INTRODUCTION OF PM (2).pdf

PHARMACEUTICAL MICROBIOLOGY PHPM 2133 INTRODUCTION OF PHARMACEUTICAL MICROBIOLOGY DIPLOMA IN PHARMACY SEMESTER 6  Explain fundamental of pharmaceutical CLO1 microbiology in quality control...

PHARMACEUTICAL MICROBIOLOGY PHPM 2133 INTRODUCTION OF PHARMACEUTICAL MICROBIOLOGY DIPLOMA IN PHARMACY SEMESTER 6  Explain fundamental of pharmaceutical CLO1 microbiology in quality control LEARNING LO1 Define terminology related to pharmacological microbiology OUTCOME Describe advantages and disadvantages of LO2 microorganism in pharmaceutical Describe the main category of microorganism LO3 in pharmaceutical LO4 Explain nutrition requirement in microbial  DEFINITION PHARMACEUTICAL MICROBIOLOGY INOCULATION PHARMACEUTICAL PRODUCTS CULTURE CULTURE MEDIA QUALITY CONTROL COLONY QUALITY ASSURANCE INCUBATION GOOD MANUFACTURING PRACTICE PHARMACEUTICAL MICROBIOLOGY Definition: Part of microbiology which has an pplication to every aspect of pharmacy. Sebahagian mikrobiologi yang diaplikasikan kepada semua aspek farmasi.  MEDIUM KULTUR: Cecair atau gel yang direka khas untuk pertumbuhan mikroorganisma atau sel Liquid medium Blood agar Nutrient medium  COLONY: A cluster of microorganisms growing on a solid surface (eg: the surface of an agar culture medium). The cluster may be identified with the naked eye. Sekelompok mikroorganisma yang membiak di atas permukaan pejal (cth: permukaan kultur medium). Kelompok sedemikian boleh dilihat melalui mata kasar. Can you spot the colonies?  CULTURE: To grow microorganism in a specially prepared nutrient medium Untuk membiak mikroorganisma dalam sediaan medium nutrien yang khas  INOCULATION: Process of introducing certain microorganism(s) into a suitable situation for growth Proses memperkenalkan sesuatu/beberapa mikroorganisma kepada sesuatu keadaan yang sesuai untuk pembiakan Apa itu inkubasi?  INCUBATION: Process of keeping a cell culture in controlled conditions favorable for growth and development Proses menyimpan sesuatu kultur sel dalam keadaan terkawal yang sesuai untuk pembiakan dan perkembangan  INOCULATION AND INCUBATION Controlled Conditions Temperature pH Osmotic Pressure  APPLICATION Penghasilan Antibiotik Diagnosis Dan Rawatan Rawatan Sisa Dan Bahan Perindustrian Menggalakkan Pertumbuhan Tumbuhan (Plant Growth) Identifikasi Mikroorganisma Ujian Bagi Sokongan Sterility Assurance System Penyediaan Bahan Steril Pensterilan Pengeluaran Enzim, Vaksin Dan Produk Farmaseutikal KEPASTIAN KUALITI FARMASEUTIKAL Sistem kepastian kualiti farmaseutikal yang efektif hendaklah dilaksanakan untuk memastikan semua ubat yang diterima oleh pengguna adalah selamat, efektif, berkualiti dan memenuhi semua tentuan dan standard dalam setiap peringkat bekalan sepanjang jangka hayat ubat tersebut. Aktiviti kepastian kualiti farmaseutikal hendaklah melibatkan semua pihak dalam rangkaian pembekalan ubat. Undang-undang hendaklah diperuntukkan untuk mengawal kualiti ubat, perkhidmatan dan aktiviti profesional yang mempunyai kesan terhadap kualiti ubat.  KEPENTINGAN MIKROBIOLOGI UBAT-UBATAN PENGURUSAN BAHAN ALAM SEKITAR MAKANAN BAHAN KIMIA PERLOMBONGAN INDUSTRI PETROLEUM PERTANIAN  Good Manufacturing Practice GMP is part of a quality system covering the manufacture and test ing of active pharmaceutical ingredients and pharmaceutical products. Guidelines that outline the aspects of production and testing that can impact the quality of a product Created to ensure a controlled QC and QA Ref: www.FDA.gov  DEFINITION Quality control: Quality assurance: – part of GMP which is concerned – the sum total of the organized a with sampling, specifications, rrangements with the objective testing and within the of ensuring that products will be organization, documentation of the quality required for their and release procedures which intended use ensure that the necessary and – Company based relevant tests are carried out – Lab based Memberi perkhidmatan yang saksama mengikut prosedur yang standard agar pelan ggan mendapat perkhidmatan yang memuaskan.  