Class 10000 Clean Room Manufacturer

Class 10000 Clean Room: A Complete FAQ Guide

Class 10000 Clean Room is considered the most common class of cleanrooms, and it is similar to the ISO 7 cleanroom. Cleanrooms mostly fall into six, seven, or eight categories. The cleanroom is rated ISO 7 when it is in working.

It is a room that controls the concentration of airborne particles, and the room is constructed to be used in a manner that minimizes the generation, retention, and introduction of particles present inside the room.

In such rooms, it is necessary to control various parameters, including humidity, pressure, and temperature.

When choosing a Class 10000 Clean Room, you must have to remember some of the essential things which are mentioned below. Let’s go through them.

Scientists Working in Class 10000 Clean Room

1.What is a Class 10000 Clean Room?
2.What are the Key Features of Class 10000 Clean Room?
3.What are the Standard Specifications of Class 10000 Clean Room?
4.What are the Major Components of Class 10000 Clean Room?
5.What are the Typical Considerations Required in the Manufacturing of Class 10000 Clean Room?
6.How does Class 10000 Clean Room Works?
7.In Which Industries Class 10000 Clean Room is used?
8.What are the Factors that Helps you to Choose the Correct Class 10000 Clean Room?
9.What is the Method of Building a Class 10000 Clean Room?
10.What are the Applications of Class 10000 Clean Room?
11.How Many Times does Air Changes Per Hour in Class 10000 Clean Room?
12.What are the Outstanding Advantages of Class 10000 Clean Room?
13.What are the Different Types of Cleanrooms That Works Well for Class 10000 Clean Room?
14.What are the Elements on Which Testing of Class 10000 Clean Room Depends?
15.How can you Make your Class 10000 Clean Room Last for Longer?
16.What is the Importance of Cleanliness of Fittings and Valves in Class 10000 Clean Room?
17.What are the Three States on Which Classification of Class 10000 Clean Room Depends?
18.What are the Tips to Clean your Class 10000 Clean Room?
19.What are the Key Points of Sanitizing your Class 10000 Clean Room?
20.What are the Environment Protocols of Class 10000 Clean Room?
21.Conclusion.

What is a Class 10000 Clean Room?

Clean rooms are usually used in production or scientific researches.  The cleanroom is described as a controlled environment having pollutants at a very low level including airborne microbes, dust, chemical vapors, and aerosol particles.

Class 10000 Clean Room consists of a hard-sided wall that uses a HEPA system of filtration for maintaining the level of air cleanliness of up to 10000 particles which are equal to 0.5µm per cubic foot.

Sunnyda Class 10000 Clean Room

What are the Key Features of Class 10000 Clean Room?

Features of Class 10000 Clean Room includes:

• GMP

• Interlock Door Systems

• Unidirectional Airflow

• Desiccator Cabinets

• Low Power Consumption

• Horizontal Flow Wall Modules

• Environmentally Friendly

• Access Control

• HEPA Filters

• Temperature Control

• Air Filtration

• Horizontal Laminar Flow Clean Benches

• Fan Filter Units

• Laminar Flow Canopy

• Laminar Flow Cabinets

• Air Showers

• Cleanroom Ceiling System

Class 10000 Clean Room Air Shower Room

What are the Standard Specifications of Class 10000 Clean Room?

At first, the standard specification of Class 10000 Clean Room was explained under the federal standard of US 209E.

And at this time, it is defined under the standard of ISO 14644-1. Still, both of them are being used regularly as points of reference.

Federal Standard of US 209E works by denoting the number of particles that are smaller or equal to 0.5 µm per cubic foot.

ISO 14644-1 was a replacement of federal standard 209E of US in the year 2001; however, it is still being used for a reference purpose and represents the particle’s numbers ranging from ≥0.1µm-≥5µm per cubic meter of air.

What are the Major Components of Class 10000 Clean Room?

These are the significant components of Class 10000 Clean Room:

• Sealed Lighting

• Sticky Mats on Entrance and Exit

• Airlocks

• Bunny Suit, and Booties, Hood Requirements

• Bench Made Up Of Stainless Steel

• Gowning Atrium

• Hands-Free Sink

• HEPA Fan Filters

• Air Conditioners

• Pass-Through for Products

• Epoxy Floors or Heat Welded Vinyl

Class 10000 Clean Room Ceiling Light

What are the Typical Considerations Required in the Manufacturing of Class 10000 Clean Room?

