Cleaning validation
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Cleaning validation is an important process in the pharmaceutical industry to ensure product safety and purity. It involves documenting evidence that an approved cleaning procedure will adequately clean equipment used in pharmaceutical production. The cleaning validation process includes planning, execution, analytical testing, and reporting phases. A cross-functional team plans the validation program, which involves grouping products, equipment, cleaning agents, and methods. Sampling techniques like swab and rinse sampling are used in the execution phase. Acceptance criteria are established and analytical tests are performed on samples to verify cleaning levels. A validation report documents the results and conclusions to obtain approval. Revalidation may be required if any changes are made to the cleaning process.
Cleaning validation
- 1. CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRIES Guided by : Dr.S.S.Mahajan Prepared by : Shweta Sambhaji Shelke Quality Assuranace(3rd sem) 1
- 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. 2
- 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 . 3
- 7. RESPONSIBILITIES OF TEAM MEMBERS 7
- 8. • Coordinating entire team • Monitoring process • Compiling data • Preparing final reports Validation officer • Prepare SOP’s for new process or equipment • Assist in collection of validation data Production department officer • Prepare SOP’s for the cleaning of new packaging • Assist in the collection of validation data Packaging department CLEANINGVALIDATIONTEAM 8
- 9. • Defining requirements. • Training • Informing relevant departments Maintenance department • Perform microbiological testing • Provide data for active ingredient and cleaning agent Quality control department • Reviewing & approving the validation • Assessment in case of deviations Quality assurance department • Defining the process to be validated • Provide technical assistance Product development laboratory CLEANINGVALIDATIONTEAM 9
- 11. PRODUCT GROUPING Worst case product Least soluble Most toxic Highest cocentration Others Subdivide it Formulation Process Selection of product Low & high risk drugs Solid & liquid dosage Soluble & insoluble ingredients Sterile & nonsterile facilities 11
- 12. EQUIPMENT GROUPING Can implement C V procedure Small scale Large scale Subdivide into Dedicated & Non dedicated Minor & Major Noncritical & Critical site Non product & product contact Equipment train :single & complex Equipment selection Design function 12
- 13. Cleaning agent grouping Equipment grouping Product formulation Select type such as acid & base cleaning method grouping Automated and manual cleaning Clean in place and clean out of place 13
- 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 14
- 16. ULTRASONIC CLEANING 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. Principle Image 16
- 17. ULTRASONIC CLEANING Separates the liq and microscopic void Creates compression wave in liq U.S.Waves fluid changing size & Ultrasound generating transducer built into chamber In a ultrasound chamber 17
- 18. VAPOR DIGRESSING 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 eupment . 18
- 19. HOT WATER EXTRACTION It is a typical cleaning method that uses a combination of high water pressure for agitation, and hot water to increase reaction rate. surface is dried to avoid surface saturation lower the pH of the fibers to a neutral state. use an acetic acid solution surface is thoroughly rinse out the preconditioner light agitation with a grooming brush preconditioning of the soiled surface with an alkaline agent 19
- 21. SWAB SAMPLING The extract examined by a suitable analytical method By adding it to dilution solvent The swab is extracted A small area of the cleaned equipment is swabbed 21
- 22. SWAB SAMPLING Dissolves & physically remove sample Adaptable to wide variety of surfaces May allow sampling of defined area Applicable to active , microbial & cleaning agent residue An invasive technique that introduce fiber Complex & hard to reach complex areas Advantages Disadvantages 22
- 23. RINSE SAMPLING In 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. 23
- 24. RINSE SAMPLING 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 Advantages Disadvantages 24
- 25. ANALYTICAL TESTING PHASE Accuracy Precision Repeatability Intermediate Specificity LOD LOQ Linearity Range 25
- 26. 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 26
- 27. 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 27
- 28. 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 . 28
- 29. 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 . 29
- 30. CONCLUSION Cleaning 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. 30
- 31. REFERENCES S.I.Haider ,E.S .Asif , “Cleaning validation manual ,a comprehensive guide for pharmaceutical &biotechnogy industries:”,CRC Press publication,page no -1-30. Active pharmaceutical ingredients committee ,“Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants”,december 2008 Andrew walsh , “cleaning validation for 21st century :the overview of new ISPE cleaning guide 31
- 32. REFERENCES S.W.Harder , “validation of cleaning processes” pharmaceutical technology.(1984) Sudha T., Krishana Kanth , Nukala Poorana Chandra Sainath1, Mishal1, Saloman Raja , Ganesan , “Method Development and Validation- A Review”, Journal of Advanced Pharmacy Education & Research (2012) 32
- 33. THANK YOU 33