Storing Pharmaceuticals: Important Guidelines to Consider

Storing Pharmaceuticals: Important Guidelines to Consider

gmp synthesis

When it comes to pharmaceuticals, proper storage is absolutely essential. Guidelines and regulations for GMP storage conditions are in place because even if a product is manufactured properly, something can go wrong if the product is stored improperly. So let’s explore a few basic guidelines to keep in mind when storing pharmaceuticals.

 

Airflow: It’s important to have proper airflow in the storage facility for two main reasons. First, to ensure that any harmful fumes aren’t stagnant in the area. And second, to aid in temperature and humidity control. Without proper ventilation and circulation, the fumes from the products can become trapped in the area and cause issues for both the staff and the product itself. So by using fume hoods, fans, and adhering to clean room standards, airflow can be properly maximized.

 

Sunlight and Heat: Pharmaceutical products need to be manufactured and stored at proper temperatures. If the temperature is too hot or too cold, the batch can be deemed unusable. So this is why monitoring temperature and sunlight is so important. Any windows in the facility should be covered if they let in direct sunlight. And all products should be stored in proper packaging to protect the products from sunlight and heat. Sunlight and heat can cause serious damage to GMP synthesis products, making temperature monitoring crucial.

 

Refrigeration: If products need to be stored in refrigerators or freezers, horizontal units are more efficient than vertical units. In vertical units, heat will still rise, making the bottom part the coldest. It’s important that products stored in refrigeration units are all stored at the same temperature. Additionally, if a storage facility has multiple refrigerators or freezers, the area should have sufficient air conditioning to combat the heat produced by the units.

Fortunately, today’s technology can help GMP synthesis storage facilities to follow these important guidelines. In fact, clean room humidity measurements can be maintained and monitored with strict tolerances as close as plus or minus 1% by using electronic sensing devices. So by adhering to these storage guidelines and investing in the proper services and technology, pharmaceutical manufacturers can ensure their products remain safe and ready to use.

Why are GMP Regulations Important in Today’s Pharmaceutical Labs?

Why are GMP Regulations Important in Today’s Pharmaceutical Labs?

radiolabeled

 

With the U.S. holding more than 45% of the global pharmaceutical market, it’s important for laboratories to abide by certain regulations. The regulations in place help to maintain pharmaceutical quality so they’re safe for consumers. Good Manufacturing Practice (GMP) regulations give pharmaceutical labs standards they need to meet to ensure their products are both safe and effective. So let’s take a closer look at why GMP regulations are so important in today’s pharmaceutical labs.

First off, what exactly are Good Manufacturing Practice regulations? Well, these regulations provide standards for monitoring, designing, and controlling pharmaceuticals. Under these regulations, the quality and purity of drug products are assessed in several ways. These regulations also see over aspects like:

 

  • Quality management system
  • Reliable testing facilities
  • Obtaining raw materials
  • Cleanliness of lab settings
  • Process validation
  • Verifying equipment

This is especially important in laboratory settings that handle potentially dangerous radiolabeled compounds. All in all, GMP standards cover the manufacturing, testing, and storing of drug products.

When a company fails to comply with GMP storage conditions, process standards, or any other regulations, any drug products the company has produced or stored is considered “adulterated”. If the FDA inspects pharmaceutical manufacturing facility and determines they have not followed GMP regulations, this does not necessarily mean the drug product is unsafe, but rather healthcare professionals will have to use their best judgment to tell their patients whether or not the drug is safe to take.

 

So, why are GMP regulations important? When a consumer buys a drug product, they have no way of knowing whether it’s safe to take or not. They have to trust that the drug was made, tested, and stored properly so they can safely use the product. And this is where GMP regulations come into play. While all drug products are tested, tests are generally done only on sample batches, not every single product. So GMP regulations are in place to ensure that each and every drug product is manufactured and stored properly. This way, if a sample batch is tested and passed, the manufacturers can assume that the remainder of the batch is good as well.

 

Overall, GMP regulations are in place to ensure every drug product and radiolabeled materials is manufactured safely. Under these regulations, the public can rest assured that the drug products they’re taking are safe to consume and use.

C14 Radiolabeling: What You Need to Know

C14 Radiolabeling: What You Need to Know

c14 radiolabelingCarbon is an element that has been used for a variety of scientific purposes over the years, like radiocarbon dating, which was developed around 1946 by Willard F. Libby. But in today’s pharmaceutical labs, carbon 14 plays a crucial role in drug development. And because of depleting supplies and increasing prices, carbon 14 production is at an all-time high. But what can carbon 14 be used for and how is it used safely? Let’s take a look at a few important things to know about C14 radiolabeling.

 

Why Use Carbon 14?

