ORIGINAL Confidential

BRACKETING/GROUPING
OF CLEANING VALIDATION

Document No. : VAL-LV/BRP/MB/016

Revision No. : 04
Date : 03 MARCH 2017

Product : PRODUCTS USED WEIGHING ROOM, ELECTRIC

BALANCE, THIEF SAMPLER AND STAINLESS SCOOPE
Code : N/A
MS No. : N/A
TS No. : N/A
Site : PT. CAPRIFARMINDO LABORATORIES
(Pharmaceutical Plant)
Jl. Industri Cimareme No. 8 Block H
Kabupaten Bandung Barat

Prepared by:
Function Name/Title Signature Date
Purwantoro /
PPIC
PPIC Manager
Fajar Rachmadi Sidiq /
Validation
Cleaning Validation Engineer

Reviewed & Approved by:

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

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 2 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

TABLE OF CONTENTS
1. PURPOSE.....................................................................................................................................3
2. SCOPE..........................................................................................................................................3
3. DEFINITION................................................................................................................................3
4. REFERENCES.............................................................................................................................3
5. RESPONSIBILITY AND AUTHORITY.....................................................................................3
6. PROCEDURES............................................................................................................................3
7. PRODUCTS DATA......................................................................................................................4
8. SCORING AND EVALUATION...............................................................................................13
9. CONCLUSION...........................................................................................................................16
10.ATTACHMENT..........................................................................................................................16
11.REVISION HISTORY................................................................................................................16

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 3 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

1. PURPOSE
To determine the worst case product for cleaning validation to make an effective and efficient
cleaning validation plan based on scientific evaluation

2. SCOPE
This bracketing/grouping proposal of cleaning validation is applied to products used Weighing
Room, Electric Balance, Thief Sampler and Stainless Scoope in PT. Caprifarmindo
Laboratories.

3. DEFINITION
LD50: The minimum dose, given all at once, which causes the death of 50 % of population

4. REFERENCES
4.1. PICS for Guide to Good Manufacturing Practice For Medicinal Products, 2009
4.2. PDA Journal of Pharmaceutical Science and Technology, Technical Report No. 29, Points
to Consider for Cleaning Validation,1998
4.3. USP 38, 2015
4.4. British Pharmacopeia 2013
4.5. Japan Pharmacopeia XIV , 2001
4.6. Merck Index, 13th edition, 2001
4.7. Internet Literature (www.usp.org ; www.sciencelab.com ; www.merckmillipore.com ;
www.spectrumchemical.com ; www.aplichem.com ; www.nipponham.co.jp ;
ww.labchem.com ; www.inchem.org ; www.pharmacopeia.cn ;
pubchem.ncbi.nlm.nih.gov; www.jostchemical.com ; www.caymanchem.com ;
www.ncbi.nlm.nih.gov ; www.researchgate.net ; www.atsdr.cdc.gov; www.drugs.com;
www.rxwiki.com; www.reference.medscape.com; www.rxlist.com;
www.metabolics.com; www.ncbi.nlm.nih.gov)
4.8. Drug Information Handbook, 17th edition, 2009
4.9. Alternative Medicine Review Volume 14, Number 4, 2009
4.10. Asian Pacific Journal of Tropical Biomedicine, “Hepatoprotective efficacy of curcumin
against arsenic trioxide toxicity”, VV Mathews et al, 2012.
4.11. European medicines Agency Science Medicine Health, “Assessment report on
Glycyrrhiza glabra L. and/or Glycyrrhiza inflata Bat. and/or Glycyrrhiza uralensis Fisch,
radix”, 2011.

5. RESPONSIBILITY AND AUTHORITY

The originator is responsible to review product formulation and select the most difficult
product formulation to be cleaned.
The originator is responsible to apply this bracketing/grouping results.

6. PROCEDURES
6.1 Collect the solubility in water of each substance in formulation of products used the
machine data
6.2 Collect the LD50 of each active ingredients in formulation of products used the machine
data

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 4 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

6.3 Collect the concentration of each substance in formulation of products used the machine
data
6.4 Give score to each product based on its drug category, solubility, toxicity, concentration of
active ingredient, and formulation complexity
6.5 Select the most difficult product to be clean

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
 ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 5 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

6. PRODUCTS DATA
LD50 Minimum
Solubility In Concentration Antibiotic/
No. Product Name Composition (mg/kg BB Rat Therapeutics
Water (g/mL) (%B/B) Non Antibiotic
per Oral Dose
1 Baquinor Forte Ciprofloxacin HCl 500 mg 5,000 10-15 1 : 100 75.88 Antibiotic
2 Biferce Ascorbic Acid 1000 mg 11,900 35-100 1 : 1-10 23.33 Non Antibiotic
3 Biosanbe Fe (II) Gluconat 250 mg 2,100 0.27 1:10-30 53.19 Non Antibiotic
Manganase Sulfate 0.2 mg 2,150 1.9 1:1-10 0.05 Non Antibiotic
Cupric Sulfate 0.2 mg 30 0.002 1:1-10 0.04 Non Antibiotic
Ascorbic Acid 50 mg 11,900 30 1: 1-10 10.85 Non Antibiotic
Folic Acid 1 mg 10,000 0.1 1:1,000-10,000 0.22 Non Antibiotic
Cyanocobalamin (Vit B12) 7.5 mcg ˃ 5,000 0.0009 1:30-100 2.23 Non Antibiotic

