à Corridor D vs D
8 Utensils Washing Room à Corridor D vs D
9 Changing Room In Out à Corridor D vs F
10 Buffer Room In Out à Corridor D vs D
Changing Room 1 ruang uji
11 sterilitas
à Corridor C vs D
12 Airlock ß Corridor D vs D
13 Airlock à Corridor D vs F
14 Positive Control Room ß Buffer Room ruang identifikasi C vs C
Buffer Room ruang
15 identifikasi
à Changing Room ruang identifikasi C vs C
16 Microbial Limit Room à Buffer Room ruang uji non steril C vs C

Buffer Room ruang uji non
17 steril
à Changing Room ruang uji non steril C vs C
18 Sterility Room à Air Lock ruang uji sterilitas B vs B
19 Air Lock ruang uji sterilitas à Changing Room 2 ruang uji sterilitas B vs B
Changing Room 2 ruang uji

29 sterilitas
à Buffer Room 1 ruang uji sterilitas B vs C
Buffer Room 1 ruang uji

27 sterilitas
à Changing Room 1 ruang uji sterilitas C vs C
39 Changing Room In Out ß Buffer Room In Out D vs D

Hari Syarat Hasil
Rata-Rata
1 2 3 Sama Kelas 5≤ 6
8 8 87 34.33 Beda Kelas 10 ≤
12 12 12 12.00
8 7 8 7.67
12 12 12 12.00
6 6 7 6.33
7 7 8 7.33
6 6 7 6.33
8 8 8 8.00
13 13 13 13.00
6 6 6 6.00
14 14 14 14.00
7 6 7 6.67
15 15 14 14.67
7 7 7 7.00
8 8 7 7.67
7 7 8 7.33
7 7 8 7.33
8 8 7 7.67
8 8 8 8.00
13 13 12 12.67
9 8 8 8.33
6 6 6 6.00
Woman Room Airlock (202
out Changing 7.2
(2019) vs Buffer 7
Room (2018) 6.8
1.5 6.6
1 6.4
DP
0.5
DP
6.2
0
1 6
Hari ke- 5.8
5.6
5.4
Differential Pressure 1
Alert Limit Min
Alert Limit Max
Action Limit Min
Action Limit Max
The The
Waste
Waste
The
Granule
Waste
Granule
Crushing
Granul
Crus
ClassClass
C Corrid
CClas
Co
14 14 14
12 12 12
10 10 10
8 8 8
DP
DP
DP
6 6 6
4 4 4
2 2 2
0 0 0
1 1 1 2
Hari ke-
Ha
Differential
Differenti
Pre
0 0 0
1 1 1 2
Hari ke-
Ha
Differential
Differenti
Pre
Janitorial
Janitorial
Storage
Storage
RoomRo(2
Corridor
Corr
7 7
6 6
5 5
4 4
DP
DP
3 3
2 2
1 1
0 0
1 1 2
Hari ke-
Differential
Differe
Pre
Airlock (2022) vs Class C Corridor Janitorial Washing Room (2

7.2
Corridor
7 16
6.8 14
6.6 12
6.4 10
DP
6.2 8
DP
6 6
5.8 4
5.6 2
5.4 0
1 2 3 1 2
Hari ke- Hari ke-
Differential Pressure Differential Pre

aste
e Waste
The
Granule
Waste
Granule
Crushing
Granule
Crushing
Room
Crushing
Room
(2024)
Room
(2024)
vs (2024)
vs vs In Process
In Process
InControl
Process
Control
Room
Control
Room
(2028)
Room
(2028)
vs (2028)
Class
vs Clas
Cv
ClassClass
C Corridor
CClass
Corridor
C Corridor Corridor
Corridor
Corridor
14 7.2 7.2 7.2
12 7 7 7
6.8 6.8 6.8
10
6.6 6.6 6.6
8 6.4 6.4 6.4
DP
DP
DP
6 6.2 6.2 6.2

6 6 6
4
5.8 5.8 5.8
2 5.6 5.6 5.6
0 5.4 5.4 5.4
1 1 1 2 2 2 3 3 3 1 1 1 2 2 2 3
Hari ke-
Hari ke- Hari ke- Hari ke-
Hari ke- Hari ke-
Differential
Differential
Pressure
Differential
Pressure Pressure Differential
Differential
Pressure
Differential
Pressure Pressure
0 5.4 5.4 5.4
1 1 1 2 2 2 3 3 3 1 1 1 2 2 2 3
Hari ke-
Hari ke- Hari ke-
Differential
Differential
Pressure
Differential
Differential
Pressure
Differential
Pressure Pressure
orial
Janitorial
Storage
Storage
RoomRoom
(2026)
(2026)
vs Class
vs CClass C Cap Storage
Cap Storage
RoomRoom
(2029)
(2029)
vs Class
vs CClass
Corridor
C Co
Corridor
Corridor 15.2 15.2
15 15
14.8 14.8
14.6 14.6
14.4 14.4
DP
DP
14.2 14.2
14 14
13.8 13.8
13.6 13.6
13.4 13.4
1 1 2 2 3 3 1 1 2 2 3
Hari ke- Hari ke- Hari ke- Hari ke-
Differential
Differential
PressurePressure Differential
Differential
PressurePressure
rial Washing Room (2027) vs Class C Preform Temporary Storage Room (2031) vs
Corridor Class C Corridor
8
7
6
5
4
DP
3
2
1
0
1 2 3 1 2 3
Hari ke- Hari ke-
Differential Pressure Differential Pressure

ontrol
m
Room
(2028)
Room
(2028)
vs (2028)
Class
vs Class
C vsCClass C BottleBottle
Blowing
Blowing
RoomRoom
(2032)
(2032)
vs Class
vs CClass
Corridor
C Corridor
dor
orridor
Corridor 8.2 8.2
8 8
7.8 7.8
7.6 7.6
7.4 7.4
DP
DP
7.2 7.2
7 7
6.8 6.8
6.6 6.6
6.4 6.4
2 2 2 3 3 3 1 1 2 2 3 3
ri ke-
al
erential
Pressure
Differential
Differential
PressurePressure
6.4 6.4
2 2 2 3 3 3 1 1 2 2 3 3
ri ke-
al
erential
Pressure
Differential
Differential
PressurePressure
9)
(2029)
vs Class
vs CClass
Corridor
C Corridor Airlock
Airlock
(2038)(2038)
vs Class
vs CClass
Corridor
C Corridor
9 9
8 8
7 7
6 6
5 5
DP
DP
4 4
3 3
2 2
1 1
0 0
2 2 3 3 1 1 2 2 3 3
ri ke- Hari ke- Hari ke- Hari ke-
Differential
al PressurePressure Differential
Differential
PressurePressure
rage Room (2031) vs Raw Material Storage Room (2039) vs Class C

