Modular Clean Room Manufacturer

Modular Clean Room Manufacturer-A Complete Guide by Sunnyda.

Different research-based organizations require a contaminate-free environment for quality assured working.

A Modular Clean Room Manufacturer designs a wide variety of modular cleanrooms for different applications that protect against contaminants and chemical attacks.

It manufactures hard wall cleanrooms and soft wall cleanrooms. It meets the ISO standards and GMP guidelines ensuring the credibility of its products.

Modular cleanrooms are integrated with different types of panels and pass through. It provides flexibility, expandability, easy installation, and maintenance.

The manufacturing company also prevents the customer from taxes of cleanroom installing site. These cleanrooms also have low power consumption.

So under these credibility and standardized credentials, it can be said that a Modular Clean Room Manufacturer is the best option for purchasing a cleanroom. Let’s know more about it.

Modular Clean Room Performance Testing

1. What is a Modular Clean Room Manufacturer?
2. How Does a Modular Clean Room Manufacturer Design a Modular Clean Room?
3. For Which Purpose Does a Modular Clean Room Manufacturer Construct a Modular Clean Room?
4. Which Factors Does a Modular Clean Room Manufacturer Follow for a Modular Clean Room?
5. What are the Basic Features that a Modular Clean Room Manufacturer Comply for a Modular Clean Room?
6. Which Types of Panels Does a Modular Clean Room Manufacturer Design for Different Applications?
7. Why Does a Modular Clean Room Manufacturer Provide Customizing Services?
8. What GMP Guidelines Does a Modular Clean Room Manufacturer Follow to Meet Credentials of Regulatory Agency?
9. What are EU GMP Guidelines for a Modular Clean Room Manufacturer?
10. Which ISO Standardization Does a Modular Clean Room Manufacturer Use for a Modular Clean Room?
11. What is DOP Testing Used by Modular Clean Room Manufacturer?
12. Which Category Off-Sale Servicing Does a Provide to Customers?
13. What are Validation Services Offered by a Modular Clean Room Manufacturer?
14. For Which Applications Do a Modular Clean Room Manufacturer Prepare Modular Clean Rooms?
15. How Many Types of Air Flow Design Pattern Does a Modular Clean Room Manufacturer Use?
16. How PIC/PICS Based Clean Zone Grading is Supportive for a Modular Clean Room Manufacturer?
17. Which Documented Verification Protocols Does a Modular Clean Room Manufacturer Issued for you During Product Sale?
18. Which Inspection Process Modular Clean Room Manufacturer Face for Product Authenticity Under Risk Base Compliance Program?
19. How is Product-Related GMP Inspection Different from Triggered Inspection for a Modular Clean Room Manufacturer?
20. Why Does a Modular Clean Room Manufacturer Perform QC/QA Testing?
21. Conclusion.

What is a Modular Clean Room Manufacturer?

A Modular Clean Room Manufacturer is a renowned company among different organizations for its reliable and lower power-consuming modular cleanroom productions.

The company is working with extensive knowledge and ingenious ideas to develop the customized as well as standardized cleanrooms.

Modular cleanrooms are equipped with an air shower, clean booth, sandwich panels, sandwich panel, wall panels, HEPA filters, and pass-through door for contamination-free material transferring.

The manufacturing company follows the GMP guidelines of regulatory agencies as EU GMP and FDA GMP to commercialize its products in foreign countries.

Pharmaceutical, research institutes, nanotechnology, biotechnology, and health care department are some of its applications for which it designs cleanroom.

Sunnyda Modular Clean Room

How Does a Modular Clean Room Manufacturer Design a Modular Clean Room?

A Modular Clean Room Manufacturer has extensive experience and knowledge about designing and manufacturing reliable modular cleanrooms for different applications.

The company designs a cleanroom under the following steps:

Considerations About Cleanroom Designing:

• Classification of Cleanrooms

Before starting the manufacturing process, the class of cleanroom is selected. When customers place the order, it is checked that under which class the demands of the customers are belong.

