**Learning Materials are updated to include the revised USP Chapter <797> Standards**
COMPREHENSIVE STERILE COMPOUNDING is an accredited 3-day, 20-hour (2.0 CEUs) application-based certificate program designed for pharmacists and technicians who are experienced in compounding.
Completion of the Fundamental Compounding Course is recommended. Physicians and other health care professionals are welcome to attend. This course will also provide initial aseptic training for pharmacists and technicians required by their state board of pharmacy in order to compound sterile preparations.
Participants are instructed in the proper aseptic techniques for preparations and quality control tests to prepare compounded sterile preparations. Participants will work in a simulated sterile environment in a USP 795 laboratory, focusing on the aseptic process and practical knowledge that meet the requirements for USP 797.
During the third day, a non-sterile to sterile media-fill test process will be conducted in a simulated clean room. Attendees will also learn how to prepare non-sterile to sterile compounds, including sterile solutions and manipulation of injectable solutions, cleaning and disinfection methods. Practical considerations about USP <800> will be discussed to facilitate the understanding of exposure routes and risks for those who handle hazardous drugs.
Our low instructor/participant ratio allows for individual attention and interaction. The program is structured to demonstrate skills that can be immediately implemented by participants. Learn about the ACA Compounding Training Instructors at acainfo.org/instructors.
Physicians and other health care professionals are welcome to attend.
*Funding for this course is provided in part by an unrestricted educational grant from the ACA Research and Education Foundation.
- Introduction to USP <797> and Sterile Compounding
- Lab Safety, Garb & PPE
- Cleaning & Use of the PEC
- Calibration & Use of the Balance
Lunch (45 min – 1h)
- Introduction to USP <797> and Sterile Compounding (continued)
- Practice aseptic technique
Adjourn (as you finish approx. 5 pm)
- Regulatory Update
- Training and Competency Requirements
- Sterile to Sterile Media Fill Testing
Lunch (45 min – 1h)
- Compound sterile dosage forms using filtration, steam sterilization, and dry heat sterilization (injection, ophthalmic solution, ophthalmic ointment)
Adjourn (as you finish approx. 5 pm)
- Non-Sterile to Sterile Media Testing Discussion: Sterilization Methods
Adjourn (as you finish approx. 12 pm)
At the conclusion of Comprehensive Sterile Compounding, the participating pharmacists and pharmacy technicians will be able to:
Comprehensive Sterile Compounding — (20h)
UAN: 0201-0000-23-020-L07-P/T | Application Based
- Define sterile compounding and practices within and outside the scope of USP <797> Pharmaceutical Compounding – Sterile Preparations
- Define Quality Assurance and Quality Control
- Identify responsibilities of the designated person(s)
- Describe categories of compounding and when immediate-use may be used
- Discuss facility and environmental monitoring requirements
- Explain the use, maintenance, and cleaning of primary and secondary engineering controls and equipment used in compounding
- Explain the appropriate selection and use of components and supplies
- Discuss aseptic processing and methods of terminal sterilization
- Discuss requirements for release testing including visual inspections, sterility, and endotoxin testing
- Determine appropriate BUDs
- Differentiate between label and labeling requirements
- Demonstrate proper hand hygiene and garbing
- Demonstrate cleaning and disinfection of the ISO Class 5 PEC
- Demonstrate staging of equipment and supplies
- Identify critical sites and avoid shadowing
- Demonstrate aseptic technique
- Compound various CSP dosage form
- Identify regulations and standards pertaining to sterile compounding
- Review key FDA guidance documents
- Explain requirements for selection of components used in compounding
- Discuss the importance of a certificate of analysis and what calculations may be needed
- Differentiate between training and competency
- Explain <797> training requirements for compounders, oversight personnel, and non-compounding personnel
- Explain <797> competency testing requirements for compounders, oversight personnel, and non-compounding personnel
- Describe competency testing requirements for hand hygiene and garbing using observation and gloved fingertip and thumb testing
- Describe competency testing requirements for aseptic manipulation using observation and media fill testing
- Discuss when corrective actions may be needed
- Outline the framework for a quality assurance program
- Specify SOPs needed for sterile compounding
- Identify master formulation record and compounding requirements
- Discuss quality control procedures
- Explain other USP <797> documentation requirements
- Describe HD facility requirements
- Differentiate between containment primary and secondary engineering controls
- Identify the role and responsibilities of the HD designated person
- Select which drugs must be included on a facility’s HD list
- List required policies and procedures
- Differentiate between deactivation, decontamination, cleaning, and disinfection
- Describe PPE requirements for sterile HD compounding
- Determine when an assessment of risk may be used
- List training requirements for personnel who handle HDs
REGISTER EARLY & SAVE $70!
Special promotional pricing will be automatically applied to all registrations completed six weeks before the beginning of class. No code necessary; does not apply to pharmacy student fees, EVP, or ACA Compound Academy. The best value in compounding training just got a little better.