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is something that is a concern of around 20% of laboratory owners and a third of the fume hoods replaced are old and outdated.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.

How Important Is Chemical Purity In The Pharmaceutical Industry?

gmp api manufacturing

Over the years, the pharmaceutical industry has grown in leaps and bounds. Today, they have been able to formulate high-quality drugs to eradicate some of the deadliest diseases in the world and control the rest. The acceptability and efficacy of these drugs is reliant on the purity of the chemical substances used for medicinal effect also known as active pharmaceutical ingredients (APIs).

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Top 5 Methods of Assessing Chemical Purity

Top 5 Methods of Assessing Chemical Purity

The United States stands as the largest chemical producer in the world. However, the accolades should be directed to the chemical manufacturers who are involved in mixing these chemicals and coming out with a particular chemical that is used for a particular role. These manufacturers are always involved in a hard and complex task of determining chemical purity. It’s important to highlight that an impure chemical could have devastating impacts on the users, especially in the medical sector, where people use chemicals for medical purposes. But how do chemical manufacturers assess purity?

Assessing chemical purity is a complex task that involves incorporation of several styles and techniques that will give clear information on the composition of a particular chemical. The most important activity in determining chemical purity is understanding the specific components of a particular chemical and its physical or chemical properties. Some of the strategies used by chemical manufacturers to determine the purity of chemicals have been discussed below.

1. Use of Radiolabeled compounds

Radiolabeled compounds are carbon compounds that are used in chemical and biochemical processes of understanding the chemical constituents of a particular compound. Radiolabeled compounds are mostly used in the drug development stage and help in highlighting the compound formed after two or more molecules combine. Therefore, in a chemical process, radiolabeled compounds will be very useful in highlighting the physical and chemical properties of a particular product that has resulted after two or more chemicals combine. It is important to highlight that drug manufacturers know drugs by assessing physical and chemical properties.

2. Physical Comparison with Pure Standard

Physical comparison has been used in understanding the purity of a particular compound. It is the simplest method of checking purity as it only involves comparing a particular chemical with a certified pure sample. There is an argument against the use of physical comparison, but it is obvious that this method can show significant differences between products. Physical comparison is very useful in revealing large impurities such as colored impurities and dirt. Smell tests will also reveal the differences between the chemical undergoing tests and the actual and pure state of a particular compound. However, it’s important to note that only non-toxic chemicals can be tested through touch, taste, and smell.

3. Boiling and Melting Point Determination

It is obvious that the physical properties of a chemical can be used to indicate whether it is pure or not. Most of the chemical products have defined boiling and melting points. Pure chemicals are known to boil and melt at specific temperatures, and that is documented. However, if the melting point of a particular chemical is lowered, there is a great sense that the chemical is not pure. The boiling point will be higher than normal. This is a simple method of determining the purity of a product and is highly applied in various chemical manufacturing plants.

4. Colorimetric Methods

The colorimetric method is another widely used strategy of determining the purity of a chemical compound. Biochemically, some chemical compounds change into a particular color when they are exposed to a certain chemical. This is widely known, documented, and used as a standard way of determining the purity of various products. One of the major applications of the colorimetric method is in determining the presence of specific illegal drugs such as cocaine and heroin. Colorimetric purity testing is highly preferred because it does not only indicate the purity of a chemical but also the percentage purity.

5. Analytical Testing

Although other methods of testing purity are highly appropriate and advanced, analytical testing is the most accurate and highly preferred method of testing chemical purity. Analytical testing involves a standard procedure that is used in testing various chemicals. These procedures are applied in drug and chemical industries, and they indicate the presence and the number of impurities. Some of the analytical purity testing methods include titration, infrared spectroscopy, paper chromatography, and optical rotation, among others.

These are some of the strategies used in testing the presence of impurities in chemical compounds. However, the method that one applies depends on the resources available, the magnitude of the entire process, and the chemical under consideration. However, any method is likely to indicate the presence of impurities in a particular chemical.

Types of Radiolabeling

Isotopic Labeling

radiolabeling

Radiocarbon dating, the backbone of Isotopic Labeling, was developed by physicist Willard F. Libby in the 1940s. Over the last 80 years, there have been a number of advances that have increased the scope and application of Libby’s method. This is mostly done with radiolabeling.

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Ductless Fume Hoods: 5 Benefits That Every Clean Room Can Take Advantage Of

fume hoods

The U.S. holds over 45% of the global pharmaceutical market. Our dominance of scientific and medical fields has allowed us to raise the bar when it comes to the development and circulation of life-saving and life-changing medications. Before these medicines can be offered to the general public, however, they must undergo a grueling testing period; clean room standards must be met to ensure that they aren’t tainted or contaminated. From GMP storage conditions to GMP quality control, there are a number of steps and tools that play a major role in this sterile environment. Let’s take a look at some of the benefits that ductless fume hoods in particular offer.

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US Chemical And Manufacturing Industries Oppose Tariff Hike On Chinese Imports

chemical manufacturers

The U.S. is the number one largest national producer of chemical products in the world. Our scientific and medical advancements — and dedication to GMP standards and GMP quality control — allow us to dominate the market; everything from radiolabeled compounds (Tritium, a radioactive isotope of hydrogen, is often used) to GMP synthesis originates in this country. With the new tariffs on Chinese imports, however, that may change.

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