Competency information
Details
Work safely and accurately in accordance with standard operating procedures (SOPs), carrying out environmental checks and in- process checking procedures.
Considerations
- Differences when working under the regulations for licensed premises or Section 10 Exemption.
- Limitations relating to the licensed status of the premises; preparation for individual patients, preparation for stock.
- Basic clean room design, layout and function of plant/air handling units, different work zones, processing environments’ airflow types, including aseptic suites, laminar flow cabinets, isolators and satellite units.
- Range of aseptically prepared products and their intended use; central intravenous additives, parenteral nutrition and cytotoxic preparations.
- Requirements for safe handling, storage and transportation, including waste disposal and Control of Substances Hazardous to Health.
- Temperature control and monitoring of starting materials and finished products, before, during and after preparation, including storage areas and transport.
- Creation of SOPs and their purpose within the wider quality management system.
- Working to SOPs, and recognising the limits of your role and referral procedures.
- Local changing procedures, as appropriate to specific workstations
- How to calculate and select the appropriate components
- How to assemble the components and record individual details on worksheets and batch records
- Routine environmental checks, before, during and after preparation, and actions to be taken with out-of-range results.
- Quality management systems, including quality control.
- EU Good Manufacturing Practice, Good Clinical Practice, Good Scientific Practice, Good Laboratory Practice relating to the working environment,
Relevant learning outcomes
| # | Outcome |
|---|---|
| # 2 | Outcome Complete hand and gowning validation. |
| # 3 | Outcome Undertake aseptic transfer (decontamination) operation. |