Cleaning Validation Samples
Cleaning contamination identification

Cleaning Validation Sample Testing

Ensuring Effective Cleaning Validation in Pharmaceutical Manufacturing

Cleaning validation is a critical GMP requirement. Regulators expect robust evidence that manufacturing equipment is effectively cleaned between product campaigns, preventing cross-contamination and ensuring patient safety. A key part of this validation is the sampling and testing of equipment surfaces and rinse waters.

Honeyman Laboratories provides a complete cleaning validation support service — from onsite sampling by trained GMP personnel to MHRA-approved laboratory analysis and interpretation of results. By integrating with the wider Honeyman Group expertise, we ensure that your cleaning validation programme meets the expectations of the MHRA, FDA, EMA, PIC/S and WHO.

Sampling Methods We Support

We provide both direct and indirect sampling approaches in line with global regulatory guidance (EU GMP Annex 15, FDA Process Validation Guidance, PIC/S PI 006):

Swab sampling of equipment surfaces using validated recovery techniques and defined surface areas (commonly 25 cm² as recommended in PDA TR29)

Rinse water sampling for indirect assessment of equipment cleanliness, particularly for hard-to-reach areas

Visual inspection protocols in accordance with Annex 15

All samples are taken under strict GMP conditions, transported under validated chain of custody, and analysed in our own laboratories to ensure data integrity and regulatory compliance.

Analytical Methods

Our laboratories perform a wide range of compendial and bespoke analyses for cleaning validation samples, including:

Total Organic Carbon (TOC) for non-specific detection of organic residues (Ph. Eur. 2.2.44, USP <643>)

High-Performance Liquid Chromatography (HPLC) for product-specific residues, degradants and cleaning agent traces (USP <621>, Ph. Eur. 2.2.29)

Gas Chromatography (GC Headspace) for residual solvents in line with ICH Q3C and USP <467>

Conductivity and pH to verify cleaning agent removal (Ph. Eur. 2.2.38, USP <791>)

Microbiological analysis for bioburden and endotoxins where applicable (Ph. Eur. 2.6.14, USP <85>)

Where required, Honeyman develops and validates bespoke analytical methods specific to the product or cleaning agent being assessed.

Acceptance Criteria and Recovery Studies

Cleaning validation acceptance limits are generally based on toxicological or dose-based calculations, supported by visual cleanliness as per EMA/ISPE guidance. Common approaches include:

Not more than 10 ppm of a previous product in the next batch

Not more than 0.1% of the minimum therapeutic dose of the previous product

TOC acceptance levels typically set at ≤500 ppb for non-specific testing

Honeyman performs recovery studies to confirm that swabbing and rinse sampling methods can reliably recover known amounts of residue from representative surfaces, ensuring that negative results are valid and defensible.

Why Choose Honeyman?

End-to-end service: GMP-trained samplers onsite, validated transport, MHRA-approved lab testing

Full GMP compliance aligned with Annex 15, FDA Process Validation Guidance, ICH Q7 and PIC/S standards

Analytical flexibility with both compendial methods and bespoke method development

Regulatory confidence with audit-ready documentation and trending data packages

Part of the Honeyman Group, integrating with Honeyman Water engineering and consultancy for system-level improvements

Lifecycle Support

Cleaning validation is not a one-off activity. Honeyman provides ongoing support for periodic revalidation, trending of TOC and HPLC results over time, review of acceptance limits, and remedial action planning in the event of non-compliance.

With Honeyman, you gain a partner that provides complete lifecycle support, ensuring your cleaning validation programme remains effective, compliant and inspection-ready.

Partner With Honeyman

Cleaning validation failures are one of the most common causes of regulatory findings. Partner with Honeyman Laboratories for trusted GMP sampling, laboratory testing and documentation that keeps your products — and your patients — safe.

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