Hospitals preparing intravenous admixtures and cytotoxic doses need tightly controlled aseptic services to protect patients and staff. This course covers cleanroom management, aseptic technique governance, cytotoxic handling and quality assurance for pharmacy compounding units. It is aimed at African hospital pharmacies building or improving safe preparation services.
Ready to book? Secure your place on this programme.
Register for this course| Module | Topic | Main competency |
|---|---|---|
| 01 | Aseptic services governance | Accountable governance of a compounding service |
| 02 | Cleanroom management and monitoring | Control of the compounding environment |
| 03 | Aseptic technique and validation | Validated and repeatable aseptic practice |
| 04 | Cytotoxic handling and safety | Safe preparation and handling of hazardous medicines |
| 05 | Quality assurance and documentation | Assured product quality and full traceability |
| 06 | Operator competency and training | Qualified operators kept in requalification |
| 07 | Spill response and waste handling | Emergency response and safe waste disposal |
| 08 | Service capacity and performance | Measured and managed service delivery |
| 09 | Integrated risk management | Systematic risk control across the service |
| 10 | Integrated case study and action planning | Applied service improvement planning |
Each training day runs 08:30 to 16:30 with morning and afternoon breaks and a lunch break. Timings can be adjusted to suit an in house group.
| Time | Session | Key topics | Activity |
|---|---|---|---|
| 08:30 to 09:00 | Registration and introduction | Introductions, expectations, course overview, delegate experience of compounding services | Delegate introductions |
| 09:00 to 10:15 | Module 1: aseptic services governance | Role of aseptic services in hospital pharmacy; types of sterile preparation; intravenous admixtures and parenteral medicines; high risk activities; patient safety; the interface between pharmacy, nursing and clinical services; governance structures and accountability | Group discussion on accountability in a compounding unit |
| 10:15 to 10:30 | Tea break | ||
| 10:30 to 11:30 | Module 1 continued: establishing a safe compounding service | Policies, procedures and standard operating procedures; risk management and escalation; service governance committees; service planning; workflow design; personnel, equipment and consumables; segregation of activities; patient specific against batch preparation | Exercise: draft a governance framework for an aseptic pharmacy unit |
| 11:30 to 12:30 | Module 2: cleanroom principles, classification and operation | Purpose of controlled environments; cleanroom classifications; critical and supporting areas; pressure differentials; airflow; temperature and humidity; personnel and material flows; entry, exit and gowning; behaviour in the cleanroom | Walkthrough of a cleanroom layout and flow |
| 12:30 to 13:15 | Lunch | ||
| 13:15 to 14:15 | Module 2 continued: environmental monitoring | Monitoring principles; air, surface and microbiological monitoring; non viable particle monitoring; monitoring frequency; alert and action levels; trend analysis; handling excursions | Interpreting a set of monitoring results and excursions |
| 14:15 to 15:00 | Module 2 continued: cleaning and disinfection | Cleaning principles; disinfectant selection and rotation; cleaning schedules; cleaning validation; cleaning records; equipment and work surfaces; managing cleaning failures | Exercise: build a cleanroom monitoring and cleaning schedule |
| 15:00 to 15:15 | Tea break | ||
| 15:15 to 16:15 | Module 3: aseptic technique and manipulation | Sources of contamination; critical sites and critical surfaces; personnel related contamination; maintaining first air; syringe, vial and ampoule handling; transfer procedures; disinfection of components; common aseptic technique failures | Workshop: identify contamination risks in a preparation process |
| 16:15 to 16:45 | Module 3 continued: validation and day one review | Purpose of validation; initial and periodic validation; competency assessment; media fill principles; operator qualification; documentation of validation | Day one review and questions |
What you take away from day 1
| Time | Session | Key topics | Activity |
|---|---|---|---|
| 08:30 to 09:00 | Day one recap | Review of governance, cleanroom control and aseptic technique | Question and answer session |
| 09:00 to 10:15 | Module 4: hazardous medicines and cytotoxic preparation areas | What makes a medicine hazardous; common cytotoxic medicines; routes of occupational exposure; patient and staff safety; risk assessment; facility requirements; dedicated preparation areas; engineering and containment controls; airflow and pressure; personnel and material movement | Risk assessment of a cytotoxic preparation area |
| 10:15 to 10:30 | Tea break | ||
| 10:30 to 11:45 | Module 4 continued: safe handling, protective equipment and exposure | Receipt, storage, preparation, labelling and transport; the administration interface; handling contaminated materials; selecting protective equipment; donning and doffing; gloves, clothing, eye, face and respiratory protection; disposal; preventive controls and response to accidental exposure | Practical: donning and doffing sequence review |
