Clean Room for Medical Devices

Clean Room for Medical Devices-An All-Inclusive Buying Guide by Sunnyda.

There is an increased risk of infection when medical devices are used for invasive surgical procedures. Therefore they have to be sterile so that no pathogens can enter the body of the patient being treated.

A Clean Room for Medical Devices is specially designed and constructed to ensure the sterility and safety of the devices.

From the vast variety of various kinds of cleanrooms, the one for medical devices is strictly controlled because it is crucial for the life of patients and the hospital staff since poor dealing can lead to nosocomial infections.

Whether it is a drill guide or an endoscope, A Clean Room for Medical Devices needs to be sterilized to the highest degree since it comes in contact with the mucous membranes of the patient and can easily introduce a pathogen in an already ill patient.

All medical devices need different degrees of sterilization before they enter the hospital door, based on the risk of inducing infection.

It comes with numerous benefits and unique features, so let’s begin the article.

Clean Room for Medical Devices Testing

1.What is a Clean Room for Medical Devices?
2. Which ISO Class is Most Suitable as a Clean Room for Medical Devices?
3. What are the Top Features of a Clean Room for Medical Devices?
4. What are the Notable Benefits of a Clean Room for Medical Devices?
5.What are the Major Requirements of a Clean Room for Medical Devices?
6.How to Effectively Remove Air Pollutants from your Clean Room for Medical Devices?
7. How to Keep your Clean Room for Medical Devices Sterile?
8. How can you use Technology to Maximize the Efficiency of your Clean Room for Medical Devices?
9.What FDA Factors Shall be Considered While Using a Clean Room for Medical Devices?
10. What is the Importance of a Clean Room for Medical Devices?
11. What are the Strict Protocols of a Clean Room for Medical Devices?
12.What are the Main Objectives of a Clean Room for Medical Devices?
13.What are the Design Instructions of Clean Room for Medical Devices?
14. What is Suitable Temperature and Humidity Adjustment of your Clean Room for Medical Devices?
15. What are the Contaminants Sources of a Clean Room for Medical Devices?
16. How to Deal with Electrostatic Discharge in your Clean Room for Medical Devices?
17.How to Control Contamination in your Clean Room for Medical Devices?
18.What Regulations are Necessary for Successful Operation of your Clean Room for Medical Devices?
19. What are the Risk Factors of Clean Room for Medical Devices?
20. Conclusion.

What is a Clean Room for Medical Devices?

A Clean Room for Medical Devices is an isolated room dedicated to making the medical devices free of any pathogenic organisms that may cause infection when coming in direct contact with the patient.

Out of all other classes of a clean room, the ISO Class 5 to ISO Class 8 are extensively used for this purpose. They deal with particles bigger than 0.5 microns per cubic meter. Smaller particles are dealt with by using other filtration techniques.

Designed with great precision and equipped with the latest technology, Clean Room for Medical Devices allows maximum cleanliness for the injection molding, packaging, and manufacturing of medical devices.

Along with gross particulate matter, it also removes the pathogenic organisms such as fungi, viruses, and bacteria that cause nosocomial and contagious infections.

The sterile room environment is maintained through strict regulation of conditions such as airflow, humidity, filtration, and temperature.

Sunnyda Clean Room for Medical Devices

Which ISO Class is Most Suitable as a Clean Room for Medical Devices?

The Classification system for all cleanrooms is very specific and elaborate. It considers all the aspects to assign a specific class to each room.

The ISO System for classification of cleanrooms suggests that out of all other classes, the class 3 cleanroom is the cleanest.

This is the system that was implemented right now. It is more specific and the calculation is done in the units of cubic meters.

However, the Federal Standard, which was considered previously, says that class 1 is the cleanest of them all. The unit used in this system is cubic feet and this is the main difference between the two systems.

However, the most suitable Clean Room for Medical Devices is ISO 7 and ISO 8 cleanroom.  The basis for both these classes is 0.5-micron particles. Class 7 requires 60 air changes for its HEPA filtration system.

It has 352,000 particles that are greater than 0.5 microns in one cubic meter. If the FED system is implied, it has 10,000 particles in one cubic foot.

