Cleanrooms Principles in Practice®
Course
In Barnard Castle
Description
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Type
Intensive workshop
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Level
Intermediate
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Location
Barnard castle
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Class hours
16h
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Duration
2 Days
This Cleanroom Training course provides a holistic view of the design, operation and management of cleanrooms. As leading consultants in sterile process manufacturing, terminal sterilisation and aseptic production, the Honeyman Group has a wealth of experience in the design, build, validation and ongoing monitoring of cleanrooms. Working with many of the world’s leading pharmaceutical and medical device manufacturers, the Honeyman Group is currently involved with a number of cleanroom design projects encompassing feasibility studies, design and build specifications and risk assessments. The Honeyman Group’s Analytical Services Laboratory works with clients to evaluate, advise upon and develop ongoing environmental monitoring, cleaning validation and disinfectant efficacy programmes.
The course has been developed by industry experts in design, validation, microbiology and quality assurance. The most effective way of understanding cleanroom operations is to be involved in hands-on exercises, demonstrations and workshops, therefore, this course consists of 50% lectures and 50% practical.
Important information
Documents
- Cleanrooms_Principles_in_Practice_V1.4.pdf
Facilities
Location
Start date
Start date
About this course
Key learning objectives of the Cleanroom Training course are:
- To have an increased knowledge of all fundamental principles for all personnel involved in the management and operations of cleanrooms
- To be able to apply the knowledge gained to participate in risk assessments and investigations in their own facility
- Have been provided the background on how GMP regulations and ISO standards define cleanroom design, operation and validation
- Understand the sources of microbiological contamination and how to control and minimise them
- Recognise current best practices for gowning, changing and operator qualification
- Appreciate the features of facility design and how the type of product and operations influence the design
- To understand the qualification of HVAC systems and how to interpret data
- To understand key tests involved in qualification, smoke testing and particle counting
- To understand how to use impact assessment to define system boundaries and identify critical components
- Be able to present a cost-effective approach to validation
- Appreciate cleaning and maintaining control
Engineers, QA, Validation and Operations personnel.
Successful design and management cannot solely be based on HVAC, but is part of a holistic approach that covers cleanroom design, operations, HVAC and monitoring processes. This three-day Cleanroom Training course delivers a comprehensive overview of the regulatory and design requirements of the facility, highlights the interaction between materials and personnel within the cleanroom, examines the principles of HVAC design, filters and air filtration, and provides guidelines for ongoing contamination control through environmental monitoring and cleaning.
Reviews
Subjects
- Cleanroom Design
- Monitoring
- Microbiology
- Pharmaceutical Clean Room
- HVAC Systems
- HEPA Filters
- RABS and Isolators
- Particle Monitoring
- Environmental Monitoring
- Risk Management of Contamination
Teachers and trainers (1)
Marcus Booth
Director of Training and Consultancy
Over the last 27 years we have trained thousands of people within the pharmaceutical, biotech, medical device and health care industries. Honeyman courses continue to remain popular because they provide delegates with a sound understanding of the scientific principles associated with each technical discipline and the opportunity to put the principles into practice during interactive workshops, demonstrations and discussion sessions. We all actively work within industry and so provide pragmatic current best practice to allow companies to cGMP requirements and regulatory expectations.
Course programme
Day TwoRABS and IsolatorsCleaning and DisinfectionEnvironmental MonitoringParticle MonitoringTesting and ClassificationPeople as a Contamination SourceRisk Management of Contamination
Day ThreeBehaviours and DisciplinesClothingEnergy ConsiderationsComparison of EU and US StandardsQualificationMicrobiological Practical Results
Cleanrooms Principles in Practice®