Medical Clean Room

Medical Clean Room- A Well-Researched Buying Guide Presented by Sunnyda.

A Medical Clean Room is a reliable, highly efficient, and best quality hygienic Room- ensuring the standards of cleanliness.

It plays a vital role in medical and several other fields. It always takes care of patient and product safety, treatment facilities, pharmacy, and medical devices.

Additionally, there are several standards based on how many pollutants there are.

The standards of Medical Clean Room vary from ISO 8 to ISO 5, depending on the pollutants ratio.

It is an excellent product, and there are many things to read. So, let’s explore it!

1. What is a Medical Clean Room?
2. What are the Basic Characteristics of a Medical Clean Room?
3. What are the Main Requirements of a Medical Clean Room?
4. What are the Major Benefits of a Medical Clean Room?
5. What is the Basic Purpose of Setting up a Medical Clean Room?
6. What is the Major Specification of a Medical Clean Room?
7. What is the Main Difference Between a Medical Clean Room and an Aseptic Clean Room?
8. How are the Cleanliness Standards of Medical Clean Room Calculated?
9. How to Set Up your Medical Clean Room?
10. What are the Main Types of a Medical Clean Room?
11. What are the Main Applications of Medical Clean Room?
12. What are the Environmental Protocols of a Medical Clean Room?
13. How to Control the Temperature in your Medical Clean Room?
14. What are the Air Flow Principles of a Medical Clean Room?
15. Which Types of Products you can have in your Medical Clean Room?
16. How Does a Medical Clean Room Benefit your Medicated Products?
17. How to Size your Medical Clean Room?
18. How to Maintain your Medical Clean Room?
19. Conclusion.

What is a Medical Clean Room?

Treatment facilities, hospitals, medical device manufacturing factories, and pharmaceutical clean room companies need a contamination-free environment for maximum productivity.

A Medical Clean Room is designed and constructed to deal with the airborne contamination in these environments.

It is built upon the latest technology and is equipped with the most efficient equipment.

It comes in various sizes and configurations and therefore has multiple applications.

In earlier times, it was only used in highly isolated areas such as pharmacy units and surgical units of hospitals, but now it is being used in burn units and corridors as well.

The purpose of a Medical Clean Room is to obtain an anti-microbial environment. No microbes, bacteria, fungi in the environment means no chance of infection and spread of communicable diseases.

This is because of greater exposure to bio-hazardous material.

According to the ISO system, various classes are depending upon the accuracy of the filtration, ranging from 1 to 9.

Class 1 is considered the cleanest and Class 9 is the dirtiest of them all. A Medical Clean Room falls in Class 5-8.

What are the Basic Characteristics of a Medical Clean Room?

The basic characteristics of Medical Clean Room are:

• It is environmentally friendly and does not produce any byproducts that harm the environment.

• A Medical Clean Room is equipped with a high filtration mechanism. Ultrafiltration techniques such as HEPA and ULPA are used.

• In addition to cleanliness, it has optimal temperature and humidity control in a clean environment.

• Because of the unidirectional flow, there is an increase in the efficiency in the removal of contaminants.

• Medical clean rooms consume 2 to 50 times the energy consumed in unclassified areas, depending on the industry and specific use.

What are the Main Requirements of a Medical Clean Room?

The main requirements of a Medical Clean Room are the following:

• It must have an innovative design so that it can be adjusted in various applications.

• It should have a reasonable size to fit in the location that is selected already.

• It requires regular maintenance and cleaning so that it stays durable for many years.

• Cleaning of the filters and replacement if necessary must also be carried out.

• There should be adequate space in a Medical Clean Room to accommodate all the equipment and materials. This is to endure that there is no mixing.

• The entry of materials and persons should be restricted so that there is no introduction of contaminant particles from the environment.

• All the staff and personnel entering the room must be gowned properly and enter with all the protocols.

• A Pass-Through Box shall be used for the transport of materials from one room to the other so that there is no chance of exposure to the unclean environment.

• There should be good lighting.

• The maintenance of a set temperature and humidity is also important for better performance.

• The conditions inside a Medical Clean Room shall be strictly regulated.

