Fan Filter Units vs. Air Handling Units for Cleanrooms
If you’re planning on building a cleanroom, one of the most important aspects of design is figuring out how the air will be filtered and moved through the space. The…
Shena Weeks
Posts by Shena Weeks
Shena Weeks
Cleanroom Validation: A Simple Guide
Building a cleanroom is one thing, but proving it works is a different story. In this article, we'll cover what cleanroom validation is, the main qualification stages, what gets tested,…
Shena Weeks
503B cGMP Cleanroom Design: What Outsourcing Facilities Need
Just because a 503B cGMP cleanroom passes an initial certification, it can still later fail an FDA inspection. More often than not, the problem can be traced back to how…
Shena Weeks
503A cGMP Cleanrooms: What They Are And What They Aren’t
Pharmacies that start work on a new cleanroom may hear the term “cGMP” used next to 503A. This can, of course, create some real confusion about what is required. Is…
Shena Weeks
Post-Build Cleanroom Planning: What to Know Early On
Before your cleanroom is built, it can look perfect on paper or in theory. You may even feel good about having designed an efficient space. The only problem is that…
Shena Weeks
How to Create a Cleanroom URS: A Short Guide
When planning a cleanroom or starting a checklist, it’s very tempting to jump straight into the design. However, before any quotes, you’ll need a clear URS (user requirement specification). In…
Shena Weeks
Cleanroom Pressure Differential Requirements: An Overview
Cleanroom pressure differential requirements are an important part of reaching compliance, whether through ISO 14644, USP 797/800, cGMP, or other guidelines. Ultimately, the purpose of pressure differentials is to keep…
Shena Weeks
Buffer Room vs Anteroom: What’s the Difference?
Within pharmaceutical manufacturing, compounding, and other drug-handling spaces, buffer rooms and anterooms are often used to keep medications safe. You’ll find them in multi-room cleanroom suites, but especially in pharmacies,…
Shena Weeks
Cleanroom Testing: A Few Common Procedures
Unfortunately, just because a cleanroom looks clean does not always mean it is clean enough or compliant. Since particles and airflow are often far too difficult to see with the…
Shena Weeks
Class 100 Cleanrooms: Definition, Design, and Requirements
If you’re working with products that can’t handle dust or dirt, you already know you need super clean air. And that’s exactly what class 100 cleanrooms are for. It keeps…
Shena Weeks
Biosafety Level Cleanrooms: A Quick Overview
Given the COVID-19 outbreak and its ramifications, it’s no secret that labs are important for studying and containing dangerous pathogens. But they also need to keep the outside world safe,…
Shena Weeks
USP 797 Cleanrooms: Definition, Requirements, and Design
USP 797 is more than just a set of guidelines; its rules were designed to protect patients. And it does this by making sure sterile medications are prepared safely in…
Shena Weeks