cGMP

Q. We have consulted your continuous exposure compatibility information for one of your detergents on various materials. We were wondering about the details of conditions used in formulating this documented info, such as temperature, detergent concentration and period of time in which these observations were made.

A. It is important to keep in mind that these documents are created for guidance and reference purposes and are based on our vast critical cleaning experience in laboratory and manufacturing settings.

Equipment used in pharmaceutical manufacturing must be cleaned before each use, and the cleaning procedure used must be in accordance with good manufacturing practices (GMPs). There are different types of CIP including, single pass systems and recirculation system. No matter which type is used, Alconox, Inc. provides support to meet cGMP regulations and detergents ideally suited for CIP systems.

Q. Are Alconox products FDA approved cleaners or detergents? Our customers need to clean pharmaceutical manufacturing equipment and medical device surfaces in compliance with Good Manufacturing Practices requiring a cleaning validation that shows that no interfering residues were left. The use of a US Food and Drug Administration (FDA) approved cleaner is desired.

Q. Why is critical cleaning necessary for the pharmaceutical industry? Are Alconox brand cleaners formulated to be used in the pharmaceutical industry?

Alconox answers the question; “What is pharmaceutical cleaning validation”? Learn more about compliance with cGMP regulations for all Alconox cleaner brands