Sterile Room Manufacturer

Sterile Room: A Complete FAQ Guide

The first and the foremost priority of a medical process is complete sterilization which is only possible in a Sterile Room.

Processes such as infusions, injections, and vaccination require the removal of all contaminants including the microorganisms such as bacteria and viruses.

A Sterile Room is made up of scratch-free and sturdy material that is reliable and requires very little servicing. It has updated technology to kill microorganisms that are not even visible to the naked eye.

It is a mandatory part of hospitals and pharmaceutical clean room companies that need 100% sterilization.

Any breach in the integrity of the decontaminated environment can lead to serious health issues and infections thus leading to a risk of life.

It not only helps to save your time but also obtains maximum productivity. It decreases the chance of the wastage of expensive chemicals and rare preparations.

For obtaining high efficiency, you should know all the features and service requirements of a Sterile Room.

This article will help you to learn about it so that you can make the best use of it. Let’s start.

Scientist Working in a Sterile Room

1.What is a Sterile Room?
2.What are the Important Features of a Sterile Room?
3.What is the Difference Between a Clean Room and a Sterile Room?
4.What is the Basic Purpose of a Sterile Room?
5.How to Classify a Sterile Room?
6.What are the Common Applications that Need a Sterile Room?
7.What are the Requirements of a Sterile Room?
8.What shall be the Air Conditioning Inside a Sterile Room?
9.What is the Sterile Room Attire?
10.What Equipment is Required for a Sterile Room?
11.What is Meant by the Grading of your Sterile Room?
12.What is the Significance of Grey Zones in a Sterile Room?
13.What is the Mechanism Behind the Sterile Garments in the Sterile Room?
14.What Sterilization Techniques are used in a Sterile Room?
15.What are the Filtration Considerations for your Sterile Room?
16.What are the Maintenance Steps for your Sterile Room?
17.What Cleanliness Routine shall be Followed for your Sterile Room?
18.Conclusion.

What is a Sterile Room?

A Sterile Room is a controlled environment that is not only free of any contaminant particles but also is free of any microorganisms.

Any bacteria or pathogenic microorganisms in the environment are not desirable for certain processes such as filling vaccines or making Pharmaceutical drugs.

The entry of a microbe into a highly sterile process such as a medical treatment facility, preparation of an infusion, or injection can lead to serious negative effects. Therefore, any contamination in these cases must be avoided at any cost.

A Sterile Room is equipped with recent technology to fight the microorganisms such as bacteria, viruses, and other pathogens. It is manufactured of the highest quality materials to ensure safety.

As it is offered in several sizes and comes in different configurations, a Sterile Room has various features. It has an easy maintenance routine but needs to maintain a high cleanliness profile.

Sunnyda Dust Free Sterile Room

What are the Important Features of a Sterile Room?

The major features of a Sterile Room are:

• It has the most innovative design to avoid the accumulation of any contaminants.

• The construction material of a Sterile Room is non-shedding which means that it does not add to the contamination.

• The surface is scratch-resistant and non out grassing, which reduces the chances of spreading particles into the environment.

• Mostly the surface is so strong that it is resistant to isopropyl alcohol which is a major component of cleaning agents.

• The walls of the Sterile Room are resistant to UV radiation and hydrogen peroxide vapors.

• All the clean room equipment and material is aseptic and does not promote the growth of microorganisms.

• The temperature and humidity are controlled under a narrow range.

• It comes with excellent lighting.

• There are various sizes and designs available from different classes and grades.

Sterile Room Lighting

What is the Difference Between a Clean Room and a Sterile Room?

A Clean Room differs from a Sterile Room in the sense that the latter is more specific. It specifically deals with the removal of contaminants such as microorganisms that can escape the normal filtration process.

The microorganisms tend to make spores in unfavorable conditions. When the favorable conditions return, they come back to life and cause infections that may or may not be contagious.

The killing mechanism of the microorganisms needs high-tech equipment and precise technology such as ultraviolet radiation etc.

On the other hand, a Clean Room is a highly controlled environment that is monitored indoors.

