ORIGINAL Confidential

HOLD TIME STUDY PROTOCOL FOR PRODUCT WITH

LOW ROOM HUMIDITY REQUIREMENT

Document No. : VAL-PV/STP/MB/014

Revision No. : 00

Date : 13 MAY 2015

Product : VOSTEM® PLUS ORANGE EFFERVESCENT TABLET

Code : 17026
Site : PT. CAPRIFARMINDO LABORATORIES
(Pharmaceutical Plant)
Jl. Industri Cimareme No. 8 Block H
Kabupaten Bandung Barat - Indonesia

Prepared by:
Function Name/Title Signature Date
Novita Purwanti /
Production
Solid Production Manager
Giva Olviana Y. /
Validation
Validation Engineer

Reviewed & Approved by:

Function Name/Title Signature Date
Arif Agus S. /
Validation
Validation Manager
Reviewed Quality Rahmi Budi A. /
by, Control QC Manager
Khairudin /
Production
Plant Manager
Lutfi Febrina /
Approved QA Manager
Quality
by, Sumardi /
Head of Quality

\\Cimareme\Release\Capri\VAL\VAL-PV\STP\MB\014-Hold Time Study Protocol For Product With Low Room Humidity Requirement .R00.doc.
ORIGINAL Confidential
Document No. VAL-PV/STP/MB/014 Rev. 00 Page 2 of 18
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

SUMMARY

………………………………………………………………………………………………………
………………………………………………………………………………………………………
………………………………………………………………………………………………………
………………………………………………………………………………………………………

\\Cimareme\Release\Capri\VAL\VAL-PV\STP\MB\014-Hold Time Study Protocol for Product With Low Room Humidity Requirement .R00.doc.
ORIGINAL Confidential
Document No. VAL-PV/STP/MB/014 Rev. 00 Page 3 of 18
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

TABLE OF CONTENTS

SUMMARY.......................................................................................................................................4
1. OBJECTIVE................................................................................................................................4
2. SCOPE.........................................................................................................................................4
3. REFERENCES............................................................................................................................4
4. RESPONSIBILITIES..................................................................................................................4
5. PROCEDURE.............................................................................................................................5
6. DESCRIPTION OF THE PRODUCT.........................................................................................6
6.1. Bracketing Product.................................................................................................................6
6.2. Product Data...........................................................................................................................6
6.3. Parameter Selection................................................................................................................7
6.4. Scoring and Evaluation..........................................................................................................8
6.5. Conclusion..............................................................................................................................9
7. SAMPLING METHOD AND ACCEPTANCE CRITERIA.......................................................9
8. RESULTS..................................................................................................................................12
8.1. Dispensed Raw Material......................................................................................................12
8.2. Final Mixing.........................................................................................................................13
8.3. Compressed Tablets..............................................................................................................15
9. CONCLUSION.........................................................................................................................18
10. RECOMMENDATION.............................................................................................................18
11. CHANGE CONTROL..............................................................................................................18
12. LISTS OF ENCLOSURE..........................................................................................................18
13. REVISION HISTORY..............................................................................................................18

\\Cimareme\Release\Capri\VAL\VAL-PV\STP\MB\014-Hold Time Study Protocol for Product With Low Room Humidity Requirement .R00.doc.
OBJECTIVE
To provide documented evidence that will serve as basic for determination of holding time
periode of product with low room humidity requirement start from weighing of raw
materials until compressing stage. Holding time should be established to ensure that the
product can be held without any adverse effect to the quality of the materials. These time
periode must be supported by adequate data to demonstrate that the product will be stable
throughout the holding time period.

SCOPE
This validation covers holding period the batch of weighing raw material, final mixing
process, and compressing process in PT. Caprifarmindo Laboratories Cimareme.

REFERENCES
 WHO, “General Guidance For Inspectors on Hold-Time Studies, 2013.
 OMICS, Hold Time Stability Studies in Pharmaceutical Industry, 2012.