rridor Corridor
1.2
1
0.8
0.6
DP
0.4
0.2
0
1
2 3
Hari ke-
ri ke-
Differential Pressure Alert Limit Min Alert Limit Max

al Pressure Action Limit Min Action Limit Max
ridor
C Corridor Weighing
Weighing
RoomRoom
(2061)
(2061)
vs Class
vs CClass
Corridor
C Corridor Diluted
Diluted
Soluti
1.2 1.2 1.2 1.2
1 1 1 1
0.8 0.8 0.8 0.8
0.6 0.6 0.6 0.6

DP
DP
DP
DP
0.4 0.4 0.4 0.4
0.2 0.2 0.2 0.2
0 0 0 0
1 1
3 3
Hari ke- Hari ke-
Differential
Differential
PressurePressureAlert Limit
Alert
MinLimit Min Alert Limit
Alert
MaxLimit Max Differential
Diffe
Pr
Action Limit
Action
MinLimit Min Action Limit
Action
Max Limit Max Action Limit
ActioM
1 1
3 3
Hari ke- Hari ke-
Differential
Differential
Alert
Alert
Diffe
Pr
Action Limit
Action
Action
ActioM
dor Storage
Storage
RoomRoom
(2040)
(2040)
vs Class
vs CClass
Corridor
C Corridor FillingFil
R
1.2 1.2 1.2 1.2
1 1 1 1
0.8 0.8 0.8 0.8
0.6 0.6 0.6 0.6

DP
DP
DP
DP
0.4 0.4 0.4 0.4
0.2 0.2 0.2 0.2
0 0 0 0
1 1
3 3
Hari ke- Hari ke-
Differential
Differential
Alert
Alert
Diffe
Pr
Action Limit
Action
Action
ActioM
ss C Concentrated Solution Room (2041) vs Class C LAF Class

Corridor 1.2
1.2 1
1
0.8
0.8
0.6
DP
0.6
DP
0.4
0.4
0.2 0.2
0 0
1
Hari ke-
Limit Max Differential Pressure Alert Limit Min Alert Limit Max Differential Pr
Action Limit Min Action Limit Max Action Limit M
Diluted
Diluted
Solution
Solution
RoomRoom
(2043)
(2043)
vs Class
vs CClass
Corridor
C Corridor Filling
Filling
Room Filling
Room(2044)
Room
(2044)
vs (204
Dies
vs
1.2 1.2 1.2 1.2 1.2
1 1 1 1 1
0.8 0.8 0.8 0.8 0.8
0.6 0.6 0.6 0.6 0.6

DP
DP
DP
DP
DP
0.4 0.4 0.4 0.4 0.4
0.2 0.2 0.2 0.2 0.2
0 0 0 0 0
1 1 1
Ha
Differential
Differential
Alert
Alert
Differential
Pressure
Differential
Pressure Pressure
Alert Limit
Alert
Action Limit
Action
Action
Max Limit Max ActionAction
Limit Min
Limit
Action
MinLimit Min
ActionActio
Lim
1 1 1
Ha
Differential
Differential
Alert
Alert
Differential
Pressure
Differential
Pressure Pressure
Alert Limit
Alert
Action Limit
Action
Action
Max Limit Max ActionAction
Limit Min
Limit
Action
MinLimit Min
ActionActio
Lim
FillingFilling
RoomRoom
(2044)
(2044)
vs Class
vs CClass
Corridor
C Corridor
1.2 1.2
1 1
0.8 0.8
0.6 0.6
DP
DP
0.4 0.4
0.2 0.2
0 0
1 1
Hari ke- Hari ke-
Differential
Differential
Alert
Alert
MaxLimit Max
Action Limit
Action
Action
Max Limit Max
LAF Class A (2044a) vs Filling Room (2044)

1.2
1
0.8
0.6
DP
0.4
0.2
0
1
Hari ke-
Differential Pressure Alert Limit Min Alert Limit Max

Action Limit Min Action Limit Max
ling
Room Filling
Room(2044)
Room
(2044)
vs (2044)
Dies
vs Dies
Storage
vsStorage
Dies(2046)
Storage
(2046)(2046)
1.2
0.8
0.6
0.4
0.2
0
1 1 1
Hari ke-
Hari ke- Hari ke-
tial
fferential
Pressure
Differential
Pressure Pressure
Alert Limit
Alert Min
Limit
Alert
MinLimitAlert
Min Limit
Alert Max
Limit
Alert
MaxLimit Max
ction
imit Min
Limit
Action
MinLimit Min
ActionAction
Limit Max
Limit
Action
MaxLimit Max
1 1 1
Hari ke-
Hari ke- Hari ke-
tial
fferential
Pressure
Differential
Pressure Pressure
Alert Limit
Alert Min
Limit
Alert
MinLimitAlert
Min Limit
Alert Max
Limit
Alert
MaxLimit Max
ction
imit Min
Limit
Action
MinLimit Min
ActionAction
Limit Max
Limit
Action
MaxLimit Max
No Luas Jumlah No Hari
No Nama Ruangan Kelas
Ruangan Area Sample Sample 1
1 1,285,764
2 1,271,988
1 Positive Control Room 3011 C 6.38 4
3 1,264,217
4 1,304,132
1 3,319,675
2 Inactivation Room 3012 D 3.77 2
2 3,433,062
1 1,304,486
3 Changing Room ruang identifikasi 3013 C 3.9 2
2 1,093,606
1 1,179,441
4 Buffer Room ruang identifikasi 3014 C 3.94 2
2 1,230,307
1 88,661
2 29,319
5 Microbial Limit Room 3015 C 6.13 4
3 66,054
4 90,427
1 2,943,836
6 Prepare ruang uji non steril 3016 D 3.63 2
2 2,552,808
1 1,054,397
7 Buffer Room ruang uji non steril 3017 C 3.83 2
2 1,046,979
1 963,970
8 Changing Room ruang uji non steril 3018 C 3.83 2
2 981,631
1 349,346
2 235,605
9 Sterility Room 3019 B 6.41 4
3 195,690
4 214,765
1 1,054,751
10 Prepare ruang uji sterilitas 3020 D 4.28 3 2 1,051,925
3 1,091,840
1 1,241,610
11 Buffer Room 1 ruang uji sterilitas 3021 C 3.11 2
2 1,262,451
1 192,158
12 Changing Room 2 ruang uji sterilitas 3022 B 3.37 2
2 224,302
1 239,138
13 Air Lock ruang uji sterilitas 3023 B 3.89 2
2 208,053
1 622748
2 612,504
3 622,748
4 565,524
14 Cultivating Room 3024 D 28.51 8
5 511,748
6 620,628
7 519,604
8 512,539
1 1,915,224
2 1,813,140
3 1,325,679
15 Prepare Media 3025 D 11.16 6
4 1,609,678
5 1,813,140
6 2,541,858
1 2,773,225
2 2,517,838
3 2,577,484
16 Utensils Washing Room 3026 D 10.50 6
4 2,561,285
5 2,639,350
6 2,427,410
1 1,569,056
17 Changing Room In Out 3037 D 2.89 2
2 1,542,917
1 1,594,842
18 Buffer Room In Out 3038 D 2.94 2
2 1,530,907
1 1,251,854
19 Changing Room 1 ruang uji sterilitas 3039 C 2.37 2
2 1,248,322
1 1,294,489
20 Airlock 3040 D 2.36 2
2 1,645,708
1 4,332,744
2 2,987,636
3 3,121,865
21 Corridor N/A D 19.36 6
4 2,939,244
5 2,937,477
6 2,791,593
Class C corrid
12
10
Jumlah Partikel
0
1 2 3
Hari Ke
Jumlah Parti
Raw materials storage