ISO standardization has made it easy to select. ISO classified different types of classrooms based on the number of particulates in one cubic meter.

Fan filters are selected according to the criteria depicted by the client for particulate removal from the cleanroom. Mostly modular cleanrooms are designed for cleanrooms that are under ISO4-9.

• Air Flow Design Pattern for Cleanroom

HEPA filtration and ULPA filters are selected as per-requisite of contaminant removal. Single-pass airflow is selected for humidity-free clean rooms.

Recirculating air- flow is selected for cleanrooms that need temperature regulation and humidity.

• Operating Conditions

HVAC system and relative temperature/humidity are also carefully chosen by ISO cleanroom classification.

Type of cleanroom, budget, number of required pass-through, auto sliding door or roller door selection, CCTV installation, number of personnel required and equipment are all these things are taken into consideration.

After finalizing all these parameters, manufacturing is started.

Construction Process:

• First Phase

In the first phase of modular cleanroom manufacturing most of the work proceeds. Personal protective equipment as gloves, safety glasses, etc. is strictly obeyed during working.

Full hard wall or flexible wall construction, welding for water injection, filters installation, furniture settings, all are done in this first phase of manufacturing.

• Second Phase

Removal of contaminants, pollutants, and debris from cleanroom vacuum is used. The particulate count is also in this phase to set it according to the customers’ demands.

• Third Phase

In this phase, airlocks are prepared as sliding doors, dynamic or a static pass box for entry as well as specimens transport respectively.

• Fourth Phase

This final phase is called the commissioning phase in which all of the cleanroom equipment and facilities are tested for inspecting design specifications and client requirements.

Modular Clean Room Construction Process

For Which Purpose Does a Modular Clean Room Manufacturer Construct a Modular Clean Room?

A Modular Clean Room Manufacturer constructs Modular type cleanrooms that are durable, load-bearing, and insulated for the proper working of applications with different basic purposes as given below:

• The basic purpose of the manufacturing company by providing standardized and customizing cleanroom is to facilitate the customers for their business development and product reliability.

• To make the cleanroom flexible, the manufacturing company construct it in such a way, as it cannot be permanently fixed in one place. The unit can easily transfer to other sites or can be sold.

• To prevent the different products from air contamination, chemical hazards, the Modular Clean Room Manufacturer constructs cleanrooms.

• Modular cleanrooms are also manufactured to make the cleanroom capable of expanding. Prefabrication of the unit makes it flexible to expand.

• By removing the panel from one side and adding a new module, the cleanroom can easily be expanded.

• To protect the customer from tax expenses for cleanroom residing, modular cleanrooms are designed that can easily be depreciated as compared to its construction after protecting completion.

• Easy installation and repairing just by replacing the damaged panel or filter with a new one is due to the unit modular featuring.

• For constructing clean rooms within a little amount of time as well as easy designing, Modular Clean Room Manufacturer designs these modular cleanrooms to support the customer as much as possible for making the company name among overseas clients.

Prefabricated Clean Room

Which Factors Does a Modular Clean Room Manufacturer Follow for a Modular Clean Room?

There are the following factors that a Modular Clean Room Manufacturer follows during the manufacturing of modular cleanrooms:

• ISO 14644 standardization

• Considerations about the type of cleanroom for which order is placed

• EU and FDA GMP guidelines for quality assurance

• Selection of the type of cleanroom wall according to environment

• Location, and required number of cleanroom pass-through windows

• Evaluate the required number of personnel for sterilized working

• Future growth and budget planning

• Determination of space pressurization to deal with the contaminates

• Ceiling and trusses height requirements

• Temperature regulation and humidity controlling

Softwall Modular Clean Room

What are the Basic Features that a Modular Clean Room Manufacturer Comply for a Modular Clean Room?

Modular Clean Room Manufacturer designs a prefabricated, flexible modular cleanroom with double-wall and insulated panels’ integration.

