Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring
Understand and control pharmaceutical cleanrooms. The course covers classification requirements including EU GMP Annex 1, HVAC and HEPA design, testing and qualification, viable and non-viable environmental monitoring, and investigation of contamination deviations.
At a glance
- 4 days
Who it's for
- Manufacturing, QA, engineering, validation & maintenance staff (2+ years' experience)
- Microbiology & environmental monitoring staff
Learning objectives
- Understand international requirements for cleanroom classification
- Understand HVAC components, HEPA filtration and monitoring systems
- Qualify HVAC systems and run viable/non- viable monitoring
- Analyse contamination and cross- contamination deviations
- Apply gowning and aseptic practices
- Link QRM to HVAC design and operation
Detailed content
- EU GMP Annex 1 (2022), FDA aseptic guidance, WHO
- ISO 14644-1/-2 classification & monitoring
- GMP zone concepts
- HVAC requirements: design, plan & operation
- Components & HEPA filtration
- Control strategy, logic, construction features
- Barrier systems (RABS, isolators)
- Detailed cleanroom test procedures
- HVAC qualification
- QRM principles & tools (ICH Q9(R1))
- Viable & non-viable monitoring programs
- EM in sterile, vaccine & biologics facilities
- Trending; alert & action limits
- Gowning & aseptic behaviour
Day-by-day agenda
A typical schedule. In-company versions are tailored to your processes, data and timing.
- Regulatory Requirements
- HVAC Design & Components
- Testing & Qualification
- Environmental Monitoring
- Case study, action plans and course assessment
Practice, tools and assessment
Hands-on practice
- Aspects-and-impacts register for a real site
- Compliance-obligations review exercise
- Mock regulatory inspection of a GMP area
- Deviation and CAPA case study with root cause
Tools and templates you keep
- Aspects/impacts significance matrix
- Legal register template
- Deviation, CAPA and change-control forms
- Validation master plan outline
How learning is assessed
- Pre- and post-course knowledge check
- Assessment of practical exercises by the trainer
- Action plan reviewed at the end of the course
Built on these standards and bodies of knowledge
- ISO 14001:2015
- Egyptian Environmental Law 4/1994 and executive regulations
- EU GMP / PIC/S Guide; WHO GMP
Certificate
Excellence Center Certificate of Attendance
Prerequisites: Basic GMP, QRM & QMS knowledge; Intermediate English
How it is delivered
- Public courses in Cairo, in-company programs and live online training
- Practical exercises, case studies and examples from your sector
- Can also run as Train & Stay in Sharm El Sheikh, Hurghada or Cairo
Part of these career paths
Frequently asked questions
How long is Pharmaceutical Clean Rooms & HVAC: Design, Qualification and Monitoring?
The program runs 4 days. In-company versions can be adapted to your needs.
Is the course taught in Arabic or English?
Sessions are usually delivered in Arabic with English technical terms and materials. Full English delivery is available for in-company groups.
Can you run it inside our company?
Yes. In-company programs use exercises built on your own processes. Tell us the group size and preferred timing and we will send a proposal.
Will I receive a certificate?
Participants who complete the program and its assessment receive a certificate from The Excellence Center, which can be verified online.
More programs in this field
- HACCP and Food Safety Risk Analysis
- ASQ CPGP – Certified Pharmaceutical GMP Professional (Exam Preparation)15 days
- GMP Auditor Training for Quality Systems2 days
- GMP for Medical Devices (ISO 13485)2 days
- GMP for Pharmaceutical Facilities, Equipment & Utilities3 days
- GMP in Pharmaceutical Laboratories2 days
- Good Laboratory & Good Manufacturing Practices (GLP + GMP) Workshop5 days
- Good Manufacturing Practices (GMP) for the Pharmaceutical Industry5 days
- Pharmaceutical Water Systems: Principles & Practice2 days
Get dates, fees and the full outline.
Tell us whether you are joining as an individual or planning a program for your team.