RESPONSIBILITY
No. Function Name/Title Responsibilities
1 Validation Giva Olviana Y. /  Responsible for writing the protocol and
Validation Engineer final report of study.
 Coordinate activities to conduct an effective
and reliable hold time study.
 Supervise the operation to ensure that
everything is done according to this protocol.
 Responsible for conducting investigation
with production and QC if there is any out of
specification case.
2 Validation Arif Agus S./  Manage all validation activities including
Validation Manager hold time study.
 Responsible for reviewing the protocol and
final report of hold time study.
 Responsible for the judgment whether the
result valid or not.
3 Project Khairudin /  Responsible for reviewing the protocol and
Leader Plant Manager final report of hold time study.
 Responsible for ensuring that hold time study
activities conforms with quality assurance
requirements.
4 Production Novita Purwanti /  Responsible for reviewing the protocol and
Solid Production final report of hold time study.
Manager  Responsible for supporting production
personnel during the hold time study.
 Responsible for implementing any agreed
recommendations that may be made as
results of this study.
 Responsible for conducting investigation
with validation and QC if there is any out of
specification case.
 No. Function Name/Title Responsibilities
5 QC Rahmi Budi A./  Responsible for reviewing the protocol and
QC Manager final report of hold time study.
 Responsible for hold time study the
analytical method used to analyze traces of
active ingredient and analyze microbial
contaminant.
 Responsible for testing samples according to
analytical method.
6 Quality Lutfi Febrina / Responsible for approving the protocol and
QA Manager final report of hold time study.
Responsible for ensuring that hold time study
activities conforms with quality assurance
requirements
Sumardi / Responsible for approving the protocol and
Head of Quality final report of hold time study.
Responsible for ensuring that hold time study
activities conforms with quality assurance
requirements.

PROSEDURE

Dispensing Study hold time

 Raw materials stored in container (close tight)

Sifting in the weight staging room
 Note the day,date and room condition before
sampling
 Take sample → send sample to QC for analysis
Mixing  Frequency for sampling : days → 0, 3, 5

Study hold time Final Mixing

 Materials stored in container Compression

(close tight) in the weight
staging room
 Note the day,date and room
condition before sampling
 Take sample → send sample
to QC for analysis
 Frequency for sampling : days
→ 0, 1, 2, 3
 For assay will be check on
days 0 and 3
Study hold time
Compressed Tablets
 Compressed tablets stored in container (close
tight) in the weight staging room
 Note the day,date and room condition before
Packing sampling
 Take sample → send sample to QC for analysis
 Frequency for sampling : days → 0, 1, 2, 3
 For diameter, thickness, hardness, weight,
Finished Product heavy metal, identification, assay and microbial
enumeration will be check on days 0 and 3


DESCRIPTION OF THE PRODUCT

1.1. Bracketing Product
Purpose : To determine the product indicator for hold time study to make an
effective and efficient plan based on scientific evaluation.
 Scope : This bracketing of hold time study is applied to all product with low room
humudity requirement in PT. Caprifarmindo Laboratories.

1.2. Product Data

No Product Name Dosage Form Strength
1 BIFERCE Effervescent Tablet Vitamin C : 1000 mg
ORANGE
2 CALDECE Effervescent Tablet Calcium : 250 mg
ORANGE Vitamin B6 : 15 mg
Vitamin C : 1000 mg
Vitamin D3 : 300 mg
3 CALDECE Effrevescent Tablet Calcium : 250 mg
PEACH MANGO Vitamin B6 : 15 mg
Vitamin C : 1000 mg
Vitamin D3 : 300 mg
4 CALDECE Effervescent Tablet Calcium : 250 mg
STRAWBERRY Vitamin B6 : 15 mg
Vitamin C : 1000 mg
Vitamin D3 : 300 mg
5 DAY-CAL Chewable Tablet MgO : 25 mg
CaCO3 : 1000 mg
Vitamin D3 : 1 mg
6 MUNOSAN Effervescent Tablet Dried echinacea juice concentrate 15% :
1000 mg
Black eldeberry extract 10% : 100 mg
Phyllantus nirurri extract 100 mg
Lycopene : 5 mg
Zinc picolinate : 10 mg
Selenium : 15 mcg
Vit. C : 500 mg
7 SANMOL 120 Chewable Tablet Paracetamol : 120 mg
CHILD
8 SANMOL 120 Effervescent Tablet Paracetamol : 120 mg
9 SANMOL 500 Effervescent Tablet Paracetamol : 500 mg
10 SANVITA B-PLUS Effervescent Tablet Vitamin B1 : 15 mg
Vitamin B2 : 15 mg
Vitamin B3 : 50 mg
Vitamin B5 : 23 mg
Vitamin B6 : 10 mg
Vitamin B12 : 10 mcg
Vitamin C : 500 mg
Biotin : 150 mcg
Folic Acid : 400 mcg
Magnesium : 100 mg
Calcium : 100 mg
Zinc : 10 mg
11 VOSTEM PLUS Effervescent Tablet Glucosamine HCl : 750 mg
ORANGE Chondroitin SO4 : 500 mg
Methylsulphonylmethane : 250 mg
Selenium : 30 mcg
Zinc : 5 mg
Manganese : 1 mg
Magnesium : 20 mg
Vit. C : 50 mg
 No Product Name Dosage Form Strength
12 VOSTEM PLUS Effervescent Table Glucosamine HCl : 750 mg
LEMON Chondroitin SO4 : 500 mg
Methylsulphonylmethane : 250 mg
Selenium : 30 mcg
Zinc : 5 mg
Manganese : 1 mg
Magnesium : 20 mg
Vit. C : 50 mg
13 FORMUNO Effervescent Tablet Echinacea Purpurea – Dry Pressed Juice
EXTRA : 1000 mg
Phyllanthus niruri Dry Extract : 50 mg
Black Elderberry Dry Extract : 300 mg
Zinc Picolinate : 10 mg

1.3. Parameter Selection

Shelf Tapped Loss on Preservatives
Manufacturing Formulation
No. Product name Life density Drying content
stage complexity
(year) (%) (%) (%)
1 BIFERCE 3 Dry N/A < 0.5 Non No
ORANGE granulation Antibiotic,
no extract
2 CALDECE 3 Dry N/A < 0.5 Non No
ORANGE granulation Antibiotic,
no extract
3 CALDECE 3 Dry N/A < 0.5 Non No
PEACH MANGO granulation Antibiotic,
no extract
4 CALDECE 3 Dry N/A < 0.5 Non No
STRAWBERRY granulation Antibiotic,
no extract
5 DAY-CAL 3 Dry N/A N/A Non No
granulation Antibiotic,
no extract
6 MUNOSAN 2 Dry N/A < 1.0 Non No
granulation Antibiotic,
no extract
7 SANMOL 120 2 Dry N/A < 2.0 Non No
CHILD granulation Antibiotic,
no extract
8 SANMOL 120 2 Dry N/A < 1.0 Non No
granulation Antibiotic,
no extract
9 SANMOL 500 2 Dry N/A < 1.0 Non No
granulation Antibiotic,
no extract
10 SANVITA B- 3 Dry N/A < 0.5 Non No
PLUS granulation Antibiotic,
no extract
11 VOSTEM PLUS 2 Dry N/A < 1.0 Non No
ORANGE granulation Antibiotic,
no extract
12 VOSTEM PLUS 2 Dry N/A < 1.0 Non No
LEMON granulation Antibiotic,
no extract
13 FORMUNO 2 Dry N/A < 1.5 Non No
EXTRA granulation Antibiotic,
 Shelf Tapped Loss on Preservatives
Manufacturing Formulation
No. Product name Life density Drying content
stage complexity
(year) (%) (%) (%)
with extract

1.4. Scoring and Evaluation

Loss on Formulation Spec Assay
Self Life Batch
No. Product name Drying complexity of Bulk Total score
30% Size 15%
20% 20% 15%
1 BIFERCE
20 10 5 5 15 55
ORANGE
2 CALDECE
20 5 10 10 15 60
ORANGE
3 CALDECE
- - 10 - 2 12
PEACH MANGO
4 CALDECE
20 5 10 10 2 47
STRAWBERRY
5 DAY-CAL 20 20 10 15 15 80
6 MUNOSAN 30 10 15 5 2 62
7 SANMOL 120
30 10 5 15 2 62
CHILD
8 SANMOL 120
30 20 5 15 10 80
CHILD CHEW
9 SANMOL 500 30 10 5 15 5 65
10 SANVITA B-
20 5 20 5 15 65
PLUS
11 VOSTEM PLUS
30 10 15 15 15 85
ORANGE
12 VOSTEM PLUS
30 10 15 15 2 72
LEMON
13 FORMUNO
20 15 10 2 2 49
EXTRA