About Class 8, it is considered to be the dirtiest one and it has 350,200 particles greater than 0.5 microns in one cubic meter. When the FED system is considered, there are 100,000 particles in one cubic foot.

Other than the above-mentioned classes, Class 5 is also considered for sterile devices.

ISO 7 Clean Room for Medical Devices

What are the Top Features of a Clean Room for Medical Devices?

The features of the most suitable Clean Room for Medical Devices are listed down below:

• The ceiling height is ideally kept at 9’-0” and the cleanroom ceiling tiles are perfect for the purpose.

• It belongs to the ISO Class 7 and sometimes ISO Class 8.

• There is always a positive pressure maintained inside the room. This positive pressure prevents the entry of any pathogens or contaminants from the outside environment.

• The air changes requirement is convenient to follow and adds to the efficiency of the cleanroom.

• The temperature is kept at 68 degrees Fahrenheit to allow smooth working along with a comfortable environment for the staff.

• A Clean Room for Medical Devices is quite spacious and can accommodate up to 8 people at one time.

• The lighting is 80 FC and it aids in the function of providing a sterile environment.

• There is a user-friendly interface that allows one to keep concise control over the conditions in the room. The humidity, temperature, lighting, and filtration can be easily controlled remotely.

• Each filtration unit is highly efficient and comes with an easy installation procedure.

• There is a separate gowning room that allows you to change into the most suitable attire.

Clean Room for Medical Devices Ceiling Tiles

What are the Notable Benefits of a Clean Room for Medical Devices?

The excellent benefits of a Clean Room for Medical Devices are given below:

• It helps you reduce the risk and spread of diseases by sterilizing the medical devices.

• The sterilization is highly efficient and keeps the rate of nosocomial infections at the lowest.

• It comes with easy operation and does not require a specially trained person to operate it.

• There is no significant running cost and therefore it requires a one-time investment that pays you back for years.

• A Clean Room for Medical Devices reduces the chance of loss since all the medical devices manufactured and sterilized here do not cause any disease and thus are suitable for all medical procedures. This implies that there will be no discarded products thus giving the true value of money.

• The span of disease is reduced because the patient receives sterilized medical products and thus a shorter stay in the hospital.

What are the Major Requirements of a Clean Room for Medical Devices?

The notable requirements of a Clean Room for Medical Devices include the following:

• It must belong to any class between ISO 5 cleanroom and class 8 cleanroom. However the most suitable are class 7 and class 8.

• The design should be such that it cannot only control the entry of airborne particles but also microorganisms that cause diseases in patients. Any contamination can cause serious risks to the patients.

• It shall be constructed to meet the needs of the application keeping in mind the type of medical devices it shall be dealing with.

• The environment shall also be comfortable for the staff working in there.

• The size of the facility is a crucial factor so that the location and installation be decided accordingly.

• A Clean Room for Medical Devices shall be spacious enough to accommodate all the materials, equipment, and personal staff. There should be no hindrance for the staff to move around. It will help reduce cross-contamination.

• The regulation and maintenance of factors like temperature, airflow, and humidity shall also be considered.

• The ventilation is air changes play a vital role in the efficiency and productivity of your Clean Room for Medical Devices, therefore, these shall not be missed.

ISO 5 Clean Room for Medical Devices

How to Effectively Remove Air Pollutants from your Clean Room for Medical Devices?

To remove air pollutants from your Clean Room for Medical Devices, the following points must be followed:

• The air changes shall be introduced according to the ISO For example, if it is a Class 7 Clean Room, there should be at least 150 air changes to get rid of the air pollutants.

• Proper gowning and mask is important as there can be an increase in airborne particles from sneezing or coughing of the personnel working there.

• An already contaminated person or an ill person shall be prohibited from entering because he or she can be a direct source of airborne contamination.

• The machinery in the cleanroom shall be maintained well and lubricated properly so that it does not add to the contamination.

• The HEPA filter box must be monitored closely to see its efficiency. If required, it shall be replaced with a more efficient one with clean fins.

• The filtration system is the main component for controlling airborne pollutants. There are two common types named HEPA and ULPA. You can also use ionizers, carbon filters, and non-filter purifiers.

• HEPA stands for high-efficiency particulate air and it is extensively used in the medical field. It claims 99.97% removal of particles from the air.

