Discussion Forum

RE: Glassware cleaning

Contribution from Jose Luis Jimenez written on 5/23/2012 at 16:33

Original contribution: Glassware cleaning written by HB on 4/25/2012 at 09:36)

Hi, in the
HUMAN DRUG CGMP NOTES, 2ND QUARTER 2001; say this:


Should lab glassware be included in a firm's equipment cleaning validation program?

Do not expect lab glassware to be included in the processing equipment cleaning validation program. Glassware must, of course, be clean and the CGMPs consider lab equipment to be included in the scope of 211.67. The assurance of cleanliness is best assessed by inspecting laboratory procedures for the use of non-dedicated glassware and other equipment, method validation (ruggedness, e.g.), and the absence of extraneous or interfering data in the results of sample analyses. Lab cleaning procedures may include repetitive rinses with the solvent used to prepare the analyte and oven drying. The equipment need not be swabbed or otherwise tested to ensure removal of potentially contaminating residues. A firm may elect to sample its glassware for residual contamination to exclude or explore the possibility of interference in the case of particularly sensitive analyses or highly difficult to clean compounds. The possibility of carryover contamination affecting a method's performance or integrity of the results is generally considered to have a low risk to product or consumers. Contaminated lab equipment, however, should not be a frequent excuse for rejecting or discarding aberrant results.

We expect that firms maintain lab equipment in a clean and sanitary manner so as to provide confidence in the results of analysis.


Best Regards.


Jose Luis Jimenez

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