1,400,000
1,200,000
1,000,000
Jumlah Partikel
800,000
600,000
400,000
200,000
0
1 2
Hari Ke
Jumlah Parti
Juml
400,000
200,000
0
1 2
Hari Ke
Jumlah Parti
Weighing room
1,600,000
1,400,000
1,200,000
Jumlah Partikel
1,000,000
800,000
600,000
400,000
200,000
0
1 2
Hari Ke
Jumlah Parti
Changing room out (

12
10
Jumlah Partikel
0
1 2 3
Hari K
Jumlah Parti
Changing room in (wo

12
10
Jumlah Partikel
0
1 2 3
Hari Ke
Jumlah Parti
J
2
0
1 2 3
Hari Ke
Jumlah Parti
Laundry rooom
12
10
Jumlah Partikel
8
0
1 2 3
Hari Ke
Jumlah Partik
Filling room (2
12
10
Jumlah Partikel
0
1 2 3
Hari Ke
Jumlah Parti
Dies Storage (204

12
10
Jumlah Partikel
0
1 2 3
Hari Ke-
Jumlah Partikel 0,5

2
0
1 2 3
Hari Ke-
Jumlah Partikel 0,5
Filling room (20

1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
1 2 3
partikel harian alert lim

Hari Rerata
Rerata
2 3 1 2 3 Kelas
1,226,068 1,618,156 B
973,154 1,465,206 C
1,281,525 1,052,719 1,388,378 1,240,874
1,066,760 1,294,948 D
944,895 1,175,203
2,943,836 4,013,776
3,376,369 3,399,152 4,088,131 3,621,217
3,854,468 4,162,486
1,012,363 1,182,621
1,199,046 1,030,555 1,170,258 1,133,286
1,048,746 1,157,894
1,333,451 1,158,601
1,204,874 1,296,362 1,153,303 1,218,179
1,259,272 1,148,004
90,427 1,191,805
74,179 1,175,203
68,615 68,527 1,269,693 468,945
58,283 1,195,690
51,218 1,516,072
3,319,675 3,956,905
2,748,322 3,376,369 3,905,687 3,343,459
3,433,062 3,854,468
73,119 1,450,370
1,050,688 62,699 1,400,212 837,866
52,278 1,350,053
79,830 1,153,302
972,801 78,417 1,156,128 735,782
77,004 1,158,954
0 80,890
706 77,004
248,852 441 65,259 104,851
1,059 64,641
0 38,502
3,137,760 2,552,808
3,154,362 2,943,836 1,066,172 3,124,573 2,683,151 2,291,298
3,081,596 2,552,808
2,866,478 1,338,396
1,252,031 2,946,838 1,287,178 1,828,682
3,027,198 1,235,959
263,157 55,104
208,230 270,752 52,102 177,028
278,346 49,099
233,013 63,228
223,596 233,073 71,882 176,184
233,133 80,536
1,008,477 569,410
843,871 592,723
239,138 673,613
208,406 642,175
573,505 428,249 968,120 656,625
229,247 657,364
357,470 785,941
309,784 899,328
229,600 2,924,408
2,121,157 1,696,573
2,053,691 1,774,991
197,681 1,705,404
1,836,453 1,458,173 1,790,827 1,695,151
2,016,248 1,692,688
1,836,453 1,458,173 1,790,827 1,695,151
2,166,372 1,695,513
193,890 2,179,795
1,935,711 1,424,938
1,747,792 1,685,623
1,607,205 1,571,529
2,582,765 1,647,827 1,690,451 1,973,681
1,591,310 1,830,801
1,480,748 1,863,652
1,524,196 1,766,160
1,687,742 3,909,925
1,555,987 1,646,768 3,874,602 2,359,119
1,605,793 3,839,279
1,615,330 3,948,074
1,562,875 1,589,721 3,887,848 2,346,814
1,564,111 3,827,622
2,984,811 1,027,905
1,250,088 3,078,241 985,871 1,771,400
3,171,670 943,836
1,683,857 4,101,377
1,470,099 1,716,001 3,760,155 2,315,418
1,748,145 3,418,933
2,857,294 2,342,988
2,858,707 2,107,029
2,642,529 1,796,891
3,185,093 2,549,158 1,957,023 2,563,758
2,439,067 1,607,559
2,316,495 2,048,746
2,180,854 1,838,926
Kelas B 270,752
C 3,078,241
D 4,088,131
Material supply room
1,620,000
1,610,000
1,600,000
Jumlah Partikel
1,590,000
1,580,000
1,570,000
1,560,000
1,550,000
1 2 3
Hari Ke-
Jumlah Partikel 0
Class C corridor Concentrate Air lock (2009)

d solution 4,500,000
room 4,000,000
(2041) Jumlah Partikel 3,500,000
3,000,000
3,000,000 2,500,000
Jumlah Partikel
2,000,000 2,000,000
1,500,000
1,000,000 1,000,000
0 500,000
12345 0
2 3 4 5 1 2 3
Hari Ke-
Hari Ke- Hari Ke-
Jumlah Partikel
Jumlah Partikel 0,5 0,5 Jumlah Partikel 0
Raw materials storage room (2039) Diluted Bottle blowing room

solution 12
room
(2043) 10
Jumlah Partikel
8
1,200,000
1,000,000
Jumlah Partikel
6
800,000
600,000 4
400,000
200,000 2
0
12345 0
1 2 3 4 5 1 2 3
Hari Ke-
Hari Ke- Hari Ke-
Jumlah Partikel
600,000 4
Juml
400,000
Jumlah
200,000 2
0
12345 0
1 2 3 4 5 1 2 3
Hari Ke-
Hari Ke- Hari Ke-
Jumlah Partikel
Weighing room (2061) PP Granule Preform making room

Temporary 12
storage
10
room
(2010)
Jumlah Partikel
8
2,000,000 6
Jumlah Partikel
1,500,000
4
1,000,000
500,000 2
0
12345 0
1 2 3 4 5 1 2 3
Hari Ke-
Hari Ke- Hari Ke-
Jumlah Partikel
Changing room out (man) (2013) Air lock class c Corridor

(2014) 12
12
10
10
Jumlah Partikel
8 8
6
6
4
2 4
0
1 2 3 4 5 2
2 3 4 5
Hari Ke-
Hari Ke- 0
1 2 3 4
Jumlah Partikel
Jumlah Partikel 0,5 0,5 partikel 0,5 alert limit
Changing room in (women) (2020) Air lock Changing room out (w

(2021) (2019)
12 12
10 10
Jumlah Partikel
Jumlah Partikel
8 8
6 6
4 4
2 2
0 0
2 3 4 5 1 2 3 4 5 1 2 3
Hari Ke- Hari Ke- Hari Ke-
Jumlah Partikel
2
Ju
Ju
2
0 0
2 3 4 5 1 2 3 4 5 1 2 3
Jumlah Partikel
Laundry rooom (2023) Utensils Utensils Washing room

staging 12
room
10
(2036)
Jumlah Partikel
8
12
10
Jumlah Partikel
6
8
6 4
4
2 2
0 0
2 3 4 5 1 2 3 4 5 1 2 3
Jumlah Partikel
Filling room (2044) In process Janitorial Storage room

control
12
room
(2028) 10
Jumlah Partikel
12 8
10
6
Jumlah Partikel
8
6 4
4
2
2
0 0
2 3 4 5 1 2 3 4 5 1 2 3
Jumlah Partikel 0,5 Jumlah Partikel 0,5 Jumlah Partikel 0
Dies Storage (2046) Janitorial Preform temporary stor

washing (2031)
room (2027) 12
12 10
Jumlah Partikel
10 8
Jumlah Partikel
8 6
6 4
4
2
2
2 3 4 5 0
0 1 2 3 4
1 2 3 4 5
Hari Ke- Hari Ke-
Hari Ke-
Jumlah Partikel 0,5 Jumlah Partikel 0,5
Jumlah Partikel 0,5
4
Jumla
Ju
2
2
2 3 4 5 0
0 1 2 3 4
1 2 3 4 5
Hari Ke- Hari Ke-
Hari Ke-
Jumlah Partikel 0,5
Filling room (2044)
2 3 4 5
partikel harian alert limit action limit

Syarat Maximal
≤ 352000 270,752
≤ 3520000 3,078,241
For Information 4,088,131
Material supply room (2003) Cap storage room (2029)
1,620,000 12
1,610,000
10
1,600,000
Jumlah Partikel
Jumlah Partikel
8
1,590,000
1,580,000 6
1,570,000 4
1,560,000 2
1,550,000 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-
Air lock (2009) The waste granule crushing room (2024)

4,500,000 12
4,000,000
3,500,000 10
Jumlah Partikel
3,000,000
Jumlah Partikel
8
2,500,000
2,000,000 6
1,500,000 4
1,000,000
500,000 2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-
Bottle blowing room (2032) Changing room in (man) (2015)

12 12
10 10
Jumlah Partikel
Jumlah Partikel
8 8
6 6
4 4
2 2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-

4 4
Juml
Jum
2 2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-
Preform making room (2004) Air lock (2016)

12 12
10 10
Jumlah Partikel
Jumlah Partikel
8 8
6 6
4 4
2 2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-
class c Corridor Dies Storage 2046

12
10
0
1 2 3 4 5 1 2 3 4 5
partikel 0,5 alert limit action limit partikel harian alert limit max action limit
Changing room out (women) Air lock (2022)

(2019) 12
12 10
10
Jumlah Partikel
8
Jumlah Partikel
8
6
6
4
4
2 2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-

J
2
Ju
2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-
Utensils Washing room (2035) Waste transfer (2034)

12 12
10 10
Jumlah Partikel
Jumlah Partikel
8 8
6 6
4 4
2 2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-
Janitorial Storage room (2026) Dies Storage room (2030)

12 12
10 10
Jumlah Partikel
Jumlah Partikel
8 8
6 6
4 4
2 2
0 0
1 2 3 4 5 1 2 3 4
Hari Ke- Hari Ke-
Preform temporary storage room

(2031)
12
10
Jumlah Partikel
8
6
4
2
0
1 2 3 4 5
Hari Ke-
Jumlah Partikel 0,5 Alert Limit