• Ultra-low particulate matter abbreviated as ULPA is another filtration system that is not only more precise but also more effective.

• It allows 99.999% cleanliness in the environment of the room. Along with airborne particles, it removes bacteria, pollen, dust, and mold as well.

Clean Room for Medical Devices High Temperature HEPA Filter

How to Keep your Clean Room for Medical Devices Sterile?

Sterilization of your Clean Room for Medical Devices is crucial because it is responsible for the control of infection.

• To keep it sterile, you must follow the protocol for entering and working in the cleanroom. It is necessary to wear gowns, masks, and shoe covers so that no particles from the outside environment can be introduced into the cleanroom environment.

• All the filters need regular cleaning and replacement because the contaminants tend to accumulate in the grilles.

• Ultraviolet radiation is a great way to kill all the microorganisms in a cleanroom. It kills pathogens by disrupting their molecular structures.

• High-quality disinfectants can be used for the cleanroom walls and the surfaces so that there is no growth of disease-causing microorganisms.

• Dry heat and moist heat sterilization techniques are useful in this case but Autoclave is the best method because it kills the bacteria as well as the spores which reduces the chance of further spread of disease.

• The staff must follow a good personal hygiene routine and the behavioral standards shall also be met efficiently.

• If you keep a tight schedule of maintaining the sterilization of your Clean Room for Medical Devices, it will be even more effective because you can keep a daily register.

Clean Room for Medical Devices Filter Replacement

How can you use Technology to Maximize the Efficiency of your Clean Room for Medical Devices?

The efficiency of a Clean Room for Medical Devices can be maximized by incorporating innovative technology like the following:

Ultraviolet Radiation 

This method is not only effective and convenient but also reduces the risk of emergence of contamination shortly since it kills the spores too.

Pass-Through Box

By using a pass-through box, you would be able to decrease the chance of contamination furthermore.

It is done because the transport of materials through the pass-through box reduces the risk of contamination on the material to be transported.

HEPA and ULPA Filtration system

Efficient and convenient filtration systems like HEPA and ULPA can deal with the removal of contaminants with great efficiency.

With some maintenance and the right location of the filters, you can achieve the efficiency you have been targeting for. The air changes also play an important role.

Clean Room for Medical Devices Pass Through Cabinet

What FDA Factors Shall be Considered While Using a Clean Room for Medical Devices?

The FDA factors for using a Clean Room for Medical Devices are listed down below.

• Dressing and attire of the staff shall be according to the protocol.

• The areas under the cleanroom must be observed for entry and exit of all the materials and the personnel.

• Eating and drinking are strictly prohibited because the crumbs can attract insects and can also add to the contamination. Smoking is also not allowed.
• Use of lead pencils is not allowed.

• The storage of glassware and other containers must be regulated properly.

• The design of the surfaces and the seating shall be by the use of the cleanroom.

• All the non-important equipment shall be immediately removed so that there is enough space.

• All the components and raw materials shall be maintained and stored under strict observation.

• The sterility and purity of your Clean Room for Medical Devices shall also be monitored to keep it according to the need.

• The cleanliness and maintenance of the filtration system play a significant role in the overall efficiency.

Wear Attire Before Entering in Clean Room for Medical Devices

What is the Importance of a Clean Room for Medical Devices?

A Clean Room for Medical Devices holds great importance because it is involved in the control and spread of diseases and nosocomial infections.

Whether it is the injection modulation, packaging of medical devices, or sterilization of medical devices, it makes them safe to be used for patients.

The risk of spreading of infection while the patient is under observation in the hospitals, with a catheter or a Foley tube, there is a high risk that he might catch any infection from the invading medical device.

A patient behind an ICU door is more prone to infection because of low immunity and there is a high chance that the hospital staff can also catch the disease.

Medical Devices Manufacturing in Medical Clean Room

What are the Strict Protocols of a Clean Room for Medical Devices?

The strict protocols to be followed while entering and working in a Clean Room for Medical Devices include the given points:

• The working staff shall not be fit, active, and clean. They must be very hygienic, that is, properly bathed and dressed.

• Only a limited number of people shall be allowed to enter, that too with all the protocols.

• All the materials and staff entering must pass through the air shower This is to make sure that all the contaminants are knocked off from the body.

