Metronidazol 5mg Data PQR Fix
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Metronidazol 5mg Data PQR Fix
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SPESIFIKASI Produk Ruahan
Nilai
Max
Volume rata-rata (mL)
PH (25 C)
Berat Jenis 25C (g/mL)
Kadar zat aktif (%)
Warna
Bentuk
Larutan jernih, bebas partikel asing
SPESIFIKASI Produk Jadi
Volume rata-rata (mL)
PH (25C)
Berat Jenis 25C(g/mL)
Kadar zat aktif (%)
Endotoksin (EU/mg)
Bahan Partikulat 10
Bahan Partikulat 25
Kebocoran botol Infus
Warna
Bentuk
102.0
4.5
1.0
90.0
Agak Kekuningan
Nilai
Min
102
4.5
1.0
90.0
Negatif
Agak Kekuningan
Larutan jernih, bebas partikel asing
Nilai
Critical Proses Parameter (CPP)
Min
104.0
7.0
1.1
110.0
gak Kekuningan
Mixing
Mixing
Mixing
Mixing
Proses
Larutan 1
Larutan 2
Lar 1 + Lar 2
Tambahan Aqua
Waktu (Menit)
20
10
10
10
bebas partikel asing
Nilai
Critical Quality Atribut (CQA)
Max
104.0
7
1.1
110.0
0.4
6000
600
Negatif
gak Kekuningan
bebas partikel asing
Sterilisasi alat filling
Sterilisasi Baju Operator
Sterilisasi Produk Jadi
Rekonsiliasi pengolahan
Rekonsiliasi Pengemasan Primer
Rekonsiliasi Pengemasan Sekunder
SuhuC
121
121
121
ter (CPP)
Waktu (Menit)
20
10
10
10
Quality Atribut (CQA)
SuhuC
121
121
121
Waktu (Menit)
30
30
30
A. Proses Penimbangan
Penimbangan bahan awal
Bahan aktif
Bahan tambahan
B. Pencucian Botol & Peralatan
Cuci Botol dan Peralatan
Sterilsasi
C. Pencampuran
Tampung WFI dan user point
dinginkan sampai suhu 30-40 (25C)
Pembuatan Larutan 1
Aqua pro injeksi
Asam Citrat Monohidrat
Disodium hidrogen fosfat dihidrat
Masukkan kedalam Mixing Tank Steril
Aduk 20 menit ad homogen
Larutan 1
Pembuatan Larutan 2
Masukkan NaCl Kedalam Larutan 1
Aduk 10 menit ad homogen sambil dialiri gas nitroge
Larutan 2
Pencampuran bahan aktif
Masukkan Metronidazole BP
Aduk 10 menit ad homogen sambil diali
Masukkan Aqua Pro injeksi ad 2
sambil dialiri gas nitrogen aduk 10 meni
Infus metronidazol 5 mg/m
D. Proses Pengisian
Ruang kelas A / LAF dengan surround
isikan larutan infus metronidazol 5 mg/ml ke
sambil dialiri gas nitrogen yang sudah disarin
1m bebas pirogen dan bakteri filte
tutup botol infus dengan rubber s
E. Proses Capping
Ruang Capping (kelas D)
Lakukan Capping pada botol infus
F. Proses Sterilisasi Akhir
Ruang Sterilisasi akhir (Kelas
Lakukan sterilisasi akhir produk deng
0 (25C)
eksi
nohidrat
osfat dihidrat
xing Tank Steril
homogen
am Larutan 1
mbil dialiri gas nitrogen
kkan Metronidazole BP
homogen sambil dialiri gas nitrogen
n Aqua Pro injeksi ad 200 L
nitrogen aduk 10 menit ad homogen
metronidazol 5 mg/ml
LAF dengan surrounding kelas B
etronidazol 5 mg/ml kedalam botol infus
gen yang sudah disaring dengan prefilter
rogen dan bakteri filter 0,2 m
infus dengan rubber stopper
pping (kelas D)
ng pada botol infus
Sterilisasi akhir (Kelas F)
asi akhir produk dengan autoclaf
Parameter : Pemerian
Produk Ruahan
No. Batch
L10176503
L10176510
L10176521
L10176522
Status
Bentuk
Parameter Hasil
Larutan Jernih,bebas partikel asing
sesuai
Larutan Jernih,bebas partikel asing
Sesuai
Larutan Jernih,bebas partikel asing
Sesuai
Larutan Jernih,bebas partikel asing
Sesuai
Warna
Parameter Hasil
Agak Kekuningan
sesuai
Agak Kekuningan
sesuai
Agak Kekuningan
sesuai
Agak Kekuningan
sesuai
Parameter : Identifikasi
Produk Ruahan
No. Batch
Identifikasi
L10176503
Metronidazole (+)
L10176510
Metronidazole (+)
L10176521
Metronidazole (+)
L10176521
Metronidazole (+)
Parameter hasil
(+)
(+)
(+)
(+)
Parameter : Rekonsiliasi Pengemasan Sekunder
Produk Jadi
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Hasil Teoritis
Hasil Aktual
Susut %
1892
1955
1955
1954
0
0
0
0
0
0
0
0
No Batch
L10176503
L10176510
L10176521
L10176522
Hasil Teoritis
Hasil Aktual
Rendemen %
1892
1953
1955
1954
1892
1955
1955
1954
100
100
100
100
Rekonsiliasi Pengemasan Sekunder
Susut
2500
2000
1500
1000
500
0
Rekonsiliasi Pengemasan
Hasil Teoritis
Hasil Aktual
Susut %
Batch
Rendemen %
1600
1100
600
100
Batch
konsiliasi Pengemasan Sekunder
1600
1100
600
100
Hasil Teoritis
Hasil Aktual
Rendemen %
Batch
Parameter : Rekonsiliasi Pengemasan Primer
Produk Jadi
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Hasil Teoritis
Hasil Aktual
Susut %
199.85
199.85
199.85
199.85
2.811
3.575
3.369
3.266
1.41
1.79
1.69
1.63
No Batch
L10176503
L10176510
L10176521
L10176522
Hasil Teoritis
Hasil Aktual
Rendemen %
199.85
199.85
199.85
199.85
197.038
203.425
203.219
203.116
98.59
101.79
101.69
101.63
Rekonsiliasi Pengemasan Primer
Susut %
250
200
150
100
50
0
Rekonsiliasi Pengemasa
200
150
Hasil Teoritis
Hasil Aktual
Susut %
Batch
100
Rendemen %
50
Batch
Rekonsiliasi Pengemasan Primer
200
150
Hasil Teoritis
100
Hasil Aktual
50
Rendemen %
Batch
Parameter : Rekonsiliasi Pengolahan
Produk Jadi
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Hasil Teoritis
Hasil Aktual
200
200
200
200
0
0
0
0
Susut %
0
0
0
0
No Batch
L10176503
L10176510
L10176521
L10176522
Hasil Teoritis
200
200
200
200
Hasil Aktual
Rendemen %
200
200
200
200
100
100
100
100
Rekonsiliasi Pe
Susut %
300
200
100
0
Batch
usut %
Rekonsiliasi Pengolahan
300
200
100
0
Rekonsiliasi Pengolahan
Hasil Teoritis
Hasil Aktual
Susut %
Rendemen %
250
200
150
100
50
0
Batch
Batch
ndemen %
Rekonsiliasi Pengolahan
