Critical Environments Columns

71. Calculating Process Capability Of Cleaning Processes With Partially Censored Data 5/19/2022

    When cleaning sample results are below the detection limits (DLs) of an analytical method, these data are known as "non-detects" or "left-censored" data. There are basically two broad classes of methods that are applied to left-censored data: Substitution and Estimation. This article explores these methods for use with cleaning sample data when some of the points are below the DL.

72. How To Evaluate & Manage Safety Risks In Biopharma 5/2/2022

    Safety risks can be described and modelled as cause-and-effect relationships using system risk structures. This article structures risks beginning with a defined danger or threat so they can be effectively understood and then managed. Examples include wearing protective gloves (as a simple risk) and handling antibody-drug conjugates (as a complex risk).

73. Technical Due Diligence Considerations For Multi-Site Biopharma Acquisitions 4/14/2022

    Part 1 of this 2-part article series shared considerations for standalone biopharma manufacturing facility acquisitions. This article, Part 2, shares considerations for multi-site acquisitions when the seller is manufacturing part or all its products in-house.

74. Tech Due Diligence: Acquiring A Biopharma Manufacturing Facility 4/8/2022

    As a consultant, this author has been approached on several occasions to perform on-site technical due diligence for facilities that his clients were considering to acquire. In this article, he shares the considerations you should keep in mind when acquiring a stand-alone biopharma manufacturing facility.

75. Key Considerations For cGMP Building Conversions 3/16/2022

    As the life sciences workforce has increased, companies need more space to accommodate them. One emerging option is searching for buildings such as offices and warehouses and converting them into biopharma manufacturing facilities. However, not all conversion projects are as easy as you would hope. This article shares key considerations for such a project.

76. Factory/Site Acceptance Testing & Commissioning Responsibilities 2/22/2022

    Execution of factory acceptance testing (FAT) and site acceptance testing (SAT) is a business-critical activity when it comes to commissioning of a new system or equipment. FAT is conducted at the equipment manufacturer’s site and SAT is conducted at the final site of installation. This article shares best practices.

77. Facilities Remediation, Renovation & Reconstruction: When Does It End? 2/7/2022

    We sit at the beginning of 2022 amid the industry’s frantic and hurried effort to acquire, expand, and prepare more aseptic plant capacity — and to make it useable, compliant, and productive. This article provides a deep-dive on planning and design for your project, including walls, floors, ceilings, interstitial and mechanical spaces.

78. 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.

79. How AstraZeneca Optimized Vapor Phase Hydrogen Peroxide Gassing Cycle Development 12/22/2021

    Demonstration of efficacious decontamination is a critical aspect of aseptic processing and sterility testing. By adopting enzyme indicators in the cycle development phases, greater understanding of efficacy of the gassing process can be achieved by providing quantitative results in a faster time frame. Here's how AstraZeneca did it.

80. 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.