Compiled by Sue Forsyth
Cleaning agents are used on walls, ceilings, floors and equipment in the cleanroom. A well-rounded systematic approach to choosing, evaluating and using cleaning agents is critical to maintaining control of contamination.
The TexShield Sterile 70% Isopropyl Alcohol and Sterile 70% Isopropyl Alcohol with water for injection (WFI) are easy and safe to use, cost effective, and maintain their sterility assurance level throughout prolonged normal use. The bottles are recyclable and the contents can be completely dispensed. The TexShield alcohol products are all packaged using the SteriShield Delivery System (patent pending). This system holds the liquid inside an ultra-clean, medical grade, polyolefin bag that does not allow air to be drawn back into the bag when the trigger spray mechanism is operated. Testing shows the contents remain sterile for three months after first operating the trigger. Packaged in one-liter and five-liter containers, the sterile alcohols are useful for surface cleaning, cleaning gloved hands in sterile suites, and wiping down items for pass through into a controlled environment. ITW Texwipe Mahwah, NJ www.texwipe.com
The SimpleMix system is a sealed multi-chamber, handheld container that, when activated, mixes a sterilizing solution with USP water for injection (WFI) quality water. The side chamber contains the sterile concentrate disinfectant or sporicide, and the larger chamber holds the sterile UPS WFI-quality water. The system is available in either the 16-ounce trigger sprayer or a gallon-sized container for larger uses. All SimpleMix products are manufactured in a Class 100 GMP filling operation, filtered at 0.2 micron, double-bag packed per bottle, gamma irradiated, and lot sterility tested per current USP compendium. The SimpleMix system has been developed for the company's Decon Phene, Decon Phase, Decon Cycle, Decon Quat 100, Decon Clean, and Decon Spore 200 Plus. Veltek Associates Inc. Malvern, PA www.sterile.com
Point-of-use cleaning solutions
The One Solution Vesphene Vesphene IIst system and One Solution LpH st system are complete, efficient, point-of-use cleaning solutions for critical environments. Each system includes a pre-measured, single-use formulation of Vesphene IIst or LpH st and one gallon of water for injection (WFI), double-bagged with linear tear strips for easy introduction into the cleanroom core. The systems are irradiated to a 10-6 sterility assurance level. Steris Corporation Mentor, OH www.steris.com
Sterile alcohol solution
The CiDehol ST 70% IPA solution is made to meet water for injection (WFI) specifications with regard to endotoxin levels. Endotoxin testing is performed on all lots of finished sterile alcohol products to ensure this claim and results are listed on the company's lot-specific document, which is shipped with each case. The sterile alcohol solutions are filtered to 0.22 µm, bottled and double-bagged in a Class 100 cleanroom, then gamma-irradiated and tested for sterility. Decon Labs Inc. Bryn Mawr, PA www.deconlabs.com