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Technical Note

Effect of X-ray Inspection on Pharmaceutical Products

Cameras are commonly used for quality inspection of pharmaceutical products, but are you aware of X-ray inspection systems for the internal inspection of pharmaceutical products? X-ray inspection systems are preeminent in the inspection of non-transparent packaged drugs as shown below. However, we understand that many people are concerned about the effects of X-rays on the quality and/or physical properties of pharmaceutical products when they consider introducing such a system into their facilities. For this reason, we will discuss the effects of X-ray inspection on pharmaceutical products.

X-ray inspection image
Is drug efficacy unaltered even after the drug has been exposed to X-rays?

In order for pharmaceutical manufacturers to use X-ray inspection systems without concerns, Anritsu has been working with the Ozeki laboratory of Nagoya City University since 2011 and has been analyzing pharmaceutical products that have been exposed to X-rays. The analysis results have confirmed that there are no problems associated with the quality of preparations (results of tests on changes in drug content and pharmaceutical preparation testing). The test method and some of the test results are shown below.

●Test method

The three ingredients shown on the right were tested.

Inspection target (testing is performed with four levels of radiation doses)

The ingredients were tested at four different X-ray radiation doses to ascertain if there was any effect on the ingredients at any dose.

Testing is performed with four levels of radiation doses

●Endpoints

To evaluate the effect on the quality of pharmaceutical products and the physical properties of preparations, we established a total of six endpoints for the pharmaceutical preparation testing; drug content test, elution test, disintegration test, hardness test, content change, and appearance/sensory test. The test method and some of the test results are shown below.

●Results

In addition to the drug content test, elution test, disintegration test, hardness test, content change, and appearance/sensory test, no adverse effects caused by X-ray inspection were found when acceleration tests (1, 3 and 6 months) and a color change test were conducted.

Drug content

Drug content

Elution test

Elution test

Hardness test

Hardness test

Disintegration test

Disintegration test
Reference: ANRITSU SANKI SYSTEM CO LTD (former company name), Drug Delivery Graduate School of Pharmaceutical Sciences, Nagoya City University
Drug Development and Industrial Pharmacy 2015 41: 953-958

●Summary

None of the results showed changes that may affect the quality of the pharmaceutical products; therefore, we believe that X-ray inspections can be used without concern.
Use of X-rays for shape detection and foreign matter contamination inspection makes it possible to extend the inspection range to the inside of pharmaceutical products, where visual inspection is difficult, helping to establish a more advanced quality control system. Please contact us.

Pharmaceutical Products
Would our drugs be unaffected by X-rays?

>>> We are accepting requests for X-ray radiation tests.

If you need an X-ray radiation test to verify the effect of X-ray radiation exposure, please contact us.
We will perform X-ray radiation tests according to your use conditions such as radiation dose and irradiation duration, and report the results.
However, we do not perform an impact assessment.


Anritsu products information: https://www.anritsu.com/infivis/
Contact us: https://www.anritsu.com/infivis/contact-us

Issue: November 2018, TN1810-012JP-00 ©ANRITSU INFIVIS. All rights reserved.

References: Separate Volume of Journal of Pharmaceutical Machinery and Engineering Vol. 23 No. 4
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