Cleaning validation and cleaning program development
Full cleaning lifecycle support for drug, OTC, and personal care manufacturers, from detergent selection and cycle development through validation protocols and periodic review.
A lifecycle approach to cleaning
Cleaning validation shows that your cleaning procedures consistently remove product, detergent, and microbial residues to scientifically justified limits. Inspectors expect a program, not a one-time study: a cleaning validation master plan, justified limits, validated sampling and analytical methods, and ongoing monitoring.
We start with a gap analysis of your current program against regulatory guidance and industry practice. From there we help with detergent selection, CIP recipe and cycle development, and the SOPs operators follow, then write and execute the validation protocols.
Limits, grouping, and worst cases
We set maximum allowable carryover (MACO) and maximum safe carryover limits on a documented scientific basis, and use equipment grouping and product matrix approaches so you validate the worst cases instead of every combination.
Dirty and clean hold times are established by study, and swab and rinse recovery studies confirm that your sampling actually recovers the residue you are looking for from each product-contact material.
What we deliver
- Cleaning validation master plans (CVMPs)
- Program gap analysis
- MACO and MSC limit calculations
- Equipment grouping and product matrix rationales
- CIP recipe and cycle development
- Dirty and clean hold time studies
- Swab and rinse recovery studies
- Cleaning validation protocols and reports
- Cleaning SOPs and periodic review
Regulations and standards
- 21 CFR 211.67
- ISO 22716
- ICH Q9
- ICH Q2 for residue methods
- FDA guide to inspections: validation of cleaning processes
Common questions
How are cleaning validation acceptance limits set?
Limits should be justified scientifically. Common inputs are the toxicological or therapeutic profile of the previous product, the batch size and dose of the next product, shared equipment surface area, and the capability of the analytical method. Visual cleanliness is a baseline requirement alongside calculated limits.
How many cleaning runs are needed to validate a procedure?
Three consecutive successful runs is the traditional expectation, but the number should be justified by risk, process knowledge, and variability. A well-characterized automated CIP cycle and a manual cleaning procedure warrant different levels of evidence.
Do cosmetics and personal care sites need cleaning validation?
ISO 22716 expects cleaning and sanitization procedures that are defined and effective. Sites that also make OTC drug products fall under 21 CFR 211 and need a full validation program. We help mixed-portfolio sites build one program that satisfies both.
Tell us about your project
Whether it's a single qualification or an audit on the calendar, send a few details and we'll reply within one business day.