The walls of the cleanroom are epoxy coated and cleaned with disinfectant methods. These properties give an aesthetic look to the cleanroom.

More elaborative features are as given below:

• Laminar flow cabinet and canopy

• HEPA filtration

• Deck system designing

• Insulated doubled wall panels

• GMP based credentials

• Environmental friendly behavior and low energy consumption

• Clean benches of horizontal laminar airflow

• ISO-based standardization from ISO 4-9 under 14644 guidelines

• Temperature regulation and proper air filtration

• Power saving ACS2000 based system

• Pass-through windows for contamination-free specimen transfer

• Cleanroom monitoring ACS3000 based system

• Reliable ULPA filtration

• Pass-thru windows and doors with interlock system

• Air shower and ceiling system

Excellent Features of Modular Clean Room

Which Types of Panels Does a Modular Clean Room Manufacturer Design for Different Applications?

An assorted number of panels are used as per the environmental conditions of an application by a Modular Clean Room Manufacturer for cleanroom construction.

The panels protect from harmful factors of the environment, chemical attacks, contamination, and scratches.

The different types of panels used by cleanroom manufacturers are given below:

1-Cleanroom Sandwich Panel

The sandwich panel consists of a core region and two outer facings. Different types of sandwich panels are designed that vary based on core region as:

• PU sandwich panel

• EPS panel

• PIR sandwich panel

• Rockwool sandwich panel

• PVC sandwich panel

The Modular Clean Room Manufacturer uses different core material as PIR, Polyurethane material, honeycomb, etc. as per application requisite.

The panel facings can be of galvanized steel, aluminum, and stainless steel material, etc.

2-Ceiling Access Panel

These access panels are used by the company to make the cleanroom flexible for customizing services.

Cleanroom ceiling is equipped with these ceiling access panels that provide easy access for electrical connections, maintenance activities as well as easy repairing.

Access panels are of different types that can be used as:

• Metal Access Panels

• Acoustic Panels

• Fire-Rated Panels

• Slime Line And Metal Access Panel

• Drywall Panel

3-Wall Panels

The Modular Clean Room Manufacturer also designs wall panels that are mostly rectangular with a flat surface structure.

Wall panels can easily be adjusted on one side of the cleanroom walls if the other side is made of bricks.

These wall panels act as soundproof and insulated units.  These are not with specific lengths. The wall panels can be cut or customized according to the clients’ orders.

Modular Clean Room Wall Panel

Why Does a Modular Clean Room Manufacturer Provide Customizing Services?

A Modular Clean Room Manufacturer meets the needs of a large number of applications that require a cleanroom for their working by preparing products according to the customer requirements.

• A modular cleanroom is designed in such a way so that it can be customized for different cleaning grades.

• The booth cleanroom provides easy accessibility to move the cleanroom at the site where working is required. Wall panels can be changed or mold into shorter or longer lengths for the site of interest.

• To get a license for its products commercializing in overseas countries, the manufacturer provides customized services according to ISO standards for different cleanroom classifications.

• The Modular Clean Room Manufacturer follows the EU cleanroom GMP and FDA guidelines to ensure its product quality and reliable customizing services.

• A modular cleanroom is designed with a flexible structure, deck panels, and duck system to come up with different clean grading zones.

• By providing different types of modulating, standardized, and customizing services, the manufacturing company desires to grab more customers from all over the world with satisfaction.

Customized Modular Clean Room

What GMP Guidelines Does a Modular Clean Room Manufacturer Follow to Meet Credentials of Regulatory Agency?

GMP or ‘’Good Manufacturing Practices’’ are the best strategy that is implemented by the manufacturing companies to maintain the stability and quality of products.

Modular Clean Room Manufacturer is renowned for its reliable and flexible quality products because it follows the GMP guidelines and meets the standardized credential set by regulatory agencies.

These GMP guidelines are given below:

• The product quality should be high.

• The product must fulfill the requirements of marketing authorization.

• Manufactured products must be adjusted with installing area for superb working.

• Manufactured products should be contaminant and pollutant-free.