4 Biothicol DS Thiamphenicol 125 mg ˃ 5,000 25-50 1 : 1,000 – 4.6 Antibiotic

10,000
5 Biothicol Forte Thiamphenicol 250 mg ˃ 5,000 25-50 1 : 1,000 – 14.14 Antibiotic
10,000
6 Biothicol 500 Thiamphenicol 500 mg ˃ 5,000 25-50 1 : 1,000 – 78.13 Antibiotic
10,000
7 Caldece Eff Calcium Carbonate 250 mg 6,450 45-65 1: 1,000-10,000 19.57 Non Antibiotic
Pyridoxine HCl (Vitamin B6) 15 0.36
4,000 0.9 1: 10-100 Non Antibiotic
mg
Vitamin C 1000 mg 11,900 75 1 : 1-10 22.34 Non Antibiotic
Vitamin D3 300 mg 42 10 1: > 10,000 0.07 Non Antibiotic
8 Centabio Gel Placenta Extract 100 µg/g >5000 0.1 1:10-30 10 Non Antibiotic
Neomycin Sulfate 5 mg/g >4325 0.1 1:30-100 0.52 Antibiotic
9 Cinolon Cream Fluocinolone Acetonide 0.25 mg/g 14 0.25 1:30-100 0.025 Non Antibiotic
10 Cinolon N Cream Fluocinolone Acetonide 0.25 mg/g 14 0.25 1:30-100 0.025 Non Antibiotic
Neomycin Sulfate 5 mg/g >4325 0.1 1:30-100 0.524 Antibiotic
11 Clobesan Cream Clobetasol Propion ate 3,000 0.5 1 : >10,000 0.052 Non Antibiotic
12 Dolones Cream Lidocaine 25 mg/g 317 4.5 1 : >10,000 2.45 Non Antibiotic
Prilocaine 25 mg/g 980 3-5 1 : 100-1,000 2.45 Non Antibiotic
13 Episan Suspension Sucralfate 500 mg >8000 40-80 1 : > 10,000 10 Non Antibiotic
14 Erysanbe DS Erythromycin 2000 mg 4600 30-50 1:1000-10,000 12.82 Antibiotic
15 Day-Cal Magnesium Oxide 3,870 80 1 : 100-1,000 20.83 Non Antibiotic
Calcium Carbonate 6,450 45-65 1: 1,000-10,000 71.43 Non Antibiotic
Vitamin D3 42 10 1: > 10,000 0.05 Non Antibiotic
16 Flamar 25 Diclofenac sodium 53 50 1 : 10-30 20.4 Non Antibiotic
17 Flamar Emulgel Diclofenac sodium 53 50 1 : 10-30 1.19 Non Antibiotic
18 Formyco Ketoconazole 20 mg/g 86 3.3-6.6 1 : >10,000 2 Non Antibiotic
19 Funtas Cream Miconazole Nitrate 20 mg 920 1: 1,000-10,000 2.1 Antibiotic
20 Funtas HC Miconazole Nitrate 20 mg 920 1: 1,000-10,000 2.1 Antibiotic
Hydrocortisone 10 mg 5,000 2.5-10 1 : > 10,000 1.0 Non Antibiotic
21 Lafalos Menthol 55 mg 3,300 60 - 120 1 : 100-1,000 5.78 Non Antibiotic
Eugenol 14 mg 2,680 1 : 100-1,000 1.47 Non Antibiotic
Methyl Salicylate 887 50 1 : 30-100 10.71 Non Antibiotic
22 Lafalos Plus Menthol 55 mg 3,300 60 - 120 1 : 100-1,000 5.78 Non Antibiotic
Eugenol 14 mg 2,680 1 : 100-1,000 1.47 Non Antibiotic
Methyl Salicylate 102 mg 887 50 1 : 30-100 10.71 Non Antibiotic
Vitamin E Acetate 30 mg 4,000 4 1 : >10,000 3 Non Antibiotic
23 Mefinal 500 Mefenamic Acid 500 mg 1,050 250 1 : >10,000 55.56 Non Antibiotic
24 Mefurosan Memetasone Furoate 1 mg/g >2,000 1 1 : >10,000 0.10 Non Antibiotic
25 Mezatrin Azithromycin 250 mg >2,000 10 1 : 30-100 61.4 Antibiotic
26 Pasquam Dexphantenol 50 mg/g 15,000 25-50 1 : 1-10 5.15 Non Antibiotic
28 Pibaksin Ointment Mupirocin 20 mg/g >5,000 20 1 : 1,000-10,000 2.06 Antibiotic
29 Pirofel gel Piroxicam 5 mg/g 216 0.2-0.3 1: 1,000-10,000 0.5 Non Antibiotic
30 Poldan Mig Paracetamol 400 mg 2,404 10-15 1 : 100-1,000 44.44 Non Antibiotic

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
 ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 6 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

