ARTICLES BY ANDREW WALSH
Intro To ASTM E3263-20: Qualification Of Visual Inspection For Residues1/8/2021
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 Products12/4/2020
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 Products11/6/2020
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 Devices9/28/2020
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 Limits7/1/2020
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 & E32195/6/2020
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 Validation12/11/2019
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.
Recovery Studies: Common Issues & Using Statistical Tools To Understand The Data9/18/2019
This article explores some of the typical issues that may be encountered during recovery studies, and explains how the use of statistical tools for assessing recovery data can provide greater insight to guide decisions concerning recovery studies.
Cleaning Process Development: Cleanability Testing And “Hardest-To-Clean” Pharmaceutical Products1/18/2019
Cleanability is clearly an important parameter for determining the hardest-to-clean product for use in cleaning validation studies, and reliable methods for this determination are needed. For any analysis, quantitative methods should be preferred over qualitative methods as they are scientific, not subjective, and allow the easy application of statistical evaluation.