ARTICLES BY ANDREW WALSH

• Calculating Cleaning Process Capability: Analysis Of Total Organic Carbon

  1/10/2022

  This article will examine a data set of actual total organic carbon (TOC) swab data collected during cleaning validation for a pharmaceutical manufacturing facility and will show how much cleaning process knowledge and cleaning process understanding can be easily obtained through some simple statistical evaluations of such data.

• Calculating The Process Capabilities Of Cleaning Processes: A Primer

  11/1/2021

  The industry has begun the movement to science-, risk-, and statistics-based approaches to cleaning process development and validation. Process capability has become an important measure for demonstrating acceptable cleaning processe performance. Explore process capability, techniques used for its calculation, and how it's applied to cleaning processes. 

• Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues

  1/8/2021

  The new E3263 standard provides the science-, risk-, and statistical-based guidance and the tools needed for companies to implement the use of visual inspection within a quality risk management program that meets the criteria promulgated in the EMA's new Q&A 7 and Q&A 8.

• Cleaning Process Development: Time To Clean Studies & The Cleaning Assurance Level For Pharmaceutical Products

  12/4/2020

  A simple time to clean study can provide a rapid and efficient way to evaluate the behavior of a product during cleaning and obtain a reasonable estimate of the actual amount of time needed to achieve acceptable cleaning.

• Cleaning Process Development: Selection Of Cleaning Agents For Pharmaceutical Products

  11/6/2020

  This article will discuss how bench-scale studies can be used for selecting the best cleaning agent for certain products and provide answers to the questions "Which cleaning agent provides the best cleaning?" and "Can we demonstrate that two cleaning agents are equivalent?"

• ASTM Standards For Cleanability Testing Of Pharmaceuticals And Medical Devices

  9/28/2020

  This article discusses two longstanding ASTM standards on cleanability testing for use in the oxygen service industry that have been updated for use in cleanability testing for the pharmaceutical and medical device manufacturing industries.

• ASTM E3219 Standards For Derivation Of Health Based Exposure Limits

  7/1/2020

  The procedures outlined in the newly published HBEL standard are expected to greatly aid professionals in the derivation of acceptable levels of carryover and should be used in the risk assessment of cleaning processes using the ASTM E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation.

• Introduction To The ASTM E3106 “Standard Guide To Science-Based And Risk-Based Cleaning Process Development and Validation”

  6/5/2020

  The new ASTM E3106 focuses much more attention on applying science and risk at the risk identification and risk analysis stages, including cleaning process development, than has been done in the past.

• Introduction To Science- And Risk-Based Cleaning Validation Using ASTM E3106 & E3219

  5/6/2020

  This article discusses some of the history that began the movement from compliance-based approaches to cleaning validation to the science- and risk-based approaches introduced in the American Society for Testing and Materials (ASTM) E3106 Standard Guide for Science Based and Risk Based Cleaning Process Development and Validation and the ASTM E3219 Standard Guide for Derivation of Health Based Exposure Limits (HBELs).

• The Shirokizawa Matrix: Determining The Level Of Effort, Formality, & Documentation In Cleaning Validation

  12/11/2019

  This article shows how health-based exposure limits (HBEL)-based and process capability-based scales can be combined into a matrix that provides a clear visual guide for adjusting the level of effort, formality, and documentation for cleaning validation based on the level of risk.