Ju
2
0
1 2 3 4 5
Hari Ke-

om (2029)
3 4 5
i Ke-
artikel 0,5
shing room (2024)
3 4 5
Ke-
rtikel 0,5
n (man) (2015)
3 4 5
ari Ke-
Partikel 0,5
3 4 5
ari Ke-
Partikel 0,5
(2016)
3 4 5
ari Ke-
Partikel 0,5
ge 2046
4 5
t limit max action limit
(2022)
3 4 5
ari Ke-
Partikel 0,5
3 4 5
ari Ke-
Partikel 0,5
fer (2034)
3 4 5
ari Ke-
Partikel 0,5
oom (2030)
3 4 5
ari Ke-
Partikel 0,5
No Luas Jumlah No Hari
No Nama Ruangan Kelas
Ruangan Area Sample Sample 1
1 1,766
2 6,358
1 Positive Control Room 3011 C 6.38 4
3 4945
4 5,651
1 32,144
2 Inactivation Room 3012 D 3.77 2
2 18721
1 4,592
3 Changing Room ruang identifikasi 3013 C 3.9 2
2 1,766
1 4,238
4 Buffer Room ruang identifikasi 3014 C 3.94 2
2 1,412
1 1,412
2 353
5 Microbial Limit Room 3015 C 6.13 4
3 353
4 1,766
1 38855
6 Prepare ruang uji non steril 3016 D 3.63 2
2 24,373
1 5,298
7 Buffer Room ruang uji non steril 3017 C 3.83 2
2 7,417
1 15,895
8 Changing Room ruang uji non steril 3018 C 3.83 2
2 13,069
1 1,412
2 0
9 Sterility Room 3019 B 6.41 4
3 353
4 706
1 1,059
10 Prepare ruang uji sterilitas 3020 D 4.28 3 2 1,059
3 1,412
1 4,592
11 Buffer Room 1 ruang uji sterilitas 3021 C 3.11 2
2 2,825
1 0
12 Changing Room 2 ruang uji sterilitas 3022 B 3.37 2
2 353
1 2,825
13 Air Lock ruang uji sterilitas 3023 B 3.89 2
2 706
1 4,592
2 1,412
3 1,412
4 353
14 Cultivating Room 3024 D 28.51 8
5 353
6 3,532
7 1,766
8 706
1 9,537
2 8,477
3 9,537
4 5,651
5 12,716
6 44,860
1 4,592
2 11,303
3 4,238
16 Utensils Washing Room 3026 D 10.50 6
4 4,945
5 5,651
6 1,766
1 12,009
17 Changing Room In Out 3037 D 2.89 2
2 6,358
1 2,825
18 Buffer Room In Out 3038 D 2.94 2
2 2,472
1 1,412
19 Changing Room 1 ruang uji sterilitas 3039 C 2.37 2
2 1,059
1 2,119
20 Airlock 3040 D 2.36 2
2 1,412
1 16,248
2 22,960
3 10,243
21 Corridor N/A D 19.36 6
4 11,656
5 7,417
6 10,243
Class C corrido
12
10
Jumlah Partikel
0
1 2 3
Hari Ke-
Jumlah Partikel 0
Raw materials storage ro

1,400,000
1,200,000
1,000,000
Jumlah Partikel
800,000
600,000
400,000
200,000
0
1 2 3
Hari Ke-
Jumlah Partikel 0
Juml
400,000
200,000
0
1 2 3
Hari Ke-
Jumlah Partikel 0
Weighing room (2
1,600,000
1,400,000
1,200,000
Jumlah Partikel
1,000,000
800,000
600,000 PP Granule T
400,000
200,000
16,000
0
1 14,0002 3
12,000
10,000 Hari Ke-
8,000
um
6,000
Jumlah Partikel 0
4,000
2,000
0
1
Changing room out (ma
12
10 Partikel Counter
Jumlah Partikel
6 Changin
4
2 12
10
0
1 2 3
Jumlah Partikel
8
Hari Ke-
6
4
Jumlah Partikel 0
2
0
1
Changing room in (wom
partikel haria
12
10
a
Jumlah Partikel
8
12
6
10
jUMLAH PARTIKEL
4
8
2
6
0
1 2 4 3
2 Hari Ke-
0
1
Jumlah Partikel 0
J
2
jUMLAH PAR
6
0
1 2 4 3
2 Hari Ke-
0
1
Jumlah Partikel 0
partikel harian
Laundry rooom (20
12
10
Changin
12
Jumlah Partikel
8
6 10
JUmlah PArtikel
8
2 6
0
1 42 3
2 Hari Ke-
0
1
Jumlah Partikel 0
partikel ha
Filling room (204
12
10 Janito
12
Jumlah Partikel
6 10
4 8
Airlock 2022
2 6
0 4
1 2 3
2
Hari Ke-
0
1
Jumlah Partikel 0
partikel h
Dies Storage (2046)
12
Bottl
10
12
Jumlah Partikel
8
10
6
8
4
Airlock 2022
6
2
4
0
1 2 2 3
0 Hari Ke-
1
Jumlah Partikel 0,5
partikel
2
4
Airlock
0
1 2 2 3
0 Hari Ke-
1
Jumlah Partikel 0,5
partikel
Filling room (204
1
0.9
0.8
0.7
0.6
0.5
0.4
0.3
0.2
0.1
0
1 2 3 4
partikel harian alert limit

Hari Rerata
Rerata
2 3 1 2 3 Kelas
6,004 25,785 B
2,825 17,661 C
4,680 3,620 15,277 7,859
3179 9890 D
2,472 7,771
8,830 10,596
25,433 7,594 7,594 13,540
6,358 4,592
706 7,064
3,179 2,649 4,945 3,591
4,592 2,825
4,592 2,119
2,825 3,356 2,649 2,943
2,119 3,179
3,179 3,179
1,059 1,412
971 1,148 1,413 1,177
0 353
353 706
8,830 8,830
31,614 9,713 7,417 16,248
10,596 6,004
706 3,532
6,358 353 3,356 3,355
0 3,179
1,412 7,771
14,482 883 5,652 7,005
353 3,532
0 0
706 0
618 441 88 382
1,059 0
0 353
4,238 1,059
6,711 1,412 1,177 4,473 1,647 2,432
2,471 2,471
2,825 6,004
3,709 3,532 4,062 3,767
4,238 2,119
706 0
177 530 177 294
353 353
706 0
1,766 530 0 765
353 0
18,368 2,119
9,537 2,119
13,776 5,651
0 8,124
1,766 10,508 5,121 5,799
2,472 7,417
37,795 8,830
2,119 4,592
0 2,119
4,238 2,825
7,771 2,825
6,711 2,119
15,130 6,947 1,942 8,006
9,184 1,766
15,130 6,947 1,942 8,006
9,184 353
4,592 1,766
7,064 706
11,303 5,298
7,417 2,472
5,416 5,592 2,590 4,533
3,885 2,472
2,472 2,825
1,412 1,766
5,651 11,303
9,184 9,184 10,244 9,537
12,716 9,184
28,965 21,547
2,649 23,313 21,900 15,954
17,661 22,253
5,298 2,472
1,236 3,885 3,002 2,708
2,472 3,532
6,352 25,432
1,766 5,119 25,962 10,949
3,885 26,492
3,885 10,243
3,885 2,472
2,119 9,890
13,128 3,650 4,415 7,064
1,766 706
6,358 1,766
3,885 1,412
Kelas B 1,766
C 15,277
D 31,614
Material supply room (2003)
1,620,000
1,610,000
1,600,000
Jumlah Partikel
1,590,000
1,580,000
1,570,000
1,560,000
1,550,000
1 2 3 4 5
Hari Ke-
Jumlah Partikel 0,5
Class C corridor Concentr Air lock (2009)