There are many factors that help in determining the classifications of a Class 10000 Clean Room, and the default standard of choosing those specifications is different for every industry.

In the case of packaging of medical devices, the default standard of classification is a class 10,000 cleanroom.

The things which are must-have to remember while choosing an ISO 7 cleanroom includes:

• The HEPA or High-Efficiency Penetration Air Filtration installed in it is ninety-nine percent effective, and this is the thing that must be considered when selecting ISO class 7.

• Both hard wall and soft wall constructions in a cleanroom are perfect in adjusting to the environment of ISO class 7.

• In such a case where an organization works for the GMP grades, then the most responsive solution there is Monobloc because it gives access to unique features, including coved floors and interlocked doors.

• These cleanrooms must include the changing atrium, which is supposed to be placed separately from the working area for gowning. It works to reduce the contaminants which enter the cleanroom.

Hard Wall Class 10000 Clean Room

How does Class 10000 Clean Room Works?

Class 10000 Clean Room works by limiting the contamination by dust, microbes, or other such agents within a specific procedure, including:

• Particular pressure of air to stop the air from the entrance

• Humidity Control

• Temperature Control

• Systems of Air Filtration

The cleanroom maintains the air by freeing it from the particles using HEPA filters. Such filters use the unidirectional flow of air. Single direction flow of air sent the stream of filtered air in a downward direction constantly.

Single directional flow of air, when moves along with the ceiling it maintains the constant flow. Airflow systems of turbulent can also be used, but they are not much effective.

In Which Industries Class 10000 Clean Room is used?

Class 10000 Clean Room is used in many industries such as:

• Research Institutes

• Health Care

• Universities

• Pharmaceutical

• Biotech

• Food Manufacture

• Manufacturing

• Cosmetics

• Nanotech

• Police

• Defense

What are the Factors that Help you to Choose the Correct Class 10000 Clean Room?

The Class 10000 Clean Room can be determined by the following factors such as:

• Industry Standards

• Restriction of Access

• Government Regulations

• Ease of Cleaning

• Customer Requirements

• Temperature

• Particulates

• Microorganism

• Humidity

After the consideration of all these factors, it will be easier to choose the perfect cleanroom according to the operation you want to implement in it, or it will help to find whether the implemented operation will suit perfectly a controlled environment.

What is the Method of Building a Class 10000 Clean Room?

The process of building a Class 10000 Clean Room consists of 10 significant steps, including:

Evaluation of the Layout for Material Flow/People:

The first step in this process is the evolution of material flow and people in the cleanroom. The largest contaminant sources in the cleanroom are the workers of the cleanroom.

That is why all processes must be isolated from personal pathways and doors.

Determine the Classification of the Space of Cleanliness:

For selecting the classification of cleanroom, it is necessary to be well aware of the primary standard specification of the cleanroom and also the requirements of specific performance for every classification.

Cleanliness classification has a significant effect on the construction of the cleanroom, its maintenance as well as energy costs. It is required to evaluate the rates of contamination and rejection carefully.

Determine the Pressure of Space:

To maintain a suitable pressure of the air space for adjoining the dirtier classifications of the air space, it is vital for preventing the contaminants which may result in infiltrating the medical cleanroom.

It is complicated to maintain the cleanliness of the space in the presence of neutral or negative space pressure; therefore, it should be positive.

Determine Supply of Airflow of Space:

Classification of the cleaning space is an integral part of choosing the airflow supply. Every classification has its air changing rate. Class 10000 Clean Room has a rate of air change of 60-90 times.

The air changing rate of the cleanroom must have the anticipated activity inside the cleanroom.

Determine the Flow of Air Exfiltration of Space:

Primarily clean rooms having positive pressure result in air exfiltration turns into the adjoining spaces, and those that have low pressure results in light fixtures, door frames, window frames, wall/ceiling interface, access doors, and wall/floor interface.

It is essential to have the understanding that the cleanroom is not sealed hermetically so that it may have leakage.

Determine the Air Balance of Space:

In this step complete flow of air must have to be added into the Space, including supply and infiltration. And also contains the airflow, which leaves the Space, including exfiltration, return, exhaust all becomes equal.

Until now, we have done determining the infiltration, cleanroom supply, exfiltration, exhaust, and return flow of air. Now in the final step, the returning airflow is adjusted during the start-up.

