This product is an ASHP Learning Center activity accessible at https://elearning.ashp.org/.
Accreditation
The American Society of Health-System Pharmacists is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education with Commendation.
Target Audience
The Practical Training in Compounding Sterile Preparations Certificate is intended for pharmacists and pharmacy technicians who are interested in increasing their knowledge and competency in compounding sterile preparations. This certificate is a PTCB-recognized education/training program for certified pharmacy technicians who are preparing for PTCB's Compounded Sterile Preparation Technician (CSPT©) Certification.
Overview
The Practical Training in Compounding Sterile Preparations Certificate is a self-guided, online learning activity intended for pharmacists and pharmacy technicians who wish to build their knowledge and skills in compounding sterile preparations. The intent of this certificate is to provide participants with the foundational knowledge necessary to compound sterile preparations safely and effectively. The modules within the curriculum build upon one another to establish this foundation. For this reason, learners are required to progress through the moduels sequentially.
This well-rounded curriculum addresses the following topics:
- Sterile preparation practice standards and regulations
- Expectations for cleanroom personnel behaviors
- Pharmacy calculations related to compounding sterile preparations
- Compounding facilities, engineering controls, equipment, and materials
- Aseptic technique
- Stability, sterility, and beyond-use dates
- Compounded sterile preparation dosage forms and administration
- Nonsterile-to-sterile compounding
- Sterile preparation of hazardous drugs
- Maintaining the cleanroom environment
- Processes related to compounding sterile preparations
- Selection, receipt, and storage of ingredients
- Flow of materials through the cleanroom and compounding
- Labeling and repackaging
- Verification and recordkeeping
- Storage, transport, and disposal of final preparations
After completing all of the learning modules, participants should be proficient in the fundamental concepts required to ensure safe and compliant sterile preparations.
Practical Training in Compounding Sterile Preparations Certificate Requirement
Successful completion of an online comprehensive exam and specified practice exercises is required to earn the professional certificate.
Once a learner has successfully completed the educational curriculum, they will have the opportunity to complete the online comprehensive exam. If the learner successfully completes the exam (minimum 80% passing rate; unlimited attempts permitted), they must then complete and submit videos and other supporting documentation of practice exercises demonstrating the learner’s knowledge and competency in garb and glove procedures, gloved fingertip testing, aseptic technique in horizontal and vertical airflow, laminar airflow workbench cleaning, and media fill. Content experts review these demonstrations and, if approved, the learner will be awarded the professional certificate.
A learner is allowed up to three attempts on practice exercises. Learners must have access to a cleanroom to complete these practice exercises.
Educational Activities
Introduction to Compounding Sterile Preparations
ACPE: 0204-0000-26-729-H07-P&T
Application-based
1.25 contact hours
Learning Objectives:
- List the standards of practice that apply to sterile compounding in the United States.
- Identify resources with best practices to ensure sterile compounding safety.
- Identify the key responsibilities of compounding designated persons including scenarios that designated persons are expected to address.
- Explain the role of the compounder in assuring the safety of compounded sterile preparations.
Practical Pharmacy Calculations
ACPE: 0204-0000-26-730-H07-P&T
Application-based
2 contact hours
Learning Objectives:
- Calculate doses in both weight and volume using proportions with concentrations expressed as fractions, percents, and ratios.
- Use common conversions to perform sterile compounding calculations.
- Select quantity of dosage units required to supply an order for a specified time period.
- Calculate infusion rates.
- Apply the alligation method to calculate parts of two solutions with different concentrations to compound a solution with a different desired concentration.
Overview of Compounding Facilities and Engineering Controls
ACPE: 0204-0000-26-731-H07-P&T
Application-based
1.25 contact hours
Learning Objectives:
- Describe the primary engineering controls used in sterile compounding.
- Explain the principles of generating a laminar airflow environment in the primary engineering control.
- Identify the secondary engineering control elements in a clean room environment.
- Differentiate between a segregated compounding area and a clean room.
- Discuss essential design elements for a sterile compounding facility.
- Analyze the advantages and disadvantages of available finish materials.
