CIPE FormAction™: from design to validation

A two-day course on cleanrooms and HVAC, followed by four one-day case studies, all of them taught by Dr. Aziz Chraibi at CIPE.

These FormAction™ courses cover the key points of design, commissioning and validation. Controlled environments (cleanroom air quality and air handling, materials, architectural finishes, flow and cleanroom layout) must be kept under control in line with regulatory requirements and the ISO 14644 standard.

The five sessions

• September 26–27: From design to validation of pharmaceutical facilities and cleanrooms (classified areas)
• October 3: Case study No. 2, sterile and injectable products
• October 4: Case study No. 3, BSL-2 and BSL-3 bioprocesses, sterile and non-sterile
• October 10: Case study No. 4, with flammable and explosive components
• October 11: Case study No. 5, chemical containment of highly potent products (OEL 2 to 5)

By the end of the course, participants can

• Write a URS based on ICH Q9 and the technical specifications for an HVAC system, including its filtration cascades
• Develop a GMP-compliant layout of classified areas (FDA, ANSM, Health Canada) that reduces cross-contamination
• Develop the PFD and P&ID for a laboratory HVAC unit, and diagnose failures and nonconformances
• Define the documents, tests and critical instruments to calibrate, and how often, according to ISO 14644
• Put in place the monitoring, IQ and OQ qualification and preventive maintenance that keep air quality under control
• Optimize energy costs with clean, less energy-intensive technologies

What the case studies cover

Regulatory framework, gowning and protection; room classification; room and HVAC design; separations, flows and pressure cascades; airlocks and pass-throughs; laminar airflow hoods, FFUs, RABS and isolators; aseptic processing or terminal sterilization; the new PURS, FURS, VURS concept; matrix of room specifications and critical parameters; instruments, PLCs, BMS and SCADA (GAMP, 21 CFR Part 11, Annex 11); commissioning and validation of premises and HVAC. Each case study adds its own requirements: ATEX for explosive atmospheres, biological containment, highly potent products.

Who it’s for

Managers and technicians in engineering, maintenance, validation, compliance, production, regulatory affairs, quality assurance and quality control, and development, as well as project managers, consultants and engineers.

The trainer

Dr. Aziz Chraibi, Eng., PhD, was director of engineering and projects at Validapro and SNC-Lavalin Pharma before founding PBE Expert in 2012. A CIPE trainer since 2013, he has been invited to give talks and workshops at several pharmaceutical conferences: GMP Summit (OMICS), A3P, Maghreb Pharma and the 1st International Conference of the Jordan FDA.