Sterile Compounding Advanced Certificate Training (ACT) - Digital + Print
Recorded On: 09/07/2023
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NHIA’s Sterile Compounding ACT is the definitive training program for Sterile Compounding competency, including what you need to know about the revised USP General Chapter <797>. The training is a must-have resource for all clean rooms and especially for <797> designated persons. The advanced training will provide a certificate upon completion, as well as prepare individuals with the knowledge required for the BCSCP (Pharmacist) and CSPT (Pharmacy Technician) certification exams.
The program was written by pharmaceutical microbiology expert and USP Sterile Compounding Expert Panel member Abby Roth and reviewed by the expert NHIA Sterile Compounding Practice Committee.
The Sterile Compounding Advanced Certificate Training includes 10 units comprised of:
- Definitions and Scope of the USP Standards
- Categories of Compounded Sterile Preparations (CSPs) and Beyond Use Dates
- Facilities and Engineering Controls
- Maintenance of the Clean Room
- Aseptic Practices
- Viable Air and Surface Sampling
- CSP Preparation, Handling and Transport
- Training and Evaluation
- Standard Operating Procedures
- USP <800> Hazardous Drug Compounding
Note:
Individuals who do not work for a NHIA member will need to request a free NHIA
online account to purchase:
Abby Roth, BS, CMQ/OE
Founder
Pure Microbiology
Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.
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Access Sterile Compounding Digital Version
Recorded 09/07/2023 | 480 minutes
Recorded 09/07/2023 | 480 minutes
Unit 1 Summary: Definitions and Scope of the USP Standards
Open to download resource.
Open to download resource.
USP set the stage of General Chapter <797> by providing introductory information and defining the chapter’s scope. It describes the purpose of the chapter and identifies how the chapter applies to the different compounding acts. In addition, provisions and exemptions to following the chapter are also defined. Understanding the fundamentals discussed in this first section of the chapter is essential to applying the rest of the chapter to one’s compounding practice.
• Define compounding as it relates to home infusion.
• Explain the difference between an aseptically prepared product and a compounded sterile preparation.
• Discuss situations when compounders are exempt from the following USP <797> standards.
Unit 1: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 1: Post Education Survey
5 Questions
5 Questions
Unit 1: Definitions and Scope of USP - 0.75 CE
Unit 1: Required to Claim CE
Up to 0.75 medical credits available | Certificate available
Up to 0.75 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 2 Summary: Categories of Compounded Preparations (CSPs) and Beyond Use Dating (BUD)
Open to download resource.
Open to download resource.
Compounded sterile preparations (CSPs) can be assigned to three categories, Category 1, 2, or 3. Compounding Categories focus on where the CSP was prepared, with BUDs based on whether certain testing is performed. Each Category has its own unique requirements to ensure the safety and efficacy of the medications prepared for patient use.
• Differentiate between a beyond use date and an expiration date.
• Identify the facility conditions under which the different categories of CSPs can be prepared.
• Discuss the additional quality-related requirements necessary for the compounding of Category 3 CSPs.
Unit 2: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 2: Post Education Survey
5 Questions
5 Questions
Unit 2: Categories of Compounded Sterile Preparations (CSPs) and Beyond-Use Dating (BUD) – 1.5 CE
Unit 2: Required to Claim CE
Up to 1.50 medical credits available | Certificate available
Up to 1.50 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
_____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 3 Summary: Facilities and Engineering Controls
Open to download resource.
Open to download resource.
USP <797> provides the minimum requirements for the structural design of the sterile compounding facility. Ensuring a state of control in all areas where compounding activities are performed is needed to minimize the risk of environmental sources of contamination. A state of control in the compounding facilities is achieved using primary and secondary engineering controls. Understanding facility design and function are essential to creating a safe environment for the preparation of sterile medications.
• Recall the differences between a clean room suite and segregated compounding area.
• State the facility finish requirements that are required by USP <797>.
• Identify the different primary engineering controls and explain their placement within the facility.
• Recognize the certification testing required and recall the acceptance criteria of each test.
