Pharmaceutical Clean Room Manufacturer

Pharmaceutical Clean Room- A Complete Guide by Sunnyda.

Manufacturing of pharmaceuticals is a very precise and intricate process and therefore a Pharmaceutical Clean Room is a necessity. It is used to create a contaminant-free environment so that the best product can be obtained.

Any change in the basic composition and structure of a pharmaceutical drug can result in disastrous effects on the human body. Therefore the air quality shall be strictly controlled.

The number of staff is also limited and the Pharmaceutical Clean Room is specifically operated to manage the highest efficiency.

It is made sure that only high-quality equipment is used so that productivity is maximized. Although it requires some cleaning and maintenance, it serves the purpose well.

A Pharmaceutical Clean Room comes at a reasonable price but there is no decrease in the quality. It can be customized as per the requirement of your setup in terms of size and model.

To obtain maximum benefit, you must have a good understanding of the Pharmaceutical Clean Room. This article contains all you need. So let’s begin.

1.What is a Pharmaceutical Clean Room?
2.What are the Important Features of a Pharmaceutical Clean Room?
3.What are the Different Types of a Pharmaceutical Clean Room?
4.What are the Common Contaminants in a Pharmaceutical Clean Room?
5.What are the Causes of Contamination in a Pharmaceutical Clean Room?
6.How to Measure the Contamination of your Pharmaceutical Clean Room?
7.How to Classify Pharmaceutical Clean Room Based on Air Flow?
8.What is the ISO Standard Classification of Pharmaceutical Clean Room?
9.What are the Required Steps Before Entering your Pharmaceutical Clean Room?
10.What is the Pharmaceutical Clean Room Protocols?
11.What are the Important Design Considerations for the HVAC System of a Pharmaceutical Clean Room?
12.What is the Filtration Mechanism of a Pharmaceutical Clean Room?
13.How can you Perform Filter Testing in your Pharmaceutical Clean Room?
14.How to Setup your Pharmaceutical Clean Room?
15.What Facts to Keep in Mind While Setting Up your Pharmaceutical Clean Room?
16.How to Operate your Pharmaceutical Clean Room?
17.What are the Cleaning Tips for your Pharmaceutical Clean Room?
18.Conclusion.

What is a Pharmaceutical Clean Room?

A Pharmaceutical Clean Room is an isolated environment free of any contamination. It is the space created to obtain favorable and clean conditions for the production of medicines and other highly precise compositions that affect the function of the human body.

Any contamination in the process of making pharmaceutical drugs can lead to a different product with a deranged function. Such products can be seriously dangerous and toxic for the human body.

A Pharmaceutical Clean Room is constructed and designed to avoid contaminants such as dust particles, human hair, chemicals, or any other material out of the way of the process.

As the production of pharmaceutical compositions must be carried out under an extremely clean environment, it is mandatory to maintain the cleanliness level at any cost.

The composition of a Pharmaceutical Clean Room is also precise and it comes in various sizes and designs. The only high-quality raw material is used and it comes with recent technology and significant features.

What are the Important Features of a Pharmaceutical Clean Room?

• A Pharmaceutical Clean Room is fabricated of prime quality stainless steel raw material.

• It has corrosion resistance properties due to the solidity of the metal.

• Although it is composed of strong material, its installation and mounting are quite easy.

• A Pharmaceutical Clean Room is equipped with a HEPA filtration system which adds to its efficiency.

• It has in-built air showers to knock off any excess dirt and debris from entering materials or people.

• It is quite well ventilated and therefore, the decontamination process is quite reliable.

• Designed specially to fulfill the needs of the Pharmaceutical industry, it has round corners so that the dirt and debris do not accumulate here.

• It comes with great innovative technology and user -friendly interface.

What are the Different Types of a Pharmaceutical Clean Room?

A Pharmaceutical Clean Room is classified based on micron-sized particles in one cubic meter of air.

However, different types have the same mechanism of contamination but only differ in the terms of construction.

