This module describes the building designs utility supplies and waste management systems associated with Healthcare practices.
Facility Design and Hygiene:
High and low level hygiene requirements. Zoning- restricted access zoning. Raw material receipt and segregation. Total traceability. Settle plates. Particle counts. Work flow and contamination control.
Legislation governing the design of laboratories
BS3202, BS 7258, BS 5726 and CEN standards. Control of Substances Hazardous to Human Health Regulations (COSHH).
Cleanroom Technology:
Control of contamination by using cleanrooms. Personnel clothing requirements. Cleanroom design and construction. Cleanroom classification. Cleanroom configuration. Estimation of viable and non viable counts. Relevant standards e.g. Fed Std 209E.
Heating Ventilation 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 and Chemical Standards. Bioburden recovery. Storage. FDA rules. Alert and action limits. Performance monitoring e.g. conductivity measurements. Storage vessels. Heat exchangers.
Validation of pharmaceutical water system:
Documentation, change control, validation report, sampling plan and frequency of tests. Establishing a maintenance programme. Self audits of the water system.
Aseptic Processing:
Microbial Ecology and Spoilage of Pharmaceutical Products: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. Clean steam requirements.
Primary Containment Facilities for Biomedical Laboratories
Facility Design and construction. Barrier and Isolator Technology. Controlled access zones, airlocks as laboratory entrances. Sinks and handwashing facilities in laboratories. Biological Safety Cabinets; Class I, II, and III. Waste disposal facilities. Personnel clothing, shoe covers, hair covers, masks, visors, gloves, coats etc.
Designing Infective Waste Management Systems within Laboratories
Floor coverings. Bench top surfaces. Identification of high risk wastes- special precautions. Infective and aesthetic factors in hospital waste management. Guidelines for the handling, transport, storage and disposal of laboratory wastes, surgical and other clinical wastes. Design considerations for biohazardous wastes, toxic wastes, radionucleide wastes, sharps wastes are generated.
Waste Disposal:
Waste segregation. Waste minimisation. EPA guidelines on waste reduction /management.Waste disposal/decontamination e.g. sterilisation and incineration. Design considerations.
Utility requirements for biomedical laboratories:
Air handling: specialised ventilation and air treatment systems.Fume hoods, laminar air flow and bio-safety cabinets. Location. Operation. Storage space within laboratories. Work surfaces and decontaminating equipment.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 50 |
| Formal Examination | 50 |