SAITECH MEDICARE PVT LTD

Trilokpur Road Kala Amb (HP)

CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 1 of 25

EQUIPMENT CLEANING

VALIDATION PROTOCOL

FOR

ACECLOFENAC /ETODOLAC

TABLETS
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 2 of 25

TABLE OF CONTENT
S. No. Subject Page No.
1.0 Protocol Approval 3
2.0 Introduction 4
3.0 Objective 4
4.0 Scope 4
5.0 Responsibilities 4
6.0 Cleaning procedure 5
6.1 Cleaning agent selection criteria 5
6.2 Solubility pattern and cleaning agent 5
Details Of Equipment Used, Contact Surface Area Manufacturing 6
6.3
Stage And Cleaning Sop
6.4 Batch size of the product 6
6.5 Process flow Diagram 7
7.0 Maximum Allowable limit 8
7.1 Spike Recovery study 9
8.0 Sampling plan 10
8.1 Scientific rational for selecting sampling plan 10
9.0 Sampling Procedure 10
9.1 Visual inspection 10
9.2 Swab sampling for Microbial Analysis 10
9.3 Swab sampling for chemical Analysis 11
10.0 Acceptance criteria 12
10.1 For Visual inspection 12
10.2 For Microbial contamination 12
10.3 For chemical contamination 12
11.0 Detailed Analytical Method 13
11.1 For Microbial contamination test 13
11.2 For chemical analysis 14
11.2.1 Standard stock solution 14
11.2.2 Dilute solution 14
11.2.3 Blank Preparation 14
11.2.4 Test sample preparation 14
11.2.5 Procedure and calculation 15
12.0 Revalidation Criteria 16
13.0 Change control 16
14.0 Review 16
15.0 Results 16
16.0 Conclusion 16
17.0 Summary Report and Approval 16
18.0 Table for spike recovery (for swab) FORM - A 17
Table for visual inspection, chemical and Microbial contamination
18.1 18
level by swab. FORM - B
Table for visual inspection, chemical and Microbial contamination
18.2 19
level by swab. FORM – BI
Table for visual inspection, chemical and Microbial contamination
18.3 20
level by swab. FORM – B II
19.0 Table for Summary Report and Approval 21
A Table for Summary of visual inspection 21
B Table for summary of Microbial and chemical contamination test 22
20.0 Abstract and approval 23
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 3 of 25

1.0 Protocol Approval:

Prepared By Checked By Approved By

Signature

Name

Date

Dept. Asst. Q.A. Manager QC Manager Plant Head QA Manager

 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 4 of 25

2.0 Introduction:
Cleaning is necessary to avoid cross contamination from active ingredients, excepient, degradation
products, etc from previous products, contamination from lubricant used for equipment, cleaning
agent if any and cleaning tools such as brushes mops etc. during cleaning process. It also
establishes bioburden of the equipment. Present study involves the validation of cleaning procedure
of various equipment used for manufacturing of Aceclofenac / Etodolac tablets by using prospective
approach. Three consecutive batches shall be taken for validation of cleaning process after
manufacturing of Aceclofenac / Etodolac.

3. 0 Objective:
Objective of the protocol is to provide documented evidence through the scientific data to show that
the cleaning procedure used after Manufacturing of the Aceclofenac / Etodolac tablets is effective
and consistently performs as expected and produce a result that meets a predetermined acceptance
criteria when manufactured in Granulation area.

4.0 Scope:
The scope of the protocol is to evaluate the acceptability of cleaning procedure used in cleaning of
equipment of tablets granulation area II (Refer table No.-2) using well-established analytical and
microbiological method to determine the Chemical and microbiological cleaning of the equipment.

5.0 Responsibilities :

Department Responsibility
Quality Assurance To prepare the cleaning validation protocol for the batches to be
(Team Leader) validated, co-ordinate the entire cleaning validation activity related to
the protocol, preparation of report & summary. As a team leader, he
is responsible for coordinating & compilation of cleaning validation
protocol & report.
Quality Control To provide the validated method and analyze the various samples
collected during the cleaning validation & submit the data with
comments.
Production To perform the cleaning process in accordance with the respective
SOP of equipment cleaning & provide the necessary resources.
Engineering To provide the surface area of the equipment used in the process.
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 5 of 25

6. 0 Cleaning Procedure :
6.1 Cleaning agent selection criteria :
As per standard operating procedure. [Purified water]
6.2 Solubility pattern and cleaning agent :
The table below gives the solubility pattern of the Aceclofenac
Table No. 1

Name of active ingredient Solubility profile

Aceclofenac Practically insoluble in water, Freely soluble in acetone, Soluble in
alcohol.

