Aseptic Services 2

Module details

Title

Aseptic Services 2

Type

Specialist

Module code

SPE220

Credits

15

Requirement

Compulsory

Aim of this module

To introduce the trainee to the practical systems and processes that contribute to ensuring the quality of aseptically prepared products.

Competencies

#	Learning outcome	Competency	Action
# 1	Learning outcome 1	Competency Interpret and analyse monitoring data and diagnose problems.	Action View
# 2	Learning outcome 1	Competency Observe trends and patterns reported from microbiology results and consider the impact of contamination in the clinical environment.	Action View
# 3	Learning outcome 1	Competency Interpret stability data to determine the shelf life of a product.	Action View
# 4	Learning outcome 2	Competency Assist with a range of quality assurance procedures within the aseptics unit.	Action View
# 5	Learning outcome 2	Competency Perform, under supervision, the release of a range of products produced in the aseptics unit.	Action View
# 6	Learning outcome 3	Competency Assist in the training and monitoring of aseptic services personnel.	Action View
# 7	Learning outcome 3,5,6	Competency Critically evaluate the design of a clean room installations and clean room procedures manuals.	Action View
# 8	Learning outcome 3,5	Competency Assist in the commissioning of a clean room/equipment following modification or installation.	Action View
# 9	Learning outcome 4,6	Competency Assist with and critically evaluate in- situ high-efficiency leak testing (DOP).	Action View
# 10	Learning outcome 4,6	Competency Assist with and critically evaluate operator protection testing.	Action View
# 11	Learning outcome 4,6	Competency Assist with and critically evaluate toxic substance monitoring.	Action View
# 12	Learning outcome 4,6	Competency Assist with and critically evaluate a range of microbiological methods of monitoring (including control of contamination).	Action View
# 13	Learning outcome 4,6	Competency Assist with and critically evaluate clean room clothing monitoring.	Action View

Assessments

You must complete:

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

Undertake a risk assessment following a breach potential breach of the unit	DOPS
Assist directing staff with a validation exercise being undertaken eg process validation, cytotoxic residue testing	DOPS
Demonstrate effective cleaning of equipment and premises, and identify key points for prevention of cross contamination	DOPS
Discuss with colleagues the findings from a breach risk assessment the root cause analysis and the corrective action necessary to implement change	OCE
Undertake and document a product recall or an annual recall simulation. Discuss the deficiencies found. Suggest corrective measures	OCE
Explain to a clinical colleague why an aseptically prepared dispensed product cannot be released for clinical use	OCE

Learning outcomes

1. Perform a range of procedures to ensure the quality of product processing, labelling, storage and dispensing in accordance with the standards, practices and quality assurance procedures from design through to the formulation and testing of parenteral products.
2. Assist in the quality assurance process within the release of a range of finished aseptically prepared products.
3. Assist in the training and monitoring of aseptic services personnel, ensuring competence and compliance with the relevant standards.
4. Follow local error reporting procedures, exception procedures and communication channels.
5. Assist in the commissioning of a clean room environment/equipment following planned maintenance, modification or installation.
6. Critically evaluate the use of a range of environmental monitoring tests within a clean room environment. (This should include: (i) in-situ high-efficiency leak testing (DOP); (ii) operator protection testing (KI discus); (iii) toxic substance monitoring; (iv) microbiological methods of monitoring (including control of contamination); and (v) clean room clothing monitoring.)

Learning outcomes

1. Discuss and justify all standards, practices and quality assurance arrangements relating to aseptic preparation and dispensing of medicines and their application to patient safety and patient-centred care.
2. Explain pharmaceutical microbiological aspects of aseptic manufacture and preparation and their application in the workplace.
3. Evaluate the use of clean rooms/clean air devices to the best of their design potential.
4. Discuss the correct commissioning procedures for a clean room environment.
5. Critically evaluate process and operator validations.
6. Explain the function and operation of monitoring equipment and the maintenance of operational records.
7. Interpret monitoring data and diagnose problems.

Indicative content

Aseptic dispensing and production

• Aseptic processing and Good Manufacturing Practice
• Aseptic manufacturing
• Personnel aspects and training
• Facilities and equipment (design, construction, commissioning and operation)
• Policies and Standards
• Process design
• Process and operator validation
• Protective clothing
• Documentation, as applicable to specialist activities
• Starting materials and components
• Storage and handling
• Labelling of aseptic products
• Product shelf life
• Quality assurance and release of finished products
• Transfer of materials
• Pharmaceutical microbiology as applied to aseptic dispensing and preparation

Clean rooms 

• Environmental considerations
  • Premises design – dependent on product
  • Materials used in pharmaceutical plant
  • Air conditioning and clean room design
  • (External) Environmental monitoring
  • Secure and appropriate storage
  • Maintenance of services
• Clean room construction
  • Design, construction, commissioning and operation
  • Clean/aseptic rooms
  • Air filtration plant
  • Clean air devices, e.g. laminar flow cabinets (LFCs), isolators
  • Control of particulate contamination
  • Cleaning and disinfection
• Environmental monitoring
  • Clean/aseptic rooms
  • Clean air devices, e.g. laminar flow cabinets, isolators
  • In-situ high-efficiency leak testing (dispersed oil particles)
  • Operator protection testing (KI discus)
  • Toxic substance monitoring
  • Specification and standards, e.g. BS 5726, ISO-EN 14644, USP 297
  • Microbiological methods of monitoring (including control of contamination)
  • Clean room clothing monitoring

Activities

• Observe an inspection (internal or external quality control or the Medicines and Healthcare products Regulatory Agency [MHRA]) of a clean room premises and discuss the outcomes of the process with your training officer.
• Undertake environmental and personnel monitoring, using equipment including physical and microbiological tests, and produce a short report summarising your key learning from this activity.
• Receive quality assurance reports and analyse exception reports, trends and patterns observed, generating a short report highlighting the strengths and areas for improvement.
• Critically evaluate how the range of aseptically prepared products contributes to disease management in patient care, including dosing regimens, prescribing trends, dose banding and formularies.
• Discuss the range of associated clinical assessments (full blood count, urea and electrolytes, therapeutic drug monitoring) with your training officer.
• Discuss the nature and risks of unlicensed and off-label products prepared in aseptic services with your training officer.
• Contribute to training new personnel within the service and identify the strengths of the training programme and areas for improvement.