The amount of contaminant particles, the pressure, humidity, and temperature, everything is controlled according to the necessities of the process.

The HEPA filtration system is used in a Clean Room whereas it might not be sufficient for a Sterile Room, which needs more precise control over the contaminants.

What is the Basic Purpose of a Sterile Room?

The purpose of a Sterile Room is to obtain an environment where there is no possibility of growth or survival of microorganisms that can be the cause of disease or infection.

It is used to decrease the incidence of nosocomial infections and increase the chance of prognosis with 100% sterilization.

Sterilization is a process that not only kills the microorganisms but also destroys the latent spores which can later become the cause of disease.

A Sterile Room is mandatory for medical procedures, especially dealing with situations where the microorganisms can get an entry into the human system. That is injections, infusions, vaccines, etc.

How to Classify a Sterile Room?

A Sterile Room is classified based on the method of sterilization and the following：

Terminal Sterilization

Products are sterilized before or during packaging, but not produced in a sterile environment. Terminal sterilization can be done with additional equipment.

Moist heat

The air is removed from the final packing before steam sterilization penetrates. Moist heat is utilized in this process.

Dry heat

Sterilized with air filtration while manufacturing, where air can enter via the HEPA filter. Positive pressure produced in the Sterile Room prevents entering of the non-sterile air.

Aseptic Manufacturing

If the product cannot be decontaminated with air filtration or in the final phase with humid heat, it must be produced in a sterile environment.

This process involves some risks because some viruses or mycoplasma can pass through filters with nominal pore sizes of 0.2 μm. Risks can be reduced by merging filtration with heat treatment.

Aseptic Manufacturing in a Sterile Room

What are the Common Applications that Need a Sterile Room?

A Sterile Room is created to avoid any contamination in terms of microorganisms like viruses and bacteria.

These contaminants can cause serious health hazards if not kept away from the processes listed down below:

• Infusions

• Organ Transplant Surgeries

• Ophthalmic Preparation Solutions

• Filling of Vaccines

• Sterilization of Surgical Instruments

• Sterilization of Sterile Attire

• Pharmaceutical Industries

• Medical clean room Laboratories

• Pathology Laboratories

As it is a closed system, the entry of any incoming contaminant can also be closely monitored and prevented.

Vaccine Filling in a Sterile Room

What are the Requirements of a Sterile Room?

Activities like the preparation of intravenous eye drops and parenteral nutrition solutions that are included in the Non-Cytotoxic Drugs Reconstitution need a Sterile Room for maximum productivity.

• It must have a personnel dressing room, component space, preparation room, and area for storage, receipt, and distribution activities.

• The floor must be a continuous non-crack material that is mechanically strong and chemically resistant.

• Preferably, the floor shall be coated with a wide vinyl sheet with welded stitches and covering to the sidewall.

• The walls and ceilings of the Sterile Room shall be free of cracks.

• The construction shall be smooth and there should be a proper sanitation system.

• To avoid condensation problems, sandwich panel wall systems shall be used.

• Nude wood, edge, and other unused surfaces must be avoided.

• Glass windows are needed for the preparation room and the glass shall be a flushed double glass type.

• There shall be two parts of the personnel dressing room.

• The second or final part of the personnel dressing room leading to the preparation room must have the same value as the last.

• The sink for handwashing can be installed in the first or previous part of the Sterile Room.

• The preparation room does not necessarily need sinks or waterways.

• The tap must be operated by elbows, legs, or beams.
• The surface of the material, including the top of the bench, must have minimum joints and stitches.

Sterile Room Crack Free Flooring

Sterile Room Pharmaceutical Preparation Facilities

The requirements of a Sterile Room in the Pharmaceutical industry are as follows:

• All doors must be equipped with an interlocking system so that only one door can be opened at a time so that pressure maintenance is not compromised.

• The Doors and windows must have hard, smooth, waterproof results and they must close tightly. The fitting in the surrounding wall shall also be perfect.

• There shall be enough space under the cabinet to allow the cleaning process

• The Sterile Room must be class B if the airflow cabinet is in line.

