IPLUSO 19594

Aseptic Production Technology

• ApresentaçãoPresentation

  It is intended that at the end of this course, students will have acquired skills of intervention in the planning and structuring of Pharmaceuticals services, combining aspects from quality and safety in handling and preparing galenic formulations to skills and aseptic technique procedures that lead to quality at all stages of manipulation of non-sterile and sterile drugs. The student must be able to effectively organize and manage the time and resources available within the scope of its activity, being sensitive and responsible regarding the high degree of complexity of some activities associated with handling cytotoxic drugs and parenteral nutrition, applying theoretical knowledge and develop the practice of asepsis techniques in the context of hospital pharmacy
• ProgramaProgramme

  Sterile preparations in hospital 1. Types of sterile preparations in hospital: 1.1. Cytotoxic manipulation 1.2. Pararenteral nutrition 1.3. Radiopharmaceuticals 1.4. Other aseptic preparations 2. Requirements for the manipulation of sterile drugs in Hospital Pharmacy 2.1. Areas, facilities and equipment 2.2. Personal protective devices (EPI) 2.3. Preparation and organization of the working environment 2.4 Decontamination procedures 2.5 Procedures in case of spillages 3. Aseptic environment handling techniques 3.1. Rules and general principles 3.1.1. Manipulation horizontal laminar air flow chamber 3.1.2. Manipulation vertical laminar air flow chamber 4. Sterilization, disinfection and antisepsis 4.1. Sterilization Definition 4.2.Desinfecção and antisepsis: 5. Quality Control 5.1 Standardization of procedures 5.2 Quality Control and Indicators 5.3 Microbiological Control
• ObjectivosObjectives

  Understand the concepts and general principles of aseptic techniques; - Know the methods of decontamination, disinfection and sterilization; - Know the different practical ways to develop aseptic techniques in pharmacy and its application in different contexts according to different levels of demand; - To acquire critical thinking in real situations and know that techniques used in each context, promoting global security and the quality of work; - Apply the theoretical knowledge and develop the practice of aseptic techniques in pharmacy context; - Identify the technical conditions (plant and equipment) ideal for the application of these techniques and present, whenever possible, suggestions for improvement andquality; - Organize and manage effectively, the time and resources available within its activity.
• BibliografiaBibliography

  • Aulton, M.E., ( 2002) Pharmaceutics - The Science of Dosage Forms Design, 2nd edition, Edinburgh, Churchill Livingstone • Lachman, Lieberman, Kanig, (2001) Teoria e Pratica na Indústria Farmacêutica, Lisboa, Fundação Calouste Gulbenkian, • Niazi, S. K. ,(2009) Handbook of Pharmaceutical Manufacturing Formulations: Sterile Products. (vol. six - 2nd ed.) New York: Informa Healthcare, • Nunes, F. (2006) – Segurança e Higiene no Trabalho – “Manual Técnico”. Amadora: Editora Gustave Eiffel. 1ª ed.,  • Oliveira, Lurdes (2007) – Segurança, Higiene e Saúde no Trabalho “Manual de Apoio”. Porto: Vida Económica, 2ª ed. Karen Davis (2014) Sterile Processing for the Pharmacy Technicians, (Elsevier, Alabama) Mike Johnston (2011) Sterile Products and Aseptic Techniques for the Pharmacy Technician, second edition”, (Pearson) 
• MetodologiaMethodology

  In this curricular unit, the Team-based learning (TBL) methodology is used, with tasks carried out in small groups, allowing the development of the ability to analyze and apply theoretical concepts.  
• LínguaLanguage

  Português
• TipoType

  Semestral
• ECTS

  4
• NaturezaNature

  Mandatory
• EstágioInternship

  Não