ated 4,500,000
solution 4,000,000
room 3,500,000
(2041)
Jumlah Partikel
3,000,000
2,500,000
4,000,000
2,000,000
Jumlah Partikel
3,000,000
1,500,000
2,000,000 1,000,000
1,000,000 500,000
0 0
2 3 4 5 12345 1 2 3 4 5
Jumlah Par-
Jumlah Partikel 0,5 tikel 0,5 Jumlah Partikel 0,5
Raw materials storage room (2039) Diluted Bottle blowing room (2032)
solution 12
room
(2043) 10
Jumlah Partikel
8
1,200,000
1,000,000
Jumlah Partikel
6
800,000
600,000 4
400,000
200,000 2
0 0
1 2 3 4 5 12345 1 2 3 4 5
Jumlah Par-
600,000 4
Juml
Jumlah P
400,000
200,000 2
0 0
1 2 3 4 5 12345 1 2 3 4 5
Jumlah Par-
Weighing room (2061) PP Preform making room (2004)

Granule 12
Tempora
10
ry
storage
Jumlah Partikel
8
room 6
(2010)
PP Granule Temporary storage room 4 Material supply room
Jumlah Partikel
(2010) 2,000,000
8,000
2
1,000,000
16,000 0 7,000
12345 0
1 14,0002 3 4 5 6,000 1 2 3 4 5
12,000 Hari Ke- 5,000
10,000 Hari Ke- Hari Ke-
4,000
um
8,000
um
Jumlah Par- 3,000

6,000 Jumlah Partikel 0,5
Jumlah Partikel 0,5 tikel 0,5 2,000
4,000
2,000 1,000
0 0
1 2 3 4 5 1 2 3
Changing room out (man) (2013)
Hari ke - Air lock class c Corridor Hari ke -
(2014) 12
Partikel Counter Alert Limit MAX Action Limit MAX 12 Partikel Counter Alert Limit MAX
10
10
Jumlah Partikel
8 8
Changing room in man 2015 airlock (2016)
6
6 12
4
12 2 4 10
10 0 8
ju mlah parikel
12345 2
2 3 4 5
Jumlah Partikel
8
Hari Ke- 6
Hari Ke- 0
6 1 2 3 4 5
4
4 Jumlah Par-
Jumlah Partikel 0,5 partikel 0,5 alert limit action lim
tikel 0,5 2
2
0
0 1 2 3
1 2 3 4 5
Changing room in (women) (2020)
Air lock Changing partikel
roomhari out
ke (women)
alert limit
(2021) (2019)
12 12
airlock (2014 10 10 airlock 2021
Jumlah Partikel
Jumlah Partikel
12 8 8
10 6 12 6
jUMLAH PARTIKEL
8 4 10 4
2
Jumlah partikel
6 8 2
0 0
2 4 3 4 5 12345 6 1 2 3 4 5
2 Hari Ke- Hari Ke- 4 Hari Ke-
0 2
1 2 3 4 5 Jumlah Par-
0
Hari ke
2
Ju
Jumlah partikel
jUMLAH PAR
Ju
6 8 2
0 0
2 4 3 4 5 12345 6 1 2 3 4 5
2 Hari Ke- Hari Ke- 4 Hari Ke-
0 2
1 2 3 4 5 Jumlah Par-
0
Hari ke
Laundry rooom (2023) Utensils Utensils Washing room (2035)
staging 12
Changing Room in Woman 2020 room
10
(2036) class c corridor
12
Jumlah Partikel
8
12
12
10 10 6
Jumlah Partikel
8 10
JUmlah PArtikel
8 6 4
8
4
2
Airlock 2022
6 2 6
0 0 4
42 3 4 5 12345 1 2 3 4 5
Hari Ke- 2
2 Hari Ke- Hari Ke-
0
1 2 3
0
1
Jumlah Partikel 0,52 3 4 5 Jumlah Par- Jumlah Partikel 0,5 hari ke
tikel 0,5
Hari ke
Filling room (2044) partikel harian alert limit action limit In Janitorial Storage room (2026)
process
12
control
Janitorial storage room 2026 room 10 preform temporary storage
12 (2028)
Airlock 2022Jumlah Partikel
8
12
10 12 6
10
Jumlah Partikel
8 8
48
Airlock 2022
6 4
26
4 0
12345 04
2 3 4 5 1 2 3 4 5
2 Hari Ke-
Hari Ke- 2 Hari Ke-
0
1 2 3 4 5 0
Jumlah Par- 1 2 3
Jumlah Partikel 0,5 hari ke tikel 0,5 Jumlah Partikel 0,5
hari ke

Dies Storage (2046) Janitorial Preform temporary storage
washing room (2031)
Bottle blowing room (2032)
room 12
12 (2027) 10
10
Jumlah Partikel
12 8
10
Jumlah Partikel
8 6
8
Airlock 2022
6 6 4
4
4 2 2
2 3 4 5 0 0
2 12345 1 2 3 4 5
0 Hari Ke- Hari Ke- Hari Ke-
1 2 3 4 5
hari ke
Jumlah Partikel 0,5 Jumlah Par- Jumlah Partikel 0,5 Alert Limit
tikel 0,5
4
Ju
Jumla
4 2
Airlock
2
2 3 4 5 0 0
2 12345 1 2 3 4 5
0 Hari Ke- Hari Ke- Hari Ke-
1 2 3 4 5
hari ke
Jumlah Partikel 0,5 Jumlah Par- Jumlah Partikel 0,5 Alert Limit
tikel 0,5
Filling room (2044)
2 3 4 5

