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What Do the GMP Qualification & Validation Processes Look Like?
In order to deem a cleanroom “GMP compliant,” it needs to meet various qualification and validation requirements. For facilities that are new to GMP standards and regulations, these processes can be a bit complicated — but we’re here to help clear things up. Let’s...
Why Do I Need a Cleanroom for Plastic Injection Molding?
Plastic is used for various tools and applications in everyday life. But where do those plastic components come from, and how are they made? Plastic injection molding! Plastic injection molding is the primary method of manufacturing for most plastic tools, packaging,...
Radiopharmaceutical Cleanroom FAQs
Interested in learning about the radiopharmaceutical industry and radiopharmaceutical cleanrooms? As an experienced radiopharmaceutical cleanroom manufacturer, we’re here to answer any questions you have about the design or installation of these innovative spaces. ...
GMP Cleanroom Requirements for Safe and Effective Workflow
One of the key aspects that sets GMP cleanroom standards apart from other cleanroom standards is that they account for more than just airborne particle control and filtration. In fact, one of the most important aspects of GMP qualification and validation is ensuring...
5 Types of Equipment Used in Cell & Gene Therapy Cleanrooms
Cell and gene therapies are both forms of regenerative medicine. Cell therapy involves transferring live, intact cells into a patient to lessen or cure a disease. The cells may be from the patient (autologous) or from a donor (allogeneic). Gene therapy involves...
How Does Cleanroom Size Affect Process Flow?
Designing and installing a large cleanroom is a lot different than designing and installing a small one — but how exactly? Let’s take a look at some cleanroom design considerations you should make at the start of a large project so that you end up with a finished...
What Is USP 825, and How Does It Affect Radiopharmaceutical Cleanroom Design?
Radiopharmaceutical Cleanroom Design? USP standards are developed by the United States Pharmacopeia (USP) to protect patient and worker safety while developing, packaging, distributing and consuming medicines and dietary supplements. Therefore, they must be adhered to...
What Are GMP Standards for Cleanrooms?
In the cleanroom industry, there are many different quality standards that both manufacturers and facilities managers must be aware of and comply with. We’ve already discussed ISO standards and Federal 209E standards, even USP standards — but one we haven’t discussed...
What to Know About USP Standards
Cleanroom classifications and standards are an important part of cleanroom design and development. They regulate many cleanroom aspects, including levels of air cleanliness, air exchange rates, workflow, pressure, and more. While we usually discuss ISO standards,...
HardWall Cleanroom Features
If you’re trying to figure out which type of cleanroom is right for you, you have three choices: SoftWall, HardWall, and RigidWall. They’re all great choices, but there’s probably one that will work better for you than others — and we’re here to help you narrow that...
Cascading Cleanroom Pressure: Explained
You probably already know how important proper air filtration is in meeting your cleanroom’s ISO requirements. But what you may not realize is how important some other environmental factors are as well. Things like temperature, humidity, static, and pressure all need...
ULPA vs. HEPA Filters for Cell & Gene Therapy Cleanrooms
In the past couple of years, cell and gene therapies have been recognized as viable forms of treatment for life-threatening conditions, leaving many healthcare professionals excited about putting more effort into researching, developing, and distributing them. But in...
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