The objective of USP <797> is to describe conditions and practices to prevent harm, including death, to patients that could result from:
- Microbial contamination
- Excessive bacterial endotoxins
- Variability in the intended strength of ingredients
- Chemical and physical contaminants
- Incorrect type or quality of ingredients in Compounded Sterile Preparations (CSPs)
USP <797> provides practice and quality standards for all persons who prepare CSP drugs and nutrients and all places they are prepared.
USP <797> requires that the preparation of CSPs occur in ISO Class 5 (Class 100) environments, buffer areas of ISO Class 7 (Class 10,000), and ante-areas of ISO Class 8 (Class 100,000). Achieving and maintaining cleanroom environments requires new procedures and protocols.
ITW Texwipe® has been the cleaning technology leader in controlled environments for more than four decades. We have the advice, tools and products for such USP <797> requirements as:
- Cleaning ISO Class 5 surfaces every shift
- Cleaning counters, work surfaces and floors daily
- Cleaning walls, ceilings and shelves monthly
- Cleaning supplies while transferring them to clean areas
- Cleaning spills
- Spraying and wiping gloves throughout the shift
- Cleaning supplies in the controlled environment
- Cleaning validation
Please review our brochure, which includes the key products compounding pharmacies need to meet these requirements. These products are available through a network of specialty distributors and supported by the ITW Texwipe technical support.
For additional information on any Texwipe products, please refer to the following PDF documents, or contact Dalatec.