• Disinfection through alcohol or any other safe disinfectant is also a necessary step.

• The meeting person must wear a gown and shoe covers. Masks and goggles shall also not be missed.

• No food or drinks are allowed inside the cleanroom because the bits of food can cause a lot of contamination and lead to the growth of bacteria and mold.

• The air changes must be observed and monitored to allow maximum airflow.

• The positive pressure of your Clean Room for Medical Devices must be maintained at all times.

Clean Room for Medical Devices Air Shower With Roller Door

What are the Main Objectives of a Clean Room for Medical Devices?

The objectives of your Clean Room for Medical Devices are explained here:

To obtain a contamination-free isolated area for synthesis, packaging, and arrangement of medical devices.

The idea is to decrease the rate of contagious diseases and nosocomial infections which are caused by using contaminated catheters, syringes, NG tubes, endoscopes, etc. these devices come in direct contact with patients’ bodies and also may affect the healthcare professionals.

Create an environment suitable for medical procedures at a reasonable price.

Just like a medical pass-through window, the chance of contamination is reduced by decreasing the contact with the outside environment.

Packaging of Medical Stuff Under a Sterilize Environment in Medical Clean Room

What are the Design Instructions of Clean Room for Medical Devices?

A Clean Room for Medical Devices must fulfill the following design criterion to be useful in this field:

• The space must be sufficient to accommodate all the machinery and the staff.

• The location must be according to the ventilation requirement.

• The position of the HEPA filters and ULPA filters is also important. If you place them on the bottom, close to the floor, they tend to be more efficient. However, if the filters are located near the ceiling, the filtration is not as efficient as in the other case.

• The surfaces of your Clean Room for Medical Devices must be smooth and made up of a material that does not add to the contamination in the room.

• An automatic roller door will be extremely helpful to maintain cleanliness.

Clean Room for Medical Devices Automatic Roller Door

What is Suitable Temperature and Humidity Adjustment of your Clean Room for Medical Devices?

The conditions like temperature and humidity shall be regulated precisely so that you can obtain maximum productivity.

Temperature

The right temperature will prevent the growth of microorganisms like bacteria and mold etc. these organisms require a hot and damp environment to grow rapidly.

The ideal temperature is 68 degrees Fahrenheit. This prevents the accumulation of contaminants and especially microorganisms. It is maintained by using an auto sliding door.

Humidity

It also plays a vital role in the growth of fungi and bacteria because these microorganisms grow better in the presence of moisture.

Some bacteria are also capable of forming spores in unfavorable conditions and these spores become difficult to get rid of.

40% humidity works well but it might be adjusted according to the comfort level of the people working in your Clean Room for Medical Devices.

Medical Clean Room Auto Sliding Door

What are the Contaminants Sources of a Clean Room for Medical Devices?

The common contaminants of a Clean Room for Medical Devices include:

Gross Contaminants

• Dust Particles

• Threads from Clothes

• Lubricants

• Wear and Tear Particles from Machinery

• Bits Because Of Friction

• Dusters and Mops

• Cleanroom Equipment Chippings

Micro Particles

• Bacteria

• Fungi

• Viruses

• Plasticizers

• Deiodinated Water

• Particulate Matter In The Air

• Floor Coatings

• Wall Chippings

• Chemicals Such Disinfectants

Humans

• Sneezing

• Coughing

• Saliva

• Germs on Hands and Clothes

• Clothing Debris

• Hair

• Skin Flakes

• Perfumes

• Oil

• Cosmetics

• Food Crumbs

• Drink Spills

Contaminants Sources of a Clean Room for Medical Devices

How to Deal with Electrostatic Discharge in your Clean Room for Medical Devices?

Electrostatic discharge is commonly experienced in a Clean Room for Medical Devices. It occurs due to the rubbing of two surfaces together.

The molecules of the two surfaces come in direct contact with each other and current is generated.

It is not produced on a gross level however, sufficient arrangements shall be made to get rid of the electrical discharge as it can be harmful. It can lead to the ignition of fire and great damage to your Clean Room for Medical Devices.

It can be avoided by using ESD protective materials against electrostatic discharge materials in the construction of the cleanroom.