LD50 Minimum
Solubility In Concentration Antibiotic/
No. Product Name Composition (mg/kg BB Rat Therapeutics
Water (g/mL) (%B/B) Non Antibiotic
per Oral Dose
Acetylsalicyclic Acid 250 mg 200 10-15 1 : 100-1,000 29.17 Non Antibiotic
Caffeine 65 mg 197 2.5 1 : 1-10 7.22 Non Antibiotic
31 Prolic 150 Clindamycin HCl 150 mg 2,193 8-20 1:10-30 53.88 Antibiotic
32 Prolic 300 Clindamycin HCl 300 mg 2,193 8-20 1:10-30 75 Antibiotic
33 Pumpitor Omeprazole 20 mg 2,210 5 1: 1,000-10,000 100 Non Antibiotic
34 Rhetoflam 2.5% Ketoprofen 25 mg/g 62.4 25-50 1 : 10 2.575 Non Antibiotic
35 Sagestam Cream Gentamycin Sulfate 1 mg/g >5,000 1.5-2 1:10-30 0.178 Antibiotic
36 Sagestam Ointment Gentamycin Sulfate 1 mg/g >5,000 1.5-2 1:10-30 0.105 Antibiotic
37 Sanaflu Paracetamol 500 mg 2,404 10-15 1 : 100 74.10 Non Antibiotic
Phenylpropanolamine HCl 1.490 6.25 1 : 1-10 1.85 Non Antibiotic
38 Sanaflu Forte Paracetamol 500 mg 2,404 10-15 1 : 100 80.25 Non Antibiotic
Phenylpropanolamine HCl 1.490 6.25 1 : 1-10 2.22 Non Antibiotic
39 Sanmol Tablet Paracetamol 500 mg 2,404 10-15 1 : 100 74.07 Non Antibiotic
40 Sanmol Syrup Paracetamol 120 mg/5 mL 2,404 10-15 1 : 100 2.4 Non Antibiotic
41 Sanvita B Plus Vitamin B1 (Thiamine) 15 mg >4000 0.2 1: 10-30 0.23 Non Antibiotic
Vitamin B2 (Riboflavin) 15 mg 10,000 0.2 1: 10-30 0.49 Non Antibiotic
Vitamin B3 (Nicotinamide) 50 mg 2,500 100-300 1: 1-10 1.09 Non Antibiotic
Vitamin B5 (Ca Panthotenic) 23 0.52
10,000 23 1: 10-30 Non Antibiotic
mg
Vitamin B6 (Pyridoxine) 10 mg 4,000 0.9 1: 10-100 0.23 Non Antibiotic
Vitamin B12 (Cyanocobalamin) 10
˃ 5,000 0.0009 1: 10-30 0.23 Non Antibiotic
mcg
Vitamin C (Ascorbic Acid) 500 mg 11,900 35-100 1 : 1-10 10.73 Non Antibiotic

Biotin 150 mcg 7,060 0.005-0.006 1: 1,000 – 0.003 Non Antibiotic

10,000
10,000 1: 1,000 –
Vitamin B9 (Folic Acid) 400 mcg 0.1 0.01 Non Antibiotic
10,000
Magnesium hydrocholide 100 mg >5,000 311 1 : 100-1,000 6.25 Non Antibiotic
Calcium Carbonate 100 mg 6,450 45-65 1: 1,000-10,000 7.66 Non Antibiotic
Zinc Sulfate 10 mg 1,260 3 1: 10-30 0.57 Non Antibiotic
42 Siclidon Capsule Doxycycline Hyclate 100 mg 1,700 2-5 1: 10-30 54.26 Antibiotic
43 Sinocort Triamcinolone Acetonide 1,451 0.025 1 : >10,000 0.105 Non Antibiotic
44 Stolax Suppo Bisacodyl 10 mg 4,320 0.3 1: 1,000-10,000 0.6 Non Antibiotic
45 Topcort Cr Desoxymethasone 2.5 mg/g 1 : >10,000 0.05 900 0.255 Non Antibiotic
46 Sanmol 120 mg Eff Paracetamol 120 mg 2,404 10-15 1 : 100 6.49 Non Antibiotic
47 Ostelox Suppo Meloxicam 15 mg 83.5 0.125 1 : >10,000 0.9 Non Antibiotic
48 Trichodazol 1g Metronidazole 1 g 500 15-35 1 : 100-1,000 37.14 Antibiotic
49 Trichodazol Plus Metronidazole 500 mg 500 15-35 1 : 100-1,000 19.807 Antibiotic
Nystatin 20 mg 10,000 33.3 1 : 1,000-10,000 0.918 Antibiotic
50 Sancortmycin Oint Hydrocortisone 10 mg/g 5,000 2.5-10 1 : > 10,000 1.05 Non Antibiotic
Oxytetracycline HCl 30 mg/g 6,696 15-25 1 : 10-30 3.77 Antibiotic
51 Sanadryl DMP Dextromethorpahan HBr 10 mg/5 1 : 30-
240 2.5 - 7.5 0.2 Non Antibiotic
mL 100
Diphenhydramine HCl 12.5 mg/5
500 5 1:<1 0.25 Non Antibiotic
mL
Ammonium Chloride 100 mg/5 mL 1,300 75 1:<1 2 Non Antibiotic
Sodium Citrate 50 mg/5 mL 6,730 5 - 15 1 : 10-30 1 Non Antibiotic
52 Sanadryl Exp Diphenhidramine HCl 12.5 mg/5 500 5 1:<1 0.25 Non Antibiotic
mL
Amonium Chloride 100 mg/5 mL 1,300 75 1:<1 2 Non Antibiotic
Potassium Guaiacolsulphonate 30
520 25 – 50 1 : 1-10 0.6 Non Antibiotic
mg/5 mL
Sodium Citrate 50 mg/5 mL 6,730 5 - 15 1 : 10-30 1 Non Antibiotic
53 Sanbeflam Ketoprofen 25 mg/g 62.4 25-50 1 : 10 2.57 Non Antibiotic
54 Visancort Clioquinol 10 mg/g 5 3 1: >10,000 1.104 Non Antibiotic

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
 ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 7 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

LD50 Minimum
Solubility In Concentration Antibiotic/
No. Product Name Composition (mg/kg BB Rat Therapeutics
Water (g/mL) (%B/B) Non Antibiotic
per Oral Dose
Hydrocortisone 10 mg/g >5,000 2.5-10 1 : >10,000 1.019 Non Antibiotic
55 Zeliris Azelaic Acid 200 mg/g >5,000 200 1: 10-30 20.39 Non Antibiotic
56 Becom C Vitamin B1 (Thiamine) >4000 0.2 1: 10-30 5.56 Non Antibiotic
Vitamin B2 (Riboflavin) 10,000 0.2 1: 10-30 2.81 Non Antibiotic
Vitamin B6 (Pyridoxine) 4,000 0.9 1.12 Non Antibiotic
1: 10-100
Vitamin B12 (Cyanocobalamin) ˃ 5,000 0.0009 1: 10-30 0.61 Non Antibiotic
Vitamin C (Ascorbic Acid) 11,900 35-100 1 : 1-10 54.70 Non Antibiotic
Vitamin B3 (Nicotinamide) 2,500 100-300 1: 1-10 10.41 Non Antibiotic
Vitamin B5 (Ca Panthotenic) 10,000 23 1: 10-30 2.24 Non Antibiotic
57 Sanmol 120 Chewable Paracetamol 120 2,404 10-15 1 : 100 28.7 Non Antibiotic
58 Damaben Metoclopramide HCl 10 mg 280 0.1-0.2 1: 10-30 5.27 Non Antibiotic
59 Tuzalos Dextromethorpahan HBr 10 mg 240 2.5 - 7.5 1 : 30-100 5.35 Non Antibiotic
Phenylpropanolamine HCl 1.490 6.25 1 : 1-10 2.03 Non Antibiotic
CTM 1 mg 306 0.35 1 : 1-10 0.14 Non Antibiotic
Paracetamol 500 mg 2,404 10-15 1 : 100 67.57 Non Antibiotic
60 Braxidin Chlordiazepoxide 5 mg 537 0.5 1 : >10,000 1.61 Non Antibiotic
Clidinium bromide 2.5 mg 492 2.5 1 : >10,000 5.32 Non Antibiotic
61 Femisic Mefenamic Acid 500 mg 1,050 250 1 : >10,000 55.55 Non Antibiotic
62 Floxacap Levofloxacin 500 mg 1,478 8 1: 10-30 74.67 Non Antibiotic
63 Levocin Levofloxacin 500 mg 1,478 8 1: 10-30 74.67 Non Antibiotic
64 Caprazole Lansoprazole 30 mg >5,000 15 1 : >10,000 100 Non Antibiotic
65 Cardicap 5 Amlodipine 5 mg 393 2.5-5 1 : 100-1,000 3.54 Non Antibiotic
66 Cardicap 10 Amlodipine 10 mg 393 2.5-5 1 : 100-1,000 3.82 Non Antibiotic
Ciprofloxacin HCl ~ Ciprofloxacin
67 Ciprec 500 5,000 10-15 1 : 100 75.88 Antibiotic
500 mg
68 Formuno FCC Echinacea purpurea Dry Ext 250 15,000 25.97 Non Antibiotic
6.78 1: 10-30
mg
Phyllanthus niruri Dry Ext 50 mg >2,000 200 1: 10-30 4.55 Non Antibiotic
Black elderberry Dry Ext 300 mg 17,000 175 1: 10-30 30 Non Antibiotic
Zinc Picolinate 10 mg 3,731 1: 10-30 0.97 Non Antibiotic
Vitamin C 100 mg 11,900 35-100 1 : 1-10 9.94 Non Antibiotic
69 Formuno Effervescent Echinacea Purpurea Dry Pressed 15,000 Non Antibiotic
6.78 1: 10-30 20.83
Extract
Black Elderberry Dry Extract 17,000 175 1: 10-30 6.38 Non Antibiotic
Phyllanthus Niruri Dry Extract >2,000 200 1: 10-30 1.06 Non Antibiotic
Zinc Picolinate 3,731 1: 10-30 0.97 Non Antibiotic
70 Ultravita Vitamin A 5000 UI 2,740 0.8 1: > 10,000 0.85 Non Antibiotic
Vitamin D 400 UI 42 10 1: > 10,000 0.34 Non Antibiotic
Vitamin B1 (Thiamine) 3 mg >4000 0.2 1: 10-30 0.27 Non Antibiotic
Vitamin B2 (Riboflavin) 3 mg 10,000 0.2 1: 10-30 0.25 Non Antibiotic
Vitamin B6 (Pyridoxine) 2 mg 4,000 0.9 0.17 Non Antibiotic
1: 10-100
Vitamin B12 (Cyanocobalamin) 2 ˃ 5,000 Non Antibiotic
0.0009 1: 10-30 0.22
mg
Vitamin C (Ascorbic Acid) 75 mg 11,900 35-100 1 : 1-10 6.25 Non Antibiotic
10,000 1: 1,000 – Non Antibiotic
Vitamin B9 (Folic Acid) 400 mcg 0.1 0.03
10,000
Lycopene 6 mg 4-8 4.85 Non Antibiotic
> 4000 1: > 10,000
Vitamin B3 (Nicotinamide) 20 mg 2,500 100-300 1: 1-10 1.62 Non Antibiotic
Calcium Lactate 100.42 mg 3,730 210 1: 10-30 8.38 Non Antibiotic
Panthotenic Acid 4.6 mg 10,000 23 1: 10-30 0.39 Non Antibiotic
Pottasium Iodide 0.15 mg 3,118 16.25 1 : 1-10 0.015 Non Antibiotic
Ferrous Fumarate 30 mg 3,850 0.27 1 : 100-1,000 7.16 Non Antibiotic
Cupric Gluconate 1 mg 1,710 0.4-1.0 1: 10-30 0.56 Non Antibiotic

