PHRM06006 2019 MANUFACTURING AND PROCESSING TECHNOLOGY

Understand the process of chemical dispensing, methods and equipment.

To describe the cleaning requirements of process equipment and methods employed by industry to combat this requirement.

To detail the mainstream systems and equipment used for generation of EP and USP grade water for Pharm/Biopharma production and manufacture.

To demonstrate a knowledge of the various information technology applications operating in the pharmaceutical industry.

To demonstrate how non sterile Pharma/cosmetic products are manufactured, processed and the packaging options/requirements suited to each type of formulation.

To demonstrate a knowledge of the methods for biologic manufacture, purification and primary fill/packaging requirements for this type formulation.

To describe the methods to ensure the sterility of pharmaceutical preparation to the point of primary container closure selection and processing.

Clear knowledge of solid dosage form, from dry powder mixing to final dosage and the packaging methods and requirements.

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Dispensing/starting material allocation

Batch Records - documentation, labeling (RFID), weighing, LAF

Solid dosage form - Tableting - Ingredient (make up) Mixing, granulation, compression, coating, blister packs

Liquids sterile, Parenterals - Formulation, Sterile manufacture, filtration, filling, packaging BFS, Terminal sterilization ETO

Biologics - Fermentation, scale up, harvesting, disruption, filtration, filling, lyophilization, packaging Vials

Non sterile  - Ingredients, Creams, gels, liquids (susp, emuls), mixing, milling, filling (tubes plastic, alu, bottles glass, plastic, sachet), packaging

Computerised system control. - Scada, PLCs, EBMR, ERP

Manufacture of Class I, II and III Medical Devices

Introduction to materials used in medical device manufacture.  Overview of molding design and extruded medical plastic manufacturing processes.  Manufacturing flow diagrams.

Purified Water systems -Organic Scavanger, Twin bed Deioniser, UF, RO, CDI, TCS, Ozonation, UV. Filtration, Carbon, depth, mixed membrane.

Cleaning systems,

Detergents, CIP, SIP, sanitation