INSPEC™ DE Solution

InSpec™ DE is a sterile preparation of 70% denatured ethanol (DE) in 30% Water For Injection (WFI) quality water.

These products are supplied sterile, double bagged, gamma-irradiated and provided with certificates of analysis, irradiation, sterility and endotoxin level.

The trigger spray bottle is designed to prevent contamination of the product with micro-organisms such as bacterial spores which can survive in 70% alcohol. The trigger spray bottle has a validated in-use shelf life.

InSpec™ DE is manufactured in an ISO 6 Cleanroom, filled under an ISO 5 localized air shower in the ISO 6 background. Batch certified covering areas such as sterility, endotoxin, and irradiation. Manufactured to GMP under an ISO 9001 quality system.

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.

Microbiological Minimum Efficacy Testing Contact

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