250
200
150
100
50
0
Hasil Teoritis
Hasil Aktual
Rendemen %
Batch
Parameter : Volume rata-rata
Frekuensi pengambilan sampel:
No Kode
No Batch
L10176503
L10176510
L10176521
L10176522
Err:512
Err:512
Err:512
Err:512
Spesifikasi Volume
102,0 104,0 ml
102,0 104,0 ml
102,0 104,0 ml
102,0 104,0 ml
Hasil
103.0
103.0
103.0
103.0
OUT OF CTRL (X)
X
103.0
103.0
103.0
103.0
MR (n=2)
0
0
0
X
103
103
103
103
PETA X BAR
LCL
UCL
103
103
103
103
CL
103
103
103
103
MR
103
103
103
103
0
0
0
PETA MR
UCL
0
0
0
0
LCL
CL
0
0
0
0
OUT OF CTRL (MR)
0
0
0
0
X INDIVIDUAL MOVING RANGE
X BAR =
MR BAR
103 n=
0 E2=
D3=
D4=
PETA X BAR
UCL
LCL
CL
PETA MR
103
103
103
0
0
0
2
2.66
0
3.267
No Batch
L10176503
L10176510
L10176521
L10176522
103
103
103
103
UCL
103
103
103
103
CL
LCL
Spek Min
Spek Max
103
103
103
103
103
103
103
103
102
102
102
102
104
104
104
104
OUT OF CONTROL
No Batch
L10176503
L10176510
L10176521
L10176522
MR
0
0
0
UCL
CL
0
0
0
0
LCL
0
0
0
0
OUT OF CONTROL
0
0
0
0
Individual moving range Volume Rata-rata
104.5
104
X
103.5
UCL
103
X Bar
CL
102.5
LCL
Spek Min
102
Spek Max
101.5
101
L10176503
L10176510
Batch
L10176521
L10176522
MR Volume Rata-Rata
1
0.9
0.8
0.7
UCL
0.6
MR
0.5
UCL
0.4
CL
0.3
LCL
CL
LCL
Spek Min
Spek Max
MR
0.2
0.1
0
L10176503
L10176510
L10176521
Batch
L10176522
MR
UCL
CL
LCL
Parameter : pH
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Spesifikasi PH (25)
4,5 7,0
4,5 7,0
4,5 7,0
4,5 7,0
Hasil
6.18
6.14
6.16
6.11
X
6.18
6.14
6.16
6.11
OUT OF CTRL (X)
PETA X BAR
LCL
MR (n=2)
0.04
0.02
0.05
6.18
6.14
6.16
6.11
6.05
6.05
6.05
6.05
UCL
CL
6.25
6.25
6.25
6.25
PETA MR
UCL
MR
6.15
6.15
6.15
6.15
0.04
0.02
0.05
0.12
0.12
0.12
0.12
LCL
CL
0
0
0
0
0.04
0.04
0.04
0.04
OUT OF CTRL (MR)
X INDIVIDUAL MOVING RANGE
X BAR =
MR BAR
UCL
LCL
CL
DIVIDUAL MOVING RANGE
6.1475 n=
0.037 E2=
D3=
D4=
PETA X BAR PETA MR
6.24503333
6.04996667
6.1475
0.11979
0
0.037
2
2.66
0
3.267
No Batch
L10176503
L10176510
L10176521
L10176522
UCL
6.18
6.14
6.16
6.11
6.245
6.245
6.245
6.245
CL
LCL
6.148
6.148
6.148
6.148
Spek Max
6.05
6.05
6.05
6.05
Spek Min
7
7
7
7
OUT OF CONTROL
4.5
4.5
4.5
4.5
OF CONTROL
No Batch
L10176503
L10176510
L10176521
L10176522
MR
0.04
0.02
0.05
UCL
CL
0.12
0.12
0.12
0.12
LCL
0.04
0.04
0.04
0.04
OUT OF CONTROL
0
0
0
0
X indivudual pH
8
7
6
5
X-bar
4
3
2
1
0
L10176503
L10176510
L10176521
Batch
L10176522
21
MR ind
0.14
0.12
0.1
X
UCL
0.08
CL
LCL
MR bar
0.06
Spek Max
Spek Min
0.04
0.02
L10176522
0
L10176503
L10176510
Ba
MR individual pH
MR
UCL
CL
LCL
L10176510
L10176521
Batch
L10176522
Parameter : Volume rata-rata
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Spesifikasi Volume
