The seminar presented by Ms. Diksha Kailas Sonawane at Mahatma Gandhi Vidyamandir’s Pharmacy College discusses cleaning validation in pharmaceutical manufacturing, emphasizing the importance of documented cleaning procedures to ensure product quality and prevent contamination. It covers various cleaning methods, validation types, and essential analytical methods for effective cleaning practices. The document also outlines the validation processes for both sterile and non-sterile facilities, ensuring adherence to regulatory standards.

1. Mahatma Gandhi Vidyamandir’s Pharmacy College,
Panchavati, Nashik- 422003
A seminar on
Cleaning validation
Presented by-
Ms. Diksha Kailas Sonawane
F. Y. M. Pharmacy (Semester II)
Roll no- 43
Under The Guidance Of –
Prof. Harshada Patil
Department of Phamaceutical
Quality Assurance
Sub: Pharmaceutical Validation

2. Vision:
“To be a centre of professional excellance by contributing honestly to the pharmacist
moulding process.”
Mission:
• Impart high quality education to graduates.
• Contribute to all spheres of professional activities.
• Up hold human values and ethics.
• Nurture them into globally competent professionals.

3. Content
• Cleaning Method development
• Validation of analytical method used in cleaning
• Cleaning of Equipment
• Cleaning of Facilities
• Cleaning in place (CIP)
• Validation of facilities in sterile and non-sterile plant
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4. Cleaning Validation
The process of providing documented evident which provides a high
degree of assurance that specific process method, will consistently
produce a result with pre – determine specificaition and acceptance
criteria
Types of validation
Analytical method validation
Process validation
Software validation
Cleaning validation
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5. Types of validation
Analytical validation Process validation
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6. Software validation Cleaning validation
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7. WHAT IS CLEANING?
Cleaning is the process of removing unwanted substances such as dirt, infectious agents
and other impurities from an object or environment. Cleaning occurs in many contexts
and uses in many different methods.
WHAT IS A CLEANING VALIDATION?
As applied to a cleaning process, validation means evaluating a cleaning SOP on specified
equipment after the manufacture of certain drug products (or APIs).
It involves setting acceptance criteria (visually clean and specific analytical limits based
on possible contamination of subsequently manufactured products).
Cleaning validation is applicable to processes that are done repeatedly. This includes a
consistent cleaning SOP and a consistent soil/drug on the equipment surfaces to be
cleaned.

9. Level of Cleaning

10. Cleaning Method Development
Cleaning methods are usually differential based on the extent of disassembly required for the cleaned
equipment and on the method of contacting the chemical cleaning agent with the surface to be cleaned.
Cleaning application are as follows :
• CIP (class-in-place)
• Agitated immersion
• Static immersion (soaking)
• Automated parts washing
• Ultrasonic cleaning
• High pressure spraying
• Manual cleaning
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11. Validation of analytical method used in cleaning
• Validation of analytical procedure is the process by which it is establish by laboratory studies, that the
performance characteristics of the procedure meet the requirements for its intended use.
• All analytical methods that are intended to be used for analyzing any cleaning samples will need to
be validated.
• Validation of analytical method is essential but time consuming activity for most analytical
development laboratories. It is therefore important to understand the requirements of method
validation in more detail and the options that are available to allow for optimal utilization of
analytical resources in a development laboratory.
• The analytical methods should be validated before the cleaning validation is performed and the
methods chosen should detect residuals or contaminants specific for the substance being assayed at
an appropriate level of cleanliness (sensitivity).
• The detection limit the established acceptable level of the residue or contaminants.
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12. Validation of analytical method should include
1. precision
2. linearity
3. accuracy
4. limit of detection
5. limit of quantitation
6. ruggedness
7. robustness