It might require some investment in the beginning but it pays back as it is for the safety of your facility.

Anti ESD Medical Clean Room Attire

How to Control Contamination in your Clean Room for Medical Devices?

To address the contamination control in your Clean Room for Medical Devices, the given steps must be taken:

Design and Construction

It must be designed in a way that there are minimum corners and nooks where there is a chance of accumulation of contaminants.

The airflow shall also be aided and good ventilation must be ensured.

Streamlined airflow goes in favor as all the layers of the air follow the path of the particles in front of them thus moving in parallel lines.

Any turbulence in the smooth flow either due to restriction or disturbance can cause the haphazard movement of particles.

The cleanroom wall material shall be sturdy enough that it does not add any wall chippings in the environment.

HEPA and ULPA Filtration Systems

The efficient and reasonable filtration systems make it possible to filter all the gross contaminations that are larger than 0.3 microns.

Although it is not responsible for all the cleanliness but does hold the credit for most of it.

Other Filtration Systems

Not only HEPA and ULPA bit there is another filtration system too, which includes ionization etc. these techniques work best for even smaller particles that can be removed through molecular interactions.

The contaminants can be gases or liquids.

Garments

It is essential to follow the Clean Room for Medical Devices protocol and wear suitable garments. It also includes gloves, gowns, masks, and safety goggles.

You might require headcovers and shoe covers as well. It is best to use a disposable jumpsuit that saves you from the hassle and keeps you protected while maintaining the cleanliness of the cleanroom.

Staff Behavior and Cooperation

Both the psychological and physical condition of the staff working in the cleanroom has a great influence on the maintenance of cleanliness.

Mentally, they have to bear with the environmental conditions such as temperature and humidity, and physically, the regenerative processes like perspiration, oil, and generation of skin flakes can add to contamination.

Medical Clean Room Sturdy Wall Material Features

What Regulations are Necessary for Successful Operation of your Clean Room for Medical Devices?

The necessary regulations for your Clean Room for Medical Devices are stated below:

• Smoking, eating, or chewing tobacco, the gum is strictly prohibited.

• Cleanroom protocol and attire are a must.

• The workers shall not be allowed to take any personal belongings like wallets, keys, or cigarettes inside your Clean Room for Medical Devices. They must be stored in the locker. Even if they are allowed, these items shall never be taken out as they might be the source of contamination.

• Any cosmetic or perfume shall be prohibited because the bits can add to the airborne contamination.

• Fabric towels and paper towels shall also not be used because they release little particles in the air when torn.

• Only ballpoint pens shall be used for writing. And the paper shall also be cleanroom approved.

• No person shall touch the medical devices directly without gloves. You can use tweezers or pliers to handle the products. The fingerprints can also cause contamination.

• Direct contact with the chemical agents, disinfectants shall also be avoided.

• Only lanolin-based soaps and some approved lotions can be used inside your Clean Room for Medical Devices. These agents don’t increase skin flaking.

• The wipers used for each class also must be approved for that class of cleanroom.

• Anyone with an illness, flu, cough, etc. cannot enter the facility.

Smoking is Strictly Prohibited in Clean Room for Medical Devices

What are the Risk Factors of Clean Room for Medical Devices?

The risk factors of using a Clean Room for Medical Devices are stated here:

• The environmental conditions such as the temperature, airflow, and humidity might be disturbing for the working staff.

• Any breach in the isolated clean environment of a medical clean room can lead to the spread of a contagious disease that might become dangerous to control.

• The dirt and debris might accumulate in the filters, corners, and pipelines giving rise to the growth of microorganisms such as viruses, fungi, and bacteria.

• The lighting might not be sufficient to visualize the gross contaminants.

• The electrical discharge from the rubbing surfaces of the machines can lead to the ignition of a fire.

• If the machines are not lubricated properly, metal chips might add to the contamination in the environment.

Maintain Medical Clean Room Regularly to Avoid Risks of Contamination

Conclusion.

A Clean Room for Medical Devices is a significant factor for the control of disease in patients and healthcare individuals. It comes with extensive features and provides maximum productivity with minimum expenditure.

By proper maintenance and regulation of optimum conditions, you can obtain a great benefit for several years.

ISO Approved Clean Rooms for Medical Devices