Have Access to the Remaining Variables

Variables that are needed to be evaluated includes:

Temperature:

The suits of workers working in the cleanrooms are supposed to be worn over the regular clothing for reducing the potential contaminants and particulate generation.

And due to those extra clothing which is worn over the regular ones, maintaining the temperature is an essential thing for the comfort of the workers.

A standard temperature in the cleanroom ranges from 66°F to 70°F, and it is enough to provide comfort to the workers.

Humidity:

Because of the high airflow in the cleanroom, there is a development of the electrostatic charge.

In case if the ceiling and walls have a higher charge and the humidity of the Space becomes low, then the particulates attach to the surface by themselves.

On the other hand, if there is an increase in the humidity of the Space and there is a discharge in the electrostatic charge, then the particles which have been captured will be accessible in a short time which causes the cleanroom to reach out of standard specification.

The higher amount of electrostatic charge may also result in discharging the electrostatic discharge.

Determine the Layout of Mechanical Systems:

Many variables have a different effect on the layout of the mechanical system of the cleanroom, including process requirements, cleanliness classifications, available funding, required reliability, building codes.

Unlike other air conditioners, the air conditioners of Class 10000 Clean Room contain more supply of air which is required for heating and cooling loads.

Perform the Calculations of Heating/Cooling:

While calculating the hotness/coolness of the cleanroom, you must have to keep following things in your mind:

Go with the most appropriable weather conditions such as 99.6 percent heating design, 0.4 percent median wet bulb /dry bulb cooling design.

The filtrations which must be included in the calculations are:

• A humidifier must be included to manifold heat into the calculations.

• Process load must be included in calculations.

• Recirculation fan heat must be included in calculations.

• Choose a space for a Mechanical Room:

Cleanrooms have both intensive, i.e., mechanical and electrical. With the cleanliness classification of the cleanroom, the Space of mechanical infrastructure requires much more adequate support for the cleanroom.

What are the Applications of Class 10000 Clean Room?

Class 10000 Clean Room is used in many different cleantech producing applications such as

• Ion Lithium Battery

• Medical Device

• Solar

• Nutraceuticals

• Film/Packaging

• Certain Packages Foods.

Class 10000 Clean Room Applications

How Many Times does Air Changes Per Hour in Class 10000 Clean Room?

Airflow in the Class 10000 Clean Room is unidirectional, and the flow is vertically from the ceiling and then to the floor, which returns for condition purposes and filtrates through the low wall.

The typical amount of changing of airflow is 60-90 times per hour, and the filtration coverage of the ceiling is 15-20% in a random array where the filtration is placed all over the maximized control area.

What are the Outstanding Advantages of Class 10000 Clean Room?

The advantages of Class 10000 Clean Room includes:

• Low wall return of air.

• A purpose-built system that depends on the applications of the cleanroom.

• Allows VHP fogging and wet washed for achieving the requirements of sterilization.

• Have nanotechnology, utilizes non-shedding systems, and is regularly vacuumed or wiped dry.

• Includes unique features glass walls, pass-thru, security cameras, glass walls, control devices.

What are the Different Types of Cleanrooms That Works Well for Class 10000 Clean Room?

Different types of cleanrooms that work well for Class 10000 Clean Room includes:

Hard Wall Cleanroom:

In a hard wall cleanroom, the maintenance of airborne pollutants and particulates occurs at a specific level in a closed zone.

This cleanroom filters the pollutants present in the polluted air according to the requirements of specific industries, including E-liquids, pharmaceuticals, science, and technology, as well as healthcare facilities.

Portable Cleanrooms:

In Portables Cleanrooms, the particular size of particles is obliged to stop from entering the clean environment.

Such cleanrooms control the air particles during the operations and manufacturing in different industries such as in healthcare, E-liquids, food production, and science and technology.

Monobloc Cleanrooms:

Monobloc Cleanrooms are manufactured in one piece instead of fabrications from different components.

The system of these cleanrooms includes the flush-fitting wall panels that are used to reduce the retention of particles and for maximizing the load-bearing capacity.

Soft Walls Cleanrooms:

Soft walls Cleanrooms are designed for keeping the air away from contaminants until a certain level. It is also used to filter the air pollutants according to the requirements of specific industries, including E-liquids, pharmaceuticals, science and technology, healthcare facilities.

Modular Cleanrooms:

Modular cleanrooms are designed to be in a way in which they can bear the higher volume of the flow of air which is necessary to achieve an ultra-clean environment that is ISO certified. It is portable and has a withstanding structure.