The cleaning procedure for equipment cleaning is followed as per respective SOP of equipment
cleaning. Water is used to clean the equipment and for sanitation 70% IPA is using.
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 6 of 25

6.3 Details of Equipment Used, Contact Surface area and Cleaning Sop
The table No. 2 gives equipment used in manufacturing, product contact surface area and Equipment
Cleaning SOP number.
Table No. 2
Equipment Surface Equipment Cleaning SOP
Sr. Equipment used in
identification area number
No. manufacturing
number (in sq. M.)
1. Scoop S-1 0.024 SM/PR//034
2. Sifter SM-PR-GT -12 1.295 SM/PR//034
3. Mass Mixer SM-PR-GT-01 4.322 SM/PR//034
4. Fluidized Bed Drier SM-PR-GT-02 6.210 SM/PR//034
5. Multi Mill SM-PR-GT -14 0.22 SM/PR//034
6. Octagonal Blender SM-PR-GT -04 6.66 SM/PR//034
7. Compression machine SM/PR/GT/06 0.5314 SM/PR//034
8. Coating Pan SM-PR-GT -10 10.509 SM/PR//034
9. Inspection Table SM-PR-GT -15 1.460 SM/PR//034
10. Blister Packing machine SM-PR-GT -07 1.601 SM/PR//034
TOTAL SURFACE AREA 32.83≡33.00

6.4 Batch Size of The Product :

Table No. 3

Product Aceclofenac [A] Next Product (B)

Batch Size in Kg. 100.00 Kg 150.00 Kg
Daily Therapeutic dose 200 mg 400 mg / day
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 7 of 25

6.5 Process Flow Chart:

EQUIPMENTS PROCESS FLOW DIAGRAM

SS Vibratory Sifter SIFTING

DRY MIXING

Mass Mixer
WET MIXING

Fluid bed Drier DRYING

MILLING OF OVERSIZE
Multi Mill GRANULES

Octagonal Blender LUBRICATION

Compression M/c COMPRESSION

Coating Pan COATING / INSPECTION

Inspection Table
Blister Machine
BLISTER PACKING
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 8 of 25

7.0 Maximum Allowable Limit:

Maximum allowable limit of active that can be carried over from one product to the next is as follows --
TD x BS x SF
MAC =
LDD
Where MAC : The maximum allowable carryover of product A into product B
TD : Single therapeutic dose of product A
BS : Batch size of product B
SF : Safety factor
LDD : Largest daily dose of product B
Reference PDA Technical report No. 29
Calculation Mg of active ingredient of product A permitted in Product B

Product A = Aceclofenac Tablets

Batch Size = 100.05 Kg. (No. of Tablets 3,33,500 Tablets)
Average Wt. = 300 mg.
Label Claim = Each coated tablets contains Aceclofenac BP 200 mg
Daily dose = 200 mg/day for Aceclofenac BP maximum.

Product B = Etodolac 400 Tablets

Batch Size = 150.00 Kg. (No. of Tablets 3, 00,000)

Average Wt. = 500 mg.
Label Claim = Each film coated tablet contains : Etodolac USP 400 mg
Daily dose = 1200 mg /day maximum.

Maximum Allowable Limit:

TD x BS x SF
MAC =
LDD

TD : Single therapeutic dose of product A

Aceclofenac BP 200 mg / Tablet

BS : Batch size of product B

Etova 400 Tablet = 150.00 Kg. (No. of Tablets 3, 00,000),
Average Wt.500 mg
3, 00,000 X500 = 15,00,00000 mg
SF : Safety factor
1/1000 = 0.001
LDD : Largest daily dose of product B
Largest daily dose = 1200 mg (tab/day)

200 x 3,00,000 x .001

MAC = = 50 mg / set of equipment
1200

For Swab : (Swab Area 5 X 5 = 25 cm2 )

50 x 25
Mg of permissible active per swab of 25 cm2 = 33.0 x 10000 = 0.0037 mg / swab
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Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 9 of 25

