VAI DECON-HAND Disinfectant
16oz and 32oz containers of gelled ethanol based hand sanitizer for cleanroom environments.
Overview
Features
- 32oz container size compatible with ASEPTI-CLEANSE dispenser
- 16oz bottles have an optional attachable pump
- Gamma irradiated at a 10-6 SAL
- Filtered and filled in an ISO 7 cleanroom
- FDA registered: NDC# 64307-001
Description
VAI DECON-HAND Disinfectant is a gelled, ethanol-based instant hand sanitizer that has been formulated and processed to comply with the standards required by the pharmaceutical, biotechnology, medical device, and healthcare industries. DECON-HAND complies with the requirements for transport into classified areas within the cleanroom operation, therefore, making it an ideal product for hand sanitizing before putting on gloves in gowning rooms. Sanitizing before glove donning is recommended to reduce cross-contamination within the cleanroom environment.
DECON-HAND is available in a 16oz bottle and the 32oz bottle compatible with the ASEPTI-CLEANSE, hands-free dispensing system. Both are available in sterile or non-sterilized versions. The 16oz bottle is delivered with an attachable hand pump or can be mounted directly to the wall for convenient sanitizing. DECON-HAND is packaged quadruple bagged using the ABCD Cleanroom Introduction SystemTM and has been completely validated for sterility and shelf life.
DECON-HAND is filled in an ISO 5 (Grade A/B, former Class 100) operation, filtered, and subsequently gamma irradiated at 10-6 SAL. All lots of DECON-HAND are sterility tested according to the current USP compendium and are completely lot traceable from start to finish. Each shipment of DECON-HAND is delivered with lot documentation materials including a Certificate of Sterility, Certificate of Irradiation, and a Certificate of Analysis. This product is manufactured in accordance with 21 CFR Part 211 Good Manufacturing Practices for Drugs and the Tentative Final Monograph for Topical Antimicrobial Drug Products for Over-The-Counter use.
Documents
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