Page 1 of 20

ANNEXURE IX

CLEANING VALIDATION PROTOCOL

(1) Purpose:
To provide a guideline to establish cleaning validation protocol with the co-ordination of Production
department and Quality Assurance department.

(2) Definition:
Cleaning validation comprises all the activities involving the planning, execution and documentation
required to demonstrate the reliability of the cleaning procedure.

(3) Objective/Scope:
Cleaning validation procedure is an important GMP requirement to provide evidence that equipments
are consistently cleaned from product traces, detergent and microbiology based on scientific
principles.

VALIDATION PROGRAM:
To set the validation program following criteria shall be considered.
Process development stages are generally based on an assessment of the ability of a cleaning agent
and a procedure to attain equipment that has been cleaned to as acceptable level.

Product Factors.
 New active drug.
 Cleaning Characteristics.
 Solubility.
 Character of substance (Potent, toxic, carcinogenic etc).

Product Family
 Equipment Factors
 Existing Equipment
 New Equipment
 Dedicated Equipment.

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ANNEXURE IX

GENERAL PROCEDURE:

Visual
Inspection

Detergents Cleaning Microbiolo Step No. 1

Eqipment gical Operating
Contaminat
ion Program.

Sampling
Rinse Sampling Rinse Sampling

Step No. 2
Analytical Executive
Testing
Program.

Result

Report Step No. 3

Compilers

A. Preliminary Conditions:
 Validation studies should be conducted according to an validation protocol,
 The equipment must be cleaned in accordance with an approved cleaning procedure.
 The over all cleanliness of the equipment must be verified by visual inspection prior to sampling.

B. Sampling and Sampling method:

Trained persons should perform sampling. Only that part of equipment, which comes into contact with
the product, should be considered. Following methods are used for sampling.
Swab Sampling:
 This method combines a through contact between swab and sampling surface with the
advantage of a defined sampling areas. It is possible to use potent solvents for recovery of
residues.
 The samples may be taken from a part of an object with or without template or from the entire
surface of an object
 The solvent used for wetting the swab must be of analytical quality with an optimum stability
and solubility for the active substance.
 To obtain reproducible analytical result the swab must be moistened with a specified quantity
of solvent.

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ANNEXURE IX

 The swab should be specified size and made a suitable material that will not interfere with the
analytical methodology.

Rinse sampling:
 Ultrasonic extraction with solvent or solution is the recommended method for complex or
inaccessible equipment parts when ever applicable. Several objects may be sampled together.
 Sampling the final cleaning rinse should only be used for inaccessible areas.

C. Analytical Testing:
 The analytical method used must be validated and shown to be specific for the analytical
substances.
 The sensitivity of the analytical method must be sufficient to ascertain quantities of residues
within the acceptance criteria.

D. Acceptance Criteria:
 The cleaning procedure should be considered effective if
 The measured or calculated concentration is less than 1/ 10,000 of the toxicological
insignificant exposure level (TIEL) or lowest therapeutically daily dose per piece of
equipment.
 The calculated cross-contaminated is not more than 1/ 1000 of the lowest therapeutic dose for
the equipment chain including packaging.
 The calculated cross-contamination is not more than 10ppm if any product must appear in the
product to follow.
 If the action limited is exceed (contamination > 1/ 10000) the cleaning result is not acceptable.
 A cleaning procedure is successfully validated if the action limit is not acceded three times
with the same product, on the same type of equipment and with the same cleaning procedure.

E. Calculation of highest acceptable residue:

R = D X S X 106
I X 10, 000
R = mg of the total residue of active to be cleaned permitted.
D = Lowest therapeutic dose of product to be cleaned in mg.
S = Lowest batch size of product to follow in Kg.
I = Maximum daily intake of product to follow in mg.

F. Validation Report:
General Information.
 Product Information
 Equipment Identification
 Sampling date.
 Cleaning SOP and analytical method
 Number of validation run.
 Status of equipment at time of sampling.

Sampling Information:
 Sampling point

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ANNEXURE IX

 Technique of sampling
 Solvent used for sampling
 Sampling Protocol

Cleaning Protocol:
 Analytical result.
 Data evaluation
 Conclusion
 Signatures

G. Revalidation:
 Revalidation will be required after every relevant change such as
 Cleaning procedure
 Cleaning agent
 Equipment design
 In case of no change, frequency of revalidation should be 3-years.

