Introduction

Introduction to Advanced Sterile Compounding: USP 797, USP 800, and Total Parenteral Nutrition (TPN) Essentials

Advanced Sterile Compounding represents the cornerstone of modern healthcare, particularly in clinical settings such as hospitals and specialized pharmacies. These processes go beyond simple solution repackaging; they involve preparing complex injectable or intravenous formulations that require exceptional precision, specialized techniques, and a strictly controlled environment to ensure Safety, Efficacy, and Sterility. Any error in these processes can pose a serious risk to patients' lives, especially those who are immunocompromised.

To ensure the highest standards of quality and safety, stringent guidelines known as the United States Pharmacopeia (USP) have been established. The standards USP Chapter <797> and USP Chapter <800> have become the fundamental regulatory pillars governing this practice:

1.     USP <797>: Pharmaceutical Compounding — Sterile Preparations:

o   This is the foundational standard for all sterile preparation operations.

o   It specifies comprehensive requirements to ensure the quality of sterile preparations, encompassing environmental classifications (e.g., cleanrooms, Biological Safety Cabinets (BSCs)), personnel practices and qualifications (training, evaluation), environmental control testing (particulate counts, microbiological monitoring), and quality control including sterility and pyrogen testing.

o   It focuses on preventing microbial, particulate, and chemical contamination during preparation.

2.     USP <800>: Hazardous Drugs — Handling in Healthcare Settings:

o   This complements USP <797> and specifically focuses on the safe handling of Hazardous Drugs (HDs), such as chemotherapy agents, and certain hormonal and immunomodulatory drugs.

o   It aims to protect healthcare workers, patients, and the environment from harmful exposure to these potentially carcinogenic, mutagenic, or teratogenic substances.

o   It establishes additional stringent requirements for training, Personal Protective Equipment (PPE), Engineering Controls (e.g., Containment Primary Engineering Controls - C-PECs), work techniques, cleaning, waste disposal, and contamination management.

Total Parenteral Nutrition (TPN) Essentials:

Total Parenteral Nutrition (TPN) is a prominent and complex example of Advanced Sterile Compounding. It provides all of a patient's nutritional needs (carbohydrates, proteins/amino acids, fats, vitamins, minerals, electrolytes, water) intravenously.

·        Preparing TPN requires a deep understanding of the chemical and physical compatibility between these diverse components to prevent precipitation, harmful interactions, or instability.

·        TPN preparation is primarily governed by USP <797> standards (to ensure sterility and general safety) and USP <800> (if it includes hazardous components like certain vitamins or additives at high concentrations).

·        It demands exceptional calculation accuracy, specialized mixing techniques (often using automated compounding devices), and comprehensive pharmacist review prior to administration.

Description

Knowledge Objectives

1. Explain the key requirements and fundamental differences between USP 797 (Sterile Compounding) and USP 800 (Hazardous Drugs) standards.

2. Identify risks associated with sterile compounding (e.g., microbial, particulate, and endotoxin contamination) and explain mitigation strategies per USP 797.

3. Describe specific health hazards linked to hazardous drug exposure and explain the engineering, administrative, and personal controls mandated by USP 800 to minimize risks.

4. Understand the principles and components of Total Parenteral Nutrition (TPN) and its clinical significance for patients unable to receive oral nutrition.

5. Describe challenges and requirements for safe and effective TPN compounding, focusing on stability, compatibility, and contamination prevention.

6. Explain environmental monitoring requirements (e.g., air and surface testing) and personnel qualification (e.g., media-fill tests, competency assessments) per USP 797 and USP 800.

Skill Objectives

7. Demonstrate advanced aseptic techniques during sterile compounding, including syringe/needle techniques and filtration methods.

8. Apply safe hazardous drug handling procedures per USP 800, including proper PPE use, decontamination, and waste disposal.

9. Perform accurate calculations for TPN components (carbohydrates, protein, lipids, electrolytes, vitamins, trace elements) while considering compatibility and stability.

10. Practice quality control procedures during/after TPN compounding (e.g., visual inspection, compatibility testing, precise documentation).

11. Execute effective cleaning and disinfection techniques for sterile compounding areas (ISO Class 5) and adjacent zones per USP 797 and USP 800.

12. Identify and manage critical events and potential risks during TPN compounding (e.g., contamination, calculation errors, incompatibility).

Compliance & Attitudinal Objectives

13. Outline the responsibilities of pharmacists and technical staff in ensuring ongoing compliance with USP 797 and USP 800 in daily practice.

14. Emphasize the importance of accurate, comprehensive documentation for all sterile/hazardous drug/TPN compounding steps as proof of compliance and quality.

15. Foster a culture of safety and perpetual vigilance in reporting incidents, near misses, and compounding errors to enable continuous improvement.

16. Proactively assess risks in advanced sterile compounding operations (including hazardous drugs and TPN) and implement risk control plans.

17. Apply quality assurance and quality control principles throughout advanced sterile compounding, focusing on procedure validation and outcome verification.

TPN-Specific Objectives

18. Analyze compatibility and stability challenges in multi-component TPN admixtures and explain strategies to prevent adverse reactions (e.g., precipitation, degradation).

19. Evaluate pre-dispensing TPN quality control protocols (visual inspection, pH testing, specific gravity testing when applicable).

20. Describe correct procedures for storing, transporting, and administering compounded TPN to maintain integrity and stability until administration.

Course Content

Overview of Standards, Guidelines, Regulations and Best Practices

Overview of Standards, Guidelines, Regulations and Best Practices

Sterile Compounding Guidelines

Federal and State Regulation of Sterile Compounding

FDA Inspections Performing Sterile Compounding

ANCILLARY COMPOUNDING EQUIPMENT

CALCULATIONS

The Key to Sterile Compounding

primary and secondary engineering controls

COMPOUNDING FACILITIES DESIGN AND MATERIAL SELECTION

Certification Maintenance and Downtime Planning

Cleanroom Behavior and Hand Hygiene

Garb and Glove Requirements for Sterile Compounding