Contamination inspections of compound pharmaceutical manufacturers increasing

Pharmaceutical companies have to follow strict guidelines to prevent contaminated products.

Pharmaceutical companies have to follow strict guidelines to prevent contaminated products.

The pharmaceutical industry is reliant on manufacturing the most pure and dependable products, as many components can alter a final medication. Companies in the industry now use heat exchangers to prevent any contamination in the manufacturing process.

Recently, several patients of the Corpus Christi Medical Center in South Texas began to run fevers after surgeries and operations, which had doctors racing to find out what was causing the problem. According to USA Today, when the sick patients were tested, they all showed signs of a bacterial infection called Rhodococcus equi, which most commonly affects horses, cattle and sheep.

The doctors quickly discovered all the patients were taking calcium gluconate, which was manufactured several hundred miles away at a pharmaceutical laboratory, USA Today reported. The compounding facility that made the drug was forced to recall batches made specifically for hospitals and doctors to administer.

"You think because there are so many controls on drugs that you're not going to be given something that will make you sick," said Eloise Soler, a patient who took months to recover from the bacterial infection from the contaminated medications, USA Today reported. "I just couldn't believe it."

FDA upping inspections
The Federal Drug Administration recently began doubling its pharmaceutical inspections for fungal infections after just one Massachusetts-based laboratory had a fungal outbreak that sickened 749 people in 20 different states and killed at least 63 patients who took the faulty medication, NBC News reported.

Once the FDA checked the laboratory, instances of contaminated medications with bacteria and fungi were discovered. According to the source, the facility was shut down for shipping large batches of the product across the nation.

The FDA explained that many pharmaceutical manufacturers in the U.S. are like the facilities in Massachusetts and Texas, which make massive batches of a product, the source reported. Pharmaceutical laboratories understand that one minor mistake in the manufacturing process can lead to multiple instances with batches being sent out to different locations.

According to USA Today, in the last two years, more than 50 recalls have been made by compounding pharmacies because of multiple drug recalls.

Using shell and tube heat exchangers designed to correspond with American Society of Mechanical Engineers (ASME) bioprocessing equipment (BPE) standards can prevent contamination with features such as a double tubesheet design. Original equipment manufacturers should consider the highest quality heat exchangers for their pharmaceutical laboratories to improve efficiency and create a safer product for consumers.

Posted in Regulatory Compliance

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