Unit 3: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 3: Post Education Survey
5 Questions
5 Questions
Unit 3: Facilities and Engineering Controls – 2.0 CE
Unit 3: Required to Claim CE
Up to 2.00 medical credits available | Certificate available
Up to 2.00 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
_____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 4 Summary: Maintenance of the Clean Room
Open to download resource.
Open to download resource.
Cleaning a sterile compounding environment is very different than cleaning a home, an office, or even a hospital room. Because of this, specialized tools, cleaning materials, and training are essential. The cleaning and disinfection of a sterile compounding facility is very complex and requires those overseeing and performing the task to have a thorough understanding of cleaning concepts and an appreciation for why these activities are so important.
• Define cleaning-related terms and identify how they apply to the maintenance of a sterile compounding facility.
• Explain why cleaning is part of a sterile compounding facility’s contamination control strategy.
• Name the attributes that are required of cleaning supplies and tools.
• State the chapter-defined cleaning frequencies for Category 1, 2, and 3 compounding.
Unit 4: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 4: Required to Claim CE
Up to 1.50 medical credits available | Certificate available
Up to 1.50 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
_____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 5 Summary: Aseptic Practices
Open to download resource.
Open to download resource.
The basis of sterile compounding is aseptic technique. Without fundamental skills and comprehension of first air, compounders put patients at risk. Every action taken in and immediately outside the sterile compounding area could impact the microbial control of the clean room suite or SCA and ultimately the CSP. This unit defines aseptic technique, provides the whys behind the contamination control elements found in USP General Chapter <797>, and describes some practical solutions for aseptic practices.
• Recall the importance of good personal hygiene when entering a sterile compounding area.
• Explain why the sterile compounding facility must define its own garbing order.
• Discuss the process for transferring items into the primary and secondary engineering controls.
• Describe how movement, comfort, organization, and concentration affect one’s ability to effectively prepare a CSP.
Unit 5: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 5: Required to Claim CE
Up to 1.50 medical credits available | Certificate available
Up to 1.50 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 6 Summary: Viable Air and Surface Sampling
Open to download resource.
Open to download resource.
Viable air and surface monitoring are necessary to understand the microbial risk to the sterile compounding environment. Sample collection provides a semi-quantitative snapshot in time of the of the number and types of bacteria, yeast, and mold that were in the sterile compounding area during that specific collection. This data allows sterile compounding organizations to make informed decisions regarding changes to workflow and procedures, resulting in process improvement.
• List the limitations of viable sampling.
• Recall the essential elements of a viable sampling program.
• Discuss the rationale for choosing meaningful viable air and surface sample locations.
• Explain why the incubation temperatures indicated in the chapter are critical to microbial recovery.
• Describe the steps that should be taken in investigating a microbial excursion.
Unit 6: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 6: Post Education Survey
5 Questions
5 Questions
Unit 6: Viable Air and Surface Sampling – 1.5 CE
Unit 6: Required to Claim CE
Up to 1.50 medical credits available | Certificate available
Up to 1.50 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 7 Summary: CSP Preparation, Handling and Transport
Open to download resource.
Open to download resource.
The preparation of a CSP is a complex process that blends contamination control, aseptic technique, and quality assurance/control principles. To ensure CSPs are properly prepared, supplies, components, and equipment must meet certain criteria identified in USP General Chapter <797>. As part of preparation, sterilization or depyrogenation may be required, both of which must be tightly controlled to produce repeatable results. Those preparing CSPs must have a grasp on the general life cycle of a CSP, from preparation through transport.
• Discuss the process for selecting, receiving, and evaluating components for use in sterile compounding.
• Describe how to evaluate equipment for use in sterile compounding processes.
• Explain the difference between using conventionally manufactured sterile products and CSPs as components to prepare a CSP.
• Name the different sterilization depyrogenation options used to ensure the safety of CSPs.
• Recognize the general processes for packaging, shipping, and transporting CSPs.
Unit 7: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 7: Post Education Survey
5 Questions
5 Questions
Unut 7: CSP Preparation, Handling, Storage, Packaging, and Transport – 1.5 CE
Unit 7: Required to Claim CE
Up to 1.50 medical credits available | Certificate available
Up to 1.50 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 8 Summary: Training and Evaluation
Open to download resource.
