6950 South Tucson Way Centennial, CO 80112 (303)-752-0076

Questions or Reservations: info@cleanroomworld.com

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 cindy@cleanroomworld.com.

Below is a list of the classes and trainings that we’re offering in 2018.

Introduction to Cleanrooms and Controlled Environments Training: 2- Day Class

April 4-5, 2018: Introduction to Cleanrooms and

Controlled Environments (includes USP and FDA

Compliance)

April 25-26, 2018: Advanced Cleanrooms and

Controlled Environments (includes USP and FDA

Compliance)

May 9-10, 2018: ESD and Control through

Ionization

May 17, 2018: Cleanroom 101 (includes USP and

FDA Compliance)

June 20-21, 2018: Cleanroom Certification and

Particle Counting

September 12-13, 2018: Introduction to

Cleanrooms and Controlled Environments

(includes USP and FDA Compliance)

September 26-27, 2018: Advanced Cleanrooms

and Controlled Environments

TBD: Cleanroom Construction, Auditing and

Compliance, Clean Manufacturing Processes…

2-day Classes $990.00

1-day Classes $165.00

1

This cleanroom training is designed 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

o Cleanroom, controlled environment, clean benches, safety cabinets

o Contamination, control

o ISO, certification (Does your environment need to be certified, or not?)

o Airborne particles

Introduction to a cleanroom

o Construction materials, how the room operates, other cleanroom options for your

business

o Materials and equipment that are recommended for use inside a cleanroom, and some

that are not recommended

o 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

o 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

o Why you must clean the cleanroom

o Why it is important to use a cleanroom cleaner and cleanroom equipment

o 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

o Hands-on use of a particle counter in our cleanroom training center

o 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)

Advanced Cleanrooms and Controlled Environments Training: 2-Day Class

This advanced cleanroom training is designed for cleanroom professionals manufacturing products

within cleanrooms or other controlled environments which might require its production occur in a

certified cleanroom space. This environment helps to ensure that the product is produced in a safe and

consistent way. 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

o Contamination, control (what is it, is it dangerous, how to get rid of it)

o GMP, ISO, Quality Systems, Compliance (basic recommended practices and

requirements for cleanroom manufacturing)

o Cleanrooms, controlled environments, clean benches, safety cabinets (the differences)

o Certification, Classification and Compliance (how it is done, what it means and how to

keep it at that level)

o Non-viable airborne particles and how they affect your Cleanliness Classification

o Other types of contamination

Introduction to a cleanroom

o Construction materials, how the room operates, other cleanroom options for your

business

o Materials and equipment that are recommended for use inside cleanrooms, and some

that are not recommended

o 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

o 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

o Why you must clean the cleanroom and why it is important to use dedicated

cleanroom solutions and equipment

o 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

o 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)

o Corrective action activities (how to regain control of the clean environment)

ESD Training and Control through Ionization Training: 2-Day Class

This ESD training is 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

o Electrostatic charge, discharge, insulators, grounds

o Materials and their naturally occurring charge, based on the materials’ electrical,

chemical and physical makeup

o ANSI/ESD, ESD STM and other standards/guidelines and their roles in a solid ESD

program

o Contamination and control through ionization

ESD Basics

o The impact of ESD on people and on your product (life or death, catastrophic product

failure)

o Monitoring- how to detect and measure ESD, use of field meters

Introduction to a cleanroom

o Construction materials, how the cleanroom operates, other clean options for your

business

o Materials and equipment that are recommended for use inside cleanrooms, and some

that are not recommended

o 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

o Learn about different types of work-surfaces, chairs, racks and mats and what makes

them appropriate in clean, ESD environments

o Hands-on use of ionization products to see how ESD can be eliminated

Learn how to properly clean a cleanroom

o Daily use cleaning of a cleanroom and major clean-downs (cleanroom wipers, mops,

vacuums, disinfectants)

o ESD Auditing

o Guidelines, practices and documentation to ensure safety and compliance

Cleanroom Certification and Particle Counting Training: 2-Day Class

This cleanroom certification training is designed 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

o Cleanroom, controlled environment, clean benches, safety cabinets-are you needing to

protect your operator or your product, or both

o HVAC System components, what they do for contamination control, preventive

maintenance

o ISO Cleanroom Classification, testing requirements and frequency for continued

compliance

o USP compliance (sterile and non-sterile compounding) and FDA compliance

o Industry requirements for testing service vendor

Introduction to a cleanroom

o Construction materials, how the cleanroom operates, other clean options for your

business

o Materials and equipment that are recommended for use inside cleanrooms, and some

that are not recommended

o 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

o Learn about different types of clean work-surfaces, chairs, racks and what makes them

compatible with cleanroom environments

o 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

o 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

o Hands-on use of a particle counter in our cleanroom training center

o 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)

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.

Cleanroom 101 Training: 1-Day Class

This introductory cleanroom class is designed 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

o Cleanroom, controlled environment

o Contamination, control

o ISO, certification (Does your environment need to be cleanroom certified, or not?)

o Airborne particles

Introduction to a cleanroom

o Construction materials, how the cleanroom operates

o Materials and equipment that are recommended for use inside the cleanroom, and

some that are not recommended

o 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)

o Understand cleanroom gowning requirements and gowning procedures

Workstation maintenance

o How to perform an effective station wipe-down

o Static control ESD