• There shall be no workbench and therefore the insulator and the cabinet shall have their stands.

• A utility cabinet, stainless steel sink with the appropriate depth, and backsplash to avoid spark and workbenches must be installed in it.

• There shall be an adequate number of plug points so that every machinery can be operated conveniently.

• There shall be separate plug points available for pharmaceutical refrigerators.

• In terms of power failure, an unbroken power supply must be provided for airflow to the cabinet/insulator and HVAC system.

What shall be the Air Conditioning Inside a Sterile Room?

Moisture, temperature, pressure, and air filtration or air hygiene must be controlled to make safe the products, personnel, and the environment.

• A suitable device for measuring and monitoring parameters must be installed in a Sterile Room.

• Legal considerations must be given to the HEPA filter placement installed on the ceiling to avoid the formation of air currents in the cabinet.

• There shall be no use of diffusers.

• The AHU and HEPA filter shall be removable. The prefilter shall be adjusted in such a way that it can be changed from the outdoor operation.

• For making the working people conform and keeping the products in the Sterile Room safe, the temperature and moisture shall be adjusted wisely.

• The temperature shall not be greater than 22 degrees Celsius and the moisture shall not be more than 5%.

• The air pressure shall be at a higher level to create a positive pressure.

• There are air refund grills on the low level which allow the sweeping of the room.

What is the Sterile Room Attire?

A Sterile Room attire refers to the clothing which is mandatory for entering a Sterile Room.

It is to avoid the entry of any foreign contaminant particle along with the person entering the room.

The attire includes the clothes, the gown, gloves, shoe cover, and cap. Everything that is used to cover the body.

It might be or might not be sterile and cleanly manufactured. It can also be manufactured in a regular clothing manufacturing unit but later sterilized to make it contaminant-free.

If for instance, the Sterile Room attire is not properly sterilized, it can be a huge hazard to the environment of the room. The reason is that it might bring unwanted microorganisms or foreign bodies with it.

With special facilities, a Sterile Room garment is constructed, designed, and sewn in a clean and controlled manufacturing unit.

Sterile Room Attire

Sterile Room Attire Protocol

Every person must dress according to the proposed protocol of the Sterile Room:

• Every worker shall be gowned properly.

• Proper disinfection and sterilization of the Sterile Room attire shall be made compulsory and monitored closely.

• Throughout the process, all the work surfaces are cleaned, disinfected, and sterilized after regular intervals.

• Once a production batch is complete, it is again sterilized to ensure 100% safety.

• The safety of the workers is also a priority and therefore, it is made compulsory that every worker is taking precautionary measures for their safety.

What Equipment is Required for a Sterile Room?

A Sterile Room requires the following equipment to function to the fullest:

• Airflow cabinets

• High-pressure insulators

• Unidirectional cabinets

• Stainless steel trolley

• Intercom system

• Stainless steel bench with wheels and high can be adjusted

• Stainless steel rack or shelf to keep sterile pockets, syringes, needles, filters, etc.

• Top phenolic bench with stainless steel drawer

• Plug Points

• Garment cabinet or five-level lockers in Sterile Room for sterile gloves, head caps, masks

• Wall mount six-foot-long mirror

• Cross over bench

• Liquid soap dispenser that can be operated with feet

• Electric hand dryer

• Cross over bench

• Pharmaceutical Refrigerator with twin door and stable electricity connection

• Computers and printers with an uninterrupted power supply

• Display for temperature, relative humidity, and pressure for cleanrooms

Sterile Room Stainless Steel Bench

What is Meant by the Grading of your Sterile Room?

A Sterile Room is graded based on the particle size that can enter or can be prevented by the sterilized environment.

There are four basic grades which have been described below:

Grade D

A grade D Sterile Room is best for the staff gowning area. This area is where the workers cover their beards, and hair and wear protective clothing to prevent the exchange of materials to and from the environment.

This room is also used for the storage of materials.

Grade C

A worker can only enter a grade C Sterile Room when they are fully prepared for the final sterilization.

