Optimizing Sterile Compounding: USP <797> Compliant PEC Solutions

Adhering to the revised USP <797> standards, effective November 1, 2023, is vital in ensuring the safety and integrity of sterile compounding practices. Contec Healthcare is committed to providing exceptional product recommendations that align with these updated standards. In this blog post, we will focus on two key products: PeridoxRTU® Sporicide, Disinfectant and Cleaner, and Contec® Healthcare TB1-3300™ Disinfectant Wipes. These EPA registered, ready-to-use one step cleaner and disinfectants, offer outstanding features and benefits for sterile compounding in Primary Engineering Controls (PECs) including their efficacy against pathogens, compatibility with cleanroom materials, and convenience in use. 

PeridoxRTU® Sporicide, Disinfectant and Cleaner 

PeridoxRTU® is an EPA registered sporicide, disinfectant, and cleaner that is highly effective against a broad spectrum of pathogens. PeridoxRTU features a patented formulation that provides a 3-minute sporicide claim, ensuring rapid and effective elimination of hard-to-kill spores. With a 99.9999% efficacy, it offers reliable and comprehensive pathogen control. As an EPA registered product, it meets the rigorous regulatory standards for cleaning and disinfectant efficacy. 

Contec Healthcare offers a validated protocol for the effective decontamination of hazardous drugs (HDs) from surfaces using PeridoxRTU. This feature ensures that compounding facilities can safely handle HDs and maintain a clean environment. Compatible with a wide range of cleanroom materials, including stainless steel, this allows the product to be used for efficient and thorough cleaning of various surfaces without causing damage or compromising the integrity of the cleanroom environment. 

According to Section 7.11 of the revised Chapter of USP <797>, sterile disinfectants MUST be used in the PEC making PeridoxRTU a great choice. Our sterile products are double bagged, ensuring their integrity and suitability for critical compounding applications. 

Contec® Healthcare TB1-3300™ Disinfectant Wipes 

Contec Healthcare TB1-3300 Disinfectant wipes is an EPA registered low-lint wipe containing a blend of quaternary ammonium and ethyl alcohol ideal for your daily cleaning and disinfecting in the PEC. The sterile wipes are sterilized by gamma irradiation and validated sterile per AAMI (Association for the Advancement of Medical Instrumentation) 11137 guidelines to a 10-6 SAL (Sterility Assurance Level and are suitable for ISO 5, 7, or 8 environments).

Contec Healthcare TB1-3300 Disinfectant wipes clean and disinfect in a single step, simplifying the cleaning process and maintaining a state of microbial control. This product demonstrates its effectiveness against a broad spectrum of bacteria and viruses with a short 1-minute contact time (dwell time). The low-lint wipe format promotes consistency when cleaning so that the process is repeatable, consistent, effective, and easier to implement, document, and validate. This saves time and eliminates the risk of undersaturation, allowing compounding professionals to focus on their core responsibilities.

By incorporating PeridoxRTU and TB1-3300 Disinfectant wipes Contec Healthcare TB1-3300 Disinfectant wipes into compounding practices, professionals can enhance their infection control measures, promote patient safety, and ensure the integrity of compounded medications. Contec Healthcare remains committed to providing innovative solutions that align with industry standards, empowering pharmacies to meet the challenges of the evolving sterile compounding landscape. 

Visit our dedicated USP <797> resource for more information on products and best practices to support you on your journey on implementing or revising protocols based on the revised standards.  

Other recommended reading: Navigating the Confusion: Understanding EPA Registered Sporicidal Agents for Cleanrooms in Healthcare Facilities.