123ArticleOnline Logo
Welcome to 123ArticleOnline.com!
ALL >> Health >> View Article

Understanding Usp 797 Standards

Profile Picture
By Author: Jamie Hanson
Total Articles: 3534
Comment this article
Facebook ShareTwitter ShareGoogle+ ShareTwitter Share

The benchmark for sterile compounding is USP 797. The USP Chapter 797 was codified by Mike Hurst, for pharmaceutical supplier Baxa Corp., and is the first implemented standard for sterile compounding and became effective from January1, 2004. The basic idea of USP 797 was to lay down procedures and practical requirements for safe compounding of sterile preparations, keeping in view patient safety concerns following professional guidelines and recommendations.

The USP 797 standards are valid to all settings where sterile preparations are compounded, but some raised concerns about the cost and ease of complying. The idea of USP 797 for sterile compounding is improving the standards. Similar to any change, USP 797 was misunderstood and certain misconceptions creeped in. The worst misinterpretation was requirement of clean room.

The application of USP 797 standards is not limited to any particular profession or any particular type or types of sterile compounding location. The standards apply to sterile compounding at any place without considering the profession of the compounding personnel. This is made for patient ...
... safety, since every patient has the right to a safe, precise and sterile dose; regardless of who prepares it or where the dose is prepared.

Low risk compound sterile preparations should follow the norm of ISO class 5 standards. The compounding should be made using aseptic ingredients, products, components and devices. This type of compounding pertains to transfer, measuring and mixing manipulations using at the most only three commercially manufactured packages of sterile products and limiting two entries into any one sterile container or package.

A mid level risk CSP can be compounded aseptically in low risk circumstances. However, these CSPs involve complex aseptic manipulations, accumulation of sterile products for administration to several patients or to a single patient several times, or the process of compounding requires a long duration. Any product to be defined as a commercially manufactured sterile drug or nutrient has to be evaluated and certified by FDA for safety and efficacy. These products are available in FDA approved labeling.

Any CSP that meets the necessity of the Sterility Test is considered a high-risk level CSP. This high-risk level product has to conform to BUD. The BUD for any CSP, whether low, medium or high risk that meet to the requirements of Sterility Test may be based on the chemical stability of the CSP, rather than microbial stability.

The personnel involved in preparing CSPs in the buffer area or clean room should be fully garbed with appropriate protective equipment. A typical clean room garb require shoe covers, gown, hair cover, mask and sterile gloves.

For more information on USP 797 and cleanroom supplies, visit Cleanroom Supply connection.

Total Views: 178Word Count: 438See All articles From Author

Add Comment

Health Articles

1. Lose Weight In One Month: Achieve Your Fitness Goals With The Right Exercise And Diet Plan
Author: taherraita

2. Detached Retina Treatment In London: Symptoms, Causes, And Advanced Surgical Solutions
Author: Mahi Muqit

3. How Root Canal Therapy Saves Teeth And Prevents Pain?
Author: Mayur

4. Understanding Modifiers 26 And Tc In Healthcare Billing: A Quick Guide
Author: Albert brown

5. Parkinson’s Disease Drug Pipeline Analysis 2024 – Trends, Key Market Dynamics, And Emerging Therapies
Author: DHRUV

6. A Comprehensive Guide To Finding The Best Fat Removal Surgery In Hyderabad
Author: Ojas Aesthetics

7. Dental Fillers In Coimbatore
Author: We Dental

8. Dental Implant Clinic In Noida – Nayar Dental
Author: Nayar Dental

9. Registered Ndis Provider Melbourne – Caring Hearts Home Care
Author: CARING HEARTS HOME CARE

10. Trusted Migraine Treatment Doctor In Bhubaneswar: Relief & Care
Author: Dr PR bhuyan

11. Analytical Science: Revolutionizing Research And Industrial Applications
Author: Gaia Science Pte Ltd

12. Dental Implants In Coimbatore | We Dental
Author: Shaad Aesthetics

13. Comprehensive Eye Care In Tucson: Essential Services For Lasting Vision Health
Author: Catalina Eye Care

14. When Should Food Sensitivity Testing Be Used?
Author: naturalweightlossflorida

15. Porcelain Veneers: The Secret To A Hollywood Smile In Dallas And Lewisville
Author: Alex Perry

Login To Account
Login Email:
Password:
Forgot Password?
New User?
Sign Up Newsletter
Email Address: