Class 100 Clean Room Manufacturer

Class 100 Clean Room: A Crucial FAQ Guide

A Class 100 Clean Room is the area responsible for the specific control of airborne particulates with the help of exchanging HEPA (high-efficiency particulate air).

It also contributes to the maintenance of the controlled environment by minimizing activities that lead to contamination.

A Class 100 Clean Room is constructed and maintained in a way to reduce contamination, prevent the entry of foreign bodies, inhibit bacterial growth, and maintain a sterile environment.

The staff is ordered to follow protective measures, wear personal protective equipment, and cover their body properly to minimize the possibility of contamination.

To know more about a Class 100 Clean Room, read this guide containing features, benefits, applications, working, and cleanliness procedures related to it. Let’s begin.

An Operator Working in Class 100 Clean Room

1.What is a Class 100 Clean Room?
2.What are Some Architectural Features of a Class 100 Clean Room?
3.What are the Filtration and Particle Control Considerations of a Class 100 Clean Room?
4.What are the Airflow and Air Rate Changes Per Hour of Class 100 Clean Room?
5.How is a Class 100 Clean Room Different from Other Clean Room Classes?
6.What are the Benefits of a Class 100 Clean Room?
7.What is the Importance of Class 100 Clean Room in Data Recovery?
8.What are the Different Biosafety Levels for a Class 100 Clean Room?
9.How does a Class 100 Clean Room Design and Construction Address Contamination?
10.What do Class 100 Clean Room Testing Requirements Include?
11.What is the Recommended Wall System Instructions Related to your Class 100 Clean Room?
12.What are the Ceiling System Considerations of your Class 100 Clean Room?
13.What are the Flooring System Ranges of a Class 100 Clean Room?
14.What is the Class 100 Clean Room Proper Working Procedure Protocol?
15.How to Wash Hands in your Class 100 Clean Room?
16.What are the Best Practices for Donning Class 100 Clean Room Gloves?
17.What does the Class 100 Clean Room Gowning Procedure Checklist Include?
18.What are the Best Practices for Class 100 Clean Room Entrance, Garments, and Ante Rooms?
19.What is the Cleaning Procedure for your Class 100 Clean Room?
20.Conclusion.

What is a Class 100 Clean Room?

A Class 100 Clean Room is an area that works for the maintenance of fewer than 100 particles having a size of 0.5 microns in every cubic foot of the air space.

Other than particle control it is also responsible for the control and maintenance of humidity and temperature at 45% RH and 70F.

It maintains high standards of sterility and cleanliness and provides a contaminant-free environment for various applicants. It provides a clean environment and ensures that the environment is controlled as per the application requirements.

A Class 100 Clean Room makes sure that the final product of the application is fully pure, has no bacterial or microbial presence, and is safe to use.

The cleanliness standards maintained in it is very high and must be followed properly to ensure maximum process efficiency.

Only specified cleaning agents are allowed to be used for the cleaning purpose following the recommended cleaning equipment and methods.

A Class 100 Clean Room is used for various application processes requiring a controlled environment with no risks of contamination.

Sunnyda Dust Free Class 100 Clean Room

What are Some Architectural Features of a Class 100 Clean Room?

The main architectural features of a Class 100 Clean Room include:

• Doors

• Glass Walls

• Viewing Windows

• Pass-Through

• Security Cameras

• Sprinkler Heads

• Access Control Devices

Class 100 Clean Room Glass Windows

What are the Filtration and Particle Control Considerations of a Class 100 Clean Room?

The filtration and particle control considerations of Class 100 Clean Room are:

• Measures particles sizes ranging between 0.5µ to 5.0µ.

• Must feature High-Efficiency Penetration Air (HEPA) filter to give 99.99% filtration efficiency at 0.3 microns.

• HEPA Fan Filter Units or Terminal HEPA modules are installed at the air entrance and perform final filtration.

Class 100 Clean Room Fan Filter Unit

What are the Airflow and Air Rate Changes Per Hour in Class 100 Clean Room?

The airflow and air rate changes per hour of Class 100 Clean Room include:

• Airflow is always unidirectional because of the harsh nature of Class 100 Clean Room environment.

• Air moves in a vertical direction from the ceiling towards the floor.

• With the help of raised access flooring (also called perforated flooring) or low wall returns air moves to the filtration and conditioning units.

• The typical air changes rate is from 240 to 480 (ACPH) or air changes per hour.

• The ceiling coverage range lies between 35 to 75 percent.

