Critical Environments Featured Articles
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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.
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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.
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In-House Manufacturing: Key To Driving A Diabetes Vaccine?
1/28/2022
Increasing constraints on today’s supply chain from the COVID-19 pandemic mean drug companies must secure strategies that can ensure product delivery in the face of these challenges.
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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.
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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.
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Enabling Bioprocess Control With Successful Automation Strategies
12/9/2021
In a recent live event with Bioprocess Online, industry experts at various stages of their automation journey discussed their approach to enhancing quality control and data integrity through automated technologies.
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Viable Monitoring Solutions To Prepare Your Contamination Control Strategy For Annex 1 FAQs
12/4/2021
In our recent webinar many thoughtful questions were asked that concern how compliance with the latest regulation changes can be met, the requirements for passive monitoring, and the industry applications affected. Here we answer questions submitted after the webinar regarding active air and settle plates, rapid micro methods, and specific applications.
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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.
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An Introduction To Biopharma Facility Design & Layout
10/11/2021
This article explores modern facility design principles that make use of the most flexible new technologies and provide a platform to rein in costs, reduce schedules, and deliver products compliantly and within business risk tolerance.
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Failing Insulation Could Lead To Catastrophic Failure In A Cleanroom Environment
10/5/2021
The pharmaceutical cold chain effectively starts in the cleanroom, therefore choosing the right insulation is a crucial first step in maintaining quality.