Open to download resource.
Training and evaluation of sterile compounding personnel is essential to the success of the organization. USP General Chapter <797> provides requirements for the minimum training and competency expectations. However, it is the responsibility of the sterile compounding organization to identify training needs specific to their operation.
• Recall the USP <797> general training requirements and the specific aspects of the hand hygiene and garbing competency, as well as the aseptic manipulation competency.
• Restate the basic five aspects that should be considered when developing an effective training program.
• Name the competency frequency requirements for those preparing Category 1, 2, and 3 CSPs.
• List the components of competency documentation required by USP <797>.
Unit 8: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 8: Required to Claim CE
Up to 1.25 medical credits available | Certificate available
Up to 1.25 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 9 Summary: Standard Operation Procedures
Open to download resource.
Open to download resource.
Quality is a simple term that can have very different meanings depending on the services or products a company or organization provides. USP General Chapter <797> provides quality-related requirements for sterile compounding organizations. However, these are minimum requirements, and to have an effective quality program, additional processes and procedures must be incorporated. Even if staff do not specifically hold a quality role in the organization, the quality system affects their everyday tasks, and it is essential staff have a foundational understanding of quality principles.
• Name the high-level quality management system (QMS) elements and the associated sterile compounding quality elements.
• Discuss the rationale for implementing a robust document control system and describe the importance of detailed SOPs to the sterile compounding operation.
• Explain the difference between a master formulation and compounding record, including when each must be used.
• Discuss the chapter requirements and practical solutions for recalls, handling complaints, and adverse events.
• Recall the testing methodologies available for USP <71> Sterility Testing and USP <85> Bacterial Endotoxins Test.
Unit 9: Post Education Quiz
10 Questions | 2 attempts | 70/100 points to pass
10 Questions | 2 attempts | 70/100 points to pass
Unit 9: Post Education Survey
5 Questions
5 Questions
Unit 9: Quality Management in Sterile Compounding – 1.5 CE
Unit 9: Required to Claim CE
Up to 1.50 medical credits available | Certificate available
Up to 1.50 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
________________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
Unit 10 Summary: USP 800 Hazardous Drug Compounding
Open to download resource.
Open to download resource.
While patient safety is a driving force in the home infusion industry, the safety of staff and the protection of the work environment are just as important in locations where hazardous drug are handled. USP General Chapter <800> is an essential resource to those handling hazardous drugs as it defines requirements and recommendations to ensure worker safety and the containment of hazardous drug residues. Staff must understand the chapter requirements as they relate to sterile compounding to ensure the safety of those who are exposed to hazardous drugs.
• Describe the responsibilities of the designated person.
• List alternate work and containment strategies that could be implemented if supported by the facility’s assessment of risk (AoR).
• Explain how the containment primary and secondary engineering controls are different from those in USP <797>.
• Name the additional personal protective equipment (PPE) that is required for the compounding of hazardous drugs and discuss the lifecycle of a hazardous CSP, from component receipt through disposal.
• Explain the connection between hazardous drug decontamination and wipe sampling.
Unit 10: Post Education Quiz
20 Questions | 2 attempts | 70/100 points to pass
20 Questions | 2 attempts | 70/100 points to pass
Unit 10: Post Education Survey
5 Questions
5 Questions
Unit 10: USP <800> Hazardous Drug Compounding – 2.0 CE
Unit 10: Required to Claim CE
Up to 2.00 medical credits available | Certificate available
Up to 2.00 medical credits available | Certificate available
**PHARMACISTS & PHARMACY TECHNICIANS MUST SELECT THE BLUE "CLAIM CREDIT" BUTTON & ENTER YOUR DOB IN ORDER TO RECEIVE CE CREDIT**
____________________________________________________________________________________________________________________________________________________________________
NHIA adheres to the ACCME’s Standards for Integrity and Independence in Accredited Continuing Medical Education. Any individuals in a position to control the content of a CME/CE activity, including faculty, panelists, planners, reviewers, or others are required to disclose all relevant financial relationships with ineligible entities (commercial interests). All relevant conflicts of interest have been mitigated prior to the commencement of the activity.