7.1 Spike Recovery Study

For Swab Test-
To ensure the effectiveness of swab sampling, spike recovery study shall be carried out as
follows.
1. Obtain a piece of SS 316 material of construction having surface area of about 25 cm². or
more.
2. Clean the surface twice with Purified water and dry.
3. Prepare a solution of Aceclofenac in alcohol having concentration based on the acceptance
limit.
4. Recovery study shall be carried out at three different levels (80%, 100% and 120%) of
acceptance limit.
5. Spike the calculated volume of solution on the marked surface area of 25 cm2.
6. Allow the spiked to air dry.
7. Wet the swab in alcohol
8. Swab the surface area of the plate using ten parallel horizontal and ten vertical strokes.
9. Extract the swab with 15 ml of Methanol; Transfer the extract ml to 50 ml volumetric flask.
Extract the same swab with 1 x 15 ml of alcohol. Diluted the extract to 50 ml with alcohol in
volumetric flask & filter.
10. Compare the recovery by treating the same aliquot in similar manner except spiking
procedure.
11. The Swab content shall be analyzed as per validated analytical method.

Formula used for calculation of Spike Recovery :

AW
x 100 = ……………….…
AS

Where AW: Peak area of spiked test solution

AS: Peak area of un-spiked test solution
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Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 10 of 25

8.0 Sampling Plan:

Surface sampling shall be considered as sampling method. Looking to the Design, Size and number of
equipment, Surface sampling shall be the main method for validation.
8.1 Scientific Rational For Selecting Sampling Points:
The Product contact surface area that is most difficult to clean shall be selected as sampling
point.
9.0 Sampling Procedure:
9.1 Visual Inspection:
After cleaning of the equipment visual inspection shall be done. If surface of the equipment is difficult to
inspect, a mirror attached to a stick shall be used.
9.2 Swab Sampling For Microbial Analysis:
For microbiological testing sterile cotton bud shall be used for swabbing. The swab shall be wet in
sterile normal saline solution Swab samples from different areas shown in Table No. 4 (these areas
shall not be same as that used for chemical testing) shall be collected. After swabbing each swab
sample shall be placed inside a properly labeled sterile test tube. Each swab sample then analyzed to
find out bioburden as per the method mentioned in Protocol.
The Sampling points are shown in the following table.
Swab Sampling Area Details For Microbial Testing:
Table No. 4
SR. NAME OF THE SAMPLE NO. OF AREA/SWAB
SWAB LOCATIONS
No EQUIPMENT NO. SWABS IN SQ.CM
1. Scoop Inner side S1 01 25
Inner rim S2 01 25
2. Sifter
Mesh S3 01 25
From Mixing Blade S4 01 25
3. Mass Mixer
From Bottom of Mass Mixer S5 01 25
Retarding chamber glass S6 01 25
4. Fluid Bed Dryer
Bowl S7 01 25
Charging chamber S8 01 25
5. Multi mill
Blade S9 01 25
Left mounting breakers of baffles S10 01 25
6. Octagonal Blender
Right mounting breakers of baffles S11 01 25
Die S12 01 25
Compression Feed frame S13 01 25
7. machine Hopper S14 01 25
Punches S15 01 25
Left Side of baffle S16 01 25
8. Coating Pan
Right Inside of baffle S17 01 25
Top surface including corner S18 01 25
9. Inspection Table
Tablet exit point S19 01 25
Hopper S20 01 25
10. Blister Machine Grooved plates
S21 01 25
[Including Groove]
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CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 11 of 25

9.3 Swab Sampling For Chemical Analysis:

After visual inspection is found satisfactory swab sampling shall be carried out. The swab shall be
wet in Water. Swab samples from different areas of equipment shall be collected. Swab area shall
be measured for swabbing. The list of equipment and swab samples details are as per Table No.5
Swabbing shall be done using 10 parallel horizontal strokes and 10 parallel vertical strokes in the
marked area assuring that the entire area is swabbed. Appropriate hand cover shall be worn during
sampling. After Swabbing, each sample shall be placed inside the stoppered Test tube / conical
flask duly labeled and submitted for analytical testing.
The Sampling points are shown in the following table.

