CLEANING VALIDATION

Presented by: Guided by:

Mr. Akshay. S. Dhole Dr. S. R. Desai
M.Pharm- I Year (Associate Professor)

Department of Quality Assurance

Vasantidevi Patil Institute of Pharmacy, Kodoli
Content
Cleaning Validation
Sources of Contamination
Cleaning validation procedure
Cleaning of Equipment
Validation Report
Analytical Methods

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Cleaning Validation
Cleaning validation is a documented evidence with a
high degree assurance that one can consistently clean
a system or a piece of equipment to predetermined
and acceptable limits.
OR
Documented evidence that provides a high degree of
assurance that a cleaning procedure will consistently
remove chemical and microbiological residues to
predetermined levels of acceptability.

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The primary regulatory concern driving the need for
cleaning validation is cross contamination of the
desired drug substance either by other API from
previous batch runs or by residues from the cleaning
agents used.
The prime purpose of validating a cleaning process is
to ensure compliance with federal and other standard
regulations

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Sources of contamination
Cross contamination
One of the real dangers in cross contamination of
active ingredients is that by being contaminated
results in a multiple ingredient product instead of
single active ingredient.
Depending on medical effects, the contamination may
enhance the action or negate the action or contaminant
may have an entirely different medical effects.

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Microbiological contamination
 This form of contamination is particularly insidious
because the contamination may develop at any time
even after cleaning.
 A major contributing factor is the storage of
equipment in a wet condition.
 This provides a natural medium in which bacteria
can grow.
Contamination by cleaning or sanitizing agents
 Some pharmaceutical operations may find it
necessary to use fairly toxic materials for cleaning
purpose for stubborn residues.
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This is particularly true in the manufacture of active
pharmaceutical ingredients (APIs).
As such, these materials represent a potential threat as
contaminants.
It seems obvious that one effective way of dealing
with this potential problem is to use cleaning agents
with the lowest toxicity that will still be effective in
removing the residue in the given cleaning situation.
The same factors also apply to sanitizing agents used
to wipe down cleaned equipment.

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 Cleaning validation process
Step 1:-
 Appropriate cleaning method.
 Develop and validate the sampling and chosen
analytical method.
 Evaluate equipment surface and determine.
Step 2:-
 Develop protocol for the product and equipment
being cleaned.
Step 3:-
 Generate report on a clean by clean basis.
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Step 4:- cleaning validation report in detail.
Cleaning of Equipments
All the equipments and area used during the
manufacturing shall be cleaned and sanitized at
appropriate levels.
Type A cleaning equipment:-
The equipment shall be dismantled first and the
dismantled parts shall be transferred to the washing
area.

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 In the washing area all the dismantled parts of the
equipment shall be cleaned with the cleansing agent
as mentioned under the respective equipment SOP for
the cleaning procedure.
 The parts that cannot be dismantled shall be cleaned
in their respective place as per their specifications.
Type B cleaning equipment:-
 The equipment shall be cleaned without dismantling
the equipment with vacuum cleaner.
The equipment shall be cleaned and mopped with
clean moist linen cloth and later with a dry cloth.

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Validation Report
A validation report is necessary to present the results
and conclusions and secure approval of the study.
The report should include the following:-
 Summary of procedures used to clean, sample and
test.
Physical and analytical test results or references.
Conclusions regarding the acceptability of the results.
Revalidation practices if applicable.
Review any deviations for the protocol that occurred.

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Analytical methods

ICH
USP Specificity
Specificity Linearity
Linearity Range
Range  Accuracy
 Accuracy Precision
Precision Limit of
Limit of
Detection
Detection Limit of
Limit of
Qualification
Qualification Reproducibility
Robustness Repeatability

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THANK YOU