Critical Environments Columns
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Introduction To ASTM E3263-20 On 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.
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Facility Engineering, Design, & Construction Tips For Up-Start Biotech Companies
1/4/2021
Fledgling biotech companies are financially fragile, and they can ultimately become controlled by demanding fund managers. Those who manage facility engineering, design, and construction for these companies must adjust their thinking and employ some new tactics to document all costs and impacts, reduce schedule, and maintain quality.
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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.
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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.
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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?"
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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.
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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.
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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.
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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.
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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.