Team:UCL London/Health & Safety Analysis

Health & Safety Analysis

A deeper approach was adopted by attending a safety training run by the Department of Biochemical Engineering at University College London, in order to know "the code of practice". An initial Hazard identification and assessment was carried as a first step, which included the identification of any compound-from ionised water, to buffers, to GMOs (Genetically Modified Organisms) and the assessment of the risk they imposed upon human health.

The critically of Health & Safety, under the Health & Safety at Work Act 1974, was emphasised and bear in mind at all times, as this is "the alpha and the omega" meaning that any professional research should be carried under the regulations published by the relevant regulatory bodies, for the health and safety of the researchers. HSE, the Health and Safety Executive in UK, is the main regulatory body providing the relevant advice and support for any industrial business. With regards to our case, we made quite a breadth and depth research into the policy surrounding the operation of a pharmaceutical industry plant and summarised some key points:

Process Validation Process validation allows understanding and control of the process, equipment and facility. QC testing After the process is validated, each batch is then validated via QC testing for Purity, potency and sterility

GMP, GLP and GCP compliance A biopharmaceutical facility must comply with the GMP, GLP, GCP requirements: General Manufacturing/Laboratory/Clinical Practices respectively, by the FDA (Food and Drug Administration) Design Qualification of equipment (DQ) Installation Qualification of systems (IQ) Operational Qualification (OQ) Process Qualification (PQ)

Accident Prevention Policy & Emergency plans Emergency procedures must be in place e.g. In case of a fire: according to the 1910(29 CFR) Subpart E (OSHA) Occupational Safety and Health Administration of the United States: Exit routes, emergency evacuation plans, first aid facilities, breathing apparatus and of course trained personnel. Staff training For example, operators risk injury from lifting and handling heavy machinery or from repetitive strain problems. This is very important, as taking breaks as often as required from daunting tasks, is within the employee's rights.

Hazard identification and assessment For example Oxygen: the dangers are fire and explosion (HSE, 2006), detergents e.g. ethanol: flammable liquid, caustic and potential carcinogen (J.T. Baker, 2006). Documentation SOP: Standard operating procedure, BMR: batch manufacturing record, records of process data and monitoring data.

Mechanical Integrity Critical when operating highly pressurised equipment such as a highly packed chromatography column, a centrifuge or other unit operations. Regular checking and maintenance is required. Waste Management Waste handling is a way of improving efficiency on the production plan as well as maximizing profits. Protein aggregation, contaminants, toxins, host cell proteins, cell debris, lipids and other by-products liquid/solid/gas must be identified and follow the suitable pre-treatment route. Waste Stream Components