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The Importance of GMP Quality Control

With today’s electronic sensing devices, the humidity of pharmaceutical cleanrooms can now be maintained and monitored with tolerances as small as one percent. Technology that helps monitor and control environmental factors is crucial for pharmaceutical, food, and cosmetic development, and related to these control factors is GMP quality control. What Are GMP Standards? Good manufacturing...

Understanding Pharmaceutical Ingredients and Compliant Manufacturing Practices

The United States produces more chemical products than any other country in the world. Pharmaceutical manufacturing involves the synthesis of active pharmaceutical ingredients (API) according to good manufacturing practice (GMP). Companies that offer API GMP solutions, tritium (3H) labeling, and carbon 14 (c14) radiolabeling (labeling with a radioactive atom or substance) can manufacture carbon isotope...

Why Pharmaceutical Companies Benefiting From GMP Storage

Pharmaceutical companies are consistently involved in research and other activities to enhance their work. They want to come up with new drugs and other biotechnology solutions to provide better products to their customers. Because of that, they are constantly looking for GMP storage solutions such as those provided by Moravek. However, every person working in...

Understanding Carbon 14 Production

When choosing radiolabeled compounds you have many options; tritium, deuterium, carbon 13, nitrogen 15 and carbon 14. For many reasons, carbon 14 is one of the most popular choices in radiolabeling. With an impressive half-life of >5000 years, as compared to tritium’s half life of 12.5 years, carbon 14 has a low energy and is...

Why Radiolabeling Services Need to Adhere to GMP Standards

Maintaining GMP standards in laboratories is important not just for ensuring staff safety, but for ensuring contamination doesn’t spread to consumer products. A fungal meningitis outbreak was traced to a pharmacy where protocols and sanitation were being overlooked. By the time the drug was recalled 48 people had already died from the contaminated drug. GMP...

What to Look for In Radiolabeling Services

In the United States, over 810,000 people are currently working in the chemical industry, including pharmaceuticals. If you are one of these individuals, then you understand how critical radiolabeled compounds can be to the testing process. Being able to track the metabolizing rate of drugs within the body is crucial for developing safe and effective...

Reasons for Choosing Carbon-14 for Radiolabeling

Radiolabeling is a scientific technique used to track the passage of a molecule. The technique incorporates a radioisotope through a reaction, cell, organism, biological system, or metabolic pathway. The reactant is labeled by replacing specific atoms by their isotope.

Understanding GMP Storage Condition Standards

Currently, the United States is responsible for 45% of the pharmaceutical market worldwide. With respect to this, GMP storage conditions are especially important in this industry. At a glance, GMP is a system that works to ensure that products are consistent and controlled with respect to quality standards. In the pharmaceutical industry, this helps minimize...

Radiolabeled Compound Handling 101

The United States remains to be the leading producer of various chemicals associated with drugs, food additives, and preservatives. With this title come several challenges, such as accidents happening in various laboratories and chemical manufacturing plants. As a leader of a chemical producing plant, you already know the accidents associated with such chemicals, especially radiolabeled...

Good Manufacturing Practice -- What Do These Guidelines Dictate?

When you are creating pure, high quality radiolabeled compounds, you need to hold your production process to the absolute highest material and clean room standards possible. There is a reason Moravek was given two large grants by the National Institutes of Health -- it is due to strict adherence to Good Manufacturing Practice, or GMP.

Understanding Carbon-14 Use In Pharmaceutical Manufacturing

In the United States, an estimated 810,000 people work in chemical production fields, including the pharmaceutical sector. In this industry, C14 radiolabeling remains the standard and is the first choice for the labeling of active pharmaceutical ingredients. This type of labeling is crucial for API GMPs, as it permits more information to be collected pertaining...

Fume Hoods: Proper Usage and Maintenance Tips

Fume hoods are an important part of any laboratory. Aiding in ventilation, these exhaust systems help remove harmful chemical fumes from the air (for instance, during radiolabeling or GMP synthesis) to better ensure the safety of scientists and personnel. Fume hoods are a crucial part of maintaining clean room standards and can prevent an excess...

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