| 11:45 to 12:30 | Module 4 case study | A cytotoxic preparation incident reviewed against the control system that should have prevented it | Case study: identify the control failures |
| 12:30 to 13:15 | Lunch | ||
| 13:15 to 14:15 | Module 5: quality management and documentation | Quality assurance against quality control; quality management systems; risk based quality management; process and product controls; standard operating procedure management; master preparation records; worksheets; batch, cleaning, monitoring, equipment and training records | Review of a batch documentation set |
| 14:15 to 15:00 | Module 5 continued: traceability, deviations and CAPA | Patient specific preparations; batch numbers; raw materials; personnel and equipment; preparation and release records; expiry and beyond use dating; identifying, documenting and investigating deviations; root cause analysis; corrective and preventive action | Exercise: investigate a deviation and draft a CAPA plan |
| 15:00 to 15:15 | Tea break | ||
| 15:15 to 16:00 | Module 5 continued: auditing and continuous improvement | Internal audits; quality indicators; trend analysis; audit findings; corrective action plans; effectiveness monitoring; continuous improvement | Building an internal audit checklist |
| 16:00 to 16:45 | Module 6: operator competency and training | Defining operator competencies; initial training; supervised practice; competency assessment; requalification and periodic reassessment; training in aseptic technique, cleanroom behaviour, cytotoxic handling, protective equipment, cleaning, spill management and documentation | Discussion of recurring competency gaps |
What you take away from day 2
| Time | Session | Key topics | Activity |
|---|---|---|---|
| 08:30 to 09:00 | Day two recap | Review of cytotoxic controls, quality systems and competency management | Question and answer session |
| 09:00 to 10:00 | Module 6 continued: assessing operator performance | Observation based assessment; practical assessment; written knowledge assessment; media fill participation; recording and acting on assessment results | Workshop: build an operator competency checklist |
| 10:00 to 10:15 | Tea break | ||
| 10:15 to 11:15 | Module 7: cytotoxic spill management and accidental exposure | Spill risk assessment; immediate actions; restricting access; spill kits and contents; protective equipment; safe clean up and decontamination; incident documentation; skin, eye and inhalation exposure; sharps incidents; reporting, escalation and occupational health follow up | Exercise: draft a cytotoxic spill response flowchart |
| 11:15 to 12:15 | Module 7 continued: hazardous pharmaceutical waste | Classification of pharmaceutical waste; cytotoxic waste segregation; sharps; contaminated protective equipment and consumables; temporary storage; internal transport; final disposal; labelling, waste tracking, contractor management and documentation | Waste segregation exercise |
| 12:15 to 13:00 | Lunch | ||
| 13:00 to 14:00 | Module 8: service capacity, workflow and performance | Demand forecasting; workload assessment; staffing and shift planning; preparation scheduling; peak workloads; workflow mapping; reducing delays; managing urgent preparations; key performance indicators covering turnaround, rejected preparations, deviations, monitoring excursions, competency compliance and incidents | Selecting a small set of indicators for a compounding unit |
| 14:00 to 14:45 | Module 9: integrated risk management and safety culture | Patient, product, environmental, personnel, equipment and supply chain risk; risk evaluation and prioritisation; control measures and residual risk; incident escalation and investigation; lessons learned; reporting culture and leadership responsibilities | Risk prioritisation exercise |
| 14:45 to 15:00 | Tea break | ||
| 15:00 to 16:00 | Module 10: integrated case study | A hospital pharmacy service carrying a cleanroom monitoring failure, operator competency concerns, cytotoxic preparation risk, documentation gaps, waste management issues, staff exposure risk and capacity pressure | Group case study: identify risks, immediate actions and root causes |
| 16:00 to 16:45 | Action planning, final assessment and close | Preventive controls; monitoring indicators; the improvement action plan; final assessment; course review and close | Individual or group service improvement action plan |
What you take away from day 3
On successful completion of the course, delegates will be able to:
This course suits hospital pharmacists, pharmacy and chief pharmacists, aseptic services pharmacists, aseptic unit supervisors, cytotoxic services managers, oncology and clinical pharmacists involved in intravenous therapy, aseptic compounding technicians, pharmacy quality assurance officers and infection prevention and control professionals. It is also useful to hospital administrators responsible for pharmacy services, healthcare risk managers and occupational health staff, and to any team establishing a new aseptic or cytotoxic facility.
Recommended entry level
Delegates should be pharmacy professionals or technical staff working in, or preparing to work in, a hospital pharmacy compounding environment. Practical experience of dispensing, sterile preparation or pharmacy operations is useful but a formal aseptic qualification is not required. Delegates should be familiar with their own institution's pharmacy policies, standard operating procedures and the regulatory requirements that apply to medicines preparation in their country.
The programme is run as practical, competency based training rather than a series of presentations, so delegates rehearse the supervisory tasks they are expected to perform on their own sites. Methods used include:
Formative assessment
Practical assessment
Final assessment
Certification
| Dates | Venue | Days | Fee | Calendar | Register |
|---|---|---|---|---|---|
| 28 to 30 Sep 2026 | Nairobi | 3 | US$1,500 | Closed | |
| 29 Sep to 1 Oct 2026 | Dar es Salaam | 3 | US$1,500 | Register | |
| 30 Sep to 2 Oct 2026 | Kigali | 3 | US$1,500 | Register | |
| 5 to 7 Oct 2026 | Kampala | 3 | US$1,500 | Register | |
| 6 to 8 Oct 2026 | Accra | 3 | US$1,500 | Register | |
| 7 to 9 Oct 2026 | Lagos | 3 | US$1,500 | Register | |
| 12 to 14 Oct 2026 | Cairo | 3 | US$1,500 | Register | |
| 13 to 15 Oct 2026 | Mauritius | 3 | US$1,500 | Register | |
| 14 to 16 Oct 2026 | Dubai | 3 | US$1,500 | Register | |
| 19 to 21 Oct 2026 | Online | 3 | US$900 | Register | |
| 11 to 13 Nov 2026 | Johannesburg | 3 | R13,000 | Register | |
| 16 to 18 Nov 2026 | Cape Town | 3 | R13,000 | Register | |
| 17 to 19 Nov 2026 | Durban | 3 | R13,000 | Register | |
| 18 to 20 Nov 2026 | Pretoria | 3 | R13,000 | Register | |
| 23 to 25 Nov 2026 | Windhoek | 3 | US$1,500 | Register | |
| 24 to 26 Nov 2026 | Gaborone | 3 | US$1,500 | Register | |
| 25 to 27 Nov 2026 | Maseru | 3 | US$1,500 | Register | |
| 30 Nov to 2 Dec 2026 | Mbabane | 3 | US$1,500 | Register | |
| 1 to 3 Dec 2026 | Lusaka | 3 | US$1,500 | Register | |
| 2 to 4 Dec 2026 | Harare | 3 | US$1,500 | Register | |
| 7 to 9 Dec 2026 | Lilongwe | 3 | US$1,500 | Register | |
| 8 to 10 Dec 2026 | Blantyre | 3 | US$1,500 | Register | |
| 9 to 11 Dec 2026 | Mozambique | 3 | US$1,500 | Register |
Fees are per delegate. South African venues are priced in rand; other locations and online in US dollars. Fees exclude 15% VAT where applicable. Group bookings of three or more delegates from the same organisation qualify for a reduced rate; contact us for a quotation.
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