Is your laboratory glassware clean?

Are you inspecting your glassware for defects?

Laboratory glassware cleaning is an important part of your equipment cleaning procedures. While that may seem obvious, oftentimes this portion of cleaning validation is overlooked. According to CFR 211.67, “Equipment and utensils shall be cleaned, maintained, and, as appropriate for the nature of the drug, sanitized and/or sterilized at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements.”

A company recently received this 483 observation: 

…..Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

Specifically, the effectiveness of laboratory glassware cleaning procedures and lifecycle related practices do not ensure adequately clean volumetric glassware employed for the quantitative analysis of regulated drug products. During the inspection we noted laboratory volumetric glassware (flasks) with etching, pitting, and residual compounds, including sharpie markings. These markings could be removed from the glassware by rubbing.

The majority of FDA 483 citations involve cleaning and sanitation processes. Something as simple as dirty glassware can prompt a citation, so be sure to keep your glassware sanitized.

For more observations pertaining to laboratory controls see Issue 1022 available today.  It also has observations pertaining to manufacturing controls, medical device controls and sterile manufacturing controls.

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