With construction as the differentiating point, there are two types:

Hard Wall

Such a cleanroom has stiff and sturdy walls. It has a mighty construction that does become difficult to handle and mount.

It is most commonly composed of metals such as stainless steel or aluminum.

Soft Wall

The walls of a soft wall cleanroom are flexible and are made up of plastic and sheets. It is much lighter in weight and works equally effectively.

However, the durability and reliability are a little compromised.

What are the Common Contaminants in a Pharmaceutical Clean Room?

The common contaminants in a Pharmaceutical Clean Room are written below:

• Dust Particles

• Human Hair

• Pieces of Clothing

• Chemicals

• Food Particles

• Paper Bits

• Broken Equipment

• Saliva

What are the Causes of Contamination in a Pharmaceutical Clean Room?

The major causes of contamination in a Pharmaceutical Clean Room are:

Entry of People

When people enter the cleanroom, they bring a lot of germs and contaminations along with them from the outside environment.

They must pass through an air shower first so that there can be enough surface disinfection. In the air shower, the high-pressure air can knock off any contaminants on the surface.

More People in the Clean Room

The more the number of people in the Pharmaceutical Clean Room, the greater are the chances of contamination.

Sneezing and coughing can also introduce viruses and other germs into the environment.

Entry of Contaminated Materials

If material is brought into the cleanroom without disinfection, the whole cleanroom environment is disturbed due to the incoming contaminants.

Therefore it is necessary to disinfect the material, tools, or machinery first.

Spilling of Chemicals

As you deal with various chemicals inside a Pharmaceutical Clean Room, there are chances that a chemical can be spilled.

It will not only decontaminate the environment but can also trigger a harmful or unwanted chemical reaction.

Eating and Drinking

While eating and drinking in the cleanroom, there are chances that the food bits remain in the environment even when the food is removed. These particles attract insects which is another issue.

Not Following Protocols

If your staff working in the cleanroom don’t take all the precautions and don’t follow the protocols, they can be the source of contamination even if they disinfect themselves before entering.

Poor Disinfection Techniques

The disinfection in the Pharmaceutical Clean Room must be strong and elaborate. It must be done in detail so that no dirty spot is left unattended.

How to Measure the Contamination of your Pharmaceutical Clean Room?

The contamination in a Pharmaceutical Clean Room is measured by counting the number of contaminant particles per cubic foot of volume of air.

The particles may be airborne and they are measured in the unit of a micron.

For example, pollen has a size of 30-50 microns whereas a human hair is 50-70 microns. Talking about even smaller particles, dust with mite feces is only 10 microns.

How to Classify Pharmaceutical Clean Room Based on Air Flow?

It can be classified based on the direction of airflow. In this case, there are two classifications.

Horizontal Air Flow Pharmaceutical Clean Room

In this class, the airflow is in the same direction as that of the floor. That means the filtered air enters from one side of the room and leaves from the other side.

Vertical Air Flow Pharmaceutical Clean Room

The airflow is provided from the ceiling towards the floor. Thus the airflow is perpendicular to the floor and it gets dispersed in the room. The most common pattern is up and down.

What is the ISO Standard Classification of Pharmaceutical Clean Room?

The ISO standard of classification classifies the Pharmaceutical Clean Room based on the size and number of particles in a given volume of air at a particular time. It has nine classes starting from 1 to 9.

1 is the cleanest and 9 is the least clean class. However, the most commonly used classes are 5 and 7.

This system of classification takes into consideration the particles even smaller than 0.5. This shows that it’s a very thorough and accurate system.

What are the Required Steps Before Entering your Pharmaceutical Clean Room?

The necessary steps before entering a Pharmaceutical Clean Room are as follows:

Dress Inexpensively

To enter a cleanroom, you should be dressed comfortably and inexpensively. This is to help you concentrate on work and not worry about getting your clothes ruined or contaminated.

Lesser People in the Room

Lesser The people, the lesser will be the chance of contamination. If the cleanroom is busy, wait for your turn and let there be enough space to accommodate another person.

Shoes

Clean your shoes properly and put on a shoe cover. Always wear a comfortable pair of shoes because you might have to stand for long hours for working.

No Food and Water

Never take any food or water with you in the Pharmaceutical Clean Room.

It will not just add to the contamination but also can be misleading for the experiments as it spreads aroma and makes the place smell weird. Finish your food first and then enter.

No Fragrances or Perfumes

Avoid any strong fragrances and perfumes. Use organic deodorants only.

The perfumes contain alcohols and spirits which might react with the chemicals in the cleanroom and lead to a disastrous chemical reaction.

Therefore, wearing perfume is quite dangerous. Also, you should avoid any other cosmetic product so that you feel comfortable while working.

Washroom

If you feel the need to go to the washroom, you must go immediately and then enter the Pharmaceutical Clean Room.

Because once you enter here, you cannot exit and then enter again for your personal needs.

Frequent entries and exits add to the contamination of the cleanroom thus compromising its efficiency.

Gowning

Go to the growing room and get gowned before entering. A gown saves you from any contaminants in the cleanroom and also blocks the transfer of any contaminants from you to the cleanroom.

Cap

A cap is a must-have because it helps you secure your hair. In this way, you don’t lose any hair in the cleanroom and thus don’t participate in further contamination.

What is the Pharmaceutical Clean Room Protocols?

Pharmaceutical Clean Room Protocols refers to all the important steps you should follow before entering and while you are staying there.

Gloves

The gloves are important so that you don’t transmit any germs or contaminants from your hands to the raw materials in the process.

Coverall

A coverall makes sure that any contaminants from your body do not enter your Pharmaceutical Clean Room.

Boots

Specialized boots are designed to decrease the spread of contamination. Regular boots have a lot of dirt and debris on their soles.

Therefore boots are a must-have while working in such a sensitive environment.

Never Block the Exits

Keep in mind that you should be very vigilant while working in the cleanroom.

The chemical reactions taking place there can be very dangerous and there is a chance that a fire may ignite. Therefore keep all walkways clear at all times.

Packaging

The packaging of the objects or material which has to be transported must be done under supervision.

It should be double-bagged and then sealed. An inert gas shall also be introduced inside the package to keep it safe.

What are the Important Design Considerations for the HVAC System of a Pharmaceutical Clean Room?

The four most important design considerations for a Pharmaceutical Clean Room are listed down below:

• To maintain the sanitation level of the room, there shall be enough airflow supplied to the room.

• The design shall be such that the air does not stay in the room and keeps flowing. If it remains stagnant, it will give birth to contaminants.

• Sufficient air condition to maintain the required humidity, temperature, and other factors.

• The specified positive air pressure has to be maintained, so enough air must be supplied for that.

What is the Filtration Mechanism of a Pharmaceutical Clean Room?

The filtration mechanisms involved in the Pharmaceutical Clean Room HEPA filtration system are described below:

Sieving and Staining

The particles which are large enough to not pass through the filter fibers remain as the residue on the filter. This process only helps you get rid of slightly larger particles.

Inertial or Impaction

All the particles possess inertia and therefore they do not get accumulated in the sides of the filter.

These particles directly impact the filters. However, if adhesives are used, these particles can be trapped.

Interception

Very small particles follow the water stream but are intercepted onto the fiber. This is due to the dimension of the fibers.

Diffusion

This mechanism is best for extremely small particles which are always in motion.

The motion of such small particles is usually vibration and due to very weak forces between them, they can easily move.

Because of the collision with one another and with the container, these particles travel from a level of higher concentration to a level of lower concentration.

How can you Perform Filter Testing in your Pharmaceutical Clean Room?

The efficiency of the filter of a Pharmaceutical Clean Room is primarily very important, therefore it must be tested correctly.

Following are some tests that can be done for this purpose:

Leak Test

A cold DOP and a photometer are used for this specific test. It is not a very satisfying test but it is common. The reason is that it’s easy to perform and does not require special equipment.