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ANNEXURE IX

PROCEDURE FOR CLEANING OF MACHINERY/EQUIPMENTS USED IN

THE MANUFACTURING PROCES

CLEANING AND ASSEMBLING OF COMPRESSION MACHINE

Procedure:
As soon as the compression of a particular batch is over, clean the entire exterior of the machine as
well as the room. Following the procedure will be adhered to:

1. Disconnect the electric supply.

2. Dismantle care fully the following parts.
- Feed hoppers.
- Acrylic guards.
- Feed frames.
- Turret guards
- Cover plate of the worn shaft.
- Nylon break plugs along with the spring steel strips.
- Die screws
- Tablets collecting chutes
- Dust collecting hold assemblies (4 No)

Clean all the above mentioned parts along with the repellent bolts thoroughly with hot tap water &
keep them a side.

a) Remove cares fully all the lower punches by removing the plug & keep these punches in a
specially designed wooden tray, serially arranged. Similarly remove all the punches & keep them
in a separate wooden tray serially arranged. Remove all the dies with the help of a SS rod & keep
them serially arranged in one of the above trays.
b) Clean all the interior area s of the machine like base of plate on which the turret is fitted , cam
tracks ,die seats, upper & lower punches holes, turret surface, first with the dry nylon brush &
than with special denatured sprit . Care should be taken while cleaning the punch hole & die seats
so that they are free from any particulate matter.
c) Wipe clean the exterior of the machine with a lint free denatured sprit.
d) Get the entire area clean by the janitor.
e) Cleaning & fitting of dies & punch.
f) Use 15 liters of distilled water to give couple of washes to the cleaned parts & the dismantled
punches dies. Inspect the final rinse water for absence of any suspected matter. If required,
additional distilled water to get the “clear” rinse water.
g) Wipe all the clean parts from steps f” with the clean dry lint free cloth.

Fitting of dies:
Before the dies are fitted, ensure all the die seats are free from any foreign matter; place the die face
downwards on the die hole. Apply light pressure with finger on the top phase of the die to locate
centrally over the die hole. After the locating the die correctly, drive the die in to its position with the
help of SS rod introduce through the upper punch guide holes. Once the die is fitted, the top position
of the die should flush with the turret surface. Now introduce all die screws & tighten again. Check
whether the die surfaces flush with the turret surface.

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ANNEXURE IX

Fitting of lower punches:

Take a low punches it dry, smear with liquid paraffin & introduce it through the lower punch die
hole taking care that each numbered punch goes in to its compression station. All the lower punches
thus introduce should move freely up & down. Put the plug back its position. Fix all the cleaned and
dried nylon plunges with spring steel strips.

Fitting of upper punches:

The cleaned & dried upper punches should be smeared with liquid paraffin & introduced in to their
corresponding holes.
1. Put back all the turret guards after wiping them dry. fit the clean & dried feed at their respective
position, install all the cleaned & dried acrylic guards & hoppers in their repellent position.
2. Assemble the cleaned dust collecting hood assemblies.
3. Cover the cleaned machine with the clean cloth cover.

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 Page 7 of 20
ANNEXURE IX

CLEANING OF DOUBLE CONE MIXER

Caution
1. Disconnect the equipment form electrical main supply.
2. Set the position of the blender vertical-butterfly valve facing the floor

A. Procedure for product of product changeover.

1. Dismantling:
a) Remove the safety guard of the blender
b) Remove the circular lid and gasket by unclamping wing nuts.
2. Cleaning external surfaces- Clean the body of the blender with dry duster first and then with
moist duster and again wipe a clean dry duster.
3. Position of the blender
a) Set the position of the blender vertically so that the butterfly valve outlet is facing the floor.
b) Keep the butterfly valve close and keep an SS container below it.

4 Cleaning of blender:
a) Initially wash the inside surface of the blender with tap water.
b) Drain out the water through butterfly valve.
c) Clean inside surface of the blender with warm water (40 to 50 º C). Clean inside surface of
the blender with 0.1% Teepol solution.
d) Wash inside of the blender with sufficient warm water to remove the traces Teepol.
e) Finally rinse with 5 micron filtered water.