• Workers and personnel should be well trained as well as equipped with PPE while working.

• All data about the working procedure should be recorded and saved by any available source as manual method and electronic data storing. Deviations or any limitation of the final product that is inspected by a specific authority should also be taken under record.

• Must check the quality of the product when manufacturing is in the process even after finalization of product and before shipment QA test is necessary.

• Well-trained operators must be hired to provide proper documentation of record.

• For making the working procedure of the product more elaborative, GDP should be followed.

GMP guidelines that are designed by European states are stricter as compared to US GMP guidelines.

A Modular Clean Room Manufacturer prefers to follow both guidelines in its designing and production to ensure the credibility of modular clean rooms.

Modular Clean Room PPE

What are EU GMP Guidelines for a Modular Clean Room Manufacturer?

There are two types of GMP-based guidelines as FDA GMP guidelines and EU GMP guidelines that highlight working standards for manufacturing companies to introduce their products on market.

• The EU GMP Annex1 guidelines for Modular Clean Room Manufacturer specify that

• Control management should be performed for sterile products

• Specifications as SCC to maintain the contaminants and airborne particulates

• Premises for filter leakage and contaminant leakage testing etc.

• Barrier technology

• Product inspection process

Which ISO Standardization Does a Modular Clean Room Manufacturer Use for a Modular Clean Room?

ISO is an international standardized organization that works under 160 above countries. ISO sets a different standard and classified cleanrooms according to the different cleaning grades.

Modular Clean Room Manufacturer designs different types of cleanrooms by using ISO 14644 standardization that indicates the guidelines for cleanroom manufacturing.

This manufacturing company mostly designs ISO 4 cleanroom to ISO 9. Cleanrooms for ISO class 5-8 are designed for the pharmaceutical industry. While ISO 7 cleanroom is used for the medical department.

ISO 6 Prefabricated Clean Room

What is DOP Testing Used by Modular Clean Room Manufacturer?

DOP testing is a specific process that is used to inspect the integrity and working efficiency of HEPA filters.

Modular Clean Room Manufacturer, ensure to perform this test so that contaminant-free clean rooms can provide to their customers.

Two types of equipment are used to perform this test:

1-Aerosol Photometer

2-Aerosol Generator

Procedure

HEPA filters are integrated into the modular cleanroom to remove the contaminating particulates and different microbes as fungus and bacteria and make the air suitable for working in the pharmaceutical industry or other research institutes.

To check their working standard set by a regulatory agency, dispersed oil is used for testing. The specific oil is taken and dispersed over the filter upstream.

While downstream, the photometer is integrated to calculate the number of particulates passing through.

Results Indications

If the particulate filtration value for 0.5 micron does not come to 99.9995% or a value deviates from 99.99% contaminant removal by 0.3micron filter, then definitely there would be a need to replace the filter.

This DOP testing also ensures the inspection and testing of different filter components as joints, filter housing, and seals, etc.

The Modular Clean Room Manufacturer directs the clients to perform this test before starting a new project. Well-trained engineers are provided by the company to perform this test.

Which Category Off-Sale Servicing Does a   Provide to Customers?

Modular Clean Room Manufacturer also offers off-sale servicing as technocrats are available for installation of the cleanroom at the site designated by the client.

Service engineers also perform DOP testing for HEPA filters and ULPA filters adjustment in working cleanrooms.

Any work-related to repairing of the cleanroom in a warranty period is also serviced by technocrats of company.

The company also offers maintenance and validation services for different working applications to infer a quality level of the cleanroom.

Modular Clean Room HEPA Filter Testing

What are Validation Services Offered by a Modular Clean Room Manufacturer?

Modular Clean Room Manufacturer provides validation services that offer confirmatory tests about your cleanroom facilities either it is working as per ISO 14644 standard or not.

The manufacturing company scheduled a testing plan and send a highly experienced and trained validation team at the site directed by the client.

The validation engineers perform a different test to evaluate the working standard of a cleanroom.