DOP Test

A DOP is a synthetic contaminant that is extensively used to check the efficiency of the filter.

A DOP penetration test tells you about the size of the particle that can escape from the filtration system.

It helps to determine the percentage of particles that can pass through the filter.

Two Flow Test

This test is as effective as a scan filter. In this test, a filter has to face a hot DOP and then the efficiency is determined.

It has further two types named as the 100% two flow test and 20% two flow test.

Laser Test

A laser-based test has the quality of sizing and counting very small particles which cannot be done using a photometer.

A laser test uses a spectrometer and a beam of laser to calculate or find out the efficiency of the filter.

Scan Test

It is only used for the filters which have passed the leak test and have a penetration which is 0.03%. It also uses cold DOP.

The best advantage of a scan test is that it not only identifies the leak but also locates it.

How to Setup your Pharmaceutical Clean Room?

The Pharmaceutical Clean Room must be set up according to the standards of ISO.

It begins with the design phase in which you should consider the maximum allowed concentration, cost, manufacturing process, and location.

You must have an elaborate discussion with the designer of your Pharmaceutical Clean Room so that you get all the features that you require.

All the needs must be met while designing it so that your investment goes in the right direction. The materials that are processed in the Pharmaceutical Clean Room must also be considered.

• Now unwrap the Pharmaceutical Clean Room once it is delivered.

• See if all the components are present in the package.

• Lift it by using a lifter or a good workforce according to your convenience.

• Set it up in the decided location.

• Set up a stable electricity supply with the help of a battery. You can also use an industrial or domestic electricity supply.

• Try a test run and see if its efficiency is up to the mark.

• Note the change in performance of the Pharmaceutical Clean Room over time.

What Facts to Keep in Mind While Setting Up your Pharmaceutical Clean Room?

While setting up your Pharmaceutical Clean Room, you must consider the following elements:

High-Efficiency Particulate Air Filters(HEPA)

Particles are as small as 0.3 microns can easily be filtered through this filter.

For good decontamination, air should be allowed to move through the filter so that the cleanroom has a fresh supply of air all the time.

Ventilation

Exhaust process and maintenance of supplying clean and fresh air to the cleanroom is essential for proper working.

A cleanroom is equipped with a lot of machinery and cooling units which also need space for ventilation.

If there is no proper ventilation, the working of other machines would be compromised. Also with fresh air, there is less chance of fungi and mildew growth or any other contamination.

Air Pressure

To avoid infiltration by wind, the Pharmaceutical Clean Room. Should have an air pressure higher than the atmospheric pressure.

It is equipped with airlocks that prevent or minimize pressure changes.

Any change in the pressure is not desirable because it might compromise the Pharmaceutical drugs manufacturing process.

Humidity and Temperature

All the equipment and the material in the Pharmaceutical Clean Room need a persistent and well-maintained temperature for optimum performance.

These factors also control the chances of fungal growth, corrosion, and condensation of surfaces.

Temperature and humidity decide the comfort of your staff at work inside the cleanroom. Another important role is that these factors control static electricity.

Architecture and Building

The movement of air in a Pharmaceutical Clean Room shall never be restricted and it shall be allowed to flow in an unrestricted path.

This is important to avoid any turbulence which gives rise to the chances of air-borne contaminants.

Also, the better the airflow, the better will be the removal of already existing contaminants in the environment of the cleanroom.

Measurements and Monitoring

The factors like humidity, airflow, cleanliness, and temperature must be kept under strict monitoring to observe any change in the outcome of the cleanroom.

These factors must be maintained at an optimum level to obtain maximum productivity.

Electrostatic Discharge

An electric charge is created in the cleanroom because of the relative movement of air, people, and material things in the cleanroom. As it has the potential to damage, it must be taken care of as a protective feature.

Lighting

A Pharmaceutical Clean Room shall be well lit. The contaminants are too small to be seen by the naked eye sometimes but good lighting is necessary to avoid overall gross contamination.

It also helps in cleaