This document discusses cleaning validation in the pharmaceutical industry. It begins by defining cleaning validation and outlining regulatory requirements for cleaning. Key factors in developing a cleaning validation protocol are then summarized, including the product being cleaned, equipment, facilities, cleaning methods, cleaning agents, and sampling and testing. The document stresses that cleaning validation ensures removal of residues and contaminants to meet purity standards for safety. It provides an overview of considerations for each validation factor to help establish effective cleaning procedures.

1. CLEANING VALIDATION
PRESENTED BY
MR.VILAS KAMBLE
M.PHARM.(II-SEM)
GUIDED BY
MRS. USHA SHINDE
PAD.DR.D.Y.PATIL COLLEGE OF PHARMACY AKURDI,PUNE.

2. CONTENT
Cleaning
validation
Introduction
Importance of
cleaning and
it’s validation
Factor in
cleaning
validation
Product
Equipment
Facilities
Cleaning
method
Cleaning
agent
Sampling
Testing
Reference

3. INTRODUCTION
 Cleaning and decontamination is
one of the major and critical activity in
pharmaceutical operations. The four
basic requirement of cGMP are_
 Identity
 Safety,
 Strength
 Purity.

4. INTRODUCTION
Cleaning validation involve following
same basic issue like
 Equipment and area
 Product
 Material of construction of the
equipment.
 Cleaning agent and its concentration.
 Degree of cleaning expected.

5. INTRODUCTION
Definition
“A process of attaining and
documenting sufficient evidence to give
reasonable assurance, given the current
state of science and technology that the
cleaning process under consideration
dose, what is purports to do”

6. INTRODUCTION
Requirement of cGMP in cleaning
21 CFR 211.67 (a)
“Equipment and utensils shall be
cleaned, maintained, and sanitized at
appropriate intervals to prevent
malfunctions or contamination that
would alter the safety, identity, strength,
quality, or purity of the drug product
beyond the official or other established
requirements”.

7. IMPORTANCE OF CLEANING AND ITS
VLIDATION
 Heart of pharmaceutical activity
 Related to safety and purity of the
products
 Level of cleanliness is achieved by
clean procedure which depends on its
validation
 Cleaning method if performed
confidently, method produced
reproducible result

8. FACTOR IN CLEANING VALIDATION

9. PRODUCT
Prime objective of cleaning validation is to
assure complete or near to complete removal
of the various materials processed earlier in the
equipment or area. This include following
categories of materials
e.g.
 Residue of previous processed material
 Cleaning agent used
 Any other material e.g. trace of oil, water, etc
 Fibers from any cleaning accessories used like
cloths, sponge, brush, etc.

10. EQUIPMENT
The cleaning method should consider
the following points related to
equipment
MATERIAL OF
CONSTRUCTION
• Compatibility of material with cleaning
agent.
COMLEXITY OF
EQUIPMENT
• Complex equipment are clean by
suitable devices.
• Also method must evolved to achieve
the cleanliness of such area.

11. EQUIPMENT
Pharmaceutical equipment can be
consider from various angles for
cleaning purpose.
PARTS OF
EQUIPMENT
• Which come in contact
with processing material.
• Do not come in contact
with processing material.
MECHANICAL SIDE
OF EQUIPMENT
• Motor
• Gear box
• Chain drives etc.
ELECTRICAL
PANALS OF
EQUIPMENT

12. EQUIPMENT
 The cleaning procedure must clearly
define the procedure for each of the
above aspects of the equipment.
Movable or fixed
Feasibility of
drying of the part
of equipment.
Feasibility of
protecting the
clean equipment

13. EQUIPMENT
The above mentioned factors and
similar other factors if any, should be
considered while designing the
cleaning method for an equipment.