102,0 104,0 ml
102,0 104,0 ml
102,0 104,0 ml
102,0 104,0 ml
Hasil
103.0
103.0
103.0
103.0
X
103.0
103.0
103.0
103.0
OUT OF CTRL (X)
MR (n=2)
0
0
0
103
103
103
103
PETA X BAR
LCL
103
103
103
103
UCL
CL
103
103
103
103
PETA MR
UCL
MR
103
103
103
103
0
0
0
0
0
0
0
LCL
CL
0
0
0
0
OUT OF CTRL (MR)
0
0
0
0
X INDIVIDUAL MOVING RANGE
X BAR =
MR BAR
PETA X BAR
UCL
LCL
CL
103
103
103
No Batch
103 n=
0 E2=
D3=
D4=
PETA MR
0
0
0
2
2.66
0
3.267
L10176503
L10176510
L10176521
L10176522
UCL
CL
103
103
103
103
103
103
103
103
103
103
103
103
LCL
Spek Min
Spek Max
103
103
103
103
102
102
102
102
104
104
104
104
OUT OF CONTROL
MR
UCL
0
0
0
CL
0
0
0
0
LCL
0
0
0
0
0
0
0
0
OUT OF CONTROL
individual Moving Range Volume Rata
104.5
104
103.5
103
X bar
102.5
102
101.5
101
L10176503
L10176510
Batch
L10176521
L10
l Moving Range Volume Rata-Rata
MR Volume Rat
1
0.9
0.8
0.7
UCL
0.6
CL
LCL
Spek Min
Spek Max
MR
0.5
0.4
0.3
0.2
0.1
176510
Batch
L10176521
L10176522
0
1
2
Batch
MR Volume Rata-Rata
MR
UCL
CL
LCL
3
Batch
Parameter : pH
Produk Ruahan
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Spesifikasi PH (25)
4,5 7,0
4,5 7,0
4,5 7,0
4,5 7,0
Hasil
6.18
6.14
6.16
6.11
OUT OF CTRL (X)
X
6.18
6.14
6.16
6.11
MR (n=2)
0.04
0.02
0.05
X
6.18
6.14
6.16
6.11
PETA X BAR
LCL
6.0500
6.0500
6.0500
6.0500
UCL
6.2450
6.2450
6.2450
6.2450
CL
MR
6.1475
6.1475
6.1475
6.1475
0.04
0.02
0.05
PETA MR
UCL
0.1198
0.1198
0.1198
0.1198
LCL
CL
0
0
0
0
OUT OF CTRL (MR)
0.0367
0.0367
0.0367
0.0367
X INDIVIDUAL MOVING RANGE
X BAR =
MR BAR
PETA X BAR
UCL
LCL
CL
6.2450
6.0500
6.1475
No Batch
6.1475 n=
0.0367 E2=
D3=
D4=
PETA MR
0.11979
0
0.0367
2
2.66
0
3.267
L10176503
L10176510
L10176521
L10176522
UCL
CL
LCL
6.18
6.14
6.16
6.11
6.2450
6.2450
6.2450
6.2450
6.1475
6.1475
6.1475
6.1475
6.0500
6.0500
6.0500
6.0500
Spek Max
7
7
7
7
Spek MinOUT OF CONTROL
4.5
4.5
4.5
4.5
No Batch
L10176503
L10176510
L10176521
L10176522
MR
0.04
0.02
0.05
UCL
CL
LCL
0.11979
0.11979
0.11979
0.11979
0.03666667
0.03666667
0.03666667
0.03666667
0
0
0
0
OUT OF CONTROL
MR
0.14
0.12
0.1
0.08
MR Bar
0.06
0.04
0.02
0
L10176503
L10176510
76503
MR individual pH
MR
UCL
CL
LCL
L10176510
L10176521
Batch
L10176522
Parameter : Berat Jenis
Produk Ruahan
Frekuensi pengambilan sampel:
No Kode
No Batch
L10176503
L10176510
L10176521
L10176522
Err:512
Err:512
Err:512
Err:512
Spesifikasi Berat Jenis
(1,0 1,1 ) g/ml
(1,0 1,1 ) g/ml
(1,0 1,1 ) g/ml
(1,0 1,1 ) g/ml
Hasil
1.0036
1.0036
1.0036
1.0038
OUT OF CTRL (X)
X
1.0036
1.0036
1.0036
1.0038
MR (n=2)
0
0
0.0002
X
1.0036
1.0036
1.0036
1.0038
PETA X BAR
LCL
UCL
1.00347
1.00347