How is a Class 100 Clean Room Different from Other Clean Room Classes?

Maximum Particles at Less Than 0.5 Microns:

• Class 10 Clean Room: 10

• Class 100 Clean Room: 100

• Class 1000 Clean Room: 1000

• Class 10000 Clean Room: 10000

• Class 100000 Clean Room: 100000

Maximum Particles at Less than 0.5 Microns:

• Class 10 Clean Room: 352

• Class 100 Clean Room: 3520

• Class 1000 Clean Room: 35200

• Class 10000 Clean Room: 352000

• Class 100000 Clean Room: 3520000

ISO Equivalent:

• Class 10 Clean Room: ISO 4

• Class 100 Clean Room: ISO 5

• Class 1000 Clean Room: ISO 6

• Class 10000 Clean Room: ISO 7

• Class 100000 Clean Room: ISO 8

Filter Coverage Percentage:

• Class 10 Clean Room: 90 to 100

• Class 100 Clean Room: 60 to 70

• Class 1000 Clean Room: 20 to 30

• Class 10000 Clean Room: 7 to 15

• Class 100000 Clean Room: 4 to 5

Light Fixture Type:

• Class 10 Clean Room: Flow-Thru or Teardrop

• Class 100 Clean Room: 2’×4′ Cleanroom Fixture or Tear Drop

• Class 1000 Clean Room: 2’×4′ Fixture

• Class 10000 Clean Room: 2’×4′ Cleanroom Fixture

• Class 100000 Clean Room: 2’×4′ Standard Fixture

Flooring Base:

• Class 10 Clean Room: 2″ To 6″ Cove

• Class 100 Clean Room: Aluminum Base Channel Or Cove

• Class 1000 Clean Room: Aluminum Base Channel Or Cove

• Class 10000 Clean Room: Aluminum Base Channel Or Cove

• Class 100000 Clean Room: Aluminum Base Channel Or Cove

CFM Per Square Foot:

• Class 10 Clean Room: 85 to 90

• Class 100 Clean Room: 36 to 65

• Class 1000 Clean Room: 18 to 32

• Class 10000 Clean Room: 9 to 16

• Class 100000 Clean Room: 4 to 8

Class 1000 Clean Room

What are the Benefits of a Class 100 Clean Room?

A Class 100 Clean Room has multiple benefits, a few are given below:

• Provides controlled environment.

• Ensures protection from contamination.

• Offers a safe environment for treatment and storage.

What is the Importance of Class 100 Clean Room in Data Recovery?

A Class 100 Clean Room has the following implication in data recovery:

• Contributes to efficient data recovery.

• Provides a safe environment for hard drive operation.

• Gives a controlled environment for opening a hard drive.

• Prevents contamination which ultimately saves from data loss problems.

• Controls electromagnetic interference.

• Maintains electric field.

• Takes care of required humidity and temperature levels.

What are the Different Biosafety Levels for a Class 100 Clean Room?

The different biosafety levels of Class 100 Clean Room are discussed below:

Biosafety Level 1:

It is suitable to work with agents with negligible pathogenicity and minimum potential risk to individuals. At this level, precautions are limited related to other levels.

Biosafety Level 2:

It protects from infectious agents or pathogens that cause less serious diseases. Effective treatments are usually available.

The disease-causing agents attack superficial susceptible surfaces of the human body with the limited spread of infection.

Biosafety Level 3:

It deals with pathogens causing human diseases. Spread of infection is possible by air but with a moderate speed of transmission. A high level of individual protection is required.

Biosafety Level 4:

It is a dangerous level of protection with the highest individual and environmental risk.

Maximum spread of infection, causing diseases with peak level severity. No therapy or vaccine is available.

Biosafety Levels

How does a Class 100 Clean Room Design and Construction Address Contamination?

A Class 100 Clean Room design and construction address contamination in the following ways:

• By stopping particles from entering via air gaps or air filtration systems.

• Filtering and removing air from the Class 100 Clean Room throughout the operation.

• Offering adjacent rooms and parallel stages with different cleanliness environments.

• Using laminar flow hoods for the isolation of air pressure and clean spaces for isolated procedures requiring hazardous chemical use and sterile compounding.

What do Class 100 Clean Room Testing Requirements Include?

Some common tests recommended for a Class 100 Clean Room are:

Air Flow:

This test follows the ISO 13644-1 Annex B4 test procedure and has a maximum time duration of 6 months. It ensures that the airflow mechanism of your Class 100 Clean Room is perfect.