5. Cleaning of gasket, rectangular lid and butterfly valve lid- Clean the parts with 0.1% Teepol
solution. Wash thoroughly with warm water (40 – 50 º C) followed by 5 micron filtered water.
6. Confirming effectiveness of cleaning- The final 5 micron filtered water rinse of blender is to be
sent to Quality Control department, to confirm the absence of previous product.
7. Drying- Wipe dry, the different parts of blender using a clean lint free duster.
8. Assembling- Fix the cleaned gasket circular lid and butterfly valve and lid to the blender.

Note:

1. Fix the ‘cleaned’ label after checking cleanliness of blender duly signed by Production Officer.
2. Step 6 is a validatory exercise to be conducted once in six months at the time of product
changeover.
3. If the cleaned blender is not used within 24 hours after cleaning or if there are any signs of dust
or powder settled on the outside surface then, before opening the lid, the exterior of the blender
should be wiped with wet duster followed by clean lint free duster.

B. Procedure for batch to batch changover

1. Dry clean to blender and lids with clean lint free duster.
2. Dedust external surfaces with clean lint free duster.

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 Page 8 of 20
ANNEXURE IX

CLEANING OF FLUIDIZED BED DRIER

Drying is required to remove moisture from wet granulation. Fluid bed drying offers saving of time and
labour thus increasing efficiency. It is better described as air diffusion drying system. It is essential that
the production supervisor confirm that the equipment is in clean condition before the same is used for
any of the operations, in order to avoid cross contamination.
Following cleaning and assembly process will be followed when ever there is a product change over or
after completion of 10 batches of the product even if the same product granulation is to be continued
thereafter.

A. Procedure for the product to product changeover

1. Cleaning external surface and plenum – clean the body of the drier and plenum with a dry duster.
Then wipe it with a duster soaked in .01% Teepol solution followed by duster soaked in 5 micron
filtered water.
2. Dismantling;
a) Detach finger bag from hook by opening perplex window in the retarding chamber.
b) Unclamp the fixing bolts of retarding chamber and allow it to rest on the trolley. Take out
trolley along with the finger bag and retarding chamber.
c) Remove finger bag.
d) Remove bowl.

3. Cleaning of finger bag – Dedust individual finger chamber of finger bag. Keep it in polythene
bag and send it for laundering to linen Dept.
4. Cleaning of retarding chamber, trolley and bowl – Take retarding along chamber with the trolley
and bowl washing area. Wash retarding chamber, trolley and bowl with hot water scrubbing with
clean nylon scurber.Then wash them with .01% Teepol solution, rinsing thoroughly with hot
water followed by 5 micron filtered water. Incase of sticky powder use steam.
5. Confirming effectiveness of cleaning – The DM water rimes of retarding chamber and bowl is
sent to QC department to confirm the absence of previous product.
6. DRYING – wipe out the body of FBD retarding chamber, trolley and bowl by using a clean dry
lint free duster. Further dry running FBD at 70 C (with out material) for 15 minutes.
7. Assembling – Fix the laundered finger bag in metallic hanger around the retarding chamber.
Clamp the retarding chamber on the body with the fixing bolts. Lift the bottom of FBD, and seal
the trolley with bowl to the retarding chamber.

Note:
1. Fix the cleaned label.
2. Step no 5 is a validatory exercise to be conducted once in a 6 months at the time of product
change over.
3. If the clean FBD is not used with in 24 hours after cleaning or there are signs of dust or powder
settled on FBD, then de-dust the bowl, retarding chamber and body by using a freshly laundered
lint free duster.

B. Procedure for batch to batch change over:

1. Clean the body of the drier and plenum with a dry clean duster.
2. Clean the interior surface of the retarding chamber bowl, trolley.
3. Wipe the interior retarding chamber and bowl with a clean duster.
4. Dedust the fingers of the finger bag.

