Direct compounding area - Study guides, Class notes & Summaries

CETA – All COMBINED LATEST UPDATE Critical Area - ANSWER An ISO Class 5 environment Critical Site - ANSWER A location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical si...

HVAC Heating ventilation air-conditioning Line of Demarcation A line that. is taped or drawn on the floor of the anteroom or area that separates the anteroom from the clean room Brainpower Read More Sticky mat A Matt compromising of multiple layers of sticky plastic it adheres to the floor in front of the door to the anteroom and or clean room . it helps to remove dirt and debris from the bottoms of shoes and shoe covers. the top most layer most frequently be removed and ...

CETA – All COMBINED LATEST UPDATE Critical Area - ANSWER An ISO Class 5 environment Critical Site - ANSWER A location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical si...

CETA TEST VERIFIED 100% CAG-002-2006 - ANSWER Compounding Isolator Testing Guide CAG-005-2007 - ANSWER Servicing Hazardous Drug Compounding Primary Engineering Controls CAG-008-2010 - ANSWER Secondaring Engineering Controls - Matrix for Sterile Compounding Facilities CAG-009-00 - ANSWER USP 797 Viable Environmental Sampling & Gowning Evaluation Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing : Current Good Manufacturing Process - ANSWER U.S. Department...

MPJE Maryland Study Guide (Latest 2023/ 2024 Update) Questions and Verified Answers| Grade A| 100% Correct Q: Requirements for Drug Delivery Answer: 1. Must document authorization to deliver 2. Must have Rph readily available for consult 3. Must be delivered to the patient or their agent (no depots) 4. Must be labeled as to not indicate drugs are inside 5. Must be packaged to show evidence of tampering Q: Rx Transfer Requirements Answer: Record of transfer and all rx in...

PTCB CSPT EXAM QUESTIONS AND COMPLETE ANSWERS Patient harmed by compounded sterile preparations non sterile compounding examples aesptic sterile compounded items Non hazardous hoods) Hazardous hoods Primary Engineering Control (PEC) secondary engineering controls Buffer or Clean Room Ante Room ISO class vertical hood Horizontal Hood Direct Compounding Area (DCA)

CETA – All COMBINED LATEST UPDATE Critical Area - ANSWER An ISO Class 5 environment Critical Site - ANSWER A location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical si...

CETA Study Guide Exam Questions With Answers All Correct Servicing Hazardous Drug Compounding Primary Engineering Controls - ANSWERCAG-005-2007 Compounding Isolator Testing Guide - ANSWER- CAG-002-2006 Secondaring Engineering Controls - Matrix for Sterile Compounding Facilities - ANSWER- CAG-008-2010 USP 797 Viable Environmental Sampling & Gowning Evaluation - ANSWER- CAG-009- 00 U.S. Department of Health and Human Services - ANSWER- Guidance for Industry - Sterile Drug Products Produ...

CETA QUESTIONS WITH VERIFIED ANSWERS Servicing Hazardous Drug Compounding Primary Engineering Controls - ANSWER CAG-005-2007 Compounding Isolator Testing Guide - ANSWER CAG-002-2006 Secondaring Engineering Controls - Matrix for Sterile Compounding Facilities - ANSWER CAG-008-2010 USP 797 Viable Environmental Sampling & Gowning Evaluation - ANSWER CAG-009-00 U.S. Department of Health and Human Services - ANSWER Guidance for Industry - Sterile Drug Products Produced by Aseptic Proce...

CETA – All COMBINED LATEST UPDATE Critical Area - ANSWER An ISO Class 5 environment Critical Site - ANSWER A location that includes any component or fluid pathway surfaces (e.g., vial septa, injection ports, beakers) or openings (e.g., opened ampules, needle hubs) exposed and at risk of direct contact with air (e.g., ambient room or HEPA filtered), moisture (e.g., oral and mucosal secretions), or touch contamination. Risk of microbial particulate contamination of the critical si...