Manual wipe cleaning toolkit
Clean Validated | Working guide | Version 2.1 | 27 October 2026
Use the forms to develop and review one defined process. Begin with T01 for the intended scope, use T04 for combination risks, and develop T02 and T05 together before confirmation. T03 records execution observations. T06 investigates departures. T07 preserves the boundaries of source evidence. T08 performs chemical unit conversion and reporting-boundary checks.
No operating concentration, pressure, overlap, area, run count or cleaning limit is supplied as a universal default. Empty fields remain unresolved.
Use and control
- Make a working copy and assign the site record ID, responsible people and applicable procedure version.
- Enter the requirement or observation, evidence reference, responsible person and date. Use Open, In progress, Complete or N/A justified. Explain N/A in the entry and link its basis.
- T03 uses Expected per SOP, Actual observation, Observation result, Deviation or evidence reference, Observer and Date. Conforms requires an actual observation; Not observed remains unresolved.
- Check each calculated completeness message. A fully populated row is ready for review; it is not a scientific acceptance or equipment-release decision.
- Use the Decision record sheet to record the manual scientific disposition: To define, Conditional, Acceptable or Reject. Link supporting evidence, conditions or actions, reviewer and date. The dropdown does not grant QA approval. Record the authorised disposition in the controlled site system and preserve raw data, deviations and sample custody.
- Read START HERE before entry. Assign the working-copy revision, preserve a controlled master, and enter data only in designated input fields. Formula cells are visibly differentiated but the sheets are not protected. Do not overwrite calculated cells; verify formulas after adaptation before controlled use.
The workbook has no macros, external data connections, electronic signatures or audit trail. It is an editable development aid, not a validated computerised GMP system. Numeric entry validation can be bypassed by paste, so formulas also check critical calculation inputs.
Forms and records
| ID | Purpose | Useful record |
|---|---|---|
| T01 | Define the SOP | Scope, hazards, materials and proposed control settings |
| T02 | Define the study | Worst cases, operators, methods, criteria and repetition rationale |
| T03 | Observe execution | Expected versus actual behaviour and any departure |
| T04 | Assess compatibility | Hazards, evidence, proposed tests and unresolved conditions |
| T05 | Map sampling | Location, area, method, controls, custody and interpretation |
| T06 | Investigate departures | Facts, impact, hypotheses, CAPA and effectiveness evidence |
| T07 | Extract evidence | Setting, endpoint, findings, access limits and commercial relationships |
| T08 | Convert chemical results | ng/mL extract concentration to ng/cm² or a censored reporting boundary |
T08 Calculation basis
Surface loading = C × V × D / (R × A). C is measured extract concentration in ng/mL. V is extraction volume in mL. D is the unapplied dilution factor. R is the approved recovery fraction. A is sampled area in cm². The output is ng/cm². This worksheet does not calculate HBEL, PDE, MACO, microbiological results or endotoxin limits.
For Quantified, enter a concentration at or above LOQ. For <LOQ or <LOD, leave the measured concentration blank and retain the numerical method limits. T08 calculates the applicable reporting boundary. It does not convert a censored result into zero or a quantified result. The boundary is not a statistical upper confidence limit.
Record sample ID, laboratory report or method reference and approval of the calculation basis. Confirm the handling of dilution and recovery to avoid applying either twice. Choose No additional correction only with R = 1. A recovery fraction above 1 needs explicit justification. No default recovery is supplied.
The numerical comparison remains unavailable if required inputs or control reviews are missing, the result class is inconsistent, the LOQ is below LOD, or values are invalid. Even a result within the numerical limit requires review under the approved site decision rule. A reporting boundary above the acceptance limit cannot demonstrate a result below that limit.
Hypothetical verification examples
| Case | Inputs and condition | Expected behaviour |
|---|---|---|
| Quantified | C 2, V 10, D 2, R 0.5, A 25 | 3.2 ng/cm² |
| Below LOQ | LOQ 0.5, same conversion, concentration blank | <0.8 ng/cm² reporting boundary |
| Below LOD | LOD 0.2, same conversion, concentration blank | <0.32 ng/cm² reporting boundary |
| Method capability | Limit 0.5 versus LOQ boundary 0.8 | Cannot demonstrate below the limit |
| Missing review | Controls accepted, raw-data review pending | Numerical comparison remains unavailable |
| Invalid area | Area 0 or missing | Input correction required, no division result |
| Double correction | No additional correction with R 0.5 | Conflicting correction basis flagged |
These are arithmetic test cases, not measured data or recommended acceptance values. The delivered workbook is blank for site entries. The test cases verify arithmetic and input handling in the supplied calculation engine; they do not establish site validation or equivalence across spreadsheet applications.
Download and adapt
Editable workbook. Individual forms in templates are supplied as DOCX, PDF, Markdown and UTF-8 CSV. The workbook is the structured editing format; CSV files carry data fields without formulas, formatting or validation. The printable forms provide space for entries and evidence references. They do not carry spreadsheet calculations.
Source basis
The forms are editorial development aids derived from the whitepaper. Annex 15 paragraphs 9.3, 10.1-10.15 and section 11 support the method, cleaning-validation and change-control questions [2]. The Annex 1 programme is addressed separately [1]. Sampling examples are informed by the interlaboratory and method-development studies [3,4].
Sources
Reference numbers are local to this publication. The whitepaper has a separate master bibliography.
[1] EU GMP Annex 1: Manufacture of Sterile Medicinal Products (2022). https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf
[2] EU GMP Annex 15: Qualification and Validation (2015). https://health.ec.europa.eu/system/files/2016-11/2015-10_annex15_0.pdf
[3] van den Berg RB, Korczowska E, Santos MSF, Portilha-Cunha MF, Ribeiro ARL, Bláhová L, Bláha L, Eyser CV, Tuerk J, van Rossen RCJM, Wilms EB, Crul M. (2025). Surface Wipe Sampling of Hazardous Medicinal Products: A European Interlaboratory Comparison Study. Drug testing and analysis. https://doi.org/10.1002/dta.3902. Full text checked.
[4] Guichard N, Boccard J, Rudaz S, Bonnabry P, Fleury Souverain S. (2021). Wipe-sampling procedure optimisation for the determination of 23 antineoplastic drugs used in the hospital pharmacy. European journal of hospital pharmacy : science and practice. https://doi.org/10.1136/ejhpharm-2019-001983. Abstract checked; detailed methods not independently appraised.