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.

 

Additional Information

For additional information on any Texwipe products, please refer to the following PDF documents, or contact Dalatec.

 

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