Swab Sampling Details For Chemical Testing:

Table No. 5
SR. NAME OF THE SAMPLE NO. OF AREA/SWAB
SWAB LOCATIONS
No EQUIPMENT NO. SWABS IN SQ.CM
11. Scoop Inner side S1 01 25
Inner rim S2 01 25
12. Sifter
Mesh S3 01 25
From Mixing Blade S4 01 25
13. Mass Mixer
From Bottom of Mass Mixer S5 01 25
Retarding chamber glass S6 01 25
14. Fluid Bed Dryer
Bowl S7 01 25
Charging chamber S8 01 25
15. Multi mill
Blade S9 01 25
Left mounting breakers of baffles S10 01 25
16. Octagonal Blender
Right mounting breakers of baffles S11 01 25
Die S12 01 25
Compression Feed frame S13 01 25
17. machine Hopper S14 01 25
Punches S15 01 25
Left Side of baffle S16 01 25
18. Coating Pan
Right Inside of baffle S17 01 25
Top surface including corner S18 01 25
19. Inspection Table
Tablet exit point S19 01 25
Hopper S20 01 25
20. Blister Machine Grooved plates
S21 01 25
[Including Groove]
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CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 12 of 25

10.0 Acceptance Criteria:

10.1 For Visual Inspection:
Equipment surfaces including “Hard to clean” areas must appear visually clean with no traces of
product any particular matter.
Surface Samples (Swab Samples)
10.2 For Microbial Contamination:
Sampling area should be between 24 cm2 and 30 cm2
Acceptance limits for microbiological testing are on the basis of our In-house Specifications.

TABLE No.: 6

Sr. No. Swab sample Acceptance limit

1. Total Viable Count NMT 25 CFU/ Swab
2. Pathogens ABSENT

10.3 For Chemical Contamination:

2
Mg of permissible active per swab of 25 cm = 0 .0303 mg / swab
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CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 13 of 25

11.0 Detailed Analytical Method:

11.1 For Microbial Contamination Test :
The swab samples shall be collected from two “Hard to Clean” area of each equipment. (The
swab locations are indicated in Table No. 4)
Area selected for Swab test will be 5 X 5 Sq cm and separate from swab area taken for Chemical
contamination test.
Microbial analysis of swab samples shall be carried out for the following microorganism as per
method given.
1. Total bacterial count.
2. Yeast & Moulds.
3. Pathogens.

Surface Monitoring
1. Prepare and sterilize Soyabean Casein Digest Agar (SCDA) as per SOP Cool the medium to
about 45–50° C and shake gently.
2. Aseptically pour approximately 20 ml medium in pre sterilized Petri Plates.
3. Allow it to solidify at room temperature.
4. After solidification of plates, Incubate the plates of SCDA at 30-35°C for 24-48 hours before
use.
5. Observe the growth.
6. If no growth is observed the plate shall used for further purpose.
7. Enter the area as per respective SOPs.
8. Take out the sterile swab from its pack which is already immersed in 9 % sterile saline.
9. Take a SS device of size 25 cm2 , put it on the surface and rub the swab on surface within
the SS device as swab should be cover all surface area .
10. Close the swab in its pack and send to the microbiology lab for further testing.
11. Take the Petri plates of SCDA in LAF and rub the swabs on the SCDA Petri plate in Zig Zag
position.
12. Incubate the plates at 20-25°C for 03 days and 30-35°C for 02 days.
13. Record the growth as CFU/swab or CFU/25cm2.
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CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 14 of 25

11.2 FOR CHEMICAL ANALYSIS

Samples shall be analyzed as per Procedure
QUANTIFICATION BY UV METHOD
INSTRUMENT : UV spectrophotometer
MAKE : Lab India
WAVELENGTH : 275 nm

11.2.1 STANDARD STOCK SOLUTION -

Weigh accurately 50 mg of Aceclofenac (WS) & transfer to 100 ml volumetric flask,
add dilute with Diluent. [methanol]

11.2.2 DILUTE SOLUTION:

Dilute 1.0 ml of Standard stock solution to make up 50 ml with Diluent [Methanol] (i.e.
10 ppm concentration).

11.2.3 BLANK PREPARATION

For Swab- Blank shall be prepared by extracting with 50 ml of Diluent [Methanol]
11.2.4 TEST SAMPLE PREPARATION
For Swab-The swab sample shall be extracted with the help of sonicator in 2X5ml of
Diluent [Methanol]. After each extraction, solution shall be transferred to 10 ml
volumetric flask and make up to the mark with Diluent [Methanol] and filter with What
man 41 filter paper.
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CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 15 of 25

11.2.5 PROCEDURE & CALCULATION

Measure the Absorbance of prepared swab sample preparation at 275 nm against
respective blank solution.