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
 ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 8 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

LD50 Minimum
Solubility In Concentration Antibiotic/
No. Product Name Composition (mg/kg BB Rat Therapeutics
Water (g/mL) (%B/B) Non Antibiotic
per Oral Dose
Manganase Sulfate 1 mg 2,150 0.003 1 : 1-10 0.24 Non Antibiotic
Magnesium Oxide 6 mg 3,870 80 1 : 100-1,000 0.80 Non Antibiotic
Zinc Sulfate Heptahydrate 1.5 mg 1,260 3 1: 10-30 0.51 Non Antibiotic
71 Sanorine 0.1% Hyaluronic acid 0.1% >800 16 1: 10-30 0.1 Non Antibiotic
72 Sanorine 0.025% Hyaluronic acid 0.025% >800 16 1: 10-30 0.025 Non Antibiotic
73 Zolacap Omeprazole 20 mg 2,210 5 1: 1,000-10,000 100 Non Antibiotic
74 Fordica XR 500 Metformin HCl 500 mg 375 500 1: 1-10 50 Non Antibiotic
75 Folavicap 400 Folic Acid 400 µg 10,000 0.1 1:1,000-10,000 0.22 Non Antibiotic
76 Folavicap 1000 Folic Acid 1000 µg 10,000 0.1 1:1,000-10,000 0.56 Non Antibiotic
77 Capritazin Tablet Cetirizine Dihydrochloride 5 mg 365 2.5 1: 1-10 5.71 Non Antibiotic
78 Liproqy Coenzym Q10 40 mg >4,000 50-200 1 : >10,000 8.25 Non Antibiotic
Lycopene 10 mg 4-8 20.19 Non Antibiotic
> 4000 1: > 10,000
Vitamin E Natural 4,000 15 1 : >10,000 21.48 Non Antibiotic
Grape seed Ext >5,000 30 1 : 30-100 4.04 Non Antibiotic
Epigallocatechin Gallate 2,000 84-386 1 : 100-1,000 16.11 Non Antibiotic
79 Capribose 50 Acarbose 50 mg 24,000 25 1 : ≤1 38.15 Non Antibiotic
80 Capribose 100 Acarbose 100 mg 24,000 25 1 : ≤1 38.15 Non Antibiotic
81 Sancurlin Vitamin B1 (Thiamine) 3 mg >4000 0.2 1: 10-30 0.06 Non Antibiotic
Vitamin B2 (Riboflavin) 2 mg 10,000 0.2 1: 10-30 0.05 Non Antibiotic
Vitamin B6 (Pyridoxine) 5 mg 4,000 0.9 0.12 Non Antibiotic
1: 10-100
Vitamin B12 (Cyanocobalamin) 5 ˃ 5,000 Non Antibiotic
0.0009 1: 10-30 0.0001
mcg
Β-Carotene 20% 2 mg >5,000 30 – 150 1 : >10,000 0.04 Non Antibiotic
Dexphantenol 3 mg 15,000 100 - 300 1 : 1-10 0.06 Non Antibiotic
Calcium Gluconate Monohydrate >5,000 Non Antibiotic
210 – 1,300 1: 10-30 6.25
300 mg
Curcuma xanthoriza Ext. 2 mg >5,000 500 1 : >10,000 0.27 Non Antibiotic
82 Sanfuliq FCC Curcuma longa Rhizoma >2,000 440-2200 1 : >10,000 0.50 Non Antibiotic
Silybin phospholipids >4,000 120 1 : 10-30 0.47 Non Antibiotic
Schizandrae fructus extrac 10,500 20 1 : 10-30 0.45 Non Antibiotic
Choline L-Bitartrate 3,400 50 1 : 1-10 0.50 Non Antibiotic
Vitamin B1 (Thiamine) >4,000 0.2 1 : 10-30 0.005 Non Antibiotic
Vitamin B2 (Riboflavin) 10,000 0.2 1 : >10,000 0.004 Non Antibiotic
Vitamin B6 (Pyridoxine) 4,000 0.9 1 : 10-100 0.01 Non Antibiotic
Vitamin B12 (Cyanocobalamin) ˃ 5,000 0.0009 1:10-30 0.01 Non Antibiotic
Vitamin E >4,000 15 1:>10,000 0.12 Non Antibiotic
83 Vostem Plus Eff Glucosamine Hydrochloride >5,000 300-500 1: 1-10 15.96 Non Antibiotic
Orange/Lemon Chondroitin Sulfate Sodium Non Antibiotic
>10,000 400 1 : 10-30 11.15
Methyl Sulphonyl Methane 17,000 50 1 : 10-30 5.43 Non Antibiotic
Sodium Selenite 1% 7 0.2 1 : 10-30 0.14 Non Antibiotic
Zinc Sulfate Monohydrate 1,260 3 1: 10-30 0.29 Non Antibiotic
Manganese Sulfate Monohydrate 2,150 0.003 1:1-10 0.07 Non Antibiotic
Magnesium Hydroxide 8,500 500 1 : 1,000-10,000 1.28 Non Antibiotic
Ascorbic Acid 11,900 35-100 1 : 1-10 1.06 Non Antibiotic
84 Acetin Acetylcysteine 600 mg 4,400 10-15 1 :1-10 13.33 Non Antibiotic
85 Caproliv FCC Silybin phosphatydilcholin Non Antibiotic
>4,000 120 1: 10-30 9.33
complex 70 mg
Schizandrae fructus extract 135 mg 10,500 20 1 : 10-30 18 Non Antibiotic
Curcuma domestica C95 extract 25 Non Antibiotic
>1,000 15 1 : >10,000 3.51
mg
Liquiritiae radix extract 135 mg 81,000 80-100 1: 10-30 18 Non Antibiotic
Choline bitartrate 150 mg 3,400 50 1: 1-10 20 Non Antibiotic
Vitamin B6 2 mg 0.9 Non Antibiotic
4,000 1: 10-100 0.39