For operational as well as performance qualification, these validation services can also be performed.

ISO Approved Modular Clean Room

For Which Applications Do a Modular Clean Room Manufacturer Prepare Modular Clean Rooms?

Contamination control and international standardization for each industry are basic parameters that are considered while manufacturing.

Under these working credibility and optimization, Modular Clean Room Manufacturer constructs cleanrooms for an assorted number of applications as given below:

• Pharmaceutical Clean Room
• Healthcare Department
• University Labs
• Breweries Industries
• Biotechnology Based Companies
• Nanotechnology-Based Companies
• Plastic Molding Industry
• Cosmetics
• Laser and Optics
• Aerospace and Automotive
• Food and Beverage Industry
• Research Centers
• Sterile Room

Modular Clean Room Applications

How Many Types of Air Flow Design Pattern Does a Modular Clean Room Manufacturer Use?

Modular Clean Room Manufacturer designs load-bearing, less power consuming, and best insulated modular cleanroom that prevents the entry of airborne contaminants and other microbe insides clean room.

For making clean room contamination-free, the company implements different airflow designs to increase the unit redundancy.

HEPA Filtration

A HEPA filter box is installed that can dissipate 99.97% of air contaminants and prevent the specimen from spoilage.

ULPA Filtration

Sometimes the company also installs ULPA filters for more accurate and optimal working with the removal of 99.999% contaminants from the air.

Except for these air filtration units, this manufacturing company manufactures modular clean rooms with two basic airflow designs according to the environmental conditions as given below:

Single-Pass Air Flow Design

In this type of airflow design pattern, ambient air enters the cleanroom through air filters and discharge from the unit in the building space.

This single air pass design is integrated with a clean room that does not require temperature regulation or humidity control.

Recirculating Air Flow Design Pattern

In this design pattern, the coming air enters inside the cleanroom through the ceiling plenum and is filtered by a specific filtering unit called an air handling unit or AHU.

The conditioned air recirculates inside the cleanroom after filtration.

The final discharge of the air takes place by low wall returns. The Modular Clean Room Manufacturer fixes this airflow design if a cleanroom requires the proper control of humidity as well as temperature regulation.

Modular Clean Room HEPA Filter

How PIC/PICS Based Clean Zone Grading is Supportive for a Modular Clean Room Manufacturer?

According to PIC/PICS, the clean zone for manufacturing spaces is divided into four basic grades as grade A, B, C, and Grade D.

This grading is based on the cleaning and particulate-free environment requirement.

This clean zone grading helps Modular Clean Room Manufacturer to design cleanrooms according to standardized values set for each cleaning zone.

The cleanroom for more critical situations is designed for grade A, while grades C and D require non-critical type cleanrooms.

Grade A Modular Clean Room

Which Documented Verification Protocols Does a Modular Clean Room Manufacturer Issued for you During Product Sale?

After completion of cleanroom manufacturing, documentation is prepared about different verification protocols as given below:

DQ Test Verification

DQ is also called design qualification. It ensures that the selected cleanroom design is according to GMP.

IQ Test Verification

Installation qualification tests verify that all equipment of the cleanroom is present with proper serial numbers, site testing as well as proper installation.

OQ Test Verification

Operational qualification tests dictate that the cleanroom is properly working with ISO standards after installation.

IQ Tested Modular Clean Room

Which Inspection Process Modular Clean Room Manufacturer Face for Product Authenticity Under Risk Base Compliance Program?

GMP-based inspections are made by ingenious inspectors and managers from different authorities.

This inspection is proceeded to report regulatory agencies as MHRA agency, so that agency may take an action if GMP cleanroom is not properly followed by a manufacturing company.

Modular Clean Room Manufacturer also undergoes this inspection process performed by the IAG group in the following way:

Inspection Process

• IAG group visits the industry or manufacturing site to evaluate the available facilities, working, documentation, and distribution sites.

• Questions are asked from working engineers and personnel for inspecting the working process.

• QC labs, manufacturing sites, sale, and purchasing processes, a temperature regulating system, sample testing system, and other R&D are also visited by the inspecting team.

• After the inspection process, a written report is provided to the Modular Clean Room Manufacturer highlighting the limiting or deficient point. Three types of deficiency reports are designed to grade the working quality.

Critical Deficiency Report

It reports that manufacturing products are going to provide danger either to humans or animals.

This report can also administrate the down flag for the manufacturing company for further sale.

Major Deficiency Report

This report infers that the manufacturing of cleanroom or any other product is not under specifications that the manufacturer provides to obey during getting a license.

Common/Undifferentiated Deficiency report

It is not specified for any respective flaws in manufacturing, but it indicates that the process is not confirmed by GMP guidelines.

After this inspection and post inspections, Modular Clean Room Manufacturer ensures its product quality to transport it for different applications even in overseas countries.

Modular Clean Room Inspection

How is Product-Related GMP Inspection Different from Triggered Inspection for a Modular Clean Room Manufacturer?

Cleanrooms manufactured by Modular Clean Room Manufacturer are sold at national and international levels, so it can face two types of inspections for retailing its products that are:

Product-Related Inspection

This type of inspection is performed by the inspection authority for MHRA regulatory agency as per requisite from this manufacturing company to get a license for marketing of modular cleanrooms in the UK.

Many other European countries also implement inspections about GMP guidelines to allow the product commercializing in the country.

GMP guidelines are the basic parameter to evaluate the quality of this type of inspection.

Triggered Inspection

This type of inspection is performed by the inspection team as a surprise, without informing them about their visit.

It proceeds if there is a new company in the market or a suspicion of a manufacturer.

Regulatory agencies as HMRA claim that organization want to confirm that GMP guidelines are followed or not by the company.

GMP is also basically checked for this kind of inspection but without and prior notice.

GMP Prefabricated Clean Room

Why Does a Modular Clean Room Manufacturer Perform QC/QA Testing?

A Modular Clean Room Manufacturer performs its QC/quality control testing and QI/quality testing during cleanroom manufacturing and after finalization, manufacturing to ensure that the product meets the quality standard.

Quality Control/ QC testing

QC testing is generally performed for ISO 7 and ISO 8 cleanroom for which the specified quality authorizations are necessary.

QC Testing helps the company to get the desired specifications for its product. This testing is performed on each step of manufacturing from raw material selection to product finalization.

At different stages of QC inspection dictates any deviation or limitation in production, so that it may fix on time.

This testing ensures that are you are introducing the best quality product in the market with a superb reputation.

QC testing also reduces the expanses for separate inspection processes as well as gets satisfied the customers for deal finalization.

Quality Assurance/QA Testing

The Modular Clean Room Manufacturer also exhibits quality assurance testing to finally assure the highest product quality before shipment.

Quality assurance is also based on documentation. Proper documents that ensure the quality are given to the customers, so that the deal may be finalized with great satisfaction.

ISO 7 acts as a driving force for the proceeding of quality assurance testing. To meet the international quality standards, and for lowering the expenses by other inspections, the QA test always remains suitable for the company to follow.

QA testing also helps the Modular Clean Room Manufacturer by preventing the products from any defects before marketing. In this way, these test helps the business expandability under trust and confidentiality.

Quality Assurance Phases of Modular Clean Room

Conclusion.

So a Modular Clean Room Manufacturer is the best modular cleanroom provider that is intended to provide a secure environment for reducing project failure.

The company manufactures the cleanroom with a wide variety. It is ISO standardized and QC/QA assured cleanrooms are transported all over the world.

Modular Clean Room Manufacturer always strives to supply cleanrooms requiring a lower budget, easy installation, and maintenance. Pass through window and auto sliding door increase sterility of cleanroom.

Thus the innovative and reliable modular cleanrooms by manufacturing companies are supporting the clients by providing a protected environment for sensitive processing.

100% Quality Tested Prefabricated Clean Room