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 Page 9 of 20
ANNEXURE IX

CLEANING OF DUST EXHAUST

Objectives:
It is essential that the processing of each and every batch of any product is designed in a such a way that
there are no chances of contamination .Dust extraction “ hood assemblies “ being the potential
contribution towards the problem of cross contimation,need regular cleaning as per the specified
procedure to exclude the chances of cross contimatimanation

Cleaning procedure:
Immediately, after the processing of each batch is over, dismantle the suction hood assembly. With the
help of a vacuum cleaner suck the entire dust on the exterior of the assembly and also from the exposed
parts of ducting.
Remove the lid from the cleaning pocket. Destroy the contents of the cleaning pocket suitably. Clean the
interior of the duct at least till the elbow with the help of vacuum cleaner. Clean the dismantled suction
hood assembly, lid and cleaning pocket and interior of the duct till the elbow with the help of non-fiber-
shedding wet cloth. Wipe it dry and assemble it back to the dust extraction system, Maintain record of
cleaning as per the following format:

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ANNEXURE IX

CLEANING OF CONVENTIONAL COATING PAN

I. PAN:
1. As soon as the clothing operating is over, remove the coated tablets in suitable containers.
Remove the dry powder from the pan, if any.
2. Pour approximately 20 liters of hot water (80 – 85 C) in to the pan and allow the pan to rotate for
about 10 minutes. Remove the turbid water using a plastic mug and transfer in to the plastic
bucket. Clean the inner surface of the pan with angular wooden brush having nylon teeth.
3. place of 00 g of Sodium Hydroxide pellets into the pan and gradually put about 20Litteers of hot
water (80 – 85 C ) in to pan , taking care that the eyes are well protected by goggles full size
PVC gloves are worn to cover arms. Allow the pan to rotate 10minutes .Remove this alkaline
turbid water.
4. Place about 10liters of lukewarm water (40 – 45 C) in to the pan. Allow the pan to rotate and
continue to clean the inner surface of the pan with the angular wooden brush with the nylon
blisters. Remove the water and check that the inner surface of the pan is free from any powder of
foreign particles.
5. Place approximately 10 litters of lukewarm water (40-45 C) in to the pan and allow the pan to
rotate for 5 minutes. Remove this water. This rinse water should be free alkali. Repeat rinsing
with 10 litters of lukewarm water till the rinse is free from alkali as indicated by a pH paper.
6. Allow the pan to rotate and wipe the inner surface of the pan with the lint free clean cloth. Look
for any starch pits on the inner surface of the pan.
7. Cover the mouth of the pan with the nylon lid; affix the cleaning ticket indicating the following.
- Equipment /Machine.
- Last product
- Cleaned and ready for product.
- Cleaned By
- Date
- Signature

II. BOWLER ASSEMBLY

A. Procedure for batch to batch changeover:
1. Dismantilng- Remove the blower pipe from the body.
2. Cleaning the blower pipe – clean the blower pipe from inside and out side using compressed air.
3. Cleaning the blower body.

B. Procedure for product to product change over.

1. Dismantilng- Remove the blower pipe from the body.
2. Clean the blower body – clean the body surface, motar and fan using compressed air form
outside as well as in side.Dedust the external surface with the duster. Wipe it with the duster and
dry it with the duster.
3. Cleaning of blower pipe –first clean it from out side and inside with the jet of potable water using
a soft nylon brush. Then clean with .01 % Teepol solution and again with a jet of potable water.
Finally rinse the DM water.
4. Drying the blower pipe:
a) Fix the clean pipe on the cleaned blower body.
b) Start the hot air blower.
c) Adjust the temperature of the air to 100 C.
d) Continue air flow till pipe gets totally dried.
e) Switch off the heater of air blower and allow to cool room temperature.

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 Page 11 of 20
ANNEXURE IX

CLEANING OF POLISHING PAN

Objective:
In order to have consistent satisfactory polishing of coated tablets, it is essential that the polishing pan is
cleaned periodically per the specified procedure. Repeated use of polishing pan is likely to render the
contact surface slightly rough. Hence the periodic cleaning facilities consistent good quality polishing.

Precaution – Wear rubber gloves, goggles and protective clothing during this procedure.