Remark :
- Self Life
0 – 2.0 year : 30
˃ 2 years : 20
- Loss on drying
1.6 – 2% : 20
1.1 – 1.5% : 15
0.6 – 1 % : 10
0 – 0.5% :5

- Formulation complexity
˃ 10 API : 20
6 – 9 API : 15
2 – 5 API : 10
< 2 API :5
- Spec. Assay of Bulk
0 – 15 % : 15
16 – 30 % : 10
> 30 % :5
N/A :2
- Batch size
 ≥ 110.01 kg : 15
80.01 – 110.00 kg : 10
50.01 – 80.00 kg :5
20.00 – 50.00 kg :2

1.5. Conclusion
The total score covers self life, loss on drying, formulation complexity, spec. assay of
bulk and batch size, show that VOSTEM® Plus Orange Effervescent Tablet has a
highest score than another product.

The result of indicator product in previous bracketing was VOSTEM® Plus Orange
Effervescent Tablet, so the hold time study will not be performed to the other products
since they have covered by above products.

SAMPLING METHOD AND ACCEPTANCE CRITERIA

Frequency
Sampling Sample
for Sampling Test Parameter Acceptance Criteria
Stage Quantities
(days)
Dispensed 0; 3; 5 Glucosamine SP-BB-G-635, REV.00 45 g
material Hydrochloride
Chondroitin Sulfate SP-BB-636, REV.02
Sodium
Methyl Sulphonyl SP-BB-756, REV.02
Methane (MSM)
Magnesium SP-BB-376, REV.01
Hydroxide 80%
Granule
Ascorbic Acid SP-BB-086, REV.06
Sodium Selenite 1% SP-BB-M-088, REV.04
Zinc Sulfate SP-BB-697, REV.02
Monohydrate
Manganase Sulfate SP-BB-A-027, REV.03
Monohydrate
Sodium Hydrogen SP-BB-S-253, REV.03
Carbonate
Citric Acid SP-BB-C-010, REV.02
Anhydrous
Polyethylene Glycol SP-BB-P-116, REV.02
6000
Orange Durarome SP-BB-S-588, REV.03
Sucralose SP-BB-O-370, REV.03
Isomaltulose SP-BB-680, REV.01
Final Mixing 0; 1; 2; 3 Color White with yellow spot @20 g
Odor Orange (top, middle,
Loss on drying Not more than 1.0% bottom)
0; 3 Assay of @50 g
Glucosamine 95.0 – 120.0% (top, middle,
Hydrochloride bottom)
Assay of Chondroitin 95.0 – 120.0%
Sulfate Sodium
 Frequency
Sampling Sample
for Sampling Test Parameter Acceptance Criteria
Stage Quantities
(days)
Assay of Methyl
Sulphonyl Methane 95.0 – 110.0%
(MSM)
Assay of Zinc
Sulfate 95.0 – 125.0%
Monohydrate
Assay of
Manganase Sulfate 95.0 – 125.0%
Monohydrate
Assay of
Magnesium
95.0 – 125.0%
Hydroxide 80%
Granule
Assay of Ascorbic
95.0 – 150.0%
Acid
Compressing 0; 1; 2; 3 Appearance Flat Round Tablet @3 tubes
process Color White with yellow spot (beginning,
Odor Orange middle, end)
Sign Plain-plain
Not more than 5
Disintegration time
minutes
0; 3 Diameter 25 mm
Thickness 7.0 ± 0.4 mm
Hardness 5 - 8 kg/cm2
Weight of tablet 4700 mg ± 3.0 %
Weight variation Not more than 2 of
individual masses
tablets deviate from the
average mass by more
than
5.0 % and none deviates
by more than 10.0 %.
Identification :
- Glucosamine HCl