Cleanroom Personnel Basics
ACPE: 0204-0000-26-732-H07-P&T
Application-based
1.5 contact hours
Learning Objectives:
- Describe sources of contamination in the cleanroom and work behaviors required to prevent the introduction of contaminants into the cleanroom environment.
- Evaluate appropriate hand hygiene technique.
- Describe donning and doffing procedures for personal protective equipment used in cleanrooms, including garb and glove requirements and procedures for non-hazardous and hazardous compounding.
- List core competencies that must be mastered by sterile compounding personnel.
- Describe the testing requirements to assess appropriate garbing and aseptic technique.
- Design a training program to ensure mastery of core competencies by sterile compounding personnel.
Materials, Equipment, and Resources for Compounding Sterile Preparations
ACPE: 0204-0000-26-733-H07-P&T
Application-based
1.75 contact hours
Learning Objectives:
- Identify supplies used in sterile compounding processes.
- Differentiate the following:
- Critical sites vs. non-critical sites on syringes, needles, vials, and bags; and
- Single-dose vs. multiple-dose vials.
- Differentiate between the types of automated compounder pumps used in compounding sterile preparations.
- Choose the appropriate compounding equipment needed for various situations.
- Interpret several types of patient medication labels.
- Create a master formulation record and a compounding record.
- Use tertiary resources to find necessary drug information.
Stability, Sterility, and Beyond-Use Dates
ACPE: 0204-0000-26-734-H07-P&T
Application-based
2 contact hours
Learning Objectives:
- List factors that influence beyond-use date assignments for compounded sterile preparations.
- Describe physical and chemical compatibility criteria for components.
- Apply USP <797> risk categories to assigning a proper beyond-use date for compounded sterile preparations.
- Recommend a beyond-use date for a final compounded sterile preparation using evidence-based information.
Mastering Aseptic Technique
ACPE: 0204-0000-26-735-H07-P&T
Application-based
3.25 contact hours
Learning Objectives:
- Compare airflow in the primary and secondary engineering controls.
- Describe the airflow patterns in a laminar airflow workbench (LAFW), compounding aseptic isolator (CAI), and a biological safety cabinet (BSC).
- Summarize how dynamic airflow visualization studies can be used to determine the location of the direct compounding area (DCA) in a particular primary engineering control (PEC).
- Visualize how first air may be disrupted when compounding a compounded sterile preparation (CSP) in horizontal and vertical airflows.
- Identify the critical sites on compounding components.
- Compare the appropriate placement of materials and components in horizontal and vertical airflow in primary engineering controls.
- Describe the workflow steps when compounding a sterile preparation in a laminar airflow workbench, compounding aseptic isolator, and biological safety cabinet.
- Describe techniques for reconstituting sterile powders including, but not limited to, strategies for preventing coring of vial stoppers.
- Contrast common preservative-free diluents with bacteriostatic diluents.
- Explain how powder displacement volume affects the volume of drug in solution following reconstitution.
- Recommend safe compounding techniques that reduce compounding-related health risks including sharps injuries, exposure to hazardous drugs, and repetitive strain injuries.
- Describe how to address a hazardous drug spill in a containment primary engineering control (C-PEC).
Dosage Forms, Administration, and Special Compounding Considerations
ACPE: 0204-0000-26-736-H07-P&T
Application-based
3.25 contact hours
Learning Objectives:
- Describe the dosage forms, preparation requirements, and routes of administration.
- Differentiate between small and large volume parenterals.
- Discuss appropriate routes of administration for compounded sterile preparations.
- Explain basic concepts related to parenteral nutrition inlcuding the following:
- Indications
- Ordering, verification, transcription, and labeling
- Macro- and micronutrients, and other additives
- Methods of, and considerations for, compounding and administration
- Assess automated compounding devices for safety, interoperability, and overall functionality.
- Describe techniques for compounding medication cassettes.
- Calculate doses and infusion rates used with medication cassettes.
- Explain how to accurately measure components using principles of volumetric accuracy.
