Q. Our pharmaceutical company is transferring product manufacture to a different one of our facilities. We used a CIP cleaning process with Citrajet detergent and are going to have to perform validation and verification tests again. What information do we need for our testing? Chemical properties might be helpful as well as the science on how this chemical works. We would also need information on disposal and the requirements for allowing this to flow to normal process drains. Any help you can provide is appreciated.
A. Here are some key pieces of information you should find helpful, in addition to our SDS and technical bulletin downloads, when Cleaning in Place (CIP) with Citrajet® Low Foaming Liquid Acid Cleaner.
Citrajet Detergent Ingredients and Functions:
- Citric and glycolic acids: provide acid chelation to bind and form water soluble complexes with acid labile inorganic residues. Also provide an acid cleaning medium that inhibits the formation of positively charged amine and other residues that tend to stick to stainless steel (which is typically negatively charged). Also inhibits precipitation of alkaline insoluble calcium, magnesium, iron and related complexes.
- Emulsifiers: to form micelles that emulsify and remove hydrophobic oily organic residues. Forming liquid/liquid mixtures that can be rinsed away and remove liquid residues off of a surface.
- Dispersants: bind to and assist in lifting and holding insoluble particulate residues in solution and stops them from redepositing on surfaces being cleaned.
- Wetting agents: reduce the surface tension of the cleaning solution and allow the acids, dispersants and emulsifiers to penetrate and access the surface residues they need to clean.
Typical recommended cleaning conditions in a spray Clean-in-place (CIP) system with Citrajet:
20 minutes of circulating at 80C in a 1% Citrajet solution (10 mL/L) followed by a thorough rinse is a typical CIP cleaning regimen for tanks and mixers with challenging pharmaceutical tablet coating residues (this can often be preceded by an alkaline wash with Solujet® Low-Foaming Phosphate-Free Liquid). Every 10C you go up, doubles the cleaning speed. Therefore a comparable cleaning regimen can be achieved at 10 minutes/90C, or for example, 80 minutes at 60C.
Use higher concentrations of detergent for heavy thick, high quantity of residue cleaning. A very thin film of residue might be perfectly well cleaned by a 0.5% solution of Citrajet (5 mL/L). A very heavy thick ointment residue might require as much as a 5% dilution of Citrajet (50 mL/L). Concentration dictates detergent capacity.
To remove waxes and silicon oil residues it is often important to be above 75C (as well as employing more powerful detergents – ex. Keylajet® Low-foaming High Alkaline Liquid.) Very large tanks may require more than 20 minutes, small tanks with little geometry and mixing equipment may be cleaned notably faster than 20 minutes.
Citrajet residue detection:
Typically to detect Citrajet residues, you use HPLC to detect Citric Acid which is present at 15% (w/w) in Citrajet. On request we can provide Citric acid HPLC methods if you do not already have such a method. You can also do glycolic acid detection by HPLC for residue detection.
Other possible methods to detect Citrajet include Total Organic Carbon (Citrajet has 14% (w/w) total organic carbon). In some cases visual inspection techniques can be considered.
To request these or any Alconox Inc. detergents for free, please complete the questionnaire at Get Sample. For more information about any one of our Alconox Inc. detergents, consult the technical bulletin for each product. Or click here to access each of our detergent’s Safety Data Sheets.
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