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
 ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 9 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

LD50 Minimum
Solubility In Concentration Antibiotic/
No. Product Name Composition (mg/kg BB Rat Therapeutics
Water (g/mL) (%B/B) Non Antibiotic
per Oral Dose
86 Munosan Dried Echinacea juice concentrate 5.21 Non Antibiotic
15,000 6.78 1: 10-30
15% 1000 mg
Black elderberry extract 10 % 100 1.06 Non Antibiotic
17,000 175 1: 10
mg
Phyllanthus niruri Dry Extract 100 2.12 Non Antibiotic
>2,000 0.002-20 1: 10-30
mg
Lycopene 5 mg 4-8 Non Antibiotic
> 4000 1: > 10,000 1.04
Zinc Picolinate 10 mg 3,731 1: 10-30 0.22 Non Antibiotic
Selenium 15 mcg 6700 0.003 1: > 10,000 0.07 Non Antibiotic
Vitamin C 500 mg 35-100 Non Antibiotic
11,900 1: 1-10 10.62
87 Sanmol 1000 Eff Paracetamol 1,000 mg 2,404 10-15 1 : 100 40 Non Antibiotic
88 Sanmol 500 Eff Paracetamol 500 mg 2,404 10-15 1 : 100 24.39 Non Antibiotic
89 Sanergo Effervescent Calcium Pantothenate 0.109 23 10,000 1: 10-30 Non Antibiotic
Powder (Orange, Non Antibiotic
Blackcurrant, Lemon) Riboflavin Sodium Phosphate 0.034 0.2 10,000 1: 10-30

Nicotinamide 0.3 100-300 2,500 1: 1-10 Non Antibiotic

Zinc Picolinate 0.413 3,731 1: 10-30 Non Antibiotic
Pyridoxine Hydrochloride 0.1 0.9 4,000 1: 10-100 Non Antibiotic
Ascorbic Acid 1 35-100 11,900 1: 1-10 Non Antibiotic
Caffeine 1 2.5 192 1: 100 Non Antibiotic
Taurine 20 30 > 5000 1: 10-30 Non Antibiotic
Ginseng 0.6 100 750 1: 10-30 Non Antibiotic
Royal Jelly 0.04 4,090 1: 30-100 Non Antibiotic
Inositol 0.5 10,000 1: 10-30 Non Antibiotic
Thiamine Hydrochloride 0.2 Non Antibiotic
0.02 3710 1: 1-10
90 Bicrolid Clarithomycin 500 mg 2,700 7.5 1 : 1,000-10,000 42 Antibiotic
Cetirizine Hydrochloride 5 mg/5 Non Antibiotic
91 Capritazin Syrup 365 2.5 1: 10-30 0.1
mL
92 Mucohexin Syrup Bromhexin HCl 4 mg/5 mL 6,000 4–8 1 : 100-1000 0.08 Non Antibiotic
93 Sanbedenta Sodium Fluoride 25 – 2,000 10 1 : 10-30 0.22 Non Antibiotic
Potassium Nitrate > 2,000 1 : 10 5 Non Antibiotic

7. SCORING AND EVALUATION

Score
Drug Solubility Toxicity Active Formulatio Production Batch Total
No. Product Name Category (25%) (25%) Ingredient/s n Frequency Size Score
(25%) Concentration Complexity (5%) (5%)
(10%) (5%)
1 Baquinor Forte 25 15 20 10 1 1 5 77

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 10 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

