Category Archives: Cleaning Validation

Cleaning Validation: Detergent Removal

Detergents

Hello good people of the world! Today’s blog post is about verification of detergent removal in cleaning validation. As we know, cleaning validation is concerned with leaving process equipment clean; that means not residual API, excipients, or detergents. One unique problem with detergents is that, while we typically know in detail the composition of APIs and excipients, detergent composition may be proprietary and not available to the end-user. Continue reading Cleaning Validation: Detergent Removal

Recovery Studies – What the Heck?!

Recovery

Hello, good people of the world! Recovery studies are studies to support surface swab processes. They typically involve “spiking” a “coupon” made from a particular material with a known amount of the contaminate you’re interested in, and then systematically quantifying the amount recovered via the swab process.

You’ll need to perform recovery studies for all product-contact materials you have in your manufacturing process. These typically include 316L stainless steel, PTFE, glass, etc.

Parts Washer Qualification – PQ

Parts Washer

This post is about Parts Washer qualification. This covers any manner of automated system that cleans parts out-of-place (Clean-out-of-place = COP). This includes process parts washers, glassware  washers, laboratory parts washers, etc. all of which may be termed COP washers.

The scope of a performance qualification of a washer is the performance of the equipment with defined recipe(s) and load(s). Be sure to capture the recipe and load configuration in the protocol prior to execution or as part of the execution itself. This is how the recipe and load configuration become “validated.” The recipe includes all steps and parameter values, and the load includes what parts or components will be washed and how they will be arranged. You’ll need to include a picture or diagram. Continue reading Parts Washer Qualification – PQ

Cleaning Validation – Visual Inspection

Visual Inspection

Visual inspection is actually a method used to collect data against an acceptance criterion.

Per PDA’s Technical Report 29 “Cleaning Validation” (2012) you only need a quantitative visual limit if visual examination is the only method used and visually clean is the only acceptance criterion. According to the report, if you are using visually clean as an acceptance criterion in conjunction with swab or rinse sampling, you do not need to quantify the visual limit and what “visually clean” means.
If you do need to quantify the visual limit, you can do so by spiking coupons with solutions at different surface densities (e.g. microgram/cm2 or ppm) and having a panel of qualified personnel determine at which level the residue ceases to be clearly visible. Distance, lighting, and viewing angle need to be considered.