United States Pharmacopeia (USP) 797

Dalatec has seen many new requirements from hospitals and pharmacies that need cleanroom consumables, wipers, swabs, mops and disinfectants for their required sterile environments. The United States  Pharmaccpeida (USP) has developed standards for compounding in sterile environments. These standards help compounding practitioners adhere to widely acknowledged, scientifically sound procedures and practices, and facilitate the delivery of consistent and good-quality prepared medicines to patients. State Boards of Pharmacy may adopt these USP standards into their regulations.

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. They require 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 these 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

Texwipe has put together a chart showing the consumable products (wipers swabs mops and disinfectants) that is provided for cleaning to be compliant to USP 797 compounding in a sterile environment.

Dalatec is a great source to provide your compounding cleanroom products.