Procedure:
As soon as the polishing operation for a particular batch of coated tablets is over, remove the polished
tablets in suitable poly-lined illumination containers. Label these containers appropriately and store these
containers in the WIP area. Ensure that the other equipments in polishing room such as tray drier,
multimill, trolley etc is suitably covered. Carry out the cleaning operation as follows:

1. Remove all the identifications of previous batch.

2. Vacuum clean the inside the pan to remove loose particles.
3. Remove excess wax by scrapping with the knife and then clean with a nylon brush.
4. Remove the canvas cloth and send for washing.
5. Install the fresh set of canvas cloth.
6. Apply a fresh coat of wax (white Bees Wax dissolved in chloroform).
7. Cover the equipments with a fresh cloth cover till the commitment of next operation.
8. Affix a cleaning label indicating the following details:
- Equipment /Machine
- Last product.
- Cleane4d and ready for product.
- Cleaned By
- Date.
- Supervisor’s Signature.

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ANNEXURE IX

CLEANING OF GRANULATOR

Caution – Disconnect the equipment from electric main supply/put off the mains.

A. Procedure for product to product changeover

1. Cleaning external surface – clean the body of the mixer assembly surface with moist duster
(dipped in potable water) and dry with a clean dry duster.
2. Cleaning of lid, and plat form – clean with a moist duster and dry with a clean duster.
3. Cleaning of bowl – discharge port dome, agitator blades and chopper assembly.

a)Put an SS drum under the collect washing.

b)Put about 100 liters potable water in the bowl assembly and add 50ml Teepol solution to it.
c)Clean the lid of mixer and run the mixer at fast speed of agitator and chopper for 5 minutes.
d)Drain out the washing through the outlet port.
e)Put main switch off.
f)Open the lid and remove dome and agitator blades by loosening the locking nuts with the
Allen key provided (6 No).
g) Dismantle the chopper blade by loosening the bolt. Turn the spanner in clockwise direction
(threads are reversed). Then remove the blade and washer with key bar.
h) Take the blades and chopper assembly to the washing area and clean it with steam, .01%
Teepol solution and potable water.
i) Rinse the blades, chopper assembly and dome with a potable water and dry with clean dry
duster.
j) Scrub the bowl with scrubber to remove the powder, sticking to the sides and bottom of
mixer.
k) Wash the bowl with jet of water till it is free from Teepol and traces of previous material.
l) Rinse thee bowl with water and dry it.
4. Confirming effectiveness of cleaning
a) Critically check the bottom of blades, crevices of the chopper , dome , locking nuts, lid
cleaning and discharge port for absence of previous material.
b) Give Distilled water rinse to the mixer and sample to the QC to confirm the absence of
previous product.
5. Assembling:
a) Reassemble the blades, dome and chopper assembly exactly in the reverse order of
dismantling.

Caution:
1. Match “no 8 “mark engraved on agitator with no 8 mark on agitator blades.
2. Threading no chopper lock nut is reversed (Rotate anti-clockwise to tighten)
3. Fix the clean lid on the top of the mixer; fix it with the tightening clamps.
4. Put status label with the officer’s signature, date and previous product.

Note:
1. Fix the cleaned label duly filled with date, sign, of officer in charge and previous product.
2. Step no 5 is validatory exercise to be conducted once in six months only and at the time of
product to product changeover.

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ANNEXURE IX

3. If a cleaned mixer is not used within 24 hrs after cleaning or if there are signs of dust or powder
settled on the surface, then before opening the lid , the exterior mixer should be wiped clean with
wet duster, followed by clean dry duster before opening it for further use.

B. Procedure for batch to batch changeover:

1. Dry clean the mixer and lid with clean lint free duster.
2. Dedust external surface with clean lint free duster.
3. Ensure external cleanliness of platform and then proceed for batch production.

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 Page 14 of 20
ANNEXURE IX

CLEANING OF SIFTER

The sifter is used to sift the various excepients such as Talcum, Magnesium Stearate, and Satiric Acid
etc. It is also used to sift active materials. Proper cleaning of the sifter at the end of sifting process
ensures prevention of cross contamination.

Procedure:
As soon as the sifting process is over , dismantle the following parts:
a) SS feed hopper.
b) SS frame, holding the sieve in a place.
c) SS wire mesh sieve.

