One cannot overstate the value of quality assurance in the pharmaceutical industry, especially when it comes to the application of active pharmaceutical ingredients (APIs). By employing a comprehensive set of activities, quality assurance systems help ensure these components—which are responsible for patient recovery—meet industry regulations. If they don’t, it can cause disaster for the company and negatively affect consumers. Read on to learn about the importance of quality assurance for APIs.

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When pharmaceutical companies need to monitor how people metabolize drugs that they are testing, they often turn to tritium. This radioisotope is useful in the radiolabeling process as researchers strive to preserve people’s safety in the consumption of pharmaceuticals. However, it requires stringent controls when used in labs. Read on for a guide outlining the best practices for handling and storing tritium.

How To Handle Tritium

Tritium is a rather small source of radiation that can’t travel through a person’s skin. However, it can still be hazardous if someone accidentally consumes it. This danger requires researchers to exercise caution and follow certain practices when working with this radioisotope.

Create a Special Area for Working With Tritium

One practice that researchers should follow when working with tritium is establishing a specially designated area for their work. This is essential for maintaining a controlled environment and preventing cross-contamination.

Mark your space clearly with appropriate signage indicating the presence of radioactive materials and restrict access to trained personnel only. Researchers should also equip the area with specialized containment systems, such as fume hoods with proper filtration, to capture any tritiated vapors that the material may release during procedures.

Surfaces should consist of materials that are easy for workers to decontaminate, such as stainless steel. Additionally, personnel should regularly monitor the space for any signs of contamination using appropriate detection equipment. This segregation minimizes the risk of accidental exposure and environmental contamination, improving your company’s overall safety and regulatory compliance.

Wear Protective Gear

Another best practice for handling tritium is using protective gear as you work with it. Researchers must wear items such as lab coats, gloves, and protective eyewear that will shield them from potential radiation exposure. Additionally, they may need to use masks or respirators to prevent them from inhaling tritiated water vapor.

Forbid Eating or Drinking in the Special Area

To further mitigate the risk of contamination, you need to prohibit your workers from eating and drinking in the designated tritium handling area. Ingesting food or beverages within this space increases the risk of a researcher exposing themselves internally to tritium.

Strict adherence to this rule ensures that any accidental contamination doesn’t lead to ingestion, thereby safeguarding the health and safety of personnel. Posting clear signage and providing employees with training on safe practices can help you enforce compliance with this essential safety practice.

Decontaminate Lab Surfaces After Use

Thorough decontamination of lab surfaces after handling tritium is essential for preventing residual contamination and reducing the risk of accidental exposure. You must clean all work surfaces, equipment, and tools used in the handling of tritium with appropriate decontamination agents.

In addition, conduct wipe tests to confirm the removal of radioactive contaminants, and address any discovery of contamination immediately. Make sure you equip your laboratory spaces with decontamination kits and train your employees so that they follow standard decontamination procedures meticulously. Proper decontamination ensures a safer working environment and facilitates regulatory compliance by maintaining low levels of radioactive contamination.

Dispose of Protective Gear When Finished

You should also dispose of your protective gear after handling tritium. Carefully remove your used protective clothing, such as lab coats, gloves, and respirators.

Place the gear into designated radioactive waste containers that you have clearly labeled. Use containers that consist of durable, leak-proof materials.

Personnel should follow established protocols for removing and disposing of this gear to minimize exposure to any residual radioactivity. You should perform regular audits and training sessions to ensure adherence to these disposal guidelines, thus allowing you to maintain a safe and controlled environment.

How To Store Tritium

Storing tritium before or after lab work also requires several important considerations.

Be Careful When Storing It as a Gas

Storing tritium as a gas can be advantageous for researchers since that is the form in which this radioisotope is most available. However, researchers must be careful. If a container containing tritium as a gas suffers a leak, it will result in more rapid contamination than it would in the form of a solid or liquid.

Use Hydride Beds When Storing Tritium

Another strategy to consider when storing tritium is using hydride beds, which can provide an effective and secure containment solution. Hydride beds work by absorbing tritium at relatively low pressures and temperatures, forming a solid metal tritide that significantly reduces the risk of tritium release.

This method benefits from the stability and efficiency of hydride materials, which can safely bind large amounts of tritium within a compact form. The storage containers designed for hydride beds are typically robust, leak-proof, and made from materials compatible with tritium.

In addition, the beds will take out impurities from your tritium whenever you put it into storage or retrieve it, allowing you to work with a less contaminated radioisotope. By using hydride beds for solid tritium storage, you can achieve a higher level of containment security, mitigating the risks associated with tritium leakage and exposure.

Consider Disposing of Tritium After Use

Given the potential hazards associated with tritium, you may also want to consider forgoing storage and disposing of it properly after you use it to ensure the safety of your work environment. If you choose this option, make sure you follow established protocols for its disposal.