1.00347
1.00347
1.0038
1.0038
1.0038
1.0038
CL
MR
1.00365
1.00365
1.00365
1.00365
0
0
0.0002
PETA MR
UCL
0.0002
0.0002
0.0002
0.0002
LCL
CL
0
0
0
0
6.66666666667E-005
6.66666666667E-005
6.66666666667E-005
6.66666666667E-005
OUT OF CTRL (MR)
X INDIVIDUAL MOVING RANGE
X BAR =
MR BAR
PETA X BAR
UCL
LCL
CL
1.00365 n=
0 E2=
D3=
D4=
PETA MR
1.0038
0.0002
1.0035
0
1.0037 6.66667E-005
No Batch
2
2.66
0
3.267
L10176503
L10176510
L10176521
L10176522
X
1.0036
1.0036
1.0036
1.0038
UCL
CL
1.0038
1.0038
1.0038
1.0038
LCL
1.0037
1.0037
1.0037
1.0037
Spek Max
1.0035
1.0035
1.0035
1.0035
1.1
1.1
1.1
1.1
Spek Min
1.0
1.0
1.0
1.0
OUT OF CONTROL
No Batch
L10176503
L10176510
L10176521
L10176522
MR
UCL
0
0
0
CL
0.0002178
0.0002178
0.0002178
0.0002178
6.6667E-005
6.6667E-005
6.6667E-005
6.6667E-005
LCL
0
0
0
0
OUT OF CONTROL
X bar Berat jenis
1.12
1.1
1.08
1.06
1.04
X-bar
1.02
1
0.98
0.96
0.94
L10176503
L10176510
L10176521
Batch
X bar Berat jenis
0.00025
0.0002
X
UCL
0.00015
CL
LCL
Spek Max
MR Bar
0.0001
Spek Min
0.00005
76510
L10176521
Batch
L10176522
0
L10176503
MR Berat Jenis
0.00025
0.0002
MR
0.00015
UCL
MR Bar
CL
0.0001
LCL
0.00005
0
L10176503
L10176510
L10176521
Batch
L10176522
MR
UCL
CL
LCL
L10176522
Parameter : Kadar
Produk Ruahan
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Spesifikasi
(90,0 110,0) %
Sampel
A
98.808
101.143
99.415
100.479
Sampel
B
98.615
101.143
99.179
100.343
C
98.665
101.100
99.936
100.707
Rata-rata X
98.696
101.129
99.510
100.510
Range R
0.193
0.043
0.757
0.364
OUT OF CTRL (X)
OOC
OOC
OOC
OOC
PETA X BAR
LCL
99.614
99.614
99.614
99.614
UCL
CL
100.308
100.308
100.308
100.308
99.961
99.961
99.961
99.961
PETA R
UCL
0.873
0.873
0.873
0.873
LCL
CL
0
0
0
0
0.339
0.339
0.339
0.339
OUT OF CTRL (R)
X Bar-R Chart
X BAR =
R BAR
UCL
LCL
CL
99.961
0.339
PETA X BAR PETA R
100.308
99.614
99.961
0.873
0
0.339
No Batch
n=
A2=
D3=
D4=
3
1.023
0
2.574
L10176503
L10176510
L10176521
L10176522
UCL
98.70
101.13
99.51
100.51
CL
100.3081
100.3081
100.3081
100.3081
LCL
99.9611
99.9611
99.9611
99.9611
99.6140
99.6140
99.6140
99.6140
Spek Max
110.0
110.0
110.0
110.0
Spek Min
90.0
90.0
90.0
90.0
OUT OF CONTROL
No Batch
OOC
OOC
OOC
OOC
L10176503
L10176510
L10176521
L10176522
UCL
0.193
0.043
0.757
0.364
0.8732295
0.8732295
0.8732295
0.8732295
CL
0.33925
0.33925
0.33925
0.33925
LCL
OUT OF CONTROL
0
0
0
0
120.00
110.00
MR Bar
100.00
90.00
80.00
L10176503
L10176510
X Bar Kadar
X
UCL
CL
LCL
Spek Max
Spek Min
0
176503
L10176510
L10176521
Batch
L10176522
R Chart Kadar
1
0.9
0.8
0.7
0.6
R bar
0.5
0.4
0.3
0.2
0.1
0
L10176503
L10176510
L10176521
Batch
L10176522
176521
R
UCL
CL
LCL
L10176522
Parameter : Pemerian Produk Jadi
Produk Ruahan
No. Batch
Bentuk
L10176503
Larutan jernih, bebas partikel asing
L10176510
Larutan jernih, bebas partikel asing
L10176521
Larutan jernih, bebas partikel asing
L10176522
Larutan jernih, bebas partikel asing
Parameter hasil
Warna
Parameter hasil
sesuai
agak kekuningan
Sesuai
sesuai
agak kekuningan
Sesuai
sesuai
agak kekuningan
Sesuai
sesuai
agak kekuningan
Sesuai
Parameter : Identifikasi
Produk Jadi
No. Batch
Identifikasi Parameter Hasil
L10176503
Metronidazol (+)
(+)
L10176510
Metronidazol (+)
(+)
L10176521
Metronidazol (+)
(+)
L10176522
Metronidazol (+)
(+)
Parameter : Kadar
Produk Ruahan
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Spesifikasi
(90,0 110,0) %
Sampel
A
98.765
98.893
100.315
100.236
Sampel
B
98.800
99.736
99.857
100.207
C
99.486
99.736
99.965
100.072
Rata-rata X
99.017
99.455
100.046
100.172
Range R
0.721
0.843
0.458
0.164
OUT OF CTRL (X)
OOC
PETA X BAR
LCL
99.113
99.113
99.113
99.113
UCL
CL
100.231
100.231
100.231
100.231
99.672
99.672
99.672
99.672
PETA R
UCL
1.407
1.407
1.407
1.407
LCL
CL
0
0
0
0
0.547
0.547
0.547
0.547
OUT OF CTRL (R)
X Bar-R Chart
X BAR =
R BAR
UCL
LCL
CL
ar-R Chart
99.672 n=
0.547 A2=
D3=
D4=
PETA X BAR PETA R
100.231
99.113
99.672
1.407
0
0.547
3
1.023
0
2.574
No Batch
L10176503
L10176510
L10176521
L10176522
UCL
99.672
99.672
99.672
99.672
100.2314
100.2314
100.2314
100.2314
CL
LCL
99.672
99.672
99.672
99.672
Spek Max
99.1133
99.1133
99.1133
99.1133
Spek Min
110
110
110
110
90
90
90
90
OUT OF CONTROL
No Batch
L10176503
L10176510
L10176521
L10176522
R
0.547
0.547
0.547
0.547
UCL
CL
1.406691
1.406691
1.406691
1.406691
LCL
0.5465
0.5465
0.5465
0.5465
OUT OF CONTROL
0
0
0
0
X Kadar
112.000
110.000
108.000
106.000
104.000
102.000
X-bar
100.000
98.000
96.000
94.000
92.000
90.000
L10176503
L10176510
L10176521
Batch
X Kadar
atch
1.600
1.400
1.200
1.000
UCL
CL
LCL
Spek Max
Spek Min
R-Bar
0.800
0.600
0.400
0.200
L10176521
L10176522
0.000
L10176503
L101
R Chart Kadar
1.600
1.400
1.200
1.000
0.800
UCL
CL
0.600
LCL
0.400
0.200
0.000
L10176503
L10176510
L10176521
Batch
L10176522
R
UCL
CL
LCL
Parameter : ukuran partikel
Produk Jadi
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Spesifikasi
6000 partikel per container
1
74.00
47.00
8.00
11.00
Ukuran partikel 10 m
2
79.00
73.00
13.00
16.00
3
79.00
54.00
3.00
9.00
4
67.00
52.00
5.00
12.00
Rata-rata X
Range R
74.75
56.50
7.25
12.00
12.00
26.00
10.00
7.00
OUT OF CTRL (X)
OOC
OOC
OOC
OOC
PETA X BAR
LCL
27.60
27.60
27.60
27.60
UCL
CL
47.65
47.65
47.65
47.65
37.63
37.63
37.63
37.63
PETA R
UCL
