Tablet Defects in Pharmaceutical Manufacturing : Pharmaguideline

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Tablet Defects in Pharmaceutical Manufacturing

Tablet defects can occur in a variety of ways, but the most common culprits are improper manufacturing processes or defective raw materials.
Defected tablets are the most common problem in pharmaceutical manufacturing. These defects may occur in any stage of manufacturing from raw material to final product packaging. The defects may occur due to any human error, equipment malfunction or any environmental factor. In this article, we will focus on tablet defects that occur during manufacturing.

Millions of tablets are produced every day by the pharmaceutical manufacturers. But every tablet looks defect-free, it took hard work and checks at every stage of manufacturing. By this, the company can produce defect-free medicines consistently for patients.

Defects in tablets may occur in any type of tablet due to different causes. For example, they can be caused by issues with the manufacturing process like any equipment malfunction or any change in equipment setting or sometimes it may occur due to human error. These tablet defects can have serious consequences that can cause harmful effects on patients.

tablet defects
Pharmaceutical companies take many steps to avoid these problems. They take samples at every stage of manufacturing and check for defects. Some automated systems are also used at different stages of the manufacturing process to check the defect and prevent the defective product from going out in the market.

Defects in Tablets during Manufacturing
Defects in tablets can arise due to problems in core tablets such as lump formation or poor compression. Some defects may occur due to problems in coating solution composition or method of coating like improper spraying of coating solution. Sometimes defects may occur in the final stage like cracking or creasing of the tablets.

Tablet defects have a significant effect on pharmaceutical product quality. They can occur at any stage of manufacturing and reduce the yield and increase the manufacturing cost. In some cases, defects can have an impact on patient safety. To avoid these problems of tablet defects, all possible sources of errors should be eliminated, those can occur during the manufacturing process. This will ensure to meet the customer expectations and production of defect-free products. To achieve this defect-free production, manufacturers need to take a number of steps such as using high-quality raw materials and equipment as well as an effective quality control system.

Causes of Tablet Defects
Tablet defects may occur in a variety of ways but the most common causes are raw material and manufacturing processes. The following are the 5 most common causes of tablet defects.

1. Inadequate Tablet Compression: Compression is one of the key steps of tablet manufacturing that compresses the powder into the tablet form. Inadequate compression can make the tablets too soft they can break easily during transport or during further steps like coating and packaging.

2. Incorrect Tablet Shape: Incorrect tablet shape is another common tablet defect that causes problems. Too round or too oblong tablets with sharp edges may have cracks easily on their edges during shipping and transportation.

3. Inadequate Tablet Coating: Coating is the protective layer of the tablet and protects the tablet from environmental conditions. But improper coating can cause defects in the tablets. It includes the improper coating solution composition, coating solution spray, or coating machine settings like rotation, spray rate or aeration.

4. Poor Quality Material: Finding the high-quality raw material is challenging for pharmaceutical manufacturers. One poor-quality ingredient can lead to the production of poor-quality tablets.

5. Faulty Manufacturing Process: A faulty manufacturing process is a leading factor in tablet defects. Issues like bubbles in the coating solution or excessive drying of material or tablets during the coating process can cause defects in the tablets. These defects look small during processing but show their high impact on finished products.
Related: Tablet defects pdf

Solution of Tablet Defects
The tablet manufacturing process is a delicate process that should be followed properly and correctly to produce high-quality products. Unfortunately, a best-managed manufacturing process can also lead to tablet defects. Defects in tablets can occur at any stage of the manufacturing process but they generally occur at the compression and coating stage of manufacturing. Following are some solutions that can help to minimize the defects.

1. Use High-Quality Raw Material: The quality of the high-quality ingredients will ensure high-quality products. It is to make sure that all ingredients used in manufacturing are of good quality and passes the specifications.

2. Follow Good Manufacturing Practices (GMP): Keep to follow good manufacturing practices strictly will help to keep the defects away from the products. These GMP guidelines include the proper control and supervision of the manufacturing process and testing of the raw material and final product before they are released to the market.

3. Use Automated Systems: As we know automated systems are error-free so use of them can reduce the possibility of any human error. They are faster than humans to save time and money.

4. Use of Quality Control Measures: Quality control checks at different stages can help to identify the problems at early stages before they affect product quality.

Tablet defects have a significant effect on the tablet quality that can have an impact on patient health. If you are involved in tablet manufacturing, you need to understand the risks associated with the tablet defects and you essentially need to take steps to prevent them. If you are facing any problems to resolve the tablet defects, you can contact us.

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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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