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Cleanroom Cleaning Tools to Comply with Visible Residue Requirements Specified by Annex 1 and ASTM E3263

by | Feb 10, 2023

The pharmaceutical and medical device industry is constantly evolving, and with it, the regulatory requirements for ensuring the cleanliness of manufacturing equipment and devices. The recent revision of the ASTM E3263 Standard for Visual Inspection of Pharmaceutical Manufacturing Equipment and Medical Devices for Residues highlights the importance of visual inspection as a tool in cleaning validation.

ASTM E3263 provides statistically valid procedures for determining the visual detection limit of residues and the qualification of inspectors to perform the visual inspection of equipment and devices. The revision considers the science-based, risk-based, and statistics-based concepts and principles outlined in Guides E31065 and E32196, as well as the regulatory expectations of the FDA Process Validation Guidance Life Cycle approach and the European Medicines Agency (EMA) Annex 1.

The significance and use of the revised E3263 Standard are to provide guidance on the qualification of visual inspection for residues on pharmaceutical manufacturing equipment and medical devices. The Standard takes into account the EMA’s Q&A Guidance (Q&A #7 and Q&A #8) and ensures that visual inspection is used per the 21 CFR 211.67(b)7 regulation.

It is important to note that the revised Standard emphasizes that visual inspection should only be used with other validation tools and techniques, such as chemical and microbial testing. The combination of these techniques provides a comprehensive approach to cleaning validation that ensures the safety and efficacy of pharmaceutical and medical products.

The Sahara+ PharmaMOP GO mop head enhances rinsing SOP’s because it enables the complete removal of Spor-Klenz® and other sporicides from cleanroom surfaces when wetted with 70% Isopropyl Alcohol.

Considering the recent revision of the ASTM E3263 Standard, Foamtec International’s Sahara + cleaning system can aid pharmaceutical and medical device manufacturers in cleaning residues from cleaning and disinfectant agents. The Sahara + system is designed to remove even the toughest residues. Its advanced cleaning technology ensures that manufacturing equipment and devices are thoroughly cleaned and free of residues that could contaminate products.

Sodium Hypochlorite stains can easily be removed using the Sahara+ System.

In conclusion, the revision of the ASTM E3263 Standard highlights the importance of visual inspection in cleaning validation and the need for a comprehensive approach to cleaning validation. Foamtec International’s Sahara + cleaning system is an ideal solution for pharmaceutical and medical device manufacturers looking to meet regulatory requirements and ensure the cleanliness of their manufacturing equipment and devices.

Watch Videos about the Sahara+ System:

https://www.foamtecintlwcc.com/video/shutdown-triple-clean-on-lyophilizer-equipment

https://www.foamtecintlwcc.com/video/upgrade-sops

Learn more about the Sahara+ System:

https://www.foamtecintlwcc.com/products/stainless-steel-rust-prevention/sahara-plus-system

For Questions or Inquiries:

Website: www.foamtecintlwcc.com

Email: contact@foamtecintlwcc.com