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TECHNICAL DATA SHEET

DE

Sterile Denatured Alcohol 70% v/v with WFI Quality Water

Rapid Action, Low Residue, Fast Drying Alcohol Disinfectant

 

 

USE INSTRUCTIONS

InSpec™ DE is designed for

spraying, wiping and mopping applications. Hold spray approximately 15cm to 20cm from wipe/area to be treated.

5L versions, pour all contents into an appropriate container for mopping. Apply to surface to ensure complete coverage. Wipes – access wipes via peel back opening, resealing as necessary. Sachets tear open.

TECHNICAL DATA

Appearance: Clear liquid free from particles. Specific Gravity (20°C): 0.880 to 0.888. Denatured Ethanol proportion: 70% +/- 2% v/v.

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).

EFFICACY

See summary table in Section 1 of this brochure.

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

  • Low residue
  • Rapid action
  • Bactericidal and Fungicidal
  • 1 Litre Trigger Spray has 3 months validated ‘in-use’ shelf life as contents are protected via ‘bag-inbottle’ technology
  • All formats manufactured with WFI quality water
  • Multiple bags for cleanroom transfer
  • Ideal surface and aseptic transfer disinfectants
  • Manufactured in accordance with GMP


TECHNICAL USER INFORMATION

InSpec™ DE is a sterile ready to use disinfectant. This is a 70% v/v denatured ethanol (TSDA 7) solution in WFI quality water.

InSpec™ DE is manufactured in accordance with GMP in an ISO 6 cleanroom. The product is filled and capped in an ISO class 5 environment.

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™ DE is supplied with Certificates of Conformity, Analysis and sterile versions also have certificates of Irradiation Sterility and Endotoxin. All formats of DE have a 24 month shelf life.


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.

 

Our Safety Data Sheets are currently being updated.If you would like to request current Safety Data Sheets, please Contact us

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