This may involve transferring the tritium to an authorized disposal facility that has the proper equipment to handle radioactive waste safely. The disposal process typically requires meticulous documentation, including tracking the quantity of tritium, its form, and the procedures followed for secure transport. By prioritizing the disposal of tritium after its intended use, organizations can significantly reduce long-term risks to personnel, the environment, and regulatory compliance, ensuring that they manage radioactive materials responsibly and effectively.

By following these practices when working with tritium, you can better manage the risks of contamination from this radioisotope. If you’re looking for a tritium labeling services provider with extensive expertise, contact Moravek. We can connect you with the right labeling method that will meet the needs of your research project and your budget.

Best Practices for Handling and Storing Tritium

When a pharmaceutical company manufactures a medication, workers should focus on preventing the products from contamination. If this were to occur, the stakes would be exceptionally high. A single lapse in purity can have severe consequences. Read on to learn about the dangers of product contamination in pharmaceuticals and who it affects.

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Pharmaceutical companies must follow Good Manufacturing Practice (GMP) standards to create safe and effective products for consumers. However, some pharmaceutical executives may believe falsehoods about these standards when operating their own firms. This blog aims to dispel common GMP myths and misconceptions, allowing you to get your company up to code.

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When consumers purchase medications for their health conditions, they do so with the expectation that manufacturers have produced these drugs with techniques that preserve their integrity and make them safe for consumption. One process that helps them meet that expectation is lyophilization. Read below to understand the role of lyophilization in pharmaceuticals and how it can help your company produce effective drugs with a longer shelf life.

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Professionals in the healthcare sector rely on many tools to develop new treatments and diagnose medical issues. However, one naturally occurring non-radioactive isotope has gained a more prominent role as a useful tool: carbon-13. Discover the common applications for carbon-13 in the medical field and how its use has proven advantageous.

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Radiolabeling has undeniably revolutionized drug discovery and development processes, allowing researchers to take a deeper look at drugs during human trials. Tritium is one isotope scientists use in this process and has proved to be invaluable. Read this brief look at the role of tritium in radiolabeling and what has made its application so beneficial.

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When some people hear the terms “drug substances” and “drug products,” they might think these are one and the same. However, the meanings of these phrases are quite different. Knowing these distinctions can help you successfully achieve your goals in the pharmaceutical industry. Read on to learn about the difference between drug substances and drug products.

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A compound’s purity is critical for pharmaceutical companies since it can directly affect a drug’s therapeutic efficacy and safety profile. This makes compound purification more than a procedural step in drug research and development. Read on to understand compound purification practices and how they work.

What Is Compound Purification?

Before we review the various practices, it’s important to understand how compound purification works. It is the process of removing a substance from a chemical compound. The goal is to isolate and remove impurities, leaving behind a product of the highest possible purity.

What Are the Various Purification Methods?

Now that you know how this procedure works, you can gain an understanding of compound purification practices. The diversity of chemical compounds necessitates a range of purification techniques for different impurities and physical states of the target compound. Let’s take a closer look at several of the methods.

Filtration

Filtration is especially useful in separating solid impurities from liquid samples. With the help of a porous barrier, scientists can separate solid particulate matter from the liquid.

Sublimation

Another technique is sublimation, which scientists use to purify compounds that transition directly from a solid to a gas when heated, bypassing the liquid phase. This method is particularly effective for separating volatile compounds from non-volatile or less volatile impurities.

Crystallization

Crystallization involves dissolving a solvent at high temperatures and cooling the solution. After the pure compound becomes a solid, you can separate it from the impure portions.

Distillation

When scientists perform distillation, they separate portions of a liquid at various boiling points. They will heat the mixture to vaporize the most non-volatile component. Then, they condense it into a liquid form in a separate container.

Chromatography

Chromatography involves separating components of a mixture with porous mediums. After the ingredients undergo this separation, scientists can obtain the pure components they need. This method is incredibly precise and indispensable in the analysis and purification of complex mixtures.

As we’ve seen, compound purification is a critical aspect of pharmaceutical research and laboratory work. Moravek can help you in this process with high and ultra-high-performance liquid chromatography that determines the radiochemical purity of your substance. We have experience in assisting clients as they advance their scientific discoveries and ensure the safety and effectiveness of their pharmaceutical products.

A patient undergoing treatment for their medical condition can feel at ease knowing the treatment passed a clinical trial to ensure its effectiveness and safety. Read below to learn what goes into clinical trials and studies to ensure your tests will be thorough.

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Patients taking prescriptions expect their medications to be safe for consumption and provide them with an effective dosage that will allow them to get better. However, chemical compound degradation can get in the way of these goals and have a devastating impact on your business. Read on to learn about the dangers of chemical compound degradation and how you can ensure the highest standards of drug safety and effectiveness.

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When you need custom chemical synthesis services, you want to ensure you hire a qualified contractor. After all, your choice can strongly impact the quality and outcome of your project. Here are five things to look for in a custom chemical synthesis company to ensure the success of your work.

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