Aseptic Services 1

Module details

Title

Aseptic Services 1

Type

Rotation

Module code

SPE201

Credits

10

Requirement

Compulsory

Aim of this module

This rotation introduces trainees to aseptics and will enable them to gain skills and experience of the work of an aseptic services unit from the design of products, formulations testing (including microbiological), validation, quality assurance and dispensing to apply underpinning knowledge. Trainees will gain experience so that they are able to observe, assist, or perform a range of routine procedures in the context of providing high-quality, safe patient care and will be expected to develop and build their professional practice.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 2,3	Competency Work safely and accurately in accordance with standard operating procedures (SOPs), carrying out environmental checks and in- process checking procedures.	Action View
# 2	Learning outcome 1,4	Competency Critically evaluate key reference texts used in aseptic preparation and produce a short report identifying the strengths and limitations of each resource.	Action View
# 3	Learning outcome 2,3	Competency Demonstrate good clean room behaviours.	Action View
# 4	Learning outcome 1	Competency Assist in performing environmental microbiological and physical monitoring.	Action View
# 5	Learning outcome 2,3	Competency Perform practical aseptic manipulation of components using correct aseptic technique and the use of principal equipment, under simulation.	Action View
# 6	Learning outcome 2,3	Competency Perform a range of operator validations, including finger dabs, transfer validation, broth transfer challenge test, and follow the process of incubation, sampling, testing and reporting on results.	Action View
# 7	Learning outcome 1	Competency Label a range of aseptically prepared products, including label validation, key information, legal requirements, label reconciliation and destruction.	Action View
# 8	Learning outcome 1	Competency Discuss the clinical context within which aseptically prepared products are used, including administration and the associated considerations.	Action View
# 9	Learning outcome 1,4	Competency Assist in the maintenance of routine documentation working consistently and making accurate entries on routine documentation and record keeping.	Action View
# 10	Learning outcome 4	Competency Interpret stability data and determine the shelf life of a range of products.	Action View

Assessments

You must complete:

• 1 case-based discussion(s)
• 1 of the following DOPS/ OCEs:

Select ingredients and or equipment against an approved worksheet	DOPS
Undertake a hand wash and gown up procedure	DOPS
Demonstrate the transfer of materials to aseptic critical zones	DOPS
Monitor clean rooms laminar flow cabinets and or isolators	DOPS
Demonstrate a range of methods of aseptic manipulation under simulation	DOPS
Perform a broth transfer test	DOPS
Demonstrate effective cleaning of equipment and premises and identify key points for prevention of cross contamination	DOPS
Discuss associated clinical test results e.g. UandEs bloods with a clinical pharmacist and rationale for any change in formulation defer treatment	OCE
Accompany a clinical pharmacist and participate in a ward clinic visit	OCE
Observe release of a finished product against a prescription, and discuss critical steps	OCE
Observe administration of a finished product to a patient within a clinical environment	OCE

Learning outcomes

1. Complete aseptic manipulation under supervision. 
2. Complete hand and gowning validation. 
3. Undertake aseptic transfer (decontamination) operation. 
4. Interpret stability data when determining the shelf life of a range of products. 

Learning outcomes

1. Discuss the role of the Clinical Scientist in Clinical Pharmaceutical Sciences in ensuring the safety of the patient, particularly related to the manufacture and quality control with reference to key patient care pathways. 
2. Explain the principles of aseptic manipulation. 
3. Describe the principles of basic pharmaceutical microbiology. 
4. Explain key chemical and physical reactions affecting the stability of medicinal products.
5. Resolve drug formulation and administration problems, particularly where they relate to the modification and optimisation.

Indicative content

Clinical Pharmaceutical Science in key patient and care pathways

• Diagnosis using radioactive materials
• Treatment relevant to the patient and care pathway, including chemotherapy
• Treatment using radioactive materials
• The role of regulation, Good Manufacturing Practice, aseptic techniques and quality assurance in ensuring patient safety

Principles of aseptic manipulation

• Practical application of quality assurance
• Aseptic technique
• Compliance with regulatory and operational requirements
• Effective working within aseptic processing environments

Pharmaceutical microbiology

• Microorganisms, microbial growth (form and actions of microbes)
• Sources and control of microbiological contamination,
• Potential risks from microbial contamination (pathogens and infection risks)
• Spoilage and control/preservation

Maintenance of essential documentation

• Completion of all logs, worksheets and reports
• Completion of necessary training records

Activities

• Observe the range of processes undertaken by an aseptic preparation and dispensing service and review the different product types prepared within aseptic services, considering their usage, including, central intravenous additives (CIVAs), parenteral nutrition, cytotoxics, monoclonal antibodies (MABs). Discuss the different product types, their intended use and contribution to safe patient treatment and care. 
• Observe the use of products prepared in the aseptic area and, with permission, talk to patients to gain insight into patient needs and discuss the critical requirement for quality-assured ready-to-administer injectables and other aseptically prepared products with your training officer. 
• Critically evaluate some of the high-profile untoward events, the National Patient Safety Agency alerts arising from such events, and generate a short report summarising the key points that should be addressed to avoid repeat incidents. 
• Observe the processes underpinning the safe use of aseptically prepared products by healthcare professionals in the prescribing, clinical validation, technical validation and administration, and reflect on your experience, identifying the strengths of the process and areas that could be improved.