31.38
31.38
31.38
31.38
LCL
CL
0
0
0
0
13.750
13.750
13.750
13.750
OUT OF CTRL (R)
X Bar-R Chart
X BAR =
R BAR
UCL
LCL
CL
37.625 n=
13.750 A2=
D3=
D4=
PETA X BAR PETA MR
47.649
31.378
27.601
0
37.625
13.750
4
0.729
0
2.282
No Batch
L10176503
L10176510
L10176521
L10176522
UCL
74.75
56.50
7.25
12.00
47.6488
47.6488
47.6488
47.6488
CL
LCL
37.625
37.625
37.625
37.625
Spek Max
27.601
27.601
27.601
27.601
Spek Min
6000
6000
6000
6000
0
0
0
0
OUT OF CONTROL
No Batch
OOC
OOC
OOC
OOC
L10176503
L10176510
L10176521
L10176522
R
12
26
10
7
UCL
CL
31.3775
31.3775
31.3775
31.3775
LCL
13.75
13.75
13.75
13.75
OUT OF CONTROL
0
0
0
0
Individual Moving Range
7000.00
6000.00
5000.00
UCL
4000.00
X-bar
CL
3000.00
LCL
Spe
2000.00
Spe
1000.00
0.00
L10176503
L10176510
Batch
L10176521
L10176522
ng Range
0176521
R Chart Ukuran Partikel 10 mikr
35
30
X
25
UCL
20
CL
LCL
Spek Max
Spek Min
R-Chart
15
10
5
L10176522
0
L10176503
L10176510
L10176521
Batch
t Ukuran Partikel 10 mikro
R
UCL
CL
LCL
76510
L10176521
Batch
L10176522
No Batch
L10176503
L10176510
L10176521
L10176522
Spesifikasi
600 partikel per container
Ukuran partik
1
1.00
0.00
2.00
0.00
Ukuran partikel 25 um
2
3
0.00
0.00
2.00
1.00
0.00
0.00
0.00
0.00
4
0.00
0.00
0.00
0.00
Rata-rata X
Range R
0.25
0.75
0.50
0.00
1.00
2.00
2.00
0.00
OUT OF CTRL (X)
PETA X BAR
LCL
-0.536
-0.536
-0.536
-0.536
UCL
CL
1.286
1.286
1.286
1.286
0.375
0.375
0.375
0.375
PETA R
UCL
2.853
2.853
2.853
2.853
LCL
CL
0
0
0
0
1.250
1.250
1.250
1.250
OUT OF CTRL (R)
X Bar-R Chart
X BAR =
R BAR
UCL
LCL
CL
ar-R Chart
0.375 n=
1.250 A2=
D3=
D4=
PETA X BAR PETA MR
1.286
2.853
-0.536
0
0.375
1.250
4
0.729
0
2.282
No Batch
L10176503
L10176510
L10176521
L10176522
UCL
0.25
0.75
0.50
0.00
CL
1.2863
1.2863
1.2863
1.2863
LCL
0.375
0.375
0.375
0.375
Spek Max
-0.536
-0.536
-0.536
-0.536
600
600
600
600
Spek Min
OUT OF CONTROL
No Batch
L10176503
L10176510
L10176521
L10176522
R
1.0
2.0
2.0
0.0
UCL
CL
2.8525
2.8525
2.8525
2.8525
LCL
1.25
1.25
1.25
1.25
OUT OF CONTROL
0
0
0
0
R-Chart Ukuran Partikel 25 mikro
700.00
600.00
X-bar
500.00
400.00
UCL
CL
300.00
LCL
Spek Max
200.00
Spek Min
100.00
0.00
L10176503
-100.00
L10176510
Batch
L10176521
L10176522
R-chart Ukuran Partikel 25 Mikro
3.0
2.5
X
2.0
UCL
CL
LCL
Spek Max
Spek Min
R-Chart
R
UCL
1.5
CL
1.0
LCL
0.5
0.0
L10176503
L10176510
L10176521
Batch
L10176522
R
UCL
CL
LCL
L10176522
Parameter : Kebocoran
Produk Jadi
Frekuensi pengambilan sampel:
Kebocoran
No Batch
L10176503
L10176510
L10176521
L10176522
Negatif
Negatif
Negatif
Negatif
X
Negatif
Negatif
Negatif
Negatif
MR Chart pH
1.2
1
0.8
0.6
0.4
0.2
0.6
0.4
0.2
0
t pH
#REF!
