Clean rooms course
General Information:
Course scope: 18 hours (9:00-17:00)
Course type: Frontal + remote
Location: Science park, Rehovot
Lecturer name: Eran Yona
Course Content:
- Terms and Outlining
- Product safety & Quality
- GMP environment
- Contamination types and sources
- Contamination risks
- What is “a controlled environment”?
- Clean room structure
- Cleanness classifications based on ISO 14644
- Clean rooms design principles
- HVAC systems
- Clean rooms fittings and furniture
- Highlights in clean room design
- Proper behavior in a clean rooms
- How to dress in a clean room (including instructions and practice)
- Maintenance and clean room cleanliness
- Aseptic production in clean rooms
- Clean rooms particles sampling & monitoring
- Clean rooms microbial sampling & monitoring
- Clean rooms and HVAC maintenance
- Clean rooms monitoring deviations root cause
- Clean rooms cleaning and disinfection
- Validation for a clean room
- Clean rooms routine monitoring
- Tips for working in clean rooms
Our consulting services
Research and development
Consulting in a variety of areas, including design, research laboratories and clean rooms, development technologies, investor business presentations, regulatory strategies, market analysis, clinical trial protocols, GLP, GCP, ISO 17025, calibration, CMC and professional training.
Design and engineering
Designing factories, clean rooms and laboratories, engineering documentation, certification, technology selection, process engineering, and validation, with a combination of theoretical knowledge, practical experience, and in-depth understanding of biomed regulations and in accordance with GxP principles.
Manufacture and packaging
Consulting on manufacturing plant design, manufacturing process development and engineering, selecting the most appropriate technology, process scale-up, technology transfer, GMP, process improvement, yield optimization and improvement, employee training, validation of equipment, systems, and production and cleaning processes.
GxP, quality and validation
Advises, establishes, accompanies and upgrades various types of quality management systems, offers GMP training and courses, coordinates adoption of GxP principles, ISO 13485, quality assurance and preparation for global regulatory audits while conducting risk analysis and evaluation, and verification and validation of equipment, systems, software, test methods, manufacturing and cleaning processes, until a successful audit outcome is obtained.
Regulation and registration
Regulatory consulting and drug registration, medical devices, CE mark, dietary/nutritional supplements and cosmetics in Israel and worldwide, building a smart regulatory strategy, helping to prepare documents and meet requirements in a professional manner, in a short time, product labeling, shelf life and graphics, import licenses and meetings with regulatory bodies, until approval (marketing authorization) is received.
Software and systems
Digital healthcare consulting, software development and medical applications in accordance with US FDA 21 CFR part 11 / EU Annex 11 / US HIPAA / EU GDPR requirements, ISO 13485/ISO 27001/ISO 27799, CE marking, risk assessment, verification and validation of software and control systems until marketing authorization (approval) is obtained.