• The pressure inside the room should always be positive. This will decrease the movement of contaminants from the outside environment.

• All the equipment shall be disinfected properly.

• The environmental conditions inside the room shall be always monitored.

What are the Major Benefits of a Medical Clean Room?

The major benefits of a Medical Clean Room are stated below:

• It provides a 100% contamination-free environment.

• There is a significant decrease in the spread of infection and communicable diseases, especially in the hospital staff. The risk of nosocomial infections is greatly decreased.

• The monitoring of indoor conditions gives a chance to keep the temperature, humidity, and pressure in a narrow range.

• A Medical Clean Room increases productivity by decreasing the chance of error because of contamination.

• It has easy installation and maintenance.

• It can be easily adjusted according to the application so that it can increase the rate of production.

• It comes with all the components and does not need any accessories to increase efficiency.

• The high technology in design helps in making it a safe choice.

• It is equipped with good lighting and airflow.

• The airflow mechanism does not allow the air to stay at one point. The stagnant air allows the growth of microbes, therefore, high ventilation is always maintained.

• It has high reliability and durability.

What is the Basic Purpose of Setting up a Medical Clean Room?

There are different types of contamination around us like:

• Particulates include dust, skin, hair makeup.

• Chemicals include oil, perfumes, metal ions.

• Biological factors like bacteria, fungi, and rodents.

• Radiations like ultraviolet rays, X rays, etc.

All these are present in our environment and cause different harmful effects. Medical Clean Rooms are a valuable tool that we used to sterile our environment.

It has a vital key role in the production of hygienic products.

It helps us to make our air space free of pollutants. Furthermore, it has an impactful effect on the production of the products.

It is mainly used in the Pharmaceutical Industry, clean room Laboratories, and Food industries. Moreover, it is also used in the production of medical and electronic equipment.

What is the Major Specification of a Medical Clean Room?

With a critical warranty, ISO 5 is an advanced Medical Cleanroom. This one has less than 3,520 components.

Air is exchanged for 250-300 HEPA filters per cubic meter> 0.5 microns over time.

ISO 6 is an advanced medical cleanroom game plan. In this ideal room, particles of 0.5 microns or more per cubic meter should be replaced with less than 35,200 HEPA-separated airs for 180 hours.

Comparable Managed data sets show that the criteria for evaluation vary from 100 to 1000 particles per cubic meter.

ISO 7 typical depiction in this defect-free room, less than 325,000 particles larger than 0.5 microns per cubic meter will change the HEPA sorting air for hours 60.

Existing applications are pharmacy USP800, uplifting room electronic conferences, and medical device manufacturing.

ISO 8 is a requirement for filthy Medical Clean Room. In this room, for all cubic meters> 0.5 microns or larger particles less than 35,200,000, the HEPA isolation air is modified for 20 hours. Plastic exhaust fuses for medical devices.

What is the Main Difference Between a Medical Clean Room and an Aseptic Clean Room?

Medical Clean Room

A Medical Clean Room is free of not only microorganisms but also airborne particles like dust, aerosol particles, and other contaminants.

Aseptic Clean Room

An Aseptic Clean Room refers to a controlled environment where there is no growth of microorganisms like bacteria, fungi, and other pathogens.

It has a highly regulated environment to prevent the growth of such organisms but the presence of airborne particles etc. is there. It requires a high level of disinfection and controlled temperature and airflow.

How are the Cleanliness Standards of Medical Clean Room Calculated?

The Medical Clean Room cleanliness standards are calculated by the statistical studies of how pure the air is.

It is measured by the ratio and size of air particles in a given volume of an atmosphere. Moreover, a Medical Clean Room is an area where air particles are controlled to maintain hygiene.

Well, according to the US scientific society, the standard of a Medical Clean Room can be measured with the total number of air particles in a cubic foot – it can be more than or the same as 0.5 µm.

Thus, these points together make up the proper standards of it.

How to Set Up your Medical Clean Room?

Here are some bit-by-bit techniques for assessing and planning clean rooms, figuring in individuals/material stream, space cleanliness arrangement, space compression, space supply wind current, the exhilaration of environmental air, the balance of air space.

Many factors are required to be mentioned.