It is mandatory to wear protective clothing which is tight on the wrists and the neck so that no microorganisms can enter or leave.

Grade B

It is a high-risk area of the Sterile Room because the manufacturing takes place here.

Grade A

When the work has to be carried on with a higher degree of cleanliness and sterilization, grade A is used.

It allows the process to run smoothly, without any contamination.

A laminar workstation is included in grade A. A laminar box can also be used here. This box is responsible for providing favorable conditions to the process.

The number of people entering and leaving a Sterile Room shall be monitored strictly. The fewer the workers, the fewer will be the chance of contamination.

Therefore, only a few people are allowed into the room, that too, only when they are fully prepared. They must be wearing their protective kits and fully gowned.

Grade A Sterile Room

What is the Significance of Grey Zones in a Sterile Room?

A Grey Zone refers to the area between two rooms. As all the equipment must be sterile in a Sterile Room, enough attention shall be paid to each piece of equipment separately.

Even if a single inch of the environment or any equipment remains unsterilized, it can give rise to contamination on a huge scale.

For example, a petri dish was not sterilized and accidentally placed with the sterilized Petri dishes. The microorganisms on unsterilized the petri dish will reproduce and increase in population.

The greater the population, the greater is the chance of infection and the need for more sterilization.

A grey zone allows the movement and transport of substances from one Sterile Room to the other provided that the two rooms are on a different level of sterilization.

The grey zone provides a passageway or a corridor to allow easy transportation. It not only saves time and risk of contamination but is also a very convenient method to minimize cross-contamination.

A pass-through box can also be used for creating a grey zone. Different grades of a Sterile Room shall also be kept in mind while transporting the materials.

The contaminants tend to move from an area of high contaminant concentration to an area of low contaminant concentration.

Pass Through Box Installed in a Sterile Room

What is the Mechanism Behind the Sterile Garments in the Sterile Room?

For making sterile garments, you need a high degree of sterilization because these garments are used for medical and surgical procedures.

In these procedures, there is no room for any contamination and therefore, a high degree of sterilization is required.

For making sterile garments, gamma rays are used to kill the microbes such as bacteria, viruses, and other infectious agents on the fabric.

It is done in a Sterile Room which is equipped with all the equipment.

Whether the garment is manufactured in a Sterile Room or not, it can always be sterilized later on even if it is manufactured in a normal, non-sterilized unit.

However, even after great care, there are many unwanted particulate matters on the fabric which must be taken off before entering into it.

What Sterilization Techniques are used in a Sterile Room?

There are different techniques of decontamination that can be used in the Sterile Room for high standard sterilization.

Sterilization After Disinfection

Decontamination is a process that kills germs at the surface level. However, this technique is not strong enough to kill the bacterial spores which survive the action of a disinfectant.

Therefore, once you have disinfected a material, it must be sterilized as well so that all the spores shall also be killed.

As sterilization kills the spores too, there is no chance of recontamination or regrowth of unwanted microorganisms.

WHO recommends that everything that comes in contact with human body fluids must be sterilized first. This is to stop the entry of germs into the human body.

Open Flaming

It is the oldest technique used for the sterilization of objects. The high temperature kills the spores of the germs but it is not in practice anymore.

Also, you cannot use open flaming in a Sterile Room for safety hazards.

In this type, the object is held close to fire with the help of a holding aid. It is kept there for some time until the germs are killed.

Moist Heat Technique

In this method, steam from boiling water is used as a medium to kill the microorganisms on an object. The water vapors have great heat trapped in them which is used in the killing of spores.

Dry Heat

It is another method where hot air is used to kill the microorganisms right away. The temperature of the air is particularly set on an optimum level.

Radiation

Radiation is a great way to get rid of microscopic organisms. It works by disrupting the basic cell structure of germs. With the disrupted cell structure, survival is not possible.

It is a well-known sterilization technique that is widely used in a Sterile Room. This technique is mostly called irradiation or ionization. Ultraviolet rays are not acceptable in this case.

Gases and Chemicals

Ethylene oxide is a gaseous sterilization agent used in a Sterile Room. It is also not as effective as an autoclave.