Class 10000 Modular Clean Room

What are the Elements on Which Testing of Class 10000 Clean Room Depends?

Testing of Class 10000 Clean Room depends on the various elements such as:

Counting Test of Particles:

It must be taken between the maximum interval of twelve months, and the procedure of this test is ISO 14644-1 Annex A.

Air Pressure Cascade:

This also must be taken somewhere between the maximum interval of twelve months, and the procedure of this test is ISO 14644-1 Annex B5.

Airflow:

The exact time interval of a maximum of twelve months and procedure of the test is ISO 14644-1 Annex B4.

Since all the above tests should be taken within the 12-month interval, so it is recommended to take tests after every six months.

How can you Make your Class 10000 Clean Room Last for Longer?

Class 10000 Clean Room is designed to minimization air airborne contaminants from getting in contact with binding sites. However, it requires a lot of care to maintain that cleanliness in the cleanroom.

The vital component that must be considered is the suitable material that is being used on the surface and going to be in contact with the inside environment.

What is the Importance of Cleanliness of Fittings and Valves in Class 10000 Clean Room?

The precision and services of cleaning the fittings and valves in the cleanroom are very important to meet the industrial needs.

There is no doubt that oxygen is not flammable by itself for burning it has to be combined with combustion and it can be relative with most of the materials.

Although that material must be compatible with the oxygen and does not contain any contaminant like grease and hydrocarbon coils. Such chemicals can ignite easily and can result in ignitions.

What are the Three States on Which Classification of Class 10000 Clean Room Depends?

There are three states in which classifications of Class 10000 Clean Room can be carried out, including:

• As-Built

• At Rest

• Operational

The as-built room has to be benchmarked and tested to get compatible with the requirements to perform. And at rest and operational state, these have to follow testing and then documentation.

In the case where contamination is not capable in the operational state of rest, then the proper steps must be taken.

Such steps may start with the examination of the process of production along with the number of workers working in the cleanroom and ends up with the testing of the performance of airflow.

What are the Tips to Clean your Class 10000 Clean Room?

The cleaning process of Class 10000 Clean Room is done in the following steps, and it starts from ceilings:

Ceilings:

Cleaning must always be done in the manner from top to bottom. If you have Tacky rollers having long handles, then cleaning the ceiling will be much easier.

Sometimes it is necessary to clean the ceiling with the help of a wet mop. While the other choice to clean the ceiling is with a flat mop having a portable handle.

Many times using a wiping material in the cleanroom has to be cut according to the size of the head of the mop handle for wrapping it around it.

The vacuum which is used in it is equipped with HEPA filters. Many compatible cleaning solvents can be used in the cleanroom for cleaning purposes including, Di Water, a blend of Isopropyl alcohol, and blends of Di Water.

Class 10000 Clean Room Cleaning

Walls:

The walls of your Class 10000 Clean Room can also be cleaned with the above-given method, but still, hand wiping has better effects and is more effective.

It will be an excellent choice to use a dry wipe for the cleanroom, and it can also be used with cleaning solvents.

A polyester knit wipe and nonwoven wipe also have the best results as both of them have a low generation of particles and are extractable from chemicals.

Surfaces:

Surfaces are cleaned with the use of hand wipes. Wipes dispensers present in the cleanroom make the distribution and storage of wipes easier.

Such dispensers are always helpful to eliminate the wasteful use of wipes as well as cross-contamination of wipes.

Floors:

The cleaning of the floor is similar to the cleaning of the ceiling except for one thing, and that is you can add an edgeless string mop to any mop of your choice.

For such type of mopping system, a wringer and an autoclavable bucked is recommended.

What are the Key Points of Sanitizing your Class 10000 Clean Room?

The critical points of sanitizing the Class 10000 Clean Room includes:

• Mops, buckets, and cleaning tools must be isolated for all the area and every room. ‘

• Choose the exact time of disinfectant dwell is complicated, so always consult with the product label company to find the exact time.

• Must clean in an appropriate cleaning manner, such as from top to bottom and from cleanest to dirtiest.

• Go with the no lining, non-shedding one use wipes for cleaning.

• Apply the strokes in one direction instead of going in a circular motion, and strokes can be overlapped. Change the used wipes from time to time.

Class 10000 Clean Room Mop

What are the Environment Protocols of Class 10000 Clean Room?

