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Cleaning Validation
Published in Sam A. Hout, Manufacturing of Quality Oral Drug Products, 2022
Cleaning methods should be developed prior to validation with an equal focus on a robust cleaning method design and the cleaning validation approach. Knowing that the purpose of pre-and post-cleaning is to remove residual product, soils, cleaning agents, and microbial contaminants to an acceptable level, teams designing and developing manufacturing processes and associated equipment need to consider cleaning method development as important as the manufacturing process itself, with heavy emphasis on process knowledge.
Cleaning Validation—Lifecycle Approach
Published in Sandeep Nema, John D. Ludwig, Parenteral Medications, 2019
Cleaning validation is demonstrated assurance that a cleaning procedure reliably and reproducibly removes prior objectionable residue from a contaminated surface. Cleaning validation includes preparatory work to develop and support the cleaning method, demonstration of the cleaning procedure, including analytical determination of residues, and monitoring of continued acceptable cleaning performance.
Cleaning Validation for the Pharmaceutical, Biopharmaceutical, Cosmetic, Nutraceutical, Medical Device and Diagnostic Industries
Published in James Agalloco, Phil DeSantis, Anthony Grilli, Anthony Pavell, Handbook of Validation in Pharmaceutical Processes, 2021
Cleaning validation involves not only the removal of residues but also the assurance that each and every piece of equipment associated with the process has been cleaned to acceptable levels. This is commonly referred to as a train-based approach. The “equipment train” is a series of equipment through which the product or products move as they progress through the manufacturing process.
Two-level process validation approach for medical devices
Published in Journal of Medical Engineering & Technology, 2019
FDA Guidance for Industry, Process Validation: General Principles and Practices (January 2011)EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use, Annexe 15: Qualification and Validation (March 2015) [4]PIC/S – Recommendation on Validation Master Plan, Installation and Operational Qualification, Non-Sterile Process Validation, Cleaning Validation (September 2007) [5]In order to facilitate the understanding of the process validation approaches in the validation guidance documents, all of their key points related to process validation approach are extracted and analysed in Tables 1–4.
A comprehensive validation framework addressing utility parameter validation for application in small and medium enterprises (SMEs):A case study in pharmaceutical industry
Published in Cogent Engineering, 2023
Vothia Surian Subramaniam, Joshua Prakash, Shahrul Kamaruddin, Sze Wei Khoo
According to Manalo and Brown (1993), inaccuracy of the validity of equipment, utility or any other system may exist if the equipment, utility or any other system is not validated adequately, thus, affecting the quality of the final product. Validation can help pharmaceutical companies save significant maintenance cost as the validated equipment and systems will yield products that are consistent in quality with minimum defects and machine downtime. This results in less maintenance works and rejects. Processes running at marginal level often incur costs because of re-inspection, re-testing, rework and rejection. Validation leads to the optimization of processes and minimizes these expenses (Haider, 2001). The top reason for compulsory requirement of validation in pharmaceutical industries is the safety of the patients, and Pelletier (2005) believes that the safety of the medical products consumed by patients worldwide is ensured by validation. Properly validated system and equipment will perform at optimum level and this will increase the capacity of the system or equipment, which plays a major role in maximizing the production yield. High yield can often become reality by having through comprehensive planning, validation, analysis and specification definition (Eastham, 2012). There are many types of validation activities practiced in pharmaceutical industries such as cleaning validation, method validation, software validation and process validation, which include facility validation, equipment validation and utility validation. Each type of validation comprises four stages of qualification which are design, installation, operational and performance qualification.