Syarat Maximal
≤ 352,000 1,766
≤ 3,520,000 15,277
For Information 31,614
Material supply room (2003) Cap storage room (2029)
1,620,000 Airlock 2009
12
1,610,000 14,000
10
1,600,000 12,000
Jumlah Partikel 8
1,590,000
10,000
6
Jumlah Pertikel
1,580,000
8,000
1,570,000 4
6,000
1,560,000 2
1,550,000 4,000
1 2 3 4 5 0
1 2 3 4 5
2,000
Hari Ke- Hari Ke-
0
1 2 3
partikel harian alert limi
Air lock (2009) The waste granule crushing room (2024)

4,500,000 12
4,000,000 Preform making ro
3,500,000 10
8,000
3,000,000
Jumlah Partikel
8
7,000
Jumlah Partikel
2,500,000
2,000,000 6 6,000
1,500,000 4 5,000
1,000,000
2 4,000
500,000
0 3,000
1 2 3 4 5 0
1 2 2,000 3 4 5
Hari Ke- 1,000 Hari Ke-
0
1 2 3
Partikel harian alert limit
Bottle blowing room (2032) Changing room in (man) (2015)

12 12
10 10
Jumlah Partikel
8 8
Changing out men
6 6
12
4 4
10
2 2
0 0 8
JUmlah partikel
1 2 3 4 5 1 2 3 4 5
Hari Ke- 6 Hari Ke-
4
2
4 4
Jum
10
2 2
0 0 8
JUmlah partikel
1 2 3 4 5 1 2 3 4 5
Hari Ke- 6 Hari Ke-
4
2
Preform making room (2004) 0 Air lock1 (2016) 2 3

12 12
Partikel hari ke alert lim
10 10
Jumlah Partikel
8 8
6 6 Changing room out wo

4 Material supply room (2003) 4
12
8,000
2 2
7,000 10
0 0
6,000 1 2 3 4 5 1 2 3 4 5
8
jumlah partikel
5,000 Hari Ke- Hari Ke-
4,000 6
3,000
2,000 Jumlah Partikel 0,5 4 Jumlah Partikel 0,5
1,000
2
0
1 2 3 4 5
0
class c Corridor Hari ke - Dies Storage
1 2046 2 3
12 hari ke
Partikel Counter Alert Limit MAX Action Limit MAX
10 partikel harian alert lim
8
airlock (2016)
12 6
die storage room (20
10 4 12
8 10
ju mlah parikel
2
8
6
0
Airlock 2022
1 2 63 4 5
1 2 3 4 5
4
4
partikel 0,5 alert limit action limit partikel harian alert limit max action limit
2 2
0 0
1 2 3 4 5 1 2 3
hari ke
Changing partikel
roomhari out
ke (women)
alert limit action limit Air lock (2022)
(2019) 12 partikel harian alert limit
12 10
10 airlock 2021
Jumlah Partikel
8
8 filling room (2044)
12 6 6
12
4
10 4 10
2
8 2 8
0 0
Airlock 2022
6 1 2 3 4 5 1 2 6 3 4 5
4 Hari Ke- 4 Hari Ke-
2
2
Jumlah Partikel 0,5 0 Jumlah Partikel 0,5
0 1 2 3
Hari ke hari ke
J
2
8 2 8
0 0
Airlock 2022
6 1 2 3 4 5 1 2 6 3 4 5
4 Hari Ke- 4 Hari Ke-
2
2
Jumlah Partikel 0,5 0 Jumlah Partikel 0,5
0 1 2 3
Hari ke hari ke
Utensils Washing room (2035)

partikel harian alert limit action limit Waste transfer (2034)
12 12
10 10
class c corridor granule waste crushing r
Jumlah Partikel
8 8
12
6 6
10 12
4 4 10
8
2 2
Airlock 2022
6 8
Airlock 2022
0 4 0 6
1 2 3 4 5 1 2 3 4 5
2 4
Hari Ke- Hari Ke-
0 2
1 2 3 4 5
0
Jumlah Partikel 0,5 hari ke Jumlah
1 Partikel 0,5 2 3
hari ke
Janitorial Storage room (2026) Dies Storage room (2030)

12 12
10 preform temporary storage room (2031)

10 dies storage room (204
Jumlah Partikel
8
12 8 12
6
10 6 10
48 4 8
Airlock 2022
6
26 2
4
04 0
1 2 3 4 5 1 2 2 3 4 5
2 Hari Ke- Hari Ke-
0
1 2 3
0
1 2 3 4 5 hari ke
hari ke
partikel harian alert limi
Preform temporary storage
room (2031)
12
10
8
6
4
2
0
1 2 3 4 5
Hari Ke-

2
0
1 2 3 4 5
Hari Ke-

Airlock 2009 air lock 2022
12
10
Airlock 2022
6
2
4 5 0
1 2 3 4
2 3 4 5 hari ke
tikel harian alert limit action limit

m (2024)
laundry room 2023
Preform making room (2004) 12
10
8
Airlock 2022
2
4 5
0
1 2 3 4
hari ke
2 3 4 5
kel harian alert limit action limit partikel harian alert limit action lim
015)
utensils staging room 2036

Changing out men (2013)
12
10
8
Airlock 2022
4 5 6
4
2
0
1 2 3 4
hari ke
10
8
Airlock 2022
4 5 6
4
2
0
1 2 3 4
hari ke
2 3 4 5
partikel harian alert limit action lim
tikel hari ke alert limit action limit
nging room out women 2019 utensils washing room 2035
12
10
4 5
8
Airlock 2022
6
4
2
0
1 2 3 4
hari ke
2 3 4 5
hari ke
partikel harian alert limit action
waste transfer 2034

e storage room (2030)
12
10
8
Airlock 2022
6
5
4
action limit 2
0
2 3 4 5 1 2 3 4
hari ke hari ke
kel harian alert limit action limit partikel harian alert limit action lim
IPC Room (2028)

g room (2044)
12
10
8
Airlock 2022
4 5 6
4
2
0
2 3 4 5 1 2 3 4
hari ke hari ke
10
8
Airlock 2022
4 5 6
4
2
0
2 3 4 5 1 2 3 4
hari ke hari ke
kel harian alert limit action limit partikel harian alert limit action
Janitor Washing Room 2027

e waste crushing room (2024)
12
10
8
Airlock 2022
6
4 5 4
2
0
1 2 3 4
2 3 4 5
hari ke
hari ke
partikel harian alert limit action