#REF!
#REF!
#REF!
#REF!
#REF!
#REF!
Parameter : Sterilitas
Produk Jadi
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
Sterilitas
Steril
Steril
Steril
Steril
Steril
Steril
Steril
Steril
Parameter : Endotoksin
Produk Jadi
Frekuensi pengambilan sampel:
No Batch
L10176503
L10176510
L10176521
L10176522
No Kode
Err:512
Err:512
Err:512
Err:512
Endotoksin
0,35
0,35
0,35
0,35
EU/mg
EU/mg
EU/mg
EU/mg
Hasil
0.35
0.35
0.35
0.35
OUT OF CTRL (X)
X
0.35
0.35
0.35
0.35
MR (n=2)
0
0
0
X
0.35
0.35
0.35
0.35
PETA X BAR
LCL
UCL
0.35
0.35
0.35
0.35
CL
0.35
0.35
0.35
0.35
MR
0.35
0.35
0.35
0.35
0
0
0
PETA MR
UCL
0
0
0
0
LCL
CL
0
0
0
0
OUT OF CTRL (MR)
0
0
0
0
X INDIVIDUAL MOVING RANGE
X BAR =
MR BAR
0.35 n=
0 E2=
D3=
D4=
PETA X BAR
UCL
LCL
CL
PETA MR
0.35
0.35
0.35
0
0
0
2
2.66
0
3.267
No Batch
L10176503
L10176510
L10176521
L10176522
UCL
0.35
0.35
0.35
0.35
0.35
0.35
0.35
0.35
CL
LCL
0.35
0.35
0.35
0.35
Spek Max
0.35
0.35
0.35
0.35
0.35
0.35
0.35
0.35
Spek Min
OUT OF CONTROL
0
0
0
0
No Batch
L10176503
L10176510
L10176521
L10176522
MR
UCL
0
0
0
0
0
0
0
CL
LCL
0
0
0
0
OUT OF CONTROL
X bar E
0
0
0
0
0.4
0.35
0.3
0.25
X-bar
0.2
0.15
0.1
0.05
0
L10176503
L10176510
Batch
X bar Endotoksi
1
0.9
0.8
X
0.7
UCL
0.6
CL
LCL
Spek Max
Spek Min
MR bar
0.5
0.4
0.3
0.2
0.1
L10176510
L10176521
Batch
L10176522
0
L10176503
MR Bar Endotoksi
1
0.9
0.8
0.7
MR bar
0.6
MR
0.5
UCL
CL
0.4
LCL
0.3
0.2
0.1
0
L10176503
L10176510
L10176521
Batch
L10176522
MR
UCL
CL
LCL
L10176522
Parameter : Pemerian Produk Jadi
Produk Ruahan
No. Batch
L10176503
Botol Infus 100 mL
Penandaan Kemasan
Etiket
Sesuai
sesuai
Kadar Air (%)
emasan
Box
sesuai
Brix
(mixing malto)%
Partikel Size (%)
Tap.den (g/ml)
Berat Rata-Rata
Total Solid
%
pH
Solubility
(larut)
Mikrobiologi
TPC (cfu/g)
YMC (cfu/g)
E.Coli (cfu/g)
Mikrobiologi
Salmonella. Sp (cfu/g)
Stap.aureus (cfu/g)
Keterangan
APM Koliform (cfu/g)
hasil
Bentuk
larutan jernih bebas partikel asing
warna
agak kekuningan
hasil
Parameter : YMC (cfu/g)
Sample size:
Frekuensi pengambilan sampel:
No Kode
No Batch
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Tanggal
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
YMC
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
Err:512
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