Autoclave

The most advanced method of sterilization which is most commonly used in a Sterile Room is autoclaving.

It is a technique in which the object is put in an autoclave machine for 30 minutes. The temperature is expected to be 121 degrees Celcius and the pressure is ideally 15 psi.

A Sterile Room uses an autoclave for getting rid of microorganisms or biological contaminants including spores.

Sterile Room Autoclave

Aseptic Filtration and Chemicals

This technique is also beneficial for sterilization on a high level. Certain chemical substances can sterilize the objects by killing the microbes and spores directly.

What are the Filtration Considerations for your Sterile Room?

Like other techniques of sterilization, sterile filtration is not capable of killing the bacteria and their spores directly.

Instead, it just separates the bacteria and the spores from a sterilized medium.

The filtration considerations for a Sterile Room are as follows:

• The Sterilization Filter

• The Organism Conundrum

• FDA View

• Dilution Effect

• EMEA View

• Double Filter Usage

• Reliance on Pore Size Ratings

• Control of Metabolites

What are the Maintenance Steps for your Sterile Room?

The maintenance tips for a Sterile Room are:

• Keep a log register for regular cleaning and maintenance of the whole assembly.

• If any of the components are damaged or broken, get them fixed ASAP. This will eliminate any chances of further damage.

• The space for the Sterile Room shall be well suited for the purpose.

• Check all the filters and pipes for any accumulation of particulate matter which might lead to further trouble.

• Maintain a good stable electricity connection.

• The lighting shall be maintained at any cost.

Sterile Room Maintenance

What Cleanliness Routine shall be Followed for your Sterile Room?

A Sterile Room shall be cleaned according to the following cleanliness routine:

• There should be a cleaning round after every turn of sterilization.

• The disinfectant or the cleaning agent shall be compatible with the surface of your Sterile Room.

• Radiation such as gamma rays can also be used for complete sterilization.

• Not even a single inch of it shall be left unclean as it can lead to further contamination.

• The filters shall be well taken care of.

Conclusion.

A Sterile Room has unique features and can be used to produce highly decontaminated and clean environments which are necessary for a few delicate processes which cannot stand any kind of contamination.

It can prove the true value of money and maximize your productivity only if it is maintained and cleaned well.

100% Quality Tested Sterile Room

FAQs of Sterile Room.

What is the Role of Prefiltration in a Sterile Room?

Prefiltration is desirable in a Sterile Room because it reduces the bioburden.

How a Sterile Room is Helpful for MRI in a Hospital?

A Sterile Room is used as a medium to produce radioactive tracers which can be injected into a tissue so that it can highlight the area in MRI.

Why is a Sterile Room the Best to be used for Radioactive Materials?

Radioactive materials are highly dangerous for the regular environment. They can be dealt with only in a Sterile Room where radioactive preparations are made which are necessary for some medical procedures.

How a Sterile Room Prevents the Spread of Nosocomial Infections?

A Sterile Room prevents the spread of nosocomial infection because the sterilization process kills the spores, thus eliminating the chance of infection.

What is Air Supply Capacity in a Sterile Room?

It is a test done to check the stability of air volumes in the Sterile Room. A certain volume is essential to allow air change in an area.

How can you Demonstrate Air Capacity in a Sterile Room?

Air capacity in a Sterile Room can either be demonstrated by measuring airflow in the supply and return duct or measuring the air volume for the required design.

What is the Significance of Air Changes in a Sterile Room?

The air changes in a Sterile Room allow maximum efficiency. There shall be 15-20 air changes per session.

How to See if there is Dead Space in the Critical Area of a Sterile Room?

To check the dead space in a critical area of a Sterile Room, you have to observe and assess the airflow pattern.

What are the Causes of Contamination in your Sterile Room?

The sources of Contamination in a Sterile Room are the people working there, the patients being treated, airborne particles or microorganisms in that space.

How a Microscopic Monitoring System is Helpful in a Sterile Room?

A microscopic monitoring system can help in the detection of any contamination in a Sterile Room with advanced methods.