USP 797 Compliance


American CleanStat carries all the products required by the USP Chapter 797 to enable your compounding and sterile preparations department to comply with the United States Pharmacopeia <USP 797> requirement.

Developed by the American Society of Health-System Pharmacists in collaboration with Baxter Healthcare Corporation, USP Chapter <797>, Pharmaceutical Compounding: Sterile Preparations, became effective January 1, 2004. It is intended to establish a standard of practice for compounding sterile preparations that could be universally adopted. USP 27/NF 22 is the published reference by the United States Pharmacopeia.

These standards may be adopted and enforced by state boards of pharmacy and surveyable by accreditation organizations. It is all about the standards of compounding correctly and maintaining sterile preparations. It requires that companies that compound, maintain and practice settings in which sterile preparations are compounded.

AMERICAN CLEANSTAT offers and supplies all the necessary sterile cleanroom products and non-sterile cleanroom products to enable your facility to be in compliance with these new mandates. Allow us to show you how to easily meet these requirements with proven products made by our industry’s leading manufacturers such as: ITW-Texwipe, Berkshire, Perfex, Veltek, Steris, Lymtech, M1 Technology, Foamex-Wilshire, Kimberly Clark, DuPont, Med-Chem, Micronova, CEEC and many other brands to select from.
 

USP < 797> MANDATES

Wipe down bottles, syringes, vials and any materials that enter the cleanroomSterile Environment: Use Sterile Pre-Wetted or Saturated Wipers with sterile alcohol and a mixture of WFI (water for injection) or Dry Wipers with Sterile Alcohol.Non-Sterile Environment: Use Non-Sterile Pre-Wetted or Saturated Wipers with a mixture of Alcohol and DI Water or use Dry Wipers with Sterile Alcohol solution. 
 
 

      1. Clean and Sanitize: Buffer room carts, equipment, hoods, walls, surfaces, floors, isolators and shelving. Sterile Environment: Use pre-wetted or Saturated Wipers with Sterile Alcohol and WFI mixture or Dry wipers with sterile 70% alcohol. Use cleanroom mops and sterile alcohol to clean walls, floors and surfaces. Non-Sterile Environment: Use pre-wetter or Saturated Wipers with Sterile Alcohol, dry cleanroom wipers with Sterile Alcohol and mops with sterile alcohol to clean walls, floors and surfaces.
         
      2. Document all compounding within the cleanroom. Sterile Environment: Use Cleanroom Paper and Cleanroom Notebooks and Pens, as well as other Cleanroom Stationery products. Non-Sterile Environment: Use Cleanroom Paper and Cleanroom Notebooks and Pens, along with cleanroom rated labels and other stationery products such as 3-Ring Binders, Tab Dividers and Shop Travelers.
         
      3. Sanitize Gloves. Sterile Environment: Use pre-wetted or saturated wipers with a mixture of 70% sterile alcohol and water for injections (WFI), or dry cleanroom wipers with Sterile 70% Alcohol. Non-Sterile Environment: Pre-wetted or saturated wipers with a mixture of 70% Sterile Alcohol or other sterilant – disinfectants, or use dry wipers with a mixture of Sterile Alcohol or other approved sanitizing – disinfectant.
         
      4. Clean floors, walls, ceilings and isolators and apply and remove disinfectants from those surfaces. Sterile Environment: Use Cleanroom Mops and accessories with Sterile 70% alcohol or disinfectant. Non-Sterile Environment: Use Cleanroom Mops and accessories with Sterile 70% Alcohol or approved rotational disinfectant solution.
         
      5. Ensure that particles do not enter into the cleanroom. Sterile Environment: Use entrance sticky or tackymats to trap particles outside the doorways to sterile compounding rooms or hoods, and use appropriate disposable or reusable footwear such as shoecovers, bootcovers or shoes and suitable cleanroom garments to minimize contamination. Non-Sterile Environment: Use entrance sticky or tackymats to trap particles outside the doorways to sterile compounding rooms or hoods, and use appropriate disposable or reusable footwear such as shoecovers, bootcovers and suitable cleanroom garments or shoes to minimize contamination.

 
 

ADDITIONAL PRODUCTS & SERVICES FOR USP 797

In addition American CleanStat can help you design and build your own modular cleanroom for sterile compounding by providing you with the truly modular line of Servicor cleanrooms and by referencing you to one of our Cleanroom Janitorial Services Providers, such as Pegasus Cleanroom Services.

Inquire about our extensive lines of equipment, services, supplies and technical support from American CleanStat. Our knowledgeable team of technical sales and support representatives is your one stop supplier for all your cleanroom and USP 797 Product requirements. We are your best source for Contamination Control Products. Please give us a call at toll free: 866-614-7828.

For more information on a particular StatStock™ program please email us or call us at:

Email: Contact Us
Phone: 714-533-2827 
Toll Free: 866 - 614 - 7828