- Chondroitin SO4

- Methylsulphonyl-

- methane (MSM)
Positive
- Selenium

- Zinc

- Manganese

- Magnesium

- Ascorbic acid
Pb : Not more than 10
ppm
As : Not more than 5
Heavy metal
ppm
Hg : Not more than 0.5
ppm
Assay of :
- Glucosamine HCl 95.0 % - 120.0 %
 Frequency
Sampling Sample
for Sampling Test Parameter Acceptance Criteria
Stage Quantities
(days)
- Chondroitin SO4 95.0 % - 120.0 %
- Methylsulphonyl-
95.0 % - 110.0 %
methane (MSM)
- Zinc 95.0 % - 125.0 %
- Manganese 95.0 % - 125.0 %
- Magnesium 95.0 % - 125.0 %
- Ascorbic acid 95.0 % - 150.0 %
- Total aerobic microbial
count: Not more than
1,000 cfu/gram
- Total combined Yeast
and mold: not more
Microbial than 100 cfu/gram
enumeration - Absence of Salmonella
spp, Pseudomonas
aeruginosa,
Escherichia coli, and
Staphylococcus aureus
in 10 gram

RESULTS
1.6. Dispensed Raw Material
- T0
Relative Humidity Temperature Inspection
Room Note
15 – 35 % 18-26°C by/Date
Weight
Staging

Chemical Test
Critical Parameter Acceptance Criteria Results Pass/ Fail

Microbial Test
Critical Parameter Acceptance Criteria Results Pass/ Fail

- T1
 Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

- T2
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

- T3
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

Chemical Test
Critical Parameter Acceptance Criteria Results Pass/ Fail

Microbial Test
Critical Parameter Acceptance Criteria Results Pass/ Fail

- T5
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

Chemical Test
Critical Parameter Acceptance Criteria Results Pass/ Fail

Microbial Test
Critical Parameter Acceptance Criteria Results Pass/ Fail
1.7. Final Mixing
- T0
Relative Humidity Temperature Inspection
Room Note
15 – 35 % 18-26°C by/Date
Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Color White with yellow spot
Odor Orange
Loss on drying Not more than 1.0%
Assay of Glucosamine
95.0 – 120.0%
Hydrochloride
Assay of Chondroitin
95.0 – 120.0%
Sulfate Sodium
Assay of Methyl
Sulphonyl Methane 95.0 – 110.0%
(MSM)
Assay of Zinc Sulfate
95.0 – 125.0%
Monohydrate
Assay of Manganase
95.0 – 125.0%
Sulfate Monohydrate
Assay of Magnesium
Hydroxide 80% 95.0 – 125.0%
Granule
Assay of Ascorbic
95.0 – 150.0%
Acid

- T1
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Color White with yellow spot
Odor Orange
Loss on drying Not more than 1.0%

- T2
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
 Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Color White with yellow spot
Odor Orange
Loss on drying Not more than 1.0%

- T3
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Color White with yellow spot
Odor Orange
Loss on drying Not more than 1.0%
Assay of Glucosamine
95.0 – 120.0%
Hydrochloride
Assay of Chondroitin
95.0 – 120.0%
Sulfate Sodium
Assay of Methyl
Sulphonyl Methane 95.0 – 110.0%
(MSM)
Assay of Zinc Sulfate
95.0 – 125.0%
Monohydrate
Assay of Manganase
95.0 – 125.0%
Sulfate Monohydrate
Assay of Magnesium
Hydroxide 80% 95.0 – 125.0%
Granule
Assay of Ascorbic
95.0 – 150.0%
Acid

1.8. Compressing
- T0
Relative Humidity Temperature Inspection
Room Note
15 – 35 % 18-26°C by/Date
Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Appearance Flat Round Tablet
Color White with yellow spot
Odor Orange
Sign Plain-plain
 Critical Parameter Acceptance Criteria Results Pass/ Fail
Disintegration time Not more than 5 minutes
Diameter 25 mm
Thickness 7.0 ± 0.4 mm
Hardness 5 - 8 kg/cm2
Weight of tablet 4700 mg ± 3.0 %
Not more than 2 of
individual masses tablets
deviate from the average
Weight variation
mass by more than
5.0 % and none deviates by
more than 10.0 %.
Identification :
- Glucosamine HCl
- Chondroitin SO4