- Describe situations when sterile filtration and/or preservative-free ingredients must be utilized when compounding preparations for central nervous system administration.
- Describe situations when additional testing and special techniques must be utilized when compounding ophthalmic preparations.
- Describe personnel qualifications, facility requirements, and compounding processes for; and designated person responsibilities related to; preparation of allergenic prescription sets.
Non-sterile-to-Sterile Compounding
ACPE: 0204-0000-26-737-H07-P&T
Application-based
2 contact hours
Learning Objectives:
- Explain the following regulatory requirements of USP <797> standards as they apply to nonsterile-to-sterile compounding including:
- Section 503A of the Food, Drug, and Cosmetic Act regarding compounding with bulk active pharmaceutical ingredients;
- Application of USP <797> standards to nonsterile-to-sterile compounding;
- Relationship between USP <797> standards, and regulatory and accreditation requirements; and
- Difference between minimum compounding standards and best practices as they relate to nonsterile-to-sterile compounding.
- Describe requirements for installation, calibration, and maintenance of equipment used in non-sterile to sterile compounding, including validation processes for sterilization equipment.
- Compare terminal and aseptic sterilization.
- Explain best practice quality assurance standards for nonsterile-to-sterile compounding including, but not limited to, sterility testing requirements as outlined in USP <71>.
- Calculate endotoxin limits for final nonsterile-to-sterile products.
Maintaining the Cleanroom Environment
ACPE: 0204-0000-26-738-H07-P&T
Application-based
1.75 contact hours
Learning Objectives:
- Design elements in sterile compounding areas that lead to easily cleanable conditions.
- Recognize insanitary conditions that can impact high quality aseptic compounding practices.
- Assess the different reagents and processes used to clean primary engineering controls.
- Describe how to clean primary and secondary engineering controls used for compounding hazardous and non-hazardous preparations to ensure regulatory compliance.
- Identify key elements of an effective environmental monitoring program.
- Recommend appropriate action plans based on personnel and environmental monitoring data.
Handling and Compounding Hazardous Drugs
ACPE: 0204-0000-26-739-H07-P&T
Application-based
2 contact hours
Learning Objectives:
- Define the scope of USP <800>.
- Describe the key requirements of USP <800> Hazardous Drugs – Handling in Healthcare Settings, including limiting risk to personnel, facility design, and safe work practices.
- Categorize the handling of hazardous drugs in one's organization to determine their eligibility for inclusion in your assessment of risk.
- Create an acknowledgement of risk document.
- Evaluate an organization's current compliance with USP <800>.
- Evaluate an organization's storage and compounding areas.
- Identify the three types of containment primary engineering controls used for compounding hazardous drugs, and the two types of containment secondary engineering controls used for storing and compounding hazardous drugs.
- Identify the key elements that must be addressed during training of personnel who handle hazardous drugs (HDs) including, but not limited to, HD compounders.
- Differentiate personal protective equipment used in HD compounding from that used in non-HD compounding.
- Describe hazardous drug work practices from receiving through compounding.
- Describe hazardous drug (HD) work practices from dispensing through disposal, including a procedure for handling HD spills.
- Apply appropriate strategies for ongoing evaluation of hazardous work practices, competency of personnel, facility monitoring, and assessment of risk.
Compounding Processes: Sourcing Through Final Check or Disposal
ACPE: 0204-0000-26-740-H07-P&T
Application-based
2 contact hours
Learning Objectives:
- Describe methods for verifying source ingredients.
- Explain cold chain requirements for refrigerated and frozen products.
- Explain USP <797> requirements and best practices for introducing materials into a controlled environment.
- Compare cleanroom storage options for hazardous drugs, high-risk medications, controlled substances, investigational drugs, non-sterile bulk ingredients, and bulk chemicals.
- Explain legal requirements and best practices for labeling sterile preparations.
- Apply FDA repackaging guidance to sterile preparations.
- List the pieces of informaiton that should be found in a master formulation record and a compounding record.
- Explain the verification methods for compounded sterile preparations including in-process and final checks, and their advantages and disadvantages.
