INSIDER INSIGHT
Coming Clean on Quality in the Chemical Manufacturing Lab
Ed Price President
PCI Synthesis
The price of ensuring quality in chemical manufacturing goes far beyond cost. Hopefully, quality problems are caught before they can affect pa- tients but even then, such problems can make or break a manufacturing organization. In the U.S., while it takes significant effort to earn and maintain cGMP standards, quality control can be the difference between a CMO’s success and failure in the race to commercialize vital drugs.
One of the key areas that best-in-class companies need to consider to ensure the most effective standards of quality in the lab is in cleaning of equipment and ensuring clean room operations.
Cleaning of Equipment
Facilities that manufacture multiple products may share the same equipment, which can significantly increase the potential for cross-contamination. So it’s critical that extreme caution be taken to properly clean equipment. cGMP requires that cleaning procedures and the analytical methods used for analysis of their samples are demonstrated to be effective and repeatable, which is known as validation of cleaning procedures and analytical methods. By assessing the toxicity and potency of existing residue on potential human consumers of the next product to be manufactured in the same equipment, labs can reduce the levels of existing process residue to meet a predetermined specification.
Ed Price is President of PCI Synthesis (www.pcisynthesis.
com), a 15-year-old custom chemical manufacturer of new chemical entities (NCEs), generic active pharmaceutical ingredients (APIs), and other specialty chemical products.
10 Pharmaceutical Outsourcing | Insider Insight 2016
Rinsing, soaking, or spraying equipment surfaces with a liquid-medium, boiling a solvent inside the enclosed space of a piece of equipment, or manual scrubbing or wiping of equipment surfaces are all different cleaning techniques. The appropriate cleaning techniques are determined based on equipment design, yet choice of cleaning techniques may also be limited by the nature of the residue. If a residue (e.g. certain polymers) is not soluble in any known solvent, the choice of cleaning technique is limited to those that rely heavily on mechanical force such as manual scrubbing/wiping or impingement by a high-pressure liquid stream.
The effectiveness of a cleaning procedure is demonstrated by analyzing rinse and swab samples taken from equipment. In order to obtain a sample
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