Texwipe has developed sterile wipes and swabs specifically for use in sterile environments.
These products are designed to clean quickly and effectively without compromising sterility. While not classified as medical devices, Texwipe adheres to stringent standards for sterilization and endotoxin testing, ensuring high-quality and safe products.
Why Sterile Wipes and Swabs are Essential
Cleanroom environments demand products that maintain sterility and do not introduce contaminants. Texwipe sterile wipes and swabs are designed to meet these needs by following guidelines from the Association for the Advancement of Medical Instrumentation (AAMI) for radiation sterilization and the United States Pharmacopeia (USP) for endotoxin testing.
Sterilization Methods
Texwipe products are typically sterilized using gamma irradiation, chosen for its superior penetrating power and ease of validation. Here’s why gamma irradiation is preferred:
- Penetration: Gamma rays penetrate deeper than electron beams, ensuring thorough sterilization even in dense materials.
- Validation: Gamma irradiation is easier to validate according to AAMI standards, making the process reliable and consistent.
- Residue-Free: Gamma radiation leaves no residues, ensuring the wipes and swabs are clean and safe to use.
- Compatibility: Compatible with many materials and solutions used in Texwipe products, gamma irradiation effectively reduces endotoxin levels.
Comparison of Sterilization Techniques
- Gamma Irradiation:
- Greater penetration
- More uniform field and dose distribution
- Slower dose rate but simpler validation
- Better reduction of endotoxins
- Electron Beam:
- Less penetration
- Less uniform field and dose distribution
- Faster dose rate but more complex validation
- Less effective in reducing endotoxins
Endotoxin Testing
Bacterial endotoxins, or pyrogens, are fever-causing materials from Gram-negative bacteria. Texwipe products are tested for endotoxins to ensure they meet the stringent requirements of USP 23, ensuring they are safe for use in critical environments.
Test Method
The Limulus Amebocyte Lysate (LAL) test is used to measure endotoxin levels. This highly sensitive test detects endotoxins at extremely low levels, ensuring Texwipe products are free from harmful contaminants.
Texwipe sterile wipes and swabs are meticulously designed and tested to ensure they meet the highest standards of cleanliness and safety. These products are ideal for use in pharmaceutical aseptic filling areas, sterile suites, microbiological laboratories, and biotech manufacturing facilities. By adhering to AAMI and USP standards, Texwipe ensures that their sterile wipes and swabs provide the best possible protection against contamination.
Explore our range of sterile products and experience the Texwipe difference for yourself. For more information or assistance in selecting the right product for your needs, contact our contamination control specialists today.