14. FACILITIES
Buildings and Surroundings.
Buildings:-It incorporate following
areas, each of these area may require
different cleaning level, and hence the
cleaning method will also vary from
area to area.
CORRIDORS OFFICES

15. FACILITIES
 STORE AND WARE HOUSE
STORE AND
WARE HOUSE
COLD ROOM A.C.STORE
PACKAGING
MATERIAL
ENGINEERING
STORES

16. FACILITIES
OTHER AREA
CHANGE
ROOM
NONSTERILE
OPERATION
STERILE
OPERATION
PROCESSING
AREA
NON STERILE
OPERATION
STERILE
OPERATION
PACKAGING
AREA
PRIMARY
PACKAGING
SECONDARY
PACKAGING
UTILITIES
AREA
E.G WORK
SHOP,BOILER
HOUSE,WATER
STATION ETC.

17. FACILITIES
 Surrounding:-
It incorporates following area
ROAD IN THE
POT
LAWNS AND
GARDEN
SECURITY
INSTALLATION
LAMP POST TRETMENT
PLANT AREA
RAW WATER
SOURCES LIKE
WELL, TUBE
WELL ETC.

18. FACILITIES
 For each of above areas the QA person
should design cleaning method and
write cleaning SOP covering following
points
Cleaning equipment used
Cleaning agent with their concentration
Frequency of cleaning
Procedure
Responsibility for supervising
Records
Acceptance criteria

19. CLEANING METHOD
Cleaning
The act of removing dirt or
something undesirable

20. CLEANING METHOD
 Designing of a cleaning method is an
important task. This process start with
considering following point.
What is being cleaned?
VESSELS EQUIPMENT FACILITIES CONTAINERS

21. CLEANING METHOD
What are the contaminant?
API EXCIPIENTS
DECOMPOSE
D MATERIAL
MICROORGA
NISM
ENDOTOXINS
PARTICULAT
E MATTER
CLEANING
AND
SANITISING
AGENT
OIL AND
MACHINE
LUBRICUNT
DUST AND
FIBRES
ANY OTHER

22. CLEANING METHOD
Any other
What is the level of cleanliness
expected and it’s acceptance criteria
Cleaning equipment
Cleaning agent
Who is doing to do cleaning
Writing sop and maintaining record.

23. CLEANING METHOD
 Once the above points is collected
then the cleaning method can be
written and tested by actual practice to
validate the method.

24. CLEANING AGENT
 Cleaning Agents :
Cleaning agents are
generally different types of chemical
agents like
Surfactants
liquid soaps
Specially compounded powders or
liquids etc.

25. CLEANING AGENT
Compatible with the areas/equipment to
be cleaned.
The concentration of the cleaning
agents must be decided on the nature
of the agents and the cleaning
requirements.
The traces of cleaning agents must be
detected preferably by a physio-
chemical method like pH, color test,
etc.

26. CLEANING AGENT
Using precautions must be known
while cleaning with cleaning agent.
These agent must be easily available ,
economically affordable and easy to
handle.

27. SAMPLING
 Sampling : Sampling is required to
evaluate the effectiveness of cleaning
method . This is done by sampling the
area, which is cleaned to detect the
residual contaminants cleaning.
There are the different methods of
sampling. Some of the common
methods used in Pharma Industry are
:

28. SAMPLING
o Swabs:-
It is widely used technique
SWAB THE
SPONGE IN
SOLVENT e.g.
WATER OR
ALCOHOL.
COLLECT THE
SAMPLE FROM
SPECIFIC AREA
TEST THE SAMPLE
BY DIFFERENT
METHODS

29. SAMPLING
o Rinse or solvent wash

30. SAMPLING
o Placebo:-
It meaning that non useable
material testing e.g. like starch,
lactose.

31. SAMPLING
 Testing:-
There are different testing method as-
Visual inspection PH
Analytical and
instrumental
method
Chromatographic
method

32. REFERENCE
Potdar M.A, Pharmaceutical Quality
Assurance,Publishied by Nirali
Prakashan,Second edition reprint
2010,8.1-8.44
Chitlange S.S. Chaudhari P.D. Shirsat
A.E. and Sangshetti
J.N.Pharmaceutical Validation,
Publishers by Suyog Publishers &
Distributors Pvt.Ltd,First Edition April
2014,6.1-6.24