0)
harian alert limit action limit
cap storage room (2029)

storage room (2046) 12
10
8
Airlock 2022
6
4
2
4 5
0
1 2 3 4
2 3 4 5
hari ke
hari ke

ock 2022
3 4 5
hari ke
alert limit action limit
y room 2023
3 4 5
hari ke
aging room 2036
3 4 5
hari ke
3 4 5
hari ke
washing room 2035
3 4 5
hari ke
transfer 2034
3 4 5
hari ke
C Room (2028)
3 4 5
hari ke
3 4 5
hari ke
Washing Room 2027
3 4 5
hari ke
e room (2029)
3 4 5
hari ke

Teoritis
Volume Ach Minimal
Ruangan No Ruang ID HEPA Debit (m3/h)
ruangan (m3) 20/Jam
1 Positive Control Room 3011 1 15.75 20 315

2 Inactivation Room 3012 1 15.1 20 302
3 Changing Room ruang identifikasi 3013 1 15.75 20 315
4 Buffer Room ruang identifikasi 3014 1 15.75 20 315
5 Microbial Limit Room 3015 1 24.5 20 490
6 Prepare ruang uji non steril 3016 1 14.5 20 290
7 Buffer Room ruang uji non steril 3017 1 15.3 20 306
8 Changing Room ruang uji non steril 3018 1 15.61 20 312
9 Sterility Room 3019 1 25.65 20 513
10 Prepare ruang uji sterilitas 3020 1 17.1 20 342
11 Buffer Room 1 ruang uji sterilitas 3021 1 12.46 20 249
12 Changing Room 2 ruang uji sterilitas 3022 1 13.49 20 270
13 Air Lock ruang uji sterilitas 3023 1 15.57 20 311
1 1140
14 Cultivating Room 3024 114.04 20
2 1140
15 Prepare Media 3025 1 44.72 20 894
16 Utensils Washing Room 3026 1 42 20 840
17 Changing Room In Out 3037 1 13.5 20 270
18 Buffer Room In Out 3038 1 13.5 20 270
19 Changing Room 1 ruang uji sterilitas 3039 1 10.8 20 216
20 Airlock 3040 1 10.84 20 217
1 20 738
21 Corridor N/A 73.8
2 20 738
Aktual
Debit (m /h)
3
AcH perHari
1 2 3 1 2 3 Rerata
358 346 352 22.7 22.0 22.3 22.35
441 445 450 29.2 29.5 29.8 29.49
365 366 360 23.2 23.2 22.9 23.09
340 344 347 21.6 21.8 22.0 21.82
610 588 590 24.9 24.0 24.1 24.33
368 366 370 25.4 25.2 25.5 25.38
350 355 356 22.9 23.2 23.3 23.12
441 412 405 28.3 26.4 25.9 26.86
712 720 715 27.8 28.1 27.9 27.90
428 429 420 25.0 25.1 24.6 24.89
283 279 286 22.7 22.4 23.0 22.69
312 315 320 23.1 23.4 23.7 23.40
456 458 461 29.3 29.4 29.6 29.44
1350 1356 1355
21.5 22.0 21.9 21.78
1100 1150 1140
1162 1156 1158 26.0 25.8 25.9 25.91
1141 1124 1133 27.2 26.8 27.0 26.97
298 284 285 22.1 21.0 21.1 21.41
361 355 359 26.7 26.3 26.6 26.54
310 299 308 28.7 27.7 28.5 28.30
305 304 302 28.1 28.0 27.9 28.01
925 924 920
21.6 21.7 21.6 21.66
670 680 677
min 21.41

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No Day 1 Day 2

1 Positive Control Room 3011 C

2 Inactivation Room 3012 D

5 Microbial Limit Room 3015 C

6 Prepare ruang uji non steril 3016 D

9 Sterility Room 3019 B

10 Prepare ruang uji sterilitas 3020 D

12 Changing Room 2 ruang uji sterilitas 3022 B

13 Air Lock ruang uji sterilitas 3023 B

14 Cultivating Room 3024 D

15 Prepare Media 3025 D

rata rata per hari #DIV/0! #DIV/0! #DIV/0! #DIV/0!

1 Positive Control Room 3011 C

2 Inactivation Room 3012 D

5 Microbial Limit Room 3015 C

6 Prepare ruang uji non steril 3016 D

9 Sterility Room 3019 B

10 Prepare ruang uji sterilitas 3020 D

12 Changing Room 2 ruang uji sterilitas 3022 B

13 Air Lock ruang uji sterilitas 3023 B

14 Cultivating Room 3024 D

15 Prepare Media 3025 D

rata rata per hari #DIV/0! #DIV/0! #DIV/0! #DIV/0!

1 Positive Control Room 3011 C

2 Inactivation Room 3012 D

5 Microbial Limit Room 3015 C

6 Prepare ruang uji non steril 3016 D

9 Sterility Room 3019 B

10 Prepare ruang uji sterilitas 3020 D

12 Changing Room 2 ruang uji sterilitas 3022 B

13 Air Lock ruang uji sterilitas 3023 B

14 Cultivating Room 3024 D

15 Prepare Media 3025 D

rata rata per hari #DIV/0! #DIV/0! #DIV/0! #DIV/0!

5 58.10 55.40 58.40

Air lock (2009)

Buffer room (man)

Air lock (2014)

Air lock (2021)

Utensils staging room

Dies Storage room

ution Diluted Material supply

Cleanin Changing room

an) Changi Changing

g room Utensil Waste

ntrol Janito Preform

Filling Stagting room

5 22.1 23.5 22.4

24.1 23.9 24.1

24.0 24.0 24.0

23.9 23.9 23.9

21.2 21.3 21.5

23.5 23.6 23.6

22.0 22.3 22.2

23.1 22.8 23.0

21.7 21.8 21.8

22.5 22.3 22.5

23.2 22.7 23.0

20.8 20.8 20.7

21.0 21.6 21.0

22.7 22.6 22.8

24.0 23.1 22.9