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Pharmaceutical Manufacturing and Packing Sourcer

Contamination Control

Pharmaceutical companies may unwittingly be putting production processes at risk of contamination by fitting mechanical seals made from unsafe materials. Seals which fail to comply with industry regulations might slip through the net, and the solution to avoiding the contamination risk could actually be very simple.

Mechanical seals have a key function in pharma production processes. However, because they are regarded as component parts, they are often overlooked when it comes to compliance with FDA regulations and pharma current Good Manufacturing Practice (cGMP).

Crossover between the pharma, biopharmaceutical, and food and beverage sectors is routine – the use of the dairy by-product β-lactose as an excipient is a typical example. Therefore, it makes sense that both cGMP and the regulations governing food contact materials (FCMs) must apply equal weight in both sectors.

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John Smiddy is the European Regional Business Development and Technical Support Director for AESSEAL. Since joining the company in 1995, he has worked in many chemical and pharma plants, solving complex sealing problems and offering solutions to extend mechanical seal life. John has extensive knowledge of the chemical, pharma, and food and beverage industries and of the regulation around pharma production. He is a leader within AESSEAL, promoting mechanical seal standards for this sector.
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