Score
Drug Solubility Toxicity Active Formulatio Production Batch Total
No. Product Name Category (25%) (25%) Ingredient/s n Frequency Size Score
(25%) Concentration Complexity (5%) (5%)
(10%) (5%)
2 Biferce 10 5 15 1 1 1 5 38
3 Biosanbe 10 20 20 10 5 1 5 75
4 Biothicol DS 25 20 15 1 1 1 5 68
5 Biothicol Forte 25 20 15 1 1 1 1 64
6 Biothicol 500 25 20 15 10 1 1 1 73
7 Caldece Eff 10 25 25 5 5 1 5 76
8 Centabio Gel 25 10 20 1 5 1 5 67
9 Cinolon Cream 10 10 25 1 1 1 5 53
10 Cinolon N
25 10 25 1 5 1 5 72
Cream
11 Clobesan Cream 10 25 20 1 1 1 1 59
12 Dolones Cream 10 25 25 1 5 1 1 68
Episan
13 10 25 15 1 1 1 5 58
Suspension
14 Erysanbe DS 25 20 20 1 1 1 5 73
15 Day-Cal 10 20 15 10 5 1 5 66
16 Flamar 25 10 10 25 1 1 1 1 49
17 Flamar Emulgel 10 10 25 1 1 1 5 53
18 Formyco 10 25 25 1 1 1 5 68
19 Funtas Cream 10 20 25 1 1 1 1 59
20 Funtas HC 10 20 25 1 5 1 1 63
21 Lafalos 10 15 25 1 5 1 5 62
22 Lafalos Plus 10 25 25 1 5 1 5 72
23 Mefinal 500 10 25 20 10 1 5 5 72
24 Mefurosan 10 25 20 1 1 1 5 63
25 Mezatrin 25 10 20 10 1 1 1 68
26 Pasquam 10 5 15 1 1 1 1 34
Pibaksin
28 25 20 15 1 1 1 1 64
Ointment
29 Pirofel gel 10 20 25 1 1 1 5 63
30 Poldan Mig 10 15 25 10 5 5 5 71
31 Prolic 150 25 10 20 10 1 1 1 68
32 Prolic 300 25 10 20 10 1 1 1 68
33 Pumpitor 10 20 20 10 1 1 1 63
34 Rhetoflam 2.5% 10 5 25 1 1 1 5 48
35 Sagestam Cream 25 10 15 1 1 1 5 58
Sagestam
36 25 10 15 1 1 1 5 58
Ointment
37 Sanaflu 10 15 20 10 5 5 5 70
38 Sanaflu Forte 10 15 20 10 5 1 5 66
39 Sanmol Tablet 10 15 20 10 1 5 5 66
40 Sanmol Syrup 10 15 20 1 1 5 5 57
41 Sanvita B Plus 10 20 25 5 5 1 5 71
42 Siclidon Capsule 25 10 20 10 1 1 1 68
43 Sinocort 10 25 20 1 1 1 1 59
44 Stolax Suppo 10 20 20 1 1 1 1 54
45 Topcort Cr 10 25 15 1 1 1 5 58
Sanmol 120 mg
46 10 15 20 1 1 1 1 49
Eff
47 Ostelox Suppo 10 25 25 1 1 1 1 64
48 Trichodazol 1g 25 15 25 1 1 1 1 69

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 11 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

Score
Drug Solubility Toxicity Active Formulatio Production Batch Total
No. Product Name Category (25%) (25%) Ingredient/s n Frequency Size Score
(25%) Concentration Complexity (5%) (5%)
(10%) (5%)
49 Trichodazol Plus 25 15 25 1 5 1 1 73
50 Sancortmycin
25 25 1 1 1 1 69
Oint 15
51 Sanadryl DMP 10 10 25 1 5 5 5 61
52 Sanadryl Exp 10 10 25 1 5 1 5 57
53 Sanbeflam 10 5 25 1 1 1 1 44
54 Visancort 10 25 25 1 5 1 1 68
55 Zeliris 10 10 15 1 1 1 1 39
56 Becom C 10 25 20 10 5 1 5 76
Sanmol 120
57 10 15 20 1 1 1 1 49
Chewable
58 Damaben 10 10 25 1 1 1 5 54
59 Tuzalos 10 15 25 10 5 1 5 75
60 Braxidin 10 25 25 1 5 1 1 68
61 Femisic 10 25 20 10 1 1 5 72
62 Floxacap 25 10 20 10 1 1 1 68
63 Levocin 25 10 20 10 1 1 5 72
64 Caprazole 10 25 15 10 1 1 1 63
65 Cardicap 5 10 15 25 1 1 1 1 54
66 Cardicap 10 10 15 25 1 1 1 1 54
67 Ciprec 500 25 15 20 10 1 1 1 73
68 Formuno FCC 10 25 15 10 5 1 5 75
69 Formuno
10 10 25 5 5 1 1 57
Effervescent
70 Ultravita 10 25 25 5 5 1 5 76
71 Sanorine 0.1% 10 10 20 1 1 1 1 44
72 Sanorine 0.025% 10 10 20 1 1 1 1 44
73 Zolacap 10 20 20 10 1 1 1 63
74 Fordica XR 500 10 5 25 5 1 1 1 48
75 Folavicap 400 10 20 15 1 1 1 1 49
76 Folavicap 1000 10 20 15 1 1 1 1 49
77 Capritazin Tablet 10 5 25 1 1 1 1 44
78 Liproqy 10 25 20 5 5 1 1 67
79 Capribose 50 10 1 15 5 1 1 1 34
80 Capribose 100 10 1 15 5 1 1 1 34
81 Sancurlin 10 25 20 1 5 1 1 63
82 Sanfuliq FCC 10 25 20 1 5 1 5 67
83 Vostem Plus Eff
10 20 25 5 5 1 5 71
Orange/Lemon
84 Acetin 10 5 20 1 1 1 1 39
85 Caproliv FCC 10 25 20 10 5 1 1 72
86 Munosan 10 25 20 5 5 1 1 67
87 Sanmol 1000 Eff 10 15 20 5 1 1 1 53
88 Sanmol 500 Eff 10 15 20 1 1 1 1 49
Sanergo Eff
Powder (Orange,
89 10 15 25 10 5 1 1 67
Blackcurrant,
Lemon)
90 Bicrolid 25 20 20 5 1 1 1 73
91 Capritazin Syrup 10 10 25 1 1 1 1 49
92 Mucohexin 10 15 15 1 1 1 1 44