- Explain the requirements and best practices related to documentation of controlled substances used in sterile compounding.
- Describe requirements and best practices for storage and transport of compounded sterile preparations within and outside of the facility.
- Explain waste practices for supplies and medications used in sterile compounding processes.
Faculty Information
Cindy Brasher, PharmD, MS, BCSCP
Manager of Compounding
St. Jude Children’s Research Hospital
Memphis, Tennessee
Matthew Brown, PharmD, DPLA, MLS (ASCP)
Manager, Duke Compounding Pharmacy & Sterility Laboratory
Duke University Health System
Durham, North Carolina
Ashley Duty, PharmD, MS, BCSCP, FASHP
Director of Inpatient Pharmacy Operations
Nationwide Children’s Hospital
Columbus, Ohio
Michael Ganio, PharmD, MS, BCSCP, FASHP
Senior Director, Pharmacy Practice and Quality
American Society of Health-System Pharmacists
Bethesda, Maryland
Kevin Hansen, PharmD, MS, BCSCP
Senior Director, Pharmacy Compounding Services
Premier, Inc.
Charlotte, North Carolina
Jaclyn Jaskowiak, PharmD, BCPS, BCSCP
Inpatient Pharmacist Specialist, Compounding Compliance and Operations
UC San Diego Health
La Jolla, California
Adam Jones, PharmD, MBA, BCSCP
Pharmacy Manager
University of Iowa Health Care
Adjunct Associate Professor
University of Iowa College of Pharmacy
Iowa City, Iowa
Patricia Kienle, RPh, MPA, BCSCP, FASHP
Director, Accreditation and Medication Safety
Cardinal Health
Wilkes-Barre, Pennsylvania
Lynda Kiliany, PharmD, BCSCP
IV Coordinator
Cleveland Clinic Akron General
Akron, Ohio
DeeAnn Wedemeyer-Oleson, PharmD, MHA, BCGP, CPHQ, CPPS
Director, Scientific Projects, Special Projects
American Society of Health-System Pharmacists
Bethesda, Maryland
Angela Yaniv, PharmD, BCSCP
Director, Sterile Products
Cleveland Clinic
Cleveland, Ohio
Relevant Financial Relationship Disclosure
In accordance with our accreditor’s Standards of Integrity and Independence in Accredited Continuing Education, ASHP requires that all individuals in control of content disclose all financial relationships with ineligible companies. An individual has a relevant financial relationship if they have had a financial relationship with an ineligible company in any dollar amount in the past 24 months and the educational content that the individual controls is related to the business lines or products of the ineligible company.
An ineligible company is any entity producing, marketing, re-selling, or distributing health care goods or services consumed by, or used on, patients. The presence or absence of relevant financial relationships will be disclosed to the activity audience.
The following persons in control of this activity’s content have relevant financial relationships:
- Lynda Kiliany: Abbvie, Pfizer, Abbott, Johnson & Johnson; equity shareholder
All other persons in control of content do not have any relevant financial relationships with an ineligible company.
As defined by the Standards of Integrity and Independence in Accredited Continuing Education definition of ineligible company. All relevant financial relationships have been mitigated prior to the CE activity.
Methods and CE Requirements
Each activity consists of audio, video, and/or PDFs and evaluations. Learners must review all content and complete the evaluations to receive continuing pharmacy education credit for each activity.
Follow the prompts to claim, view, or print the statement of credit within 60 days after completing the activity.
Important Note – ACPE 60 Day Deadline:
Per ACPE requirements, CPE credit must be claimed within 60 days of being earned. To verify that you have completed the required steps and to ensure your credits have been reported to CPE Monitor, check your NABP eProfile account to validate that your credits were transferred successfully before the ACPE 60-day deadline. After the 60-day deadline, ASHP will no longer be able to award credit for this activity.
The ASHP Professional Certificates SM educational product line contains learning activities that are ACPE-accredited knowledge and application-based continuing education. This is not an ACPE Certificate Program. Upon successful completion of the activities, the learner will be able to download an ASHP Professional Certificate.
System Technical Requirements
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