Residue control + microbial control
Evidence that clean is truly clean.
PlumGxP builds defensible studies for two different questions: was product or cleaning-agent residue removed, and does the disinfectant perform as intended on your facility surfaces?
Separate questions. Coordinated support.
Choose the evidence your program needs.
These studies complement one another, but they are not interchangeable. Each program receives a protocol designed around its own objective, materials, risks, and acceptance criteria.
Cleaning Validation & Verification
Demonstrate that residues are consistently removed using a validated nonspecific analytical method and a qualified sampling approach.
Microbial controlUSP <1072> Disinfectant Studies
Demonstrate efficacy on representative hard surfaces, supported by microbial recovery and neutralization validation.
Program 01
Cleaning Validation & Verification
We use a nonspecific analytical approach—Total Organic Carbon (TOC)—to measure organic residue without requiring a compound-specific assay. The study is designed around your product, cleaning agents, equipment, sampling locations, and scientifically justified limits.
USP <1225>ICH Q2(R2)Analytical method validation
Validation characteristics are selected for the intended use of the TOC method and may include specificity, linearity, range, accuracy, precision, detection limit, quantitation limit, and robustness.
Swab recovery studies
Recovery is evaluated from representative equipment materials at defined surface areas, using the selected swab, solvent, technique, and extraction conditions.
Rinse recovery studies
Where rinse sampling is appropriate, we evaluate recovery in the proposed rinse matrix and conditions to support meaningful residue results.
Routine verification
Once the method and recovery approach are established, PlumGxP can support scheduled or campaign-based verification samples for continued process oversight.
Clean-hold studies
We can test defined time points after cleaning to help establish how long equipment or surfaces may remain clean before use or before re-cleaning is required.
Protocol through report
Clear study design, predefined criteria, controlled execution, calculations, deviations when applicable, and a decision-ready final report.
A connected study—not a collection of isolated tests
Program 02
Disinfectant Studies
Hard-surface disinfectant efficacy studies are designed to reflect the way products are actually prepared and used in your facility—on representative surfaces, at defined concentrations and contact times, against relevant challenge organisms.
USP <1072>Hard-surface studiesRepresentative surfaces
Coupons can represent stainless steel, glass, wall and flooring materials, or other facility-specific hard surfaces included in the study rationale.
Relevant organisms
The challenge panel can combine compendial organisms with environmental isolates selected from your facility trends and contamination-control risks.
Defined use conditions
Concentration, preparation, application, wet contact time, surface condition, and other study variables are documented and controlled.
Recovery validation
The recovery process is assessed so the study can reliably recover surviving microorganisms from the test surface.
Neutralization validation
We demonstrate that the neutralizer stops residual antimicrobial activity without being toxic to the challenge organism—protecting the validity of the observed result.
Clean-hold support
Clean-hold studies can be incorporated to evaluate microbial conditions across defined time intervals after cleaning and before use.
Go beyond ideal conditions
Optional challenges for a more robust program
A useful study can deliberately examine foreseeable departures from the ideal procedure—not only a freshly opened product prepared perfectly.
Start with the process
Build a study that answers the question your Quality Unit will ask.
Bring us your product, surfaces, cleaning procedure, disinfectant rotation, or an early study concept. We will help define a practical path from protocol to final report.