Non-sterile Compounding: Hands-on Lab Training
Course Description
The hands-on lab training features a series of fundamental skills followed by the preparation of eight dosage forms. This hands-on experience gives the participant the opportunity to learn and practice general compounding lab processes and procedures, compounding techniques, operating electromechanical equipment, managing a workstation, documenting standard operating procedure logs, all while operating within a compounding facility and preparing non-sterile compounded medications.
Elements of a unique process experienced in the Virtual Seminar can now be realized in this Practical Lab, which serves as the basis for the development, and subsequent preparation of any non-sterile dosage form containing any appropriate active pharmaceutical ingredient. The unique elements include:
- Compounding by composition (i.e., powder blends, and powder-in-liquid mixtures in the form of solutions or dispersions)
- Preparatory states-of-matter and final dosage form states-of-matter (i.e., solids, semisolids and liquids)
- Routes of delivery and delivery systems
- Sites of administration and target sites of action
Featured Activities:
- Skills Development
- Weighing powders
- Measuring liquids
- Geometric Addition
- Clean transfers of semisolids
- Weight variance testing
- Organoleptic assessments
- Beyond-Use-Dating assignments
Featured Dosage Forms:
- Cellulose-based hydro-alcoholic gel in an actuated dispenser
- Oral transmucosal films using syringe-to-syringe mixing technique
- Capsules using 100-count capsule machine including aliquot calculation
- PEG-based troches including mold fill calculation
- Rapid dissolve tablets
- Oral suspension including pH step
- Suppositories using a 12-count flexible mold
- Topical cream emulsion, using an electronic blade mixer, mill and planetary motion mixer (no blades)
Instructional Design
The Practical Lab is a hands-on application-based compounding skills development session followed by the preparation of eight (8) dosage forms each with a unique chemical composition, routes of delivery and delivery system. The eight prepared compounded medications undergo a qualitative and quantitative assessment. The Practical Lab program learning assessment consists of an assessment of learned preparatory techniques, which includes those highlighted during the skills development session complemented by scores allocated to the qualitative and quantitative assessment results.
Course Format
2-day live practical lab (12 hours) where you will receive hands-on experience developing non-sterile compounding skills, and preparing eight (8) dosage forms. Each compounded dosage form concludes with a quantitative and qualitative assessment. Participants complete a self-directed learning assessment co-signed by the program facilitator.
Combine this program with Non-Sterile Compounding: Live Virtual Seminar, where you will learn about non-hazardous and hazardous drug compounding, divided into four subsections: Business Basics, Creating a Culture of Quality, Compounding Calculations, and Scientific Principles to complete the Full Certificate Program.*
Intended audience
- Pharmacists, Pharmacy Technicians, Pharmacy Managers, Designated persons in positions of responsibility, and Quality Assurance & Quality Control officers looking to advance their practical non-sterile compounding skills related to any professional setting.
- Auditors / Inspectors looking to hone their assessment skills in concert with the standards described and detailed in this Activity.
Learning Objectives
PHARMACISTS
- Demonstrate proper donning and doffing of personal protective equipment; non-hazardous and hazardous
- Demonstrate how to manage a workstation, its equipment and chemical inventory
- Demonstrate how to properly sanitize a workstation in a non-hazardous and hazardous drug environment
- Demonstrate how to properly manage and dispose of waste; non-hazardous and hazardous
- Demonstrate how to clean and disinfect an analytical balance
- Demonstrate how to verify the internal calibration of an analytical balance
- Record data in standard operating procedure logs
- Demonstrate the use of electromechanical equipment, and reusable and disposable devices
- Perform a broad range of non-sterile compounding techniques
- Prepare a number of non-sterile compounded medications
- Determine the beyond-use date for non-sterile compounded medications
- Select appropriate dispensing containers for finished non-sterile dosage forms
- Complete formulation records for finished non-sterile dosage forms
- Analyze finished dosage forms by assessing organoleptic properties and performing weight variance testing
PHARMACY TECHNICIANS
- Demonstrate proper donning and doffing of personal protective equipment; non-hazardous and hazardous
- Demonstrate how to manage a workstation, its equipment and chemical inventory
- Demonstrate how to properly sanitize a workstation in a non-hazardous and hazardous drug environment
- Demonstrate how to properly manage and dispose of waste; non-hazardous and hazardous
- Demonstrate how to clean and disinfect an analytical balance
- Demonstrate how to verify the internal calibration of an analytical balance
- Record data in standard operating procedure logs
- Demonstrate the use of electromechanical equipment, and reusable and disposable devices
- Perform a broad range of non-sterile compounding techniques
- Prepare a number of non-sterile compounded medications
- Determine the beyond-use date for non-sterile compounded medications
- Select appropriate dispensing containers for finished non-sterile dosage forms
- Complete formulation records for finished non-sterile dosage forms
- Analyze finished dosage forms by assessing organoleptic properties and performing weight variance testing
Testimonial
“A true hands-on experience with experts that teach the secrets of successful compounding. I learned a lot regarding compounding techniques, quality control, packaging, and the availability of compounding tools and aids. This training will help my day-to-day practice!”