Particle Count Test:

It follows the ISO 14644-1 Annex A testing procedure and has a maximum time period of 6 months. It helps to see if the particle concentration meets the set standards or not.

Air Pressure Cascade:

It follows the ISO 14644-1 Annex B5 testing procedure and has a maximum time limit of 6 months. This test aims to check the air pressure tolerance of Class 100 Clean Room.

Class 100 Clean Room Testing

What are the Recommended Wall System Instructions Related to your Class 100 Clean Room?

The recommended wall systems for Class 100 Clean Room are modular purpose-built wall systems varying with your application requirements.

If you are concerned with biotech applications, then non-shedding systems are required which must also have monolithic coving and seams.

This enables them to remove 90° angles, permitting wet washed down and enhancing VHP fogging for gaining sterile requirements.

If your applications are concerning non-sterile environmental requirements and nanotechnology purposes, then non-shedding systems are used but are followed by vacuuming or dry wiping steps.

What are the Ceiling System Considerations of your Class 100 Clean Room?

Purpose-built ceiling systems are used for Class 100 Clean Room varying with the category of your application.

If you are concerned with pharmaceutical or biotech applications, a plenum module ceiling system is best for getting appropriate lighting levels and perfect filter coverage.

In the case of applications concerning non-sterile environments, non-shedding blank ceiling tiles are used in combination with gasket grid systems.

Class 100 Clean Room Ceiling System

What are the Flooring System Ranges of a Class 100 Clean Room?

The flooring system ranges from a Class 100 Clean Room start from resinous flooring systems and ends at raised access flooring (having perforated tiles) or heat welded vinyl flooring systems.

The properties of each system vary with your required applications.

What is the Class 100 Clean Room Proper Working Procedure Protocol?

The proper Class 100 Clean Room working procedure protocol is:

• You should walk slowly in Class 100 Clean Room for preventing air turbulence.

• Make sure you have all the working tools and materials ready with you before you enter.

• Clean all the supplies properly using a 70% IPA solution to minimize the chances of contamination.

• Whenever a shift end, the work areas should be cleaned properly. In pharmaceutical applications, the cleaning session should be carried out after every 30 minutes.

• Make sure you know the airflow pattern of your Class 100 Clean Room so you can organize equipment accordingly.

• Do not block HEPA filtered air from getting to the product.

• Always tape or pin instruction sheets on the laminar flow tables or walls in a way that air transfer is not blocked.

• Store tools, supplies, and chemicals in their respective cabinets or containers and place them in a way that chances of contamination are minimized.

• Cover all the supplies, products, and materials properly when finished using them to prevent contamination. In case there is any spillage, clean it immediately.

• Get rid of soiled garments as soon as possible.

• Any contaminated item should be cleaning following the cleaning protocols of the Class 100 Clean Room or discarded if required.

How to Wash Hands in your Class 100 Clean Room?

Follow this guide for properly washing hands in your Class 100 Clean Room.

• Firstly wet your hands with water and then apply an adequate quantity of soap. Only use soap recommended by the manufacturer.

• If you have taken extra soap do not add it back to the soap dispenser, simply waste it.

• Now scrub the entire surface of your hands for a minimum of 15 seconds

• The use of hot water is not recommended as it can increase the chances of dermatitis.

• Use hand dryers with HEPA filtration for drying purposes. Using paper towels is strictly not allowed.

Hand Washing Procedure for Class 100 Clean Room

Some Additional Tips:

• Ask the staff about their fragrance preferences and note down any irritation or allergy problems.

• Make sure not to touch any clean garment before you finish properly washing and drying your hands.

• Use electrostatic discharge lotion for electrostatic protected areas to maintain the effectiveness of ESD monitoring stations and wristbands.

• Make sure that your fingernails are not more than ¼ inches long.

What are the Best Practices for Donning Class 100 Clean Room Gloves?

For donning Class 100 Clean Room gloves there are some tips that you ought to follow and some that you should avoid, as discussed below:

Things to Follow:

• Always use sterile gloves for aseptic processing and never wear powdered gloves.

• Make sure your hands are completely dry before wearing gloves.

• Wear a glove on your dominant hand first.

• For less movement and easy access, you can also use a wall mount consumable dispenser.

Things to Avoid:

• Do not wear gloves if you are wearing anything on your hands and nails.

• After the application of alcohol solution, make sure to not immediately speed dry your gloved hand.

• Make sure not to touch any uncovered area of your skin with your gloved hand.

