The module aims to provide the student with the knowlegde and skills required for an aseptic manufacturing environment
Heating Ventillation and Air Conditioning, (HVAC)
High efficiency particulate air (HEPA) filtration. Design and construction. Air flow direction, air flow rates. Room air pressure and air changes. Room air pressure differentials. Temperature and humidity control. Warning limits
Pharmaceutical Water Systems
Water treatment systems, USP, purified water , water for injection, (WFI), rinse water. Impurity testing. Purification methods. Microbiological assay: Bacterial endotoxins, bioburden recovery. Microbiological and chemical standards. Alert and action levels. Water pre-treatment, treatment and purification systems. FDA rules and regulations as regards pharmaceutical grade water. Water storage, water pumps , piping systems storage vessel construction, heat exchangers.
Aseptic Processing
Microbial Ecology and Spoilage of Pharmaceutical Products: Main ingredients subject to attack. Factors controlling rate of spoilage. Opportunist and acute pathogens. Observable effects of spoilage. The use of preservatives. Environmental monitoring and control. People as a source of contamination. Disinfection and its validation. Cleaning systems e.g. CIP.
Cleanroom Technology
Control of contamination by using cleanrooms. Personnel gowning requirements. Cleanroom design and construction. Cleanroom classification. Cleanroom configuration. Measurement of viable and non viable particles. Conformance to standards.
Clean in place technology and validation of CIP
Aseptic work practices. Aseptic packaging technology. Aseptic filling. Media fills. Evaluation of vial closing integrity. Microbiological evaluation. Automated microbial identification systems. Pyrogens and depyrogenation.
Isolation technology
Design, construction and testing. Applications. Validation. Microbiological evaluation. Regulatory requirements. Absolute enclosed and partial barriers. Design of barrier enclosure. Handling techniques.Sterile air. Sterile transfer technique. Enclosure sterilisation. Validation of enclosure integrity. Sterile production cycle. Packaging. Personnel protection. Lyophilisation.
Sterilisation Methods
Moist heat, dry heat, gaseous, irradiation. Fluid sterilisation by filtration, filter construction, filter integrity, the bubble point test. Filtration capacity and efficiency. Sterilisation in place (SIP). Steam in place.
Sterility testing
Limitations. Bioburden control. Process validation, validation protocol. Validation requirements, daily quarterly and yearly testing requirements. Biological chemical and physical indicators. Container mapping studies. Heat distribution studies using thermocouples. Regulatory requirements. Bacterial contamination of stainless steel equipment.Pyrogens and depyrogenation. Limulus Amebocyte Lysate Testing. Robotic applications in sterility testing. Reducing the risk of viral tranmissions in products.
Practical Course(Examples)
These practicals will be carried out in the pilot plant facility1. HEPA filter integrity-air velocity measurements and settle plates2. HEPA filter integrity –measurement of the number of particles.3. Water treatment system partial validation-isolation of bacteria from untreated/treated water4. Cleaning system evaluation-rinse and swab methods.5. Steam in place – destruction of thermophilic bacteria.6. Evaluation of disinfectants-static/cidal effect,
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 50 |
| Formal Examination | 50 |