1. Remove all the residual powder adhering to the above mentioned articles with the help of a nylon
brush.
2. Wash these articles with the help of ruining hot water.
3. Wash these articles sponge using .01% Teepol.
4. Clean the article with running hot water for at least 10 minutes to remove all the traces of
detergent.
5. Drain off all the water and dry all the articles with the help of hot water blower.
6. Clean the exterior of the sifter stand and motor assembly with the help of lint free wet cloth.
7. Carry out step 1 to 5 for the SS base plate with discharge out let attached to the sifter stand.
8. Assemble all the cleaned /dried articles from step 5 on the sifter stand frame.
9. Affix a cleaning label incorporating the following information:

a) Name of the equipment.

b) Name of the last product sifted.
c) Name of the operator who cleaned the equipments.
d) Date of cleaning.
e) Supervised By.
f) Caution: please clean before use.

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ANNEXURE IX

CLEANING OF SPRAY GUN

Caution – Use clean lint free dusters during entire cleaning operation.

1. Dismantling – Remove the gun from stand. Dismantle parts of the gun ( air- cap/ needle/nozzle).
2. Cleaning of gun:

a) Dip the gun in SS bowl contains potable water, for about ½ hr.
b) Scrub external surface of gun air cap and needle with .01% Teepol solution.
c) Clean the out and inside surface with jet of water orifice, by pressing trigger.
d) Pass the steam through orifice by pressing trigger, clean the out surface with steam.
e) Finally clean with DM water.

3. Drying of the gun body – Wipe the dismantled part and body of the gun with lint free duster.
4. Storage. Store the gun and its part in an appropriate clean poly bag until use.

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 Page 16 of 20
ANNEXURE IX

CLEANING OF TRAY DRIER

Procedure:
A. Product to product change over

1. Dismantling – Remove the tray form the chamber.

2. Cleaning of trays – Take the tray to the washing area. Wash them first with tap water and then
with .01% Teepol solution followed by tap water. Finally rings rings with UV filtered purified
water. In case of sickly material clean the tray with steam.
3. Cleaning of external surface – clean the out sides of the drier using moist and wipe with clean dry
lint free duster.
4. Cleaning of chamber – clean the chamber vacuum cleaner/ followed by moist duster.
5. Cleaning of outlet flaps of exhaust – clean the outlet flaps with moist duster.
6. Confirming effectiveness of cleaning.
a) Trays are checked visually for no deposition of any material.
b) Trays are cheeked by swabbing with clean dry lint free dusters for deposition for any
material.
7. Drying – Dry all the trays with a clean dry lint free duster.

Note:
1. Fix the “cleaned” label and cover the machine with a suitable cloth cover.
2. Step no 6 is a validatory exercise to be conducted once in a 6 months or at the time of product
changeover.
3. Dry clean the tray with a clean lint free duster, if it is not used in 24 hrs.

B. Batch to batch changeover in the same day/procedure to be followed at the end of shift:

1. Follow procedure of step no 1, 2, 3.

2. Clean the inside of the dryer body using nylon brushes and clean with a lint free duster.

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 Page 17 of 20
ANNEXURE IX

HVAC SYSTEM (TABLET SECTION)

GENERAL SECTION ANTIBIOTIC SECTION

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 Page 18 of 20
ANNEXURE IX

SUPPLY RETURN

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 Page 19 of 20
ANNEXURE IX

SPECIFICATION (TABLET SECTION)

The HVAC system for Tablet sections (General and Anti-biotic) is designed at the following parameters:
Temperature 250C±20C
Humidity <50%
Air changes 20~25per hour
Fresh air 10~15%
Cooling capacity: 36000 BTU
Level of cleanness ISO class8/feb.Std.209E Class 100.000

Air pressure zone:

The corridor of areas is maintained at a positive pressure of 0.06 inches of water gauge. Processing areas are
maintained at relative positive pressure and segregated by air lock with corridor.

Air Filtration:
The filtration system is aimed to remove all solid impurities ranging from visible grit down to fine dust. The
filtration system is design to meet the following requirement:
1- To remove impurities which are harmful to the process and to maintain the required class.
2- For the comfort of occupant and the cleanliness of process.
3- To keep the ductwork clean.

The sequence of filtration of HVAC system shall be as follow

a) aluminum washable filter in air return grill
b) pre filter 65% eff at fresh air inlet of AHU
c) Beg filter 90% eff.at inlet of AHU.
d) Panel filter 95% eff .in supply air terminal filter box

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 Page 20 of 20
ANNEXURE IX

PROOF OF HVAC SYSTEM

Quality Control Manager: ------------------------------ Production Manager: -------------------------------