Gloves Donning for Class 100 Clean Room

What does the Class 100 Clean Room Gowning Procedure Checklist Include?

Class 100 Clean Room Gowning Procedure checklist includes:

• Take six steps collectively with both feet to enter the gowning room.

• Get rid of the sticky mat layer if required.

• Clean your shoes using a shoe brush cleaner.

• Properly wear shoe cover booties.

• Now wear bouffant.

• Then thoroughly wash your hands using an alcohol solution with no water content.

• Now wear your glove liners.

• On the outside of the glove liners, apply some alcohol solution.

• After this wear your gloves.

• On the outside of the gloves, apply alcohol solution.

• If you have facial hair, wear bouffant.

• Then wear a hood and face mask.

• Now wear the coverall by only touching the clean side of the gowning bench floor.

• Tuck your hood inside your coverall.

• Make sure that gloves and booties are overlapping with the coveralls.

• Use a sterile wiper for cleaning the gowning bench.

• Check yourself in the mirror and ensure that you are all good to enter.

What are the Best Practices for Class 100 Clean Room Entrance, Garments, and Ante Rooms?

The best practices for Class 100 Clean Room entrance, garments, and anterooms are:

• The area from where you enter into the Class 100 Clean Room should have the same hygienic environment as the Clean Room itself.

• Personal items like watches, matches, cigarettes, keys, rings, and lighters should be kept safe in the locker which is put outside the gowning room.

• A waste receptacle and sticky mat should be placed at the entrance of the gowning room.

• Clothing and jewelry should be kept in the dirty area of the gowning room.

• Smoking is not allowed before 30 minutes of entry.

No Jewellery While Entering Class 100 Clean Room

What is the Cleaning Procedure for your Class 100 Clean Room?

For properly cleaning your Class 100 Clean Room here are some points that you must keep in mind:

• Whenever it is about the quality assurance processes, always count your employees in that.

• Also, tell your employees about the negative and positive hygiene standards of the Class 100 Clean Room and order them to follow the cleanliness standards.

• Before wearing a non-shedding gown or whenever you enter the anteroom make sure to thoroughly cleanse your hands.

• Make sure that there are enough protective garments present for your staff its respective of their body shape and sizes.

• In the ante-area use soap and water for washing your hands for at least 30 seconds. For this purpose, you can either use antimicrobial or no antimicrobial soap.

• Do not forget to wash your forearms and elbows too.

Things you Should Avoid:

• Never use scrub brushes on your hands because they can severely damage the skin leading to skin shedding problems.

• Only use disposable wipes instead of any other ordinary drying wipes for drying your hands.

• It would be best to use an electronic hand dryer featured with HEPA filtration if possible.

• It is not recommended to wear a gown before you are completely done with your hand hygiene. This is because splashes coming from the sink can be a source of microbial contamination when you are wearing a non-shedding gown.

• Do not use non-specified cleaning agents as they can affect the quality of cleaning standards.

• If you have to scrub floors, benches, walls or any other surface only use deionized water.

• Specifically use Class 100 Clean Room mops for cleaning purposes.

• On a daily basis, use distilled water to damp the mop for mopping the floor followed by vacuum drying.

• At the specified detergent in distilled water for mopping the floor once in a week followed by HEPA filter vacuum.

• With the help of a sponge, take distilled water for wiping the walls followed by vacuum drying once a week.

• Wash the pass-through and windows using lint-free 70% IPA wipes.

• Make sure to vacuum ceilings daily.

• On a weekly basis, take distilled water with the help of a sponge for wiping the ceilings followed by vacuum drying.

• If you see any contamination on the ceilings wash them with the solution of distilled water and the recommended detergent.

• Using a sponge, wipe troffers and overhand light lenses with distilled water every week and vacuum dry later.

• Replace sticky mats when required.

General Practices for Class 100 Clean Room Wiping:

• It is recommended to use the approved wipers for Class 100 Clean Room only.

• Make sure that there is no direct contact between the surface of the table or bench and the tool placed over it; there should always be a wipe placed between them.

• Wipe all non-packaged items with appropriate cleaning solution before they enter the gowning room.

• Use 30% isopropyl alcohol wipes for ultra-cleaning your cart items.

• Wipe your safety glasses using a suitable IPA wipe before wearing them. This will make sure that the glasses are completely clean and free of contaminants.

• Use an IPA wipe for cleaning anything dropped on the floor.

• Make sure to keep proper solvent cans for the disposal of solvent-soaked wipes.

• Ensure that all wipes have been successfully disposed of by the completion of each session.

Conclusion.

Class 100 Clean Room must be maintained as per the recommended quality standards to ensure contamination-free processing and maximum process efficiency.

Make sure to properly follow the working guide, hygiene instructions, gowning process, glove donning, and cleanliness recommendations mentioned above for maintaining the controlled environment of your Class 100 Clean Room.

100% Quality Tested Class 100 Clean Room

FAQs of Class 100 Clean Room.

What are the Environmental Limitations that you Must Consider for your Class 100 Clean Room?

The environmental parameters that are necessary to be considered for your Class 100 Clean Room include humidity, temperature, noise criteria, outgassing, lighting levels, and static control.

What are the Properties of Best Flooring Systems for a Class 100 Clean Room?

Best flooring systems for a Class 100 Clean Room must have excellent chemical resistance, good coving properties, balanced rolling weight loading, non-slip surface, and perfect static control.

What are the Common Manufacturing Applications of a Class 100 Clean Room?

Class 100 Clean Room has common applications in pharmaceutical, biotechnological, cleantech, and nanotechnological areas.

Major manufacturing applications include the production of ion lithium batteries, active medical devices, fine chemicals, solar systems, and high-end films.

What are Some Suitable Gowning Material Options for a Class 100 Clean Room?

Some suitable gowning material options for a Class 100 Clean Room include nitrile, latex, and vinyl. Nitrile is super strong and has excellent chemical, acid, and oil resistance.

Latex is well-known to have excellent elasticity and durability. Vinyl shows high resistance to wear and tear and is easy to clean and sanitize.

What are the Most Common Contaminants of Class 100 Clean Room?

The most common Class 100 Clean Room contaminants are liquids, solid dust, fungus, bacteria, human hair, human skin cells, moisture traces, cosmetic products, leaks and spills, perfumes, fibers, and lint.

What is the Purpose of Putting Waste Receptacle in Class 100 Clean Room Premises?

A waste receptacle is placed in the premises of a Class 100 Clean Room for safely holding the discarded waste items and preventing them from contaminating the environment.

Why is it Necessary to Maintain Good Hand Hygiene in Class 100 Clean Room?

The maintenance of good hand hygiene helps in preventing the destruction of the Class 100 Clean Room environment.

It also lowers the chances of bacterial contamination and transfer of microbial agents including fungus and viruses.

What are the Necessary Considerations for Successful Startup of Well Designed Class 100 Clean Room?

The necessary considerations for the successful startup of a well-designed Class 100 Clean Room include preplanning the entire startup, implementing the plan, and understanding the engineering prospects of the plan.

What is the Main Equipment Required in Class 100 Clean Room?

The main equipment required in Class 100 Clean Room includes ovens, vacuum systems, utility carts, dunnage racks, bins, racks, boxes, shelves, liners, razor blades, thermal holdings, meters, and monitors.

What are the Tools used in Class 100 Clean Room?

Tools like pliers, forceps, tweezers, hemostats, forceps, and brushes are widely used in Class 100 Clean Room. Pliers, forceps, and tweezers provide a grip for holding small particles.

Hemostats help in maintaining homeostasis. Brushes are used for cleaning purposes.

What is the Purpose of Wearing Class 100 Clean Room Gloves?

There are two main reasons why Class 100 Clean Room gloves are worn. The first is to provide protection to the wear from irritative and dangerous substances.

The second is to protect the environment from contamination.

How is Class 100 Clean Room Glove Packaged?

An easy-to-open polyethylene packaging is used for Class 100 Clean Room glove packaging. It is then washed thoroughly with deionized water.

After this step, the assemblage part is carried out in Class 10 Clean Room, followed by the final packaging step. The final packaging is then delivered to the Class 100 Clean Room.

Why should you Specifically use Class 100 Clean Room Mops for Cleaning Purposes?

Class 100 Clean Room mops should be specifically used as they contain materials like woven polyester which shows limited tearing or shedding during the cleaning process.

What Type of Mopping System is Recommended for your Class 100 Clean Room Mopping?

It is recommended to consider an autoclave-ready multi-bucket mopping system for your Class 100 Clean Room that has deep-drawn seamless buckets, a non-marring wheel, and a dirty and clean water control system.

What is the Purpose of Gowning, Buffer, and Cascaded Anter Rooms in Class 100 Clean Room?

In a Class 100 Clean Room the gowning room serves as an area for dressing and wearing protective equipment.

Whereas the buffer and cascaded anter rooms are specified for storage and preparation purposes.