Don’t Clean Centrifuges While Sample Runs Are In Progress

Don’t Perform Centrifuge Cleaning During Active Sample Runs

Remember: Never clean centrifuges while samples are being processed — it risks imbalance, contamination, and invalid results in GMP testing environments.

Why This Matters in GMP

Centrifuges are precision instruments used to separate components based on density. Cleaning them during active sample runs can introduce vibration, disrupt temperature control, or create air currents that interfere with spinning rotors. Additionally, cleaning agents may accidentally enter the chamber or come into contact with open vessels, leading to chemical contamination or invalidation of test data.

For example, if a lab technician wipes the rotor housing with an ethanol-based solution while the centrifuge is mid-cycle, vapors could condense on sample tubes or interact with proteins or reagents — altering test results or invalidating the entire analytical run. Such incidents introduce variability and data integrity risks.

Also Read: Label Cleaning Equipment with Area of Use to Prevent Cross-Contamination

Regulatory and Compliance Implications

21 CFR Part 211.160 requires that equipment used in laboratories be maintained and operated in a manner that ensures accuracy and reliability. EU GMP Chapter 6 emphasizes equipment cleaning protocols and timing, while WHO GMP discourages any actions that might interfere with in-process analytical activities.

Auditors assess lab cleaning schedules, centrifuge SOPs, deviation logs,

and analyst training records. Cleaning during operation may lead to findings under poor laboratory practices or method execution inconsistency.

Implementation Best Practices

Define clear SOPs stating that cleaning must be performed only when centrifuges are idle and unplugged (if required). Use visual status indicators (e.g., “In Use” tags) to signal active cycles. Train analysts to perform pre-use and post-use cleaning only, and to log all cleaning activity in equipment usage records.

Also Read: Audit Documentation for Completeness Before Final GMP Approval

Regularly calibrate centrifuges and validate cleaning procedures separately. Incorporate cleaning verification steps (e.g., swab tests) only after equipment is powered down and empty. Conduct internal audits to ensure compliance with cleaning schedules and equipment handling protocols.

Regulatory References

– 21 CFR Part 211.160 – Laboratory controls and equipment operation
– EU GMP Chapter 6 – Lab equipment cleaning and maintenance
– WHO TRS 957, Annex 4 – Laboratory operation practices
– USP – Qualification of Analytical Instruments