The Importance of Maintaining Clean Room Standards

Whether you are concerned with chemical purity, the efficiency of your fume hoods, or ICN radiochemicals, you cannot overlook the critical importance of maintaining clean room standards. Even if you acknowledge the importance of keeping up to date, it can still present a set of unique problems and complications that necessitate constant monitoring and ongoing education. Follow our simple guide if you want to be sure that you are operating in accordance with clean room standards.

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Understand GMP Quality Standards And How They Affect Labs

fume hoods

Laboratories are home to a number of different chemical compounds. Many don’t think about what goes on within labs — despite the fact that, physically, they take up a lot of space in the United States. Right now, nearly half of the global pharmaceutical market is taken up by the U.S., and the U.S. is among the world’s largest producers of chemical products on a global level. For that matter, chemical products are not limited to pharmaceutical products. A number of other products are created and tested within labs. With that being said, it can be difficult for labs to maintain the level of safety standards that they should — yet they must. Thanks to GMP standards and resources today, laboratories have standards to follow. Not only will these standards and guidelines ensure that those that work within laboratories are safe — but those that use chemical products as well. Below, we’re going to look into these practices, as well as the specific steps that laboratories can take to ensure that they’re producing products of the highest quality, at the safest standards possible.

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Chemical Purity and Its Impact on Manufacturing

chemical purity

Since its inception, chemical science has evolved from back-room apothecaries and botanicals to a full-fledged industry employing nearly 810,000 people, including in the pharmaceutical sector. As humans have gotten a better handle on the science of medicine, manufacturing standards have had to rise to keep up with them. When consumers take pills for medicinal purposes, it’s with the implicit understanding and trust that they’re not only getting what they’re told they’ve gotten, but that every step of the process has ensured a rigorous standard of chemical purity testing of the Active Pharmaceutical Ingredients (APIs). Over the years, governing bodies such as the WHO have created General Manufacturing Practices (GMP) for APIs. The API GMP allow every step of the process from receipt of material to distribution to undergo the same GMP quality control.

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3 Signs And Symptoms That Your Fume Hood Needs To Be Replaced

fume hoods

The U.S. alone possesses over 45% of the global pharmaceutical market. We are able to exercise such power and control thanks to our dedication to precision; our GMP quality control and clean room standards allow us to ensure that our pharmaceutical products are safe to use and of excellent quality. Though there are many factors that go into this assurance, none is more important than the state of a laboratory’s fume hood.

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What Is Radiolabeling, And Why Does It Matter?

radio labeled compounds

Chemical manufacturing, particularly when it comes to drug research and pharmaceuticals, is one of the larger industries within the United States. However, most people across the country don’t fully understand many of the basic principles of this field, despite how often they’re used by chemical manufacturers for scientific research and study. Radiolabeling, for example, remains a mystery to many people outside of the industry. So how does radiolabeling work? What are radiolabeled compounds used for?

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3 Reasons Cleanrooms Are Important in Manufacturing

Did you know that a fume hood in a laboratory has to be checked at a minimum once a year by a certifier that is independent to ensure that it has the correct airflow that meets CAL/OSHA standards? Whether it’s in a GMP API manufacturing lab or chemical manufacturers, these standards have to be met in every lab and cleanroom.

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Clean Rooms For Dirty Environments

Pharmaceutical clean room standards meet good manufacturing practice (GMP) requirements. Clean room standards do not apply to non-sterilized items; however, for sterilized products, clean rooms are required. Even non-“clean” rooms are well ventilated and filtered. And, monitoring and maintaining a pharmaceutical clean room’s humidity–measuring plus or minus 1%–is standard when using state-of-the-art electronic sensing devices. Let’s look at the specifications of a clean room.

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Chemical Purity: Why Testing Matters

assesssing chemical purity

When it comes to testing the purity of chemicals for various applications in the medical and pharmaceutical community, the right testing matters. You want to be compliant with all laws and regulations of the company, whether your company is mostly into the lab work of most projects or you’re involved in the final completion of products and medical services, chemicals in the air can pose a safety risk and hazard. You can also be in health violation if chemical purity is not up to par.

Laboratories often replace their fume hoods for one main purpose: old age. The replacement process is something that is a concern of around 20% of laboratory owners and a third of the fume hoods replaced are old and outdated. You don’t want to put your lab technicians or other professionals at risk of injury or inhaling potentially harmful fumes, so you should consider assessing chemical purity in your establishment. Here are reasons why this matters, even if you feel like you are already abiding by all guidelines.

Your Labs May Not Be As Safe As You Think

While you have never had any quality control issues before when you do your regular routine of assessing chemical purity, you still don’t know if you are up to code with everything. GMP quality assurance is essential to operating a safe and legal laboratory so you should have the chemicals tested and have air quality assessed on the regular. This can be done in accordance with the recommendations of your quality specialist, or you can do this measure as recommended by your local state laws.

Your Labs Get Fully Tested for Quality

The best way to ensure the safety of your establishment is to have records that you work hard to keep your laboratory updated and sound. When you work with a variety of different chemical manufacturers and want to make sure you aren’t imposing on chemical purity in any way, you can help make your establishment more attractive for research and testing purposes. Universities, independent pharmacies, and other establishments may see your company in a better light and extend their service needs to your lab over others in your community.

However you want to improve the safety of your laboratory, you can do so by having your chemical purity tests done on the regular. Your specialist will be able to give you what you need for accurately assessing chemical purity in your office, labs, pharmaceutical sectors, and more.