Critical Environments Columns

  1. 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.

  2. Slow-Walking The Isolator: A Cautionary Tale 12/2/2020

    Our industry has, with not insignificant regulatory assistance, obstructed the implementation of a technology that has proven safe and effective and was an enormous improvement over the conventional cleanrooms universally in place in the mid-1980s.

  3. 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?"

  4. Buyer Beware! Pharmaceutical Equipment Suppliers, Promises, & Delivery 9/30/2020

    Our industry depends on a wide spectrum of equipment suppliers that provide our manufacturing systems, utility systems, and environmental systems. This article raises a number of points to discuss with equipment suppliers and your facility engineers to plan for and assure a successful and compliant installation.

  5. 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.

  6. Repurposing An Aging Facility To Produce Cell & Gene Therapies 8/24/2020

    Many life sciences companies are shifting their operations to encompass new life-saving cell and gene therapy products, also known as advanced therapy medicinal products. In many cases, this requires converting legacy manufacturing facilities to produce these new therapies.

  7. Repurposing A Facility For Cell & Gene Therapies: Demo & Engineering 7/30/2020

    Cell therapy capacity is in high demand, real estate and property are generally available at sites around the world, and the tendency is to place cell therapy production in an existing site. The challenge is to make the renovated space a successful GMP facility by engineering and building it correctly within the confines of the space and utilities.

  8. 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.

  9. Cleaning Up The Systems Mess: A Phased Approach To Implementing Real Automation And EBRS 5/20/2020

    The biopharma industry uses the most sophisticated microbiological and genomic technology, and we experience waves of advancements in therapies driven by our computing and communications technology. So, why are we still drowning in 100-page paper batch records, books of SOPs on the plant floor, and paper documents being handled by operators?

  10. 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).