- Methylsulphonyl-

- methane (MSM)
Positive
- Selenium

- Zinc

- Manganese

- Magnesium

- Ascorbic acid
Pb : Not more than 10 ppm
As : Not more than 5 ppm
Heavy metal
Hg : Not more than 0.5
ppm
Assay of :
- Glucosamine HCl 95.0 % - 120.0 %
- Chondroitin SO4 95.0 % - 120.0 %
- Methylsulphonyl-
95.0 % - 110.0 %
methane (MSM)
- Zinc 95.0 % - 125.0 %
- Manganese 95.0 % - 125.0 %
- Magnesium 95.0 % - 125.0 %
- Ascorbic acid 95.0 % - 150.0 %
- Total aerobic microbial
count: Not more than
1,000 cfu/gram
- Total combined Yeast and
mold: not more than 100
Microbial enumeration cfu/gram
- Absence of Salmonella
spp, Pseudomonas
aeruginosa, Escherichia
coli, and Staphylococcus
aureus in 10 gram

- T1
Room Relative Humidity Temperature Inspection Note
15 – 35 % 18-26°C by/Date
 Container Container Container Container
1 2 1 2
Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Appearance Flat Round Tablet
Color White with yellow spot
Odor Orange
Sign Plain-plain
Disintegration time Not more than 5 minutes

- T2
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Appearance Flat Round Tablet
Color White with yellow spot
Odor Orange
Sign Plain-plain
Disintegration time Not more than 5 minutes

- T3
Relative Humidity Temperature
15 – 35 % 18-26°C Inspection
Room Note
Container Container Container Container by/Date
1 2 1 2
Weight
Staging

Critical Parameter Acceptance Criteria Results Pass/ Fail

Appearance Flat Round Tablet
Color White with yellow spot
Odor Orange
Sign Plain-plain
Disintegration time Not more than 5 minutes
Diameter 25 mm
Thickness 7.0 ± 0.4 mm
Hardness 5 - 8 kg/cm2
Weight of tablet 4700 mg ± 3.0 %
Weight variation Not more than 2 of
individual masses tablets
deviate from the average
 Critical Parameter Acceptance Criteria Results Pass/ Fail
mass by more than
5.0 % and none deviates by
more than 10.0 %.
Identification :
- Glucosamine HCl

- Chondroitin SO4

- Methylsulphonyl-

- methane (MSM)
Positive
- Selenium

- Zinc

- Manganese

- Magnesium

- Ascorbic acid
Pb : Not more than 10 ppm
As : Not more than 5 ppm
Heavy metal
Hg : Not more than 0.5
ppm
Assay of :
- Glucosamine HCl 95.0 % - 120.0 %
- Chondroitin SO4 95.0 % - 120.0 %
- Methylsulphonyl-
95.0 % - 110.0 %
methane (MSM)
- Zinc 95.0 % - 125.0 %
- Manganese 95.0 % - 125.0 %
- Magnesium 95.0 % - 125.0 %
- Ascorbic acid 95.0 % - 150.0 %
- Total aerobic microbial
count: Not more than
1,000 cfu/gram
- Total combined Yeast and
mold: not more than 100
Microbial enumeration cfu/gram
- Absence of Salmonella
spp, Pseudomonas
aeruginosa, Escherichia
coli, and Staphylococcus
aureus in 10 gram

CONCLUSION
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................

RECOMMENDATION
....................................................................................................................................................
....................................................................................................................................................
....................................................................................................................................................
CHANGE CONTROL
All changes that may affect this protocol should be formally requested, documented and
accepted.

LISTS OF ENCLOSURE
N/A

REVISION HISTORY
Revision
Date Description Originator
No.
00 13 MAY 2016 Initial Release Giva Olviana Yudhista