13. Cleaning of Equipment
Cleaning of equipment in cleaning validation is a critical aspect of ensuring that pharmaceutical
manufacturing equipment is adequately cleaned between batches to prevent cross-contamination
and ensure product quality and safety. Here’s an overview of the process:
1. Cleaning Procedure Development: Develop a detailed cleaning procedure that outlines the
steps, cleaning agents, equipment, and acceptance criteria for cleaning the equipment.
2. Selection of Cleaning Agents: Select cleaning agents that are appropriate for the equipment
and the residues to be removed. Consider the solubility of the residues and the compatibility
of the cleaning agents with the equipment.
3. Cleaning Validation Study Design: Design a cleaning validation study to demonstrate that
the cleaning procedure effectively removes residues to an acceptable level. Consider factors
such as worst-case scenarios, sampling locations, and analytical methods. 7
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14. 4. Pre-cleaning Inspection: Inspect the equipment before cleaning to ensure that it
is visually clean and free from any visible residues.
5. Cleaning Process: Follow the cleaning procedure, including disassembly of
equipment, application of cleaning agents, rinsing, and drying.
6. Sampling: After cleaning, take samples form critical locations on the equipment
to test for the presence of residual contaminants.
7. Analysis: Analyze the samples using validated analytical method to determine
the level of residual contaminants.
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15. Sampling Methods:
The sampling procedure refers to the selection of which surfaces are
targeted for collecting residues for measurement and to the method of
collecting the residues from the surface so that they can be measured.
The sampling methods are
1. Swab sampling
2. Rinse sampling

16. Cleaning of Facilities
Cleaning of facilities in cleaning validation involves ensuring that the manufacturing environment,
including surfaces, equipment, and utilities is cleaned to a predefined standard to prevent
contamination of pharmaceutical products.
1. Cleaning Procedure Development: Develop a detailed cleaning procedure that specifies the
cleaning agents, methods, equipment, and acceptance criteria for cleaning the facility.
2. Selection of Cleaning Agents: Select cleaning agents that are appropriate for the surfaces and
contaminants to be removed, considering factors such as compatibility factors such compatibility
factors such as compatibility and effectiveness.
3. Cleaning Validation study Design: Design a cleaning validation study to demonstrate that the
cleaning procedure effectively removes contaminants from the facility surfaces
4. Revalidation: Periodically revalidate the cleaning procedure for the facility to ensure its continued
effectiveness. 9
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17. CLEAN IN PLACE
Cleaning applications can be classified into two groups based on the extent of disassembly
• CIP(clean-in-place)
• COP (clean-out-of-place)
CIP applies to all situations in which disassembly is not performed and can apply to situations in which
process equipment is merely flooded with cleaning solution. CIP is usually used as an automated cleaning
system involving spray devices to distribute the cleaning solution to all process vessel surfaces. CIP
involves no disassembly of the equipment prior to initiation of the cleaning cycle. The equipment which is
designed with CIP in mind-it is "prepiped" to handle the introduction of chemical cleaning solutions into
the equipment, the flow of that cleaning solution through the equipment to contact and clean all surfaces,
the discharge of the spent cleaning solution to drain, the rinsing of all cleaned surfaces, and, optionally, the
drying of the cleaned surfaces. CIP systems are usually designed for cleaning with aqueous
cleaning solutions.
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18. Validation of facilities in sterile and non-sterile plant
The validation of facilities in both sterile and non-sterile plants is crucial to
ensuring the quality and safety of pharmaceutical products. Here's an overview of
the validation process for both types of facilities:
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19. Sterile Plant Validation:
1. Design Qualification (DQ): Ensure that the facility design meets the intended use, including
considerations for sterility, cleanability, and compliance with regulatory requirements.
2. Installation Qualification (IQ): Verify that the facility and its components are installed correctly and
according to the
3. manufacturer's specifications.
4. Operational Qualification (OQ): Ensure that the facility operates as intended under normal operating
conditions, including testing of equipment and systems.
5. Performance Qualification (PQ): Validate that the facility consistently produces sterile products of the
required quality, including environmental monitoring, personnel monitoring, and process
simulation studies.
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20. Non-Sterile Plant Validation:
1. Design Qualification (DQ): Ensure that the facility design meets the intended use, including
considerations for cleanliness, segregation of operations, and compliance with regulatory
requirements.
2. Installation Qualification (IQ): Verify that the facility and its components are installed correctly and
according to the manufacturer's specifications.
3. Operational Qualification (OQ): Ensure that the facility operates as intended under normal operating
conditions, including testing of equipment and systems.
4. Performance Qualification (PQ): Validate that the facility consistently produces products of the
required quality, including testing of product characteristics, equipment performance, and
process parameters
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21. References
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1. Manohar A. Potdar: pharmaceutical quality assurance: cleaning validation: page no: 8.22-
8.28 08)
2. https://www.slideshare.net/slideshow/cleaning-validation-250532151/250532151
3. Clean-in-place (CIP) in Pharmaceutical Manufacturing – Grantekhttps://grantek.com> clean-
in-place-cip-in-pharmaceutical manufacturing

22. Thank You !!!
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