Environment protocols of Class 10000 Clean Room include:

• Leave personal belongings outside the environment:

• Still, if some things must have to be brought in the cleanroom, make sure to cover them beneath the garment of the cleanroom.

• Don’t smoke, chew gum or eat in the cleanroom.

• Don’t wear perfume, makeup, etc., in the cleanroom.

This will bring contaminants inside the room and may affect its integrity.

• Don’t move or run fast inside the cleanroom environment.

• If you’re sick, don’t go to the cleanroom.

• Stick with suitable un-gowning and gowning procedures.

• Take care of your hygiene.

• Cover facial hair and skelp.

• Don’t smoke even before 10 min of entering the cleanroom.

• Don’t lean or sit on the equipment or the surfaces.

• Don’t bring your face or hair in contact with the gloved hands.

Conclusion.

This is an ultimate brief idea of Class 10000 Clean Room which contains all the necessary information related to it. After reading this guide thoroughly, we are sure you can choose the best one for you depending upon your requirements.

Class 10000 Clean Room has many benefits as it prevents the air from getting contaminated and keeps the cleanroom safe.

It can last for a longer time depending upon your and precautions that must have to be followed.

100% Quality Tested Class 10000 Clean Room

FAQs of Class 10000 Clean Room.

What is the Standard Temperature of Class 10000 Clean Room?

Generally, the cleanroom temperature is 21° C or 69.8°F, and usually, there can be a fluctuation of 2° C, which is permissible.

It is essential to maintain the standard temperature within the Class 10000 Clean Room to keep the employees comfortable.

What is the Standard Rate of Humidity of Class 10000 Clean Room?

The standard rate of humidity in Class 10000 Clean Room may lie between 35% to 40% RH for round operation within the year.

These levels always remain maintained in the tight band ±2 percent RH depending on the temperatures which are below 20°C (70°F).

Why is the Protocol of Class 10000 Clean Room Necessary?

Contaminants are usually produced because of people. Oils, Flakes of skin, hair, and skin all can act as contaminants in the environment of Class 10000 Clean Room; therefore, precautions should be taken for limiting their access.

What is the Reason Behind the Name of Class 10000 Clean Room?

Cleanrooms are classified based on the size and number of particles which is permitted per volume of the air. That’s how Class 10000 Clean Room gets its name by the number of particles and their sizes.

What is the Role of HVAC in Class 10000 Clean Room?

HVAC stands for heating, ventilation, and air conditioning systems. It works by maintaining the temperature inside the Class 10000 Clean Room.

Why do you Need the Class 10000 Clean Room?

Every cleanroom has the same purpose, and that is the control of the environment which can be done by the limitations of the presence of tiny (sub-micron) particles and also by stabling temperature in the environmental conditions.

And that level of Class 10000 Clean Room is higher than other classes, and that’s why we need it for a higher controlled environment.

Who Needs a Class 10000 Clean Room?

Many companies need a Class 10000 Clean Room because of several various reasons.

One of those reasons is that a company may require it when they are manufacturing something which is in danger of getting affected by the contaminants and particles present in the air, then you may need a cleanroom.

What are the Protocols One Must Follow Before the Procedure of Gowning in Class 10000 Clean Room?

Before starting the procedure of gowning in Class 10000 Clean Room, one must follow the following steps:

• Take a start with the washing of your hands.

• Step onto the mat for the removal of excessive dirt.

• Wear shoe cover or don disposal after removing excess dirt.

• Wear donning gloves when needed.

• Cover the beard for covering facial hairs.

• Now you are ready to enter the gowning area.

Has Class 10000 Clean Room Positive or Negative Pressure?

A Class 10000 Clean Room having a positive pressure contains the air pressure level, which is more than the environment that is present around its surroundings.

It can be achieved by the use of an HVAC system that works by pumping the filtered and clean air into the structure.

What Kind of Suits do the Technicians of Class 10000 Clean Room Wear?

Technicians of the Class 10000 Clean Room wear a bunny suit or cleanroom suit which covers all of the body as it has to be worn in the environment having a controlled level of contamination.

One type of such suit is an all-in-one coverall that is worn by nanotechnology and semiconductor line technicians, workers, and equipment engineers.

What are Class 10000 Clean Room Suits Made Up of?

Class 10000 Clean Room suits are reusable and are manufactured by using the hundred percent of filament polyester with the combination of filament polyester/carbon yarn for minimizing the shedding of particles from the yarn.