1051 CLEANING GLASS APPARATUS
Success in conducting many Pharmacopeial assays and tests depends upon the cleanliness of the glassware apparatus used. Usage of commercial detergents or inorganic reagents for cleaning should be used when necessary.
In all cases, it is important to verify that the cleaning procedure is appropriate for the particular test or assay being undertaken. This can be accomplished in a number of ways, including use of experimental controls or verification of cleaning by utilization of residue/residual testing to ensure removal of any potential contaminants. A statement should be included in the cleaning protocol describing how the success of the cleaning procedure will be assessed.
For optical measurements, special care is required for cleaning containers, but the use of chromic acid or highly alkaline solutions should be avoided.
Some particular tests, though not inclusive, wherein the use of clean glassware is critical for success include the following: pyrogen and total organic carbon tests as well as assays of heparin sodium and vitamin B12 activity.
Selected references that might be helpful in obtaining additional information on cleaning glass apparatus are listed in the Appendix. USP does not endorse these citations, and they do not represent an exhaustive list. Further information about the cleanliness of the glassware apparatus procedures mentioned in this chapter may also be found in most quantitative chemical analytical textbooks.

APPENDIX
Additional information and guidance can be found in the references listed below or in many quantitative chemical analytical textbooks:
  1. Parenteral Drug Association. Draft—Points to Consider for Cleaning Validation (Technical Report Number 29). Bethesda, MD: Parenteral Drug Association; 1998.
  2. Anderson NR. Container cleaning and sterilization. In: Olson WP, Groves MJ, eds. Aseptic Pharmaceutical Manufacturing. 1st ed. Buffalo Grove, IL: Interpharm Press; 1987:15–22.
  3. Green C. Cleaning validation—application in the laboratory; Montalvo M. The cleaning validation policy and the cleaning validation plan; Verghese G, Kaiser N. Cleaning agents and cleaning chemistry; Verghese G, Lopolito P. Cleaning engineering and equipment design. In: Pluta PL, ed. Cleaning and Cleaning Validation, Volume 1. Bethesda, MD: Parenteral Drug Association; 2009.
  4. Gordon AJ, Ford RA. Standard glassware cleaning solutions. In: Gordon AJ, Ford RA, eds. The Chemist's Companion. Hoboken, NJ: Wiley and Sons; 1973.
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