Parvaneh Moussavian | Pharmacist
FINANCIAL SUPPORT
This learning activity has received financial support from MEDISCA Inc. in the form of an educational grant.
COPYRIGHT
This CE Activity is Copyright © 2002-2024 LP3 Network.
*Composed of two components – the Non-Sterile Compounding: Home Study & Live Virtual Seminar and the Non-Sterile Compounding: Hands-on Lab Training – The Certificate Program provides Pharmacists and Pharmacy Technicians with a well-rounded, comprehensive, practical, and applicable understanding of non-sterile compounding – everything from foundations in pharmaceutical compounding, to regulations and standards of practice, to business and marketing, to quality control, to the hands-on preparation of non-sterile dosage forms, and much more. Each program has an associated learning assessment that must be successfully completed to fulfill the requirements of the Full Certificate Program. The Live Virtual Seminar and Live Hands-on Lab Training must be taken within 6 months of each other. Upon successful completion of the Full Certificate Program, participants will receive a Certificate of Completion acknowledging their achievement that can proudly be displayed in their compounding pharmacy.
Note: Facilitators are subject to change.
Editor
NEIL COHEN, BSc CE Program Developer Disclosure: None |
Contributors
JENNIFER CLARE, BSc Contributor / Facilitator, LP3 Network Senior Technical Support Service Representative, Medisca Network Disclosure: None | |
MINDY CORMIER, Pharm D, RPh Contributor / Facilitator, LP3 Network Advanced Clinical & Formulation Pharmacist, Medisca Network Disclosure: None | |
MARK FILOSI, BS Pharm, RPh Contributor / Facilitator, LP3 Network Consultant, Medisca Network Compounding Pharmacist and Co-Founder, Family Care Pharmacy Disclosure: None | |
DAVID MASTROPIETRO, PhD, RPh |
PHARMACISTS & PHARMACY TECHNICIANS
The Practical Lab is accredited for Pharmacists and Pharmacy Technicians by the Accreditation Council for Pharmacy Education (ACPE) through CPE Consultants, LLC.
Total CPE Credits: 12 CPE Hours = 1.2 CEUs
Type | Application-based |
UAN | 0864-9999-24-043-L07-P/T |
Credits | 12 CPE Hours = 1.2 CEUs |
Release Date | July 1, 2024 |
Expiration Date | July 1, 2027 |
COMPLETION REQUIREMENTS
- Complete all skills development exercises, eight dosage forms including their corresponding assessments with a minimum passing score of 70%.
- Submit to the program coordinator the completed and facilitator co-signed learning assessment document.
- Submit a completed Practical Lab evaluation online.
When the aforementioned steps have been completed and approved:
- Pharmacists and Pharmacy Technicians registered in the United States will obtain a statement of completed credits on their NABP e-Profile within 60 days.
- Pharmacists and Pharmacy Technicians registered elsewhere will receive an automated email from LP3 Network advising that they can download a statement of participation.
- All participants will receive an automated email from LP3 Network advising that they can download the LP3 Network certificate of completion.
CPE Consultants, LLC is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. |
International participants should verify with their respective governing board for accreditation equivalency.
*Note: Only programs scheduled from July 1, 2021 onward are eligible for Certificate Program recognition.
CANCELLATION AND REFUND POLICY
In the event that LP3 Network cancels a course, LP3 Network's sole liability shall be course repayment. In no event shall LP3 Network be responsible for any costs related to travel and/or accommodation. A written request must be sent to LP3 Network Inc. requesting ‘Cancellation without Transfer’ to an alternate live activity event date. If cancellation occurs at greater than or equal to 31 days from live activity event date, then registrant will receive a 75% refund; 15-30 days a 50% refund; and less than or equal to 14 days no refund. There are no refunds, returns, or transfer requests upon purchase of a home study, digital work book, webinar, and eLearning modules. LP3 NETWORK INC. shall be excused from any delay caused by reason of any occurrence or contingency beyond its reasonable control (a “Force Majeure”), including but not limited to, acts of God, hurricane, earthquake, labour disputes, strikes, riots, war, and governmental requirements. The obligation to pay money to LP3 NETWORK INC. in a timely manner is absolute and shall not be subject to this Force Majeure provision. In such event, LP3 NETWORK INC. will not issue any refunds, only transfer to an alternate live activity event date.
TRANSFER POLICY
The transfer policy is only in effect if requested greater than or equal to 14 days prior to the original live activity date. Failure to submit the “Transfer Request” at least 14 days prior to the original live activity date will default to the “Cancellation and Refund Policy”. The transfer policy can only be applied one (1) time. Transfer to a new live activity date must be within the current calendar year. Failure to attend the new live activity will result in no refund and will no longer be transferable. Confirmation of the new activity date is subject to approval by LP3 Network based on the number of available seats within the selected live activity. There are no refunds, returns, or transfers upon purchase of the home study.