What are the USP 797 Guidelines

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Learn about how to properly clean and disinfect critical pharmacy surfaces with Contec Healthcare's USP 797 Guidelines overview.

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What are the USP 797 Guidelines These refer to conditions as well as practices that the healthcare industry will need to comply with to prevent harm and patient deaths that result from contaminated environments or poor sterile preparations. What does that mean for facilities The changes in the United States Pharmacopeia USP chapters 797 in March of last year mean that facilities that perform sterile compounding must understand the changes to ensure they remain in compliance with the rules. Knowing the changes will also inform them of whatever changes they need to do to address possible issues the Pharmacy Times says. Aside from pharmacies and hospitals this is true for facilities like anterooms and cleanrooms. Given the revision in the USP 797 guidelines many facilities are now required to operate under a higher level of compounding risk and as a result will need to take stricter measures to ensure compliance.

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What does it entail The changes introduce a new definition of what compounding means. Those changes will require facilities to pay attention to three things: provide training and ongoing guidance to staff determine risk levels and develop as well as implement policies and procedures to address any issues or resolve any compliance problems the Wolters Kluwer says. Staff training. This will cover topics that include antiseptic hand washing and disinfection of nonsterile compounding surfaces. Use of protective garbs measures to maintain CSPs in an ISO class 5 environment and how staff and environments can be protected from contamination caused by radioactive agents and more. Risk determination. The 707 version identifies three levels of risk in terms of microbial contamination which include one-to- one compounding one-to-many or many to one and high-risk compounds which refer to preparations that take place outside of an ISO 5 environment. Policies and procedures. To ensure compliance under the 797 facilities must put together policies and procedures that address issues that may arise as a result of the changes of what compounding entails.

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How will this affect pharmacy cleanrooms For cleanrooms minimizing airborne contamination from critical sites is the focus of the changes in the USP chapter 797 guidelines. The following practices will help maintain compliance. When you clean areas start from the cleanest and go to the dirtiest. Cover all possible areas from top to bottom. For cleanroom wipes make sure you use non-shedding and non-linting single-use types and options. Replace used wipes frequently. When you clean the surface use unidirectional strokes that slightly overlap. Don’t use circular motions which may only succeed in spreading the dirt around. Each area should have a dedicated set of cleaning tools. This should include mops buckets and more. Observe the disinfectant dwell time. Check the product instructions to determine the contact time that works. Ensure that all employees follow the SOPs in your facility. Use the right cleanroom equipment for efficient operation. Conclusion These are just some of the changes that facilities need to be aware of in their efforts to ensure compliance. For better results follow these guidelines or visit here now

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