This module covers the environmental, health and safety management systems that are used in companies to meet their compliance with legislation and stakeholders.
It includes a holistic view of Health and Safety, understanding the basics of PPE, Noise, Radiation, Culture, IH Monitoring, Human Factors and Human Error types.
Risk assessments, Quantitative & Qualitative assessments and working practice of completing an assessment.
ISO 45001, understanding on the standard and basic principles of the standard.
Pharmaceutical manufacture
The purpose of this section is to introduce the learner to the pharmaceutical processes that are used in the manufacture of API’s. This will assist the student in career development for positions in pharma manufacturing industries.
Overview of the unit operations that occur in pharmaceutical manufacturing industries.
Green chemistry and sustainability concepts for pharmaceutical manufacturing.
1 Environmental, Health and Safety
SDG 3: Good Health and Well Being Targets and Indicators: the role of the pharmaceutical sector.
ISO 45001, Overview of the management standard, the principle and practices required to achieve and maintain standards, correction action plans, Audits and inspections, Leadership and commitment, Review, PDCA cycle, mechanisms of effective communication. Linkage to other ISO standards.
Greenhouse Gas Emissions Protocol (GHG) Scope 1, 2 & 3 Carbon Emissions.
Occupational Hygiene and Environmental Monitoring methods (workplace wellbeing) Legislative requirements in relation to employee exposures. The role of compliance testing. Sampling:-statistical methods, representative sample groups. Occupational Hygiene Survey and Work -Environmental Sampling techniques (recognized and accredited).
Chemicals: Instrumentation, Accredited methods for collection of chemical samples to include:-Dusts, VOC, Metals and Asbestos (to include clearance testing).
Determination of exposure dose and comparison with Occupational exposure limits
Risk assessments, principles of risk assessments Quantitative & Qualitative assessments and working practice of completing an assessment, hazards and risks, and adequate controls.
Environmentally sound management of chemicals and reduction of waste generation in the pharmaceutical sector.
Holistic View of Health and Safety, overview of the safety from a business point stand point, safety culture, human factors and human error, accident investigation, inclusion of Noise Surveys instrumentation, legal and occupation vs environmental noise measurement, Radiation limits and requirements, PPE protection and types.
2 Pharmaceutical Manufacture
SDG 12: Responsible Production and Consumption and how it relates to pharmaceutical manufacturing. Environmental, Social, and Governance (ESG) concerns in pharmaceutical manufacturing. Efficient use of natural resources. Design for biodegradability; from synthesis to scale up, Life Cycle Assessment. European Green Deal - transitioning to a Sustainable Economy.
Industry 5.0: Towards a sustainable, human-centric and resilient European industry. Examine the unit operations that are used from pilot scale to future-proof production including the reactors used for batch, continuous and flow systems.
From synthesis to scale up. Examination of the unit operations that are used from pilot scale to production including the reactors used for batch, continuous and flow systems.
In process control systems that are used to monitor key process parameters. Introduction to the concept of quality by design for scale up to production stages. Parameters used for key reaction completion data.
Handling systems used for gases, liquids and solids and the types of milling, mixing and blending systems that are used.
Techniques used for product isolation including, crystallisation, filtration, washing and drying.
The module is delivered by means of lectures (20 hours) including case studies and videos, tutorials (4 hours) and self-study (76 hours) to include computational problems and report writing. When possible a site visit to a pharmaceutical manufacturing plant will take place.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |