Training Center

Cleanroom World Training Center

Cleanroom, ESD, and GMP Training

Cleanroom World is pleased to offer cleanroom training, ESD training, and GMP training, at our state-of-the-art cleanroom training center, which is located in the Denver metro area.

If you have any questions about our classes and trainings, or would like to register, please call (303) 752-0076 or e-mail info@cleanroomworld.com.

Below is a list of the classes and trainings that we’re offering in 2018:
September 13, 2018: Introduction to Cleanrooms and Controlled Environments
September 20, 2018: Cleanroom Testing (Particle Counts and ISO Cerrification)
September 27, 2018: Advanced Cleanrooms and Controlled Environments
October 4, 2018:  Cleanroom 101*
October 11, 2018: Janitorial Cleaning
October 18, 2018:  ESD and Control Through Ionization
October 24, 2018:  Cleanroom Construction, Auditing and Compliance
November 1, 2018: Preparing for your cGMP Audit


Registration Fee:  $495.00 Register Early $100.00 off cost of class if you register at least 30 days in advance of the class date. Class sizes are limited, registration deadline is 14 days prior to class scheduled date.
*Cleanroom 101 Instruction/Discussion Only, no hands-on training. Registration Fee:  $165.00

Below are detailed descriptions of the classes:

Introduction to Cleanrooms and Controlled Environments Training: 1- Day Class. Presented by Shelly Cobb, Cleanroom World Training Center Coordinator.

For manufacturers and service providers needing a controlled environment to enhance their product or service.  Contamination control can be that one missing piece that could make or break a business.  If a cleanroom controlled environment is new for your business and you would like to know more about clean environment technology, or if you are wondering if your clean environment is as good as it can be, this cleanroom training is for you! The training will be held in our on-site training center, with complete ISO Class 5 cleanroom, allowing for a hands-on opportunity, to learn about and experience:

  • Industry terminology, including GMP and CGMP
    • Cleanroom, controlled environment, clean benches, safety cabinets
    •   Contamination, control
      • ISO, certification (Does your environment need to be certified, or not?)
      • Airborne particles
  • Introduction to a cleanroom
    • Construction materials, how the room operates, other cleanroom options for your business
    • Materials and equipment that are recommended for use inside a cleanroom, and some that are not recommended
    • Learn about cleanroom gowning, gloving and operating procedures in a cleanroom (what is gowning, why do we do it, what types of gowns are best for your business, the do’s and don’ts inside a cleanroom
    • Perform the cleanroom gowning process and spend time operating inside a cleanroom
      • Learn about different types of clean work-surfaces, chairs, racks and what makes them compatible with cleanroom environments
      • Learn how to properly clean a cleanroom
        • Why you must clean the cleanroom
        • Why it is important to use a cleanroom cleaner and cleanroom equipment
        • Cleaning the cleanroom versus cleaning the workstations (cleanroom wipers, mops, disinfectants)
        • Learn how to know if your cleanroom is performing as it should, based on airborne particle counting
          • Hands-on use of a particle counter in our cleanroom training center
          • Understand and use particle count data to confirm a cleanroom’s ISO classification performance (limits, cumulative versus differential data, how the counts (data) can be influenced and what this means to your cleanroom space)

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Advanced Cleanrooms and Controlled Environments Training: 1-Day Class. Presented by Shelly Cobb, Cleanroom World Training Center Coordinator.

If you are new to cleanroom environments, or if you are seasoned in the industry and need a refresher and exposure to current cleanroom technology, this advanced cleanroom training is for you! The training will be held in our on-site training center, with complete ISO Class 5 cleanroom, allowing for a hands-on opportunity, to learn about and experience:

  • Industry terminology, standards and regulations, including
    • Contamination, control (what is it, is it dangerous, how to get rid of it)
    • GMP, ISO, Quality Systems, Compliance (basic recommended practices and requirements for cleanroom manufacturing)
    •  Cleanrooms, controlled environments, clean benches, safety cabinets (the differences)
    • Certification, Classification and Compliance (how it is done, what it means and how to keep it at that level)
    • Non-viable airborne particles and how they affect your Cleanliness Classification
    • Other types of contamination
  • Introduction to a cleanroom
    • Construction materials, how the room operates, other cleanroom options for your business
    • Materials and equipment that are recommended for use inside cleanrooms, and some that are not recommended
    • Learn about gowning, gloving and operating procedures in a cleanroom (what is gowning, why do we do it, what types of gowns are best for your business, the do’s and don’ts inside a cleanroom)
    • Perform the cleanroom gowning process and spend time operating inside a cleanroom
      • Learn about different types of clean work-surfaces, chairs, racks and what makes them compatible with clean environments
      • Learn how to properly clean a cleanroom
        • Why you must clean the cleanroom and why it is important to use dedicated cleanroom solutions and equipment
        • Cleaning the workstations (cleanroom wipers, mops, disinfectants)
        • Learn how to monitor your cleanroom to ensure it is performing as it should, based on airborne particle counting and other monitoring activities
          • Hands-on use of a particle counter in our cleanroom training center and how to use particle count data to confirm a rooms ISO performance (limits, cumulative/differential data, viable particulate monitoring)
          • Corrective action activities (how to regain control of the clean environment)

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ESD Training and Control through Ionization Training: 1-Day Class. Presented by Karl White and Carl Newburg, Simco-Ion

For manufacturers, service providers and other cleanroom/controlled environment professionals needing to understand the principles of static charge (ESD), where it comes from, how it contributes to contamination levels and how to control it safely and effectively through ionization. If you are experiencing ESD issues, or if you need an effective ESD plan, Cleanroom World is offering an ESD training opportunity for you! The training will be held in our on-site training center, with complete ISO Class 5 cleanroom, allowing for a hands-on opportunity, to learn about and experience:

  • Industry terminology and discussion including
    • Electrostatic charge, discharge, insulators, grounds
    • Materials and their naturally occurring charge, based on the materials’ electrical, chemical and physical makeup
    • ANSI/ESD, ESD STM and other standards/guidelines and their roles in a solid ESD program
    • Contamination and control through ionization
  • ESD Basics
    • The impact of ESD on people and on your product (life or death, catastrophic product failure)
    • Monitoring- how to detect and measure ESD, use of field meters
    • Introduction to a cleanroom
      • Construction materials, how the cleanroom operates, other clean options for your business
      • Materials and equipment that are recommended for use inside cleanrooms, and some that are not recommended
      • Learn about gowning, gloving and operating procedures in our cleanroom (what is gowning, why do we do it, what types of gowns are best for your business, the do’s and don’ts inside a cleanroom)
      • Perform the gowning process and spend time inside a cleanroom
        • Learn about different types of work-surfaces, chairs, racks and mats and what makes them appropriate in clean, ESD environments
        • Hands-on use of ionization products to see how ESD can be eliminated
        • Learn how to properly clean a cleanroom
          • Daily use cleaning of a cleanroom and major clean-downs (cleanroom wipers, mops, vacuums, disinfectants)
          • ESD Auditing
          • Guidelines, practices and documentation to ensure safety and compliance

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Cleanroom Certification and Particle Counting Training: 1-Day Class. Presented by Matt Smyers, Technical Safety Services TSS

For manufacturers, service providers and other cleanroom professionals needing to establish and certify a cleanroom or controlled environment. An understanding of air-flow, filtration and ventilation is critical to selecting the right type of environment and for successful ISO certification, USP and FDA compliance. Learn what type of environment would work for your application and what testing is required and what to look for in searching for a quality, knowledge-able testing service vendor. If you are preparing for cleanroom certification, this cleanroom certification training is for you! The training will be held in our on-site training center, with complete ISO Class 5 cleanroom, allowing for a hands-on opportunity, to learn about and experience:

  • Industry terminology and discussion including GMP and CGMP
  • Cleanroom, controlled environment, clean benches, safety cabinets-are you needing to protect your operator or your product, or both
  • HVAC System components, what they do for contamination control, preventive maintenance
  • ISO Cleanroom Classification, testing requirements and frequency for continued compliance
  • USP compliance (sterile and non-sterile compounding) and FDA compliance
  • Industry requirements for testing service vendor
  • Construction materials, how the cleanroom operates, other clean options for your business
  • Materials and equipment that are recommended for use inside cleanrooms, and some that are not recommended
  • Learn about gowning, gloving and operating procedures in our cleanroom (what is gowning, why do we do it, what types of gowns are best for your business, the do’s and don’ts inside a cleanroom)
  • Demonstration and explanation of cleanroom certification testing protocol, including airborne non-viable particle testing, airflow measurement, average velocity, leak test, room air exchange rates,
  • Learn how to properly clean a cleanroom
    • Daily use cleaning and major clean-downs (cleanroom wipers, mops, vacuums, disinfectants)
    • Periodic non-viable particulate monitoring that you can do to verify that your cleanroom is performing as it should
      • Hands-on use of a particle counter in our cleanroom training center
      • Understand and use particle count data to confirm a cleanroom’s ISO classification performance (limits, cumulative versus differential data, how the counts (data) can be influenced and what this means to your clean space)
  • Introduction to a cleanroom
  • Perform the gowning process and spend time inside a cleanroom
    • Learn about different types of clean work-surfaces, chairs, racks and what makes them compatible with cleanroom environments