CALCULATION
For Swab-

AW WS 1 1
Aceclofenac Content in mg per
Swab area : AS X 100 X 50 X 10 X CF = Mg /swab

Where :
AW : Absorbance of sample
AS : Absorbance of standard
WS : Weight of working standard
CF : minimum Spike Recovery (Correction factor)
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 16 of 25

12.0 Revalidation Criteria:

Cleaning should only need to be validated once.
Revalidation to be done during
1. Change in cleaning procedure.
2. Change in solvent used for cleaning.
3. Modification in processing equipment
4. New processing procedure
5. New products having least solubility

13.0 Change Control:

Any change must be formally requested, documented and accepted by Change Control Committee.
The likely impact / risk of the change on the product must be assessed and the need for the extent of
re-validation should be determined.

14.0 Review:
The review of the protocol shall be initiated when ever it is experimented that the protocol & its
contents need to be change to update or incorporated latest concept. The further Re-validation shall be
carried out as per the new protocol.

15.0 Results:
Results of three consecutive batches shall be tabulated as per the enclosed format for,
1. Table for spike recovery (For Swab) (FORM A PAGE 16 OF 23)
2. Table for visual inspection (FORM B PAGE 17 OF 23)
3. Table for Microbial contamination test (FORM C PAGE 18 OF 23)
4. Table for swab sample analysis (FORM D PAGE 19 OF 23)
5. Table for summary report and Approval (FORM E PAGE 20 OF 23)

16.0 Conclusion:
Cleaning process shall be considered to be validated provided, visual inspection, Microbial
contamination and chemical contamination complies as per acceptance limits.
17.0 Summary Report And Approval:
Abstract shall be written on completed protocol study and results shall be tabulated in given format
Final remarks on completed study shall be made and approved.
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 17 of 25

FORM – A
18.0 Table For Spike Recovery Study (Swab)
Product = Aceclofenac /Etodolac Tablets
Test Solution: - Weigh about 30.30 mg of Aceclofenac. Dissolve it in Ethanol and dilute to 100 ml in
volumetric flask with Ethanol. Take 10 ml of standard stock solution and dilute to 100 ml in volumetric
flask with Ethanol. Use 0.8, 1.0 and 1.2 ml of solution in triplicate to get 0.0242, 0.0303 and 0.0.0363
mg of per spiked area.
Follow the procedure as given in ‘SPIKE RECOVERY STUDY’

Spike Amount of
Area of test solution
Sr.No Amount Recovered Mean %
SS 316 spiked SD
. (% Recovery) % Recovery RSD
sheet in (in mg.)
sq. cm

1 25 0.0242

2 25 0.0303

3 25 0.0363

Remark: Minimum recovery from different Spiked concentration is ------------------percent. This shall be
used as correction factor in Aceclofenac content determination in swab.

Performed by Checked by
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CLEANING VALIDATION PROTOCOL FOR
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Protocol No. : SM/CVP/ 003/00 Page 18 of 25

FORM – B
18.1 Table for Visual Inspection, Chemical and Microbiological contamination level
by swab:
Batch No.
Sr. Name of the Product
Swab locations Visual
No Equipment content / swab Microbial Contamination level
Inspection
in mg
Free from Total Viable Count Pathogen
visual NMT 0.0303
Limit particular Mg / swab Limit : NMT 25 cfu /swab Absent
matter
1. Scoop Inner surface
Inner rim
2. Sifter
Mesh
From Mixing Blade
3. Mass Mixer From Bottom of
Mass Mixer
Retarding
Fluid Bed
4. chamber glass
Dryer
Bowel
Charging chamber
5. Multi mill
Blade
Left mounting
Octagonal breakers of baffles
6.
Blender Right mounting
breakers of baffles
Die
7. Compression Feed frame
machine Hopper
Punches
Left side of baffle
9. Coating Pan
Right side of baffle
Top surface
Inspection
10. including corner
Table
Tablet exit point
Hopper
Blister
11. Grooved plates
Machine
[Including Groove]

Conclusion:

Performed by Checked by
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 19 of 25
 SAITECH MEDICARE PVT LTD
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CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 20 of 25

FORM – B I
18.2 Table for Visual Inspection, Chemical and Microbiological contamination level by
swab:

Batch No.
Sr. Name of the Product
Swab locations Visual
No Equipment content / swab Microbial Contamination level
Inspection
in mg
Free from Count Viable Count Pathogen
visual NMT 0.0303
Limit particular Mg / swab Limit : NMT 25 cfu /swab Absent
matter
1. Scoop Inner surface
Inner rim
2. Sifter
Mesh
From Mixing Blade
3. Mass Mixer From Bottom of
Mass Mixer
Retarding
Fluid Bed
4. chamber glass
Dryer
Bowel
Charging chamber
5. Multi mill
Blade
Left mounting
Octagonal breakers of baffles
6.
Blender Right mounting
breakers of baffles
Die
7. Compression Feed frame
machine Hopper
Punches
Left side of baffle
9. Coating Pan
Right side of baffle
Top surface
Inspection
10. including corner
Table
Tablet exit point
Hopper
Blister
11. Grooved plates
Machine
[Including Groove]

Conclusion:

Performed by Checked by
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 21 of 25

FORM – B II
18.3 Table for Visual Inspection, Chemical and Microbiological contamination level by
swab :

Batch No.
Sr. Name of the Product
Swab locations Visual
No Equipment content / swab Microbial Contamination level
Inspection
in mg
Free from Total Viable Count Pathogen
visual NMT 0 .0303
Limit particular Mg / swab Limit : NMT 25 cfu /swab Absent
matter
1. Scoop Inner surface
Inner rim
2. Sifter
Mesh
From Mixing Blade
3. Mass Mixer From Bottom of
Mass Mixer
Retarding
Fluid Bed
4. chamber glass
Dryer
Bowel
Charging chamber
5. Multi mill
Blade
Left mounting
Octagonal breakers of baffles
6.
Blender Right mounting
breakers of baffles
Die
7. Compression Feed frame
machine Hopper
Punches
Left side of baffle
9. Coating Pan
Right side of baffle
Top surface
Inspection
10. including corner
Table
Tablet exit point
Hopper
Blister
11. Grooved plates
Machine
[Including Groove]
Conclusion:

Performed by Checked by
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 22 of 25
 SAITECH MEDICARE PVT LTD
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CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 23 of 25

FORM - C
19.0 Table For Summary Report And Approval :
(Table for summary of results for Visual, Microbial and Chemical contamination test)
Following table summaries the results of Visual, Microbial and Chemical test for equipment cleaning
validation.
A. Table For Summary Of Visual Inspection Of Three Batches

Visual Inspection
S. No. Equipment used in manufacturing Batch No.

1. Scoop

2. Sifter

3. Mass Mixer

4. Fluid Bed Dryer

5. Multi mill

6. Octagonal Blender

7. Compression machine

8. Coating Pan

9. Inspection Table

10. Blister Machine

Limit:- Equipment surface including ‘Hard to clean’ areas must appear visually clean with no traces of
product or other particular matter.

Performed by Checked by
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 24 of 25

B. Table For Summary Of Microbial & Chemical Contamination Test.

Maximum value amongst three batches

Sr. Equipment Chemical

Location of swab area Microbial Contamination Test
No. No. Analysis in Swab
Pathogens Product content
Total Viable counts
(mg/Swab)
1 Scoop Inner Surface
Inner rim
2. Sifter
Mesh
From Mixing Blade
3. Mass Mixer
From Bottom of Mass Mixer
Fluid Bed Retarding chamber glass
4.
Dryer Bowel
Charging chamber
5. Multi mill
Blade
Octagonal Left mounting breakers of
6. baffles
Blender Right mounting breakers of
baffles
Die
Compression Feed frame
7.
machine Hopper
Punches
Left side of baffle
9. Coating Pan
Right side of baffle
Inspection Top surface including corner
10.
Table Tablet exit point
Hopper
Blister strip
11. Grooved plates
Machine
[Including Groove]
0.0303
ACCEPTANCE LIMITS NMT 25 cfu/swab Absent
mg. / Swab

CONCLUSION: The cleaning process of the equipment after the manufacturing of Aceclofenac
/Etodolac Tablet is Validated / Not Validated. The results reported in table ‘B’ are found to be
Satisfactory.

Performed by Checked by
 SAITECH MEDICARE PVT LTD
Trilokpur Road Kala Amb (HP)
CLEANING VALIDATION PROTOCOL FOR
ACECLOFENAC / ETODOLAC TABLETS
Protocol No. : SM/CVP/ 003/00 Page 25 of 25

20.0 ABSTRACT

Compiled By Approved By Approved By Approved By

Asst. QA Manager QC Manager Plant Head QA Manager

Date : Date : Date : Date :