Upload
deepak-kumar
View
22
Download
1
Embed Size (px)
Citation preview
1
Cleaning validation in pharmaceutical
industries
Prepared by : Deepak Kumar Pharmaceutics dept.(M-Pharm-1st Year)
2
Definition Cleaning validation – It is a documented
evidence which provides high degree of assurance that an approved cleaning procedure will provide equipment that is suitable for processing of pharmaceutical products for API.
3
Importance of cleaning validation Cleaning validation is heart of pharmaceutical
activity
Related to safety and purity of the product Level of cleanliness is achieved by cleaning
procedure which depend upon its cleaning validation method if performed confidently ,method produces reproducible results .
4
Planning phase
Execution phase
Analytical testing phase
Reporting phase
5
Planning phase
CLEANING VALIDATION TEAM
CLEANING VALIDATION PROGRAM
PERSONNEL TRAINING
CLEANING PROCESS
PLAN
6
Validation team
members :
Validation officer
Production department
officer
Packaging department
officer
Maintance department
officer (utilities/calibration/HVA
C)
Quality control
department officer
Quality assurance
department officer
Product development laboratory
officer
7
Responsibilities of team members
8
Validation officer
•Coordinating entire team •Monitoring process•Compiling data•Preparing final reports
Production departmen
t officer
•Prepare SOP’s for new process or equipment•Assist in collection of validation data
Packaging departmen
t
•Prepare SOP’s for the cleaning of new packaging•Assist in the collection of validation data
C
LEAN
ING
VAL
IDAT
ION
TE
AM
9
Maintenance department
• Defining requirements. • Training
• Informing relevant departments Quality control
department • Perform microbiological testing • Provide data for active
ingredient and cleaning agent
Quality assurance
department
• Reviewing & approving the validation
• Assessment in case of deviations
Product development laboratory
• Defining the process to be validated
• Provide technical assistance
CLE
ANIN
G V
ALID
ATIO
N T
EAM
10
CLEANING VALIDATIO
N PROGRAM
1.PRODUCT
GROUPING
2.EQUIPMEN
T GROUPING
3.CLEANING
AGENT GROUPING
4.CLEANING METHOD
GROUPING
11
Product grouping
12
Equipment grouping
13
Cleaning agent grouping
Equipment grouping
Product formulation
Select type such as acid & base
14
Personnel training Why it is required ?
To understand selection of cleaning parameters such as time , temperature , cleaning agent concentration ,sheeting , rinsing .
To evaluate step for removal of residue by following /understanding SOP’s
Therefore in cleaning validation this is also adds the same value as other considerations
15
Cleaning process
Solvent cleaning
Ultrasonic
Vapor degreasing
Hot water extraction
Aqueous cleaning
Manual
16
Ultrasonic cleaning Principle Image A process that uses
ultrasound(20-400kHz)& appropriate cleaning solvent or water
Time require for cleaning generally3-6nmin & may exeed to 20 min depend upon object to be clean.
17
Vapor degreasing Surface finishing process .Uses the solvent in the form of vapor to clean work
piece. Used where water based cleaning is impracticable .After boiling of solvent it enters the fill line & uses
spray technique to clean equipment .
18
Hot water extractionIt is a typical cleaning method that uses a
combination of high water pressure for agitation, and hot water to increase reaction rate.
19
Swab sampling
20
Swab samplingAdvantages DisadvantagesDissolves & physically
remove sampleAdaptable to wide
variety of surfacesMay allow sampling of
defined area Applicable to active ,
microbial & cleaning agent residue
An invasive technique that introduce fiber
Complex & hard to reach complex areas
21
Rinse samplingIn rinse sampling API
equipment will be cleaned by several washing cycles (runs ) OR cycles/runs
Outline - amount of residue remaining in the equipment after cleaning based on the amount of residue in the last run of the routinely used cleaning procedure.
22
Rinse samplingAdvantages Disadvantages Allow the sampling of
large surface area Allow the sampling of
unique (porous) surfaces Applicable for
actives ,cleaning agent & exipients
Inability to detect location of residue
Usually use for rinsing an entire piece of equipment
Excess of rinsing sample is required
23
Acceptance criteria Establishing acceptance limit
Samples should be practical , achievable ,and verifiable
NMT 10ppm of any product will appear in other product
NMT 0.1% therapeutic dose of any product will appear in maximum daily dose of the following
product
No quantity of residue should be visible on the equipment after cleaning procedure are performed
24
Reports A validation report is necessary to present the
results & conclusions with approval page duly signed off by corresponding signatories depicting the approval of validation study.
It should include :• Summary of procedures used to clean ,
sample ,test • Physical & analytical test results• Conclusion regarding acceptability of results • Recommendations based on result • Review of protocol deviation • Interim reports till complete study
25
Documentation The cleaning process should be documented n an SOP
Documentation should be in such a way that following information is readily available:
The area or piece of equipment cleaning
The person who carried out the cleaning
When the cleaning was carried out
The SOP defining the cleaning process
The product which was previously processed on the
equipment being cleaned .
26
Revalidation It is done if :• Cleaning procedure is changed • Raw material are changed • Change in formulation • New detergents • Modification of equipment
To avoid this regular checking is done.
The production manager ,QC manager , QA manager & whole validation team decide revalidation is necessary or not .
27
ConclusionCleaning validation is heart of
pharmaceutical industry .
If the proper cleaning is not contamination may occur in the product & whole process of formulation hampered by this.
Whole team distribute their work for attending the cleaning validation process to which QA officer gives approval based on the overall documented evidances.
28
References:- Google
Slideshare
Industrial Pharmacy ‘’Lachman and Liberman”
29
Thank you