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
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
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
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