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 12 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

Score
Drug Solubility Toxicity Active Formulatio Production Batch Total
No. Product Name Category (25%) (25%) Ingredient/s n Frequency Size Score
(25%) Concentration Complexity (5%) (5%)
(10%) (5%)
Syrup
93 Sanbedenta 10 10 20 1 5 1 1 48

Remark :
- Drug Category : 10 : Non antibiotics
25 : Antibiotics
- Solubility : 25 : Active ingredient solubility in water 1: > 10,000
20 : Active ingredient solubility in water 1: 1000-10000
15 : Active ingredient solubility in water 1: 100-1000
10 : Active ingredient solubility in water 1: 10-100
5 : Active ingredient solubility in water 1: 1-10
1: Active ingredient solubility in water 1: < 1
- Toxicity : 25 : LD50 < 1000 mg/kg BB
20 : LD50 1000 - 5000 mg/kg BB
15: LD50 > 5000 mg/kg BB
- Concentration : 10 : concentration > 50 %
5 : concentration 25 - 50 %
1: concentration < 25 %
- Formulation Complexity : 5 : > 1 active ingredient
1 : 1 active ingredient
- Production Frequency: 5 : > 15 batches per month
1 : 1 – 15 batches per month
- Batch Size : 5 : > 100 kg
1 : < 100 kg

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
 ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 13 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

The total score covers drug category, solubility, toxicity, concentration, formulation
complexity, production frequency and batch size, show that BAQUINOR FORTE CAPLET
has a highest score than another product. The active ingredient Ciprofloxacin HCl is choosen
for cleaning validation because Ciprofloxacin HCl is antibiotics substance has higher risk to
cause allergy, has lower LD50 and the active ingredient has high concentration.

9. CONCLUSION
Based on data and evaluation, the cleaning validation for Weighing Room, Electric Balance,
Thief Sampler and Stainless Scoope will be performed to : BAQUINOR FORTE CAPLET
Whereas cleaning validation will not be performed to the other active substances/ products
since they have covered by above active substances/ products.

10. ATTACHMENT
-

11. REVISION HISTORY

Revision Date Description Originator
No

00 02 January 2008 Initial Release Indra Mariana

-Includes DayCal Chewable Tablet , Biferce

01 05 November 2012 Nurul Fahmi
Effervescent, Hayati
Caldece Effervescent, Biosanbe Capsule,
Pumpitor Capsule, Damaben Tablet, Becom
C Coated Caplet, Braxidin Coated Caplet,
Formuno Coated Caplet, Formuno Ekstra
Effervescent, Ultravita, Zolacap Capsule,
Liproqy Capsule, Biothicol 500, Syclidon
Capsule, Bicrolid Coated Caplet, Floxacap
Coated Caplet, Levocin 500, Mezatrin 250,
Prolic 300
- Eliminate Ciprofloxacin 500 Tablet

02 13 Desember 2016 - Update Literature Fajar R. S.

- Add Data LD50 and Solubility of: CTM,
Dextromethorphan, Thiamine, Riboflavin,
Nicotinamide, Echinacea purpurea,
Elderberry, Blackelderberry, Ainc
picolinate, Magnesium Oxide, Clidinium
bromide, Ferrous Fumarate, Eugenol,
Placenta extract.
- Includes: Biothicol DS, Biothicol Forte,
Clobesan Cream, Dolones Cream, Episan

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc
ORIGINAL Confidential
Document No. VAL-LV/BRP/MB/016 Rev. 04 Page 14 of 14
Prepared, Reviewed, Reviewed,
Reviewed, Approved, Approved,

Suspension, Erysanbe DS, Flamar 25,

Funtas Cream, Funtas HC, Mefinal 500,
Mefurosan, Pasquam, Pibaksin Ointment,
Prolic 150, Sagestam Ointment, Sanmol
Syrup, Sanvita B Plus, Sinocort , Stoax
Suppo, Sanmol 120 mg Eff, Ostelox Suppo,
Trichodazol 1g, Trichodazol Plus,
Sancortmycin Oint, Sanadryl DMP,
Sanadryl Exp, Sanbeflam, Zeliris, Sanmol
120 Chewable, Femisic, Caprazole,
Cardicap 5, Cardicap 10, Sanorine 0.1%,
Sanorine 0.025%, Fordica XR 500,
Folavicap 400, Folavicap 1000, Capritazin
Tablet, Capribose 50, Capribose 100,
Sancurlin, Sanfuliq FCC, Vostem Plus Eff
Orange/Lemon, Acetin, Caproliv FCC,
Munosan, Sanmol 1000 Eff, Sanmol 500
Eff, Capritazin Syrup, Mucohexin Syrup.
03 03 January 2017 - Includes Sanbedenta, Sanergo Eff Powder Fajar R. S.
- Update References
- Add Category of Product Scoring:
04 16 March 2017 Fajar R. S.
Minimum Therapeutics Dose.
- Update Product scoring

\\Cimareme\Release\Capri\Validation\ Bracketing\LV\VAL-LV\BRP\MB\016 – Bracketing/Grouping For Product Used Weighing Room, Electronic

Balance, Thief Sampler and Stainless Scoope Cleaning Validation – R04.doc