American College of Apothecaries COMPREHENSIVE STERILE COMPOUNDING COURSE OUTLINE Instructed by: Comprehensive Sterile Compounding is an 18.5 hour application-based course. Brenda Pavlic, CPhT Co-Owner, SaveWay Pharmacy The overall goal of this course is to further prepare pharmacists and technicians to Newark, DE strengthen their knowledge base in Sterile Compounding. This course will provide the participant with the knowledge of preparation and quality control tests for sterile products, such as validation testing, membrane filtration, pyrogen tests, BET (bacterial endotoxin test) and others. This course will include the USP <797> guidelines. Also covered is proper hand washing and garbing. The attendee must pass their Aseptic glove test and their media fill to successfully complete the course. Upon completion of this program, the participant should be able to:  Demonstrate aseptic technique by successfully performing gloved fingertip sampling and media-fill per USP 797 standards.  Write and implement a plan for personnel validation and environmental sampling.  Describe a quality assurance program including personnel training, validation, documentation, quality control and quality improvement.  Prepare low-, medium- and high- risk preparations using aseptic technique.  Discover microbial contaminant risk levels per USP 797.  Practice aseptic processes with evaluation and validation.  Identify filter membrane housing differences and validate filter integrity using bubble point testing.  Write and implement a sterile compounding program compliant with USP 797.  Identify and document steam and dry-heat cycles using Biological Indicators.  Justify compounded sterile product strength through certificate of analysis and other reference materials.  Write site-specific Standard Operating Procedures.  Demonstrate sterilization and depyrogenation. DAY ONE 8:30 am – 9:00 am Arrival/Introductions/Objectives/ Expectations/Objectives/Binder Contents  9:00 am – 10:30 am Classroom  Definitions  Aseptic Technique  10:45 am – 11:30 am Classroom  Aseptic Technique –Needles and Syringes  Documentation  Standard Operating Procedures 11:45 am – 12 noon Classrooom  Quiz  Hand Washing and Proper Garbing Discussion and Video 1 pm – 3 pm Lab  Demonstration and Exercise  Proper Garbing  Demonstration and Exercise  Hand Washing  Hood Prep  Facility Design and Layout  Primary and Secondary Engineering Controls  Validation  Documentation Equipment Discussion  Validation  Documentation Discussion / Demonstration  Supply Selection and Staging  Needle Size and Syringe Selection  Hand Position and Material Placement in ISO Class 5 3:30 pm – 4:30 pm Lab  Hands-On Experience  Work Area Prep  Manipulations: vials, ampules, bags, etc.  Work Area Clean-up Agenda is continued on next page. American College of Apothecaries - 2830 Summer Oaks Dr., Bartlett, TN 38134 P: 901.383.8119 Register Online - www.acainfo.org American College of Apothecaries COMPREHENSIVE STERILE COMPOUNDING COURSE OUTLINE (CONTINUED) DAY TWO 8:30 am – 8:45 am Arrival/Announcements/Housekeeping DAY THREE 8:30 am Arrival/Announcements 8:45 am – 10:15 am Classroom  USP 797 Why and How to Use It  USP 797 Risk Levels and Responsibilities  Non-viable and Viable Contamination 8:45 am – 9:00 am  Quiz 1:00 pm – 1:30pm Classroom  Quiz 10:45 am – 12 noon  Chemicals  Final Check and Testing 9:00 am – 10:15 am  Discussion: Sterilization Methods 10:30 am – 10:45 am Classroom  Filtration  Quiz ▪ Filter Types and Applications  Steam: Autoclave 10:45 – 12:00 noon  Dry Heat: Convection Oven  Quality Assurance/Quality Control/Quality Improvement  SOP  Personnel  Discussion/Demonstration: Validation Methods ▪ Portfolios or Employee File  Filters: Bubble Point Test  Training  Autoclave: Biological Indicators/Steam Indicators  Validation  Convection Oven: Biological Indicators  Testing  Filter Selection : Membrane Compatibility, Features,  Documentation Benefits ▪ Process Validation 10:30 am – 10:45 am  Environmental Monitoring and Testing  Quiz  Environmental Controls 1:30 pm – 3:00 pm Lab  Personnel Validation  Media Fills  Glove Tests 3:30 pm – 4:30 pm Lab  Hands-On Experience  Gentamicin Ophth. Solution (from inj)  Simulated Process: 30 x 0.05 ml PFS 1 pm – 3 pm Lab  Prepare Media for Media Fill  Prepare High-Risk Formula and Autoclave 3 pm – 4:30 pm Cleanroom  Perform Media Fill Cost: ACA Members - $1895.00 / Non Members - $1995.00 Comprehensive Sterile Compounding, an application-based course, has been approved for 18.50 contact hours (1.85 CEU’s) of continuing education credit being obtained in the live programming with ACPE Universal Activity Numbers 02010000-14-098-L01-P/T . These UAN have an initial release date of 11/10/2014 and an expiration date of 11/10/2017. The attendee must pass their Aseptic glove test and their media fill to successfully complete the course. Attendees will be required to complete an evaluation form at the completion of the program. Attendees requesting CE will be required to provide their NABP e-Profile ID and birthdate (MMDD) to receive credit for any ACPE-accredited CPE session. The American College of Apothecaries, Inc. is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. American College of Apothecaries - 2830 Summer Oaks Dr., Bartlett, TN 38134 P: 901.383.8119 Register Online - www.acainfo.org