Some steps include:

• Measure the size for adjustment and accommodation of people and equipment.

• Select a niche for installation.

• See if the size of the niche and the Medical Clean Room is in accordance.

• Keep a patent airway for a good flow of air.

• Make proper arrangements for good ventilation.

• Determine the mechanical layout plan.

• Calculate the conditions such as temperature, pressure, and humidity so that they can be regulated over a narrow range.

• Establish a stable electricity connection to power all the equipment.

• Go for thorough sterilization and disinfection before using it.

What are the Main Types of a Medical Clean Room?

There are mainly four types. The design of every kind of cleanroom will depend on the purpose of the facility and the requirements for classifying the cleanroom.

Let’s go through the kinds of a Medical Clean Room and how they contrast in their applications, courses of action, and clean room plan.

Medical Research Clean Room 

Medical research cleanrooms are used in the following medical arrangements.

The exploration and the advancement of therapies. Medical research cleanrooms are frequently needed to be safe and have additional protection representatives and significant work from potential insecurity hazards.

Medical Device Clean Room

Medical devices are particular items used to analyze, treat, patients. In contrast to drug items, medical devices are not processed.

They can be utilized inside and remotely as an instrument by medical experts or even embedded for a drawn-out arrangement.

Since they contact tissues and layers, medical devices should be without pollutants or ready to be altogether disinfected to forestall the chance of contamination or different dangers.

Therefore, the creation, get-together, and bundling of medical devices require a controlled cleanroom climate, approved and checked by quality control.

Pharmaceutical Clean Room

Pharmaceutical cleanrooms are utilized to foster compound therapies and fixes to develop well-being further and save lives.

In the turn of events and testing of pharmaceuticals, even the smallest defilement could have genuine outcomes on medical investigation results or therapy productivity and could even prompt hazardous effects.

Along these lines, the pharmaceutical business is dependent upon weighty guidelines.

Pharmaceutical cleanrooms regularly require fluctuating degrees of cleanliness, relying upon the kind of substances, synthetics, and strategies engaged with their activity.

The base norm for pharmaceutical, Medical Clean Room is large ISO 7 with advancing necessities of ISO at least 5, which requires 240-600 air changes each hour and 35-70 percent roof inclusion to keep a climate of 100,000 0.1μm particles for every cubic meter.

Hard Wall Clean Room

Because of the great degree of control required in a pharmaceutical clean room, hard wall cleanrooms are the best arrangement.

A hard wall cleanroom offers a dependable construction to any Medical Clean Room plan, ready to keep up with strict ecological principles and take out blunders brought about by temperature, dampness, or tainting.

These kinds of Medical Clean Rooms are essential for organizations seeking after research.

It is also used in planning mixtures and devices to develop well-being further and save lives.

Significant work in the medical services industry justifies a high-performing Medical Clean Room to secure activities and representatives.

What are the Main Applications of Medical Clean Room?

The main important application of Medical Clean Room is in pharmaceuticals, food processing, and electronics. It keeps the products uncontaminated.

Also, personal protection from hazardous substances is provided by the cleanroom.

Moreover, it offers a good defense against biological and chemical substances.

It is used in applications such as:

• Surgical units of hospitals.

• MRI rooms in laboratories and hospitals.

• Medical laboratories in hospitals and research centers.

• Research laboratories for pathological purposes.

• Intensive care units for the decrease in the spread of nosocomial infections.

• Isolation rooms to decrease the entrance of contaminant particles.

• Pharmaceutical companies to reduce the contamination in the production of drugs.

• Preparation of vaccines and injections so that there is no error in the production and packaging.

What are the Environmental Protocols of a Medical Clean Room?

Environmental Employment Assessment Services

Environmental Monitoring (E / M) is a program that aims to show the management of active particles (microorganisms) and inorganic particles in the primary regions.

These regions comprise clean rooms, laminar stream hoods, organic wellbeing hoods, isolators, glove boxes, construction equipment, and consecutive construction systems.

Environmental monitoring measures include reasonable and not operational controls:

Active Monitoring

It means exposure testing and listing germs, yeast, and fungi. It contains personnel monitoring, air, and pollution control areas.

Non-Viable Environmental Monitoring

Which is an indicator of molecular testing that is measured with a laser counter.

Active tallies estimate possible contamination of organizational items as they reflect that a cleanroom operates in an orderly and well-maintained manner.

Organizations that inspect their cleanroom offices ensure that their appropriate/necessary excellence standards are met.

Areas sampled from the cleanroom comprise:

• Employees

• Wind

• Air conditioning as well as direction verification

• Dissimilar pressures of separated rooms

• Lighting level

• Testing of water as microbiological and chemical

• Monitoring Pressured air monitoring: active and inactive

• Qualification

How to Control the Temperature in your Medical Clean Room?

The temperature should be 69.8 Fahrenheit. The optimum temperature has a vital role in a Medical Clean Room.

So, it is necessary to maintain the temperature and the Humidity.

Moreover, you can lower the temperature of a clean room, decreasing the dew point of the airstream. Furthermore, you can condense the water vapor and can add temperature sensors.

Thus, these all factors together help to regulate the temperature in your Medical Clean Room.

This is to create an environment that does not allow the growth of any microorganisms like fungi and bacteria.

Effect of Uncontrolled Temperature

If the temperature and humidity of the cleanroom get uncontrolled. It could have some drastic effects, which includes:

• Corrosion on Exposure to Moisture

• Growth of Microbes

• Condensation

• Contamination of The Produced Products

What are the Air Flow Principles of a Medical Clean Room?

Unidirectional Airflow Cleanroom

Two types of filters can be used to limit the microparticles in the air:

High-Efficiency Particulate Air (HEPA) 

HEPA is the one that can remove 99.97 percent of contaminated particles. The HEPA filter is considered to be the in-depth boxed type and is mainly used for air filtration.

Moreover, the HEPA filter is purely made up of glass fibers.

It is planted in series and the first HEPA filter is used to control laminar airflow, which is defined as the air that flows downwards directly and straightly.

Steel or stainless steel is also used to make these filters. It can hold around 80% to 85% of the ceiling space and efficiently work against the 0.3 nanoparticles.

This flow of HEPA is also known as a unidirectional type of airflow because it only moves downwards. Another significant airflow filter is ULPA or Ultra Low Penetration Air.

ULPA

ULPA is another filter used in it. ULPA is a multi-directional airflow system that is also known as a turbulent airflow system.

UPLA, on the other hand, plays an essential function in cleaning the environment and particulates.

The ULPA efficiently works against the microns that have the primary size of 0.12 microns. It has medium-dry filters, which assure an efficiency of 99.997%.

Although the laminar airflow system is integrated into the turbulent airflow, the two are still distinct.

The entire enclosure is constructed using laminar flow and particle velocity, with no particle contamination.

The multi-directional system is based on air particle flow through the filters. Furthermore, turbulence is notorious for causing particle mobility, which can be troublesome when dealing with different types of particles.

Which Types of Products you can have in your Medical Clean Room?

The products in a Medical Clean Room can vary from paper to stationery and from adhesive tapes to plastic containers and cleaning supplies.

According to the scientific society, there is a list of prohibited items as well.

These are the products that are not allowed in a Medical Clean Room. These products include Food, Drinks, jewelry, makeup, or any hard cardboard sort of stuff.

You can have the following products:

• Paper and Notebooks

• Pens and Pencils

• Adhesives or Tape

• Solvents

• Plastic Containers

• Garment Cabinets & Racks

• Gowning Benches

• Bootie Racks

• Hampers

• Hand Washers & Dryers

• Cleanroom Mirrors

• Shoe Cleaners & Sticky Mats

How Does a Medical Clean Room Benefit your Medicated Products?

Medical Products benefit from a Medical Clean Room because there can be no compromise on cleanliness in the production and synthesis of products related to human health.

Any contamination can lead to failure of the effectiveness of the product thus leading to the risk of life.

Also, the spread of infection from the patients to the hospital staff, patients to their attendants, and from the hospital environment to the patients is a highly sensitive matter, so all the surgical equipment, instruments, and tools must be 100% clean.

The patients are more likely to catch a disease since they already have low immunity. Therefore, all the injectable, medicines must be pure.

How to Size your Medical Clean Room?

The size of a Medical Clean Room is determined by the needs of the industry in which it is going to be installed. The size can be adjusted and personalized.

If you only require a modest Medical Clean Room, it can be built within your current structure. However, if you want a large-scale place, you’ll need to make some changes to your building structures.

There is the step-by-step procedure of the Medical Clean Room sizing:

• Choose an appropriate size according to the space that you have.

• Look at the overall structure and see if it goes with the selected niche.

• Check if the structure and the size will allow proper operation, maintenance, and cleaning.

• Eliminate the chances of cross-contamination by sizing it rightly.

• Pay attention to the purpose of installing it in the first place.

• Plan an appropriate space for the orderly placement of equipment and materials to prevent mixing and contamination.

• Design proper flow of materials and people to prevent contamination.

How to Maintain your Medical Clean Room?

There are many ways in which we can maintain our Medical Clean Room. Some of the methods are listed below:

• There should be a record of daily, weekly, monthly, and quarterly regular maintenance procedures to help ensure compliance with a Medical Clean Room regardless of cleanroom class.

• For example, to provide indoor clean and fresh air, static pressure air must be flowing at full flow for at least 30 minutes within a Class 10 cleanroom and then cleaned.

• Start at the cleaning vertex and move to the floor.

• All surfaces, corners, and shelves are first vacuumed and then soaked in cleanroom wipes.

• Special procedures are also required for the maintenance of medical cleanroom equipment. For example, equipment that needs lubrication to prevent the spread of Greece and control molecular pollution (AMC) in the air is isolated on a polycarbonate shield.

• Fully gowned service personnel wear three pairs of latex gloves to perform this service.

• After lubricating the instrument, the service personnel flip the outer gloves off the separation shield and grease them.

• If this procedure is not followed, maintenance personnel may leave grease on doors or other surfaces when leaving the Medical clean room and then any operator who touches the handle will spread grease and organic contaminants.

• Some notable medical cleanroom equipment must also be maintained, such as HEPA filters and ionization grids.

• Vacuuming the HEPA filter every three remove particles. Recalibrating and cleaning the ionization grid every 6 months ensures proper ion emission.

• You might also need to replace the filters if necessary.

• It is important to maintain a good airflow to allow proper ventilation.

Conclusion.

Thus, we can conclude that a Medical Clean Room always helps or aids quality production by controlling environmental substances such as temperature, pressure, and Humidity.

It is the most appropriate reason they are in high demand in the pharmaceutical, medical, biological, and food packaging industries. Well, apart from their usage, Medical Clean Room has a lot of benefits that attract buyers.

The production of contaminated free products is something that attracts the most. Thus, it is an excellent technology for industry leaders.

FAQs of Medical Clean Room.

1. How Much Money will be Required for your Medical Clean Room?

The cost of your Medical Clean Room is determined by your needs and the amenities you require. Generally, the budget can be increased or decreased depending on the services you require, such as humidity control, filtration, and temperature.

2. Is the Installation of your Medical Clean Room Required the Construction of a New Structure?

No, many different types of Medical Clean Rooms can be put in existing structures.

All you need to do is consult with the specialists about your framework and get advice on the best solution within your constraints.

3. Do you Need to Get any Permits Before the Installation of your Medical Clean Room?

Although it’s not mandatory to take permits to install a small Medical Clean Room you must obtain authorization from the local building control authority in the case of a large setup.

4. How Long Does it Take to Install a Medical Clean Room?

A small setup installation of a Medical Clean Room takes 2 to 4 weeks, and a significant build-up takes 4 to 8 weeks.

5. Can your Redesigned your Old Medical Clean Room?

Yes, changes are necessary over time; Medical Clean Rooms, in particular, have backward compatibility. They can grow or shrink in size, depending on the situation.

6-How Frequently Different Tests will be Conducted to Regulate the Medical Clean Room Functions?

• Monitoring particles in air tests will show after every six months.

• HEPA Filter test will conduct once a year.

• Calculation of Air changes Rate will conduct in every six months.

• Air pressure Differentials are observed daily.

• Temperature and Humidity are checked daily.

• Microbiological monitoring will be checked daily.