Carbon 14 is often the element of choice when it comes to radiolabeling in drugs because of the ability to produce identical chemicals by substituting carbon atoms. Because carbon occurs naturally in a lot of drug molecules, it can provide an easy radiolabeling site and can be more stable than other radioisotopes. Stability is absolutely essential, particularly during storage and when it comes to using radiolabeled compounds. And due to the long half-life of carbon 14, scientists don’t have to correct for decay if they’re using this compound in long-term studies. All in all, carbon 14 is versatile and can be custom prepared during GMP synthesis. C14 radiolabeling is essential for safe and effective drug development.

 

C14 Radiolabeling and GMP Standards

And speaking of safe and effective drug development, adhering to GMP regulations is a major factor in pharmaceuticals. During manufacturing, the radiolabeled component of choice is generally only prepared and tested once in small batches. This means that the radiolabeled compound has to be manufactured correctly before it can be used. When carbon 14 is used, the C14 atom has to be in the right position and any impurities must be made known before the compound is used in drug development. But because C14 radiolabeling results in stable, effective compounds, it makes a great choice to be used when GMP regulations need to be followed.

C14 radiolabeling is easier than using other compounds due to the ability to easily move the carbon atoms as needed. This makes carbon 14 the element that can be most effective in radiolabeling and drug development as a whole.

What Exactly Is Radiolabeling?

What Exactly Is Radiolabeling?

radiolabeling

 

Radiolabeling is a process that is frequently used in medicine, drug research and development, and environmental case studies. Using this process, researchers can track the movement or breakdown of target molecules. For instance, drug researchers can see how a new drug is metabolized as it travels through the test subject’s body. To accomplish this, atoms within the target molecule are replaced by isotopes of the same atom.

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What Kind of Fume Hoods Are Available to Today’s Labs?

What Kind of Fume Hoods Are Available to Today’s Labs?

gmp standardsWhile there are a lot of essential pieces of equipment used in laboratories, fume hoods are one of the most important devices labs have. When lab technicians are working with materials that are classified with health hazards, it’s important to work in an area that has a fume hood so the harmful fumes can be removed safely from the area. A recent survey found that about one-fifth of laboratories were planning on replacing their fume hood, with one-third of them needing to be replaced due to old age. So if you’re in the market for a new fume hood, let’s take a look at some of the most common types of fume hoods.

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3 Benefits Cleanrooms Can Offer

3 Benefits Cleanrooms Can Offer

carbon 14 production

 

With the United States being the number one largest national producer of chemical products in the world, it’s no surprise that there is an astounding number of laboratories throughout the country. And whether that laboratory is engaged in Carbon 14 production or pharmaceutical research and development, many laboratory settings contain cleanrooms. In labs, cleanrooms serve a very important purpose, and this article is going to take a closer look at the benefits cleanrooms can offer.

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Why is Temperature Monitoring Important in Labs?

Why is Temperature Monitoring Important in Labs?

gmp quality controlWhen it comes to handling sensitive items in laboratories, like radiolabeled compounds, it’s important to make sure they’re stored, worked with, and manufacturers in proper temperatures. Under proper GMP storage conditions, like in a cleanroom, compounds and chemicals can be manufactured and used correctly. Cleanrooms are an important part of any laboratory — compared to the ambient outdoor air in urban areas, which contain 35 million particles per cubic meter, cleanroom environments offer just 12 particles per cubic meter. This allows lab technicians to control the environment chemicals are used in. So let’s take a look at a few reasons why temperature monitoring in labs is important.

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How Do Chemical Manufacturers Assess Purity?

How Do Chemical Manufacturers Assess Purity?

gmp storage conditionsTesting the purity of substances is one of the most important tasks chemical manufacturers are faced with. If an impure substance is used, it could cause adverse effects. For example, a 2012 fungal meningitis outbreak that caused the deaths of 48 people was traced back to a pharmacy that hadn’t been using proper cleaning and maintenance techniques. If the pharmacy had taken more time to use proper methods in the lab, including assessing the purity of the substances used in the drug that caused the outbreak and proper GMP storage conditions, the disaster could have been prevented. So, how do chemical manufacturers assess purity? Let’s take a look at a few common methods used in today’s labs.

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The Importance of Fume Hoods in Laboratory Settings

The Importance of Fume Hoods in Laboratory Settings

14c labeling

Today’s technology makes laboratory settings safer and more effective than ever. From clean rooms to effectively removing fumes, scientists can do it all with technology. In fact, electronic sensing devices allow scientists to maintain and monitor the humidity in clean rooms as close as plus or minus 1%. But despite advances in technology, when it comes to working with hazardous materials, scientists still need to work in an area that has chemical fume hoods. Let’s take a closer look at why fume hoods are so important and some basic guidelines that should be followed.

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