ADVANTAGES OF MICROORGANISM IN PHARMACEUTICAL Penicillin yang polycellulose, Lactobacillus dihasilkan daripada hyaluronic acid, yang berfaedah Penicillium untuk sistem organic acids, chrysogenum oleh pencernaan oligosaccharides and Flemming polysaccharides Penggunaan Pengeluaran mikrob sbg Biosintesis antibiotik probiotik bahan-bahan farmaseutik/pe rubatan  ADVANTAGES OF MICROORGANISM IN PHARMACEUTICAL Insulin, HGH [Human Growth Hormone] Faktor Pembekuan Vaksin dihasilkan Bertujuan Darah daripada menentukan antibiotik, mikroorganisma vitamin & conc amino hidup@mati acid Penghasilan Produk Penggunaan terapeutik Penggunaan mikrob sebagai daripada mikrob dalam organisma ujian rekombinasi pengeluaran [assay] DNA vaksin  DISADVANTAGES OF MICROORGANISM IN PHARMACEUTICAL Kontaminasi ubatan Kontaminasi ubatan steril dan non-steril steril dan non-steril Menyebabkan infeksi yang menyebabkan yang menyebabkan dan penyakit lain risiko kerosakan risiko infeksi produk (spoilage) Menyebabkan kesan Mewujudkan reservoir pyrogenic (demam) of antibiotic resistance tanpa infeksi genes  KATEGORI MIKROORGANISMA Bakteria Fungi Virus Protozoa Example of components bacterium cell Typical structure of a fungus Contoh-contoh virus NUTRITION REQUIREMENT IN MICROBIAL  Microorganisms requires macronutrients, micronutrients and growth factors, for their growth.  These nutrients help in constructing the cellular components like proteins, nucleic acids and lipids.  All microbes have a need for three things: carbon, energy, and electrons.  MACRONUTRIENT 01 Nitrogen (N) 06 Magnesium (Mg) 02 Carbon (C) 07 Phosphorus (P) 03 Oxygen (O) 08 Potassium (K) 04 Hydrogen (H) 09 Calcium (Ca) 05 Sulphur (S) 10 Iron (Fe)  MACRONUTRIENT  Nitrogen is needed for the synthesis of amino acids, nucleotides like purines and pyrimidines which are part of nucleic acids (DNA and RNA).  Phosphorus is a part of phospholipids, nucleotides like ATP and phosphodiester bonds of nucleic acids.  Carbon, Hydrogen and Oxygen are the backbone of all organic macromolecules like peptidoglycan, proteins and lipids and nucleic acids.  Sulphur is needed for the synthesis of thiamin, biotin, and amino acids like cysteine and methionine.  MACRONUTRIENT  Potassium, Calcium, Magnesium and Iron exist as cations in the cell. These element plays vital role in the metabolic activity of microorganisms. Potassium (K+) is needed for the activity of many enzym es  Example: Pyruvate Kinase.  Calcium (Ca2+) is involved in the heat resistance of bacterial endospores.  Magnesium (Mg2+) binds with ATP and serves as a cofactor of enzymes like hexokinase.  Iron (Fe2+ or Fe3+) is present in cytochromes and act as cofactors for cytochrome oxidase, catalase  and peroxidase.  MICRONUTRIENT  Nutrients that are needed in trace quantities are called micronutrients.  Example: Zinc (Zn), Molybdenum (Mo), Cobalt (Co), Manganese (Mn).  Besides macro and micronutrients, some microorganisms need growth factors like amin o acids, purines and pyrimidines and vitamins.  Example: Biotin is required by Leuconostoc sp and folic acid is required by Enterococcus faecalis.  NUTRITIONAL TYPES OF MICROORGANISMS  Autotrophs: These are organisms that utilize CO2 as their sole source of carbon.  Heterotrophs: These are organisms that use preformed organic substances from other organisms as their carbon source.  Phototrophs: These are organisms that utilize light (radiant energy) as their energy source.  Chemotrophs: These are organisms that obtain energy by oxidation of organic or inorganic compounds. Microorganisms are classified into Lithotrophs and Organotrophs based on the source from which they extract electrons. Lithotrophs are organisms that use reduced inorganic substances as their electron source whereas Organotrophs obtain electrons from organic compounds NUTRITIONAL TYPES OF MICROORGANISMS Nutrisi & Kultivasi mikroorganisma KOMPONEN ELEMEN UTAMA FUNGSI Karbohidrat Carbon Komponen utama dalam bahan (nutrien utama) sel Oksigen Komponen air dalam bahan sel Hidrogen Komponen air dan nucleic acid Protein Nitrogen Komponen amino acid, nucleic (hydrolysed) acid dan coenzyme Nutrisi & Kultivasi mikroorganisma Komponen Elemen utama Fungsi (membina) Elemen (dpd garam) Phosphorus Nucleic acid, phospholipid Sulfur Nucleic acid, coenzyme, methionine Sodium chloride Maintain osmotic pressure K, Mg, Fe, Ca Cofactor for enzyme Nutrisi & Kultivasi mikroorganisma Komponen Elemen utama Fungsi Vitamin untuk Vitamin B Cofactors dalam pertumbuhan eg: Folic acid, B1, B2, reaksi/proses enzymatik yang B6, B12 terlibat dalam pembinaan sel  JOM RANGSANGKAN MINDA 1. Define terminology of: Culture media, Colony, Incubation, Inoculation, Culture, Quality control, Quality assurance, Good manufacturing practice 2. State five (5) pharmaceutical applications of microorganisms. 3. Describe two (2) role of microorganisms in pharmaceutical industry. 4. Describe three (3) problems created by microorganisms in pharmaceutical industry. 5. Explain how the nutrition works in cultivation of microorganisms a. Macronutrient b. Micronutrient THANK YOU for your attention