Technical Data Sheet
N10
Manual Detergent Pre-Diluted and Concentrate Solutions
An alkaline detergent and hard surface cleaner for use in the biopharmaceutical and cleanroom industries.
Use Instructions
InSpec™ N10 is designed for cleaning hard surfaces by spraying, wiping and mopping. Hold spray approximately 15cm to 20cm from the surface area. 5L versions, pour into an appropriate container for mopping. 100ml concentrate added to 2.5L of water is required for mopping. Apply to surface to ensure complete coverage.
Technical Data
N10 Ready to Use (RTU) is a 4% alkaline detergent, pH12. The concentrate presentation has a pH of >13. The alkaline detergent has surfactant and sequestering agents designed to assist the removal of process residue and general soiling.
Storage & Safe Handling
Store upright in original closed containers, away from sunlight and extremes of temperature. Full guidance on the handling and disposal of this product is available in the Safety Data Sheet (SDS).
Material Compatibility
Application of solutions, when used as directed, will not affect materials normally encountered in the cleanroom. See compatibility information in the Technical Dossier.
Benefits
- Designed for cleaning floors, walls, ceiling and other hard surfaces for the removal of general process derived residue and soiling.
- Rapid action alkaline detergent. Suitable for manual cleaning.
- Available in convenient ready to use formats.
- 3 months validated 'in-use' shelf life 1L and 5L formats manufactured with WFI quality water
- Multiple bags for cleanroom transfer
- Manufactured in accordance with GMP
Technical User Information
InSpec™ N10 is available as a sterile and non-sterile detergent in prediluted and concentrated formats.
InSpec™ N10 is manufactured to GMP in an ISO 6 cleanroom. The product is filled and capped in an ISO class 5 environment.
RTU solutions are diluted with WFI quality water.
The solution is filtered through a 0.2 micron filter and gamma irradiated to a validated process (at 25-45kGy) to give a sterility assurance level SAL of 10-6.
InSpec™ N10 is supplied with Certificates of Conformity, Analysis, Irradiation and Sterility.
For screw cap bottles use the entire contents after opening.
Summary of InSpec Biocide Qualification
United States Pharmacopoeia (USP) General Chapter 1072 "Disinfectants and Antiseptics"13.
This chapter stipulates that a 3 log reduction in the viable microbial count should be demonstrated for bacteria.