Cleaning Validation – How to select the worst case? 

miniature episode 288 Cleaning Validation – How to select the worst case? monir el azzouzi easy medical device Heena Thakkar – Alceon Consulting

Have you ever had to deal with Cleaning Validation. If yes than you know the pain to select the instruments and group them and for each group find a worst case. On this episode, we tell you how this should be working so you can guarantee to provide clean products and clean instructions to your customers. 

Who is Heena Thakkar? 

Heena Thakkar is a regulatory consultant currently working with Alceon Medtech Consulting. She is based in Gujarat, India. Heena is qualified in risk management, design controls, usability engineering, clinical evaluation, clinical trial management, quality management systems and process validation. She is also a certified internal auditor.  

Heena has around 8 years of experience in the field of regulatory affairs and quality management system for medical devices. She is experienced in regulatory submissions for vast range of devices ranging from orthopaedic devices, endovascular devices, single-use consumables, ophthalmic devices and wound care devices. She also conducts external trainings in the areas such as risk management, quality management system, EU MDR and EU IVDR.  

  

Who is Monir El Azzouzi? 

Monir El Azzouzi is the founder and CEO of Easy Medical Device a Consulting firm that is supporting Medical Device manufacturers for any Quality and Regulatory affairs activities all over the world. Monir can help you to create your Quality Management System, Technical Documentation or he can also take care of your Clinical Evaluation, Clinical Investigation through his team or partners. Easy Medical Device can also become your Authorized Representative and Independent Importer Service provider for EU, UK and Switzerland. 

Monir has around 16 years of experience within the Medical Device industry working for small businesses and also big corporate companies. He has now supported around 100 clients to remain compliant on the market. His passion to the Medical Device filed pushed him to create educative contents like, blog, podcast, YouTube videos, LinkedIn Lives where he invites guests who are sharing educative information to his audience. Visit easymedicaldevice.com to know more. 

Link

  • Heena Thakkar Linkedin Profile:  

https://www.linkedin.com/in/heenathakkar?utm_source=share&utm_campaign=share_via&utm_content=profile&utm_medium=ios_app

  • Alceon Medtech Consulting Website:  
  • List of standards helpful for cleaning validation of reusable instruments  
  1. ANSI/ AAMI ST98: Cleaning validation of health care products—Requirements for development and validation of a cleaning process for medical devices https://www.aami.org/standards/featured-standards/aami-st98  
  1. USFDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (https://www.fda.gov/media/80265/download
  1. ISO 17664-1:2021: Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (https://www.iso.org/standard/81720.html
  1. ISO 15883-1:2006: Washer-disinfectors – Part 1: General requirements, terms and definitions and tests (https://www.iso.org/standard/41076.html
  1. ISO 15883-5:2021: Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy (https://www.iso.org/standard/68297.html
  1. ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3208-20.html
  1. ASTM F3293-18: Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices (https://www.astm.org/f3293-18.html

There are many additional standards that manufacturers will need to refer to in addition to the ones listed above. Contact us at contact@alceonconsulting.com for additional information or service inquiry. Thank you!  

Social Media to follow

podcast episode 288 Cleaning Validation – How to select the worst case?  monir el azzouzi easy medical device Heena Thakkar – Alceon Consulting

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