These are unique learning and networking opportunities, for seasoned clean manufacturing veterans and those who are new to the industry. Breakfast and lunch provided for all 2-day, hands-on training.  Certificate of completion and samples of disposable items (gowns, wipers) will be given to you to take and evaluate for your specific needs.

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Cleanroom 101 Training: 1-Day Class Presented by Shelly Cobb, Cleanroom World Training Center Coordinator.

For operators who are in need of cleanroom basics.  This training will include cleanroom terminology, basic documentation of cleanroom activities, airborne particulates, cleanroom classifications and how particulates are affected by movement and activities.  Why gowning is necessary, standard gowning options, behaviors to avoid within the cleanroom.  The training will also cover different items to be used within a cleanroom, items to avoid.  We will discuss particulate challenges, how to wipe down a cleanroom and static control (ESD).

  • Industry terminology and documentation requirements, including USP, FDA, GMP, and CGMP
    • Cleanroom, controlled environment
    •   Contamination, control
      • ISO, certification (Does your environment need to be cleanroom certified, or not?)
      • Airborne particles
  • Introduction to a cleanroom
    • Construction materials, how the cleanroom operates
    • Materials and equipment that are recommended for use inside the cleanroom, and some that are not recommended
    • Learn about gowning, gloving and operating procedures in a cleanroom (what is gowning, why do we do it, what types of gowns are best for your business, the do’s and don’ts inside a cleanroom)
    • Understand cleanroom gowning requirements and gowning procedures
    • Workstation maintenance
      • How to perform an effective station wipe-down
      • Static control ESD

Cleanroom Construction
Presented by Roger Smith, Howell Construction

  • For those who are considering construction of any size cleanroom. This class will provide the information you need to know before starting the project.  The course will be instructed by an experienced, construction and architectural experts. Whether you are considering a free standing facility, or modifications to an existing space, learn the things that need to be considered very early in the decision-making process, including:Requirements per ISO 14644-4
    • Design
    • Construction
    • Startup
  • Contamination Control
    • HEPA/ULPA Filtration
    • Proper architecture
    • Design
    • Electrostatic Discharge (ESD)
  • Environmental Controls
    • Temperature
    • Humidity
    • Room pressurization
  • Building Requirements
    • Building codes
    • Permitting
    • Facility occupancy requirements
    • HEPA filters
    • ULPA filters
    • How the HVAC system operates to minimize contamination in the rooms
    • Pressure differentials, what they are and how they minimize contamination in the roomsGowning/ de-gowning
    • Various types of gowning items, how they protect the clean environment
    • Industry standard practice
  • Cleanroom behavior
    • Activities which can contribute to the contamination levels in a room
    • Activities and practices which help minimize levels of contamination
    • Personal hygiene and health status
    • Acceptable and prohibited clothing, personal items in the cleanroom
  • Cleanroom cleaning equipment
    • Acceptable materials
    • Unacceptable materials
    • Cleaners, disinfectants
    • Wipers
    • Sterile/non-sterile requirements
    • Bucket system mopping (1, 2 or 3 bucket methods)
    • Cleanroom vacuums
    • Water sources for dilution of cleaning solutions
  • Cleaning methods
    • Ceilings
    • Walls
    • Floors
    • Workstations, chairs
    • Trash removal
  • Documentation
    • GDP requirements
    • How to complete a janitorial log/checklist

…..and more!!

 

Janitorial Cleaning

Presenter:  Shelly Cobb, Cleanroom World Training Center Coordinator

For those who perform janitorial cleaning of cleanrooms and controlled environments.This class will provide the basic knowledge required for providing an effective and compliant janitorial service for those facilities which require more than normal cleaning activities.  Topics covered include:

  • Cleanroom terminology
    • ISO
    • Cleanroom cleanliness levels
    • Compliance
    • Contamination- Particulates
    • Control of contamination
    • Out of Specification (OOS),Excursions
    • GMP
    • GDP
    • Documentation
  • HVAC and filtration