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closed bioprocessing

Closed Bioprocessing Cleaning Recommendations

Q: We are a mid sized small biomolecule drug manufacturer and currently use several Alconox, Inc. products in our cleanroom and manufacturing suites.  We are looking at implement (functionally) closed bioprocessing.  Are there any recommendations you can provide?
A: Some time ago, I heard a senior executive of a large biotech company express a desire to produce drugs in a “conference room.”  That day is pretty much here. 

Lab Glassware

Cleaning Glassware with Adhesives and APIs

Q. We have glassware that contains adhesive and API dissolved in organic solvents. If we do not do additional organic rinses prior to the aqueous rinses we have issues. Is there any way we can avoid the organic rinses?
A. To avoid organic rinses, you can soak in a high emulsifying cleaner such as a 1% Alconox solution (1.25 oz/gal or 10 g/L) prior to aqueous rinsing. Ideally soak in a warm or hot solution for fastest and most reliable results. The emulsifiers in Alconox will emulsify the solvents and active pharmaceutical ingredients (API). Be sure to rinse at the same temperature you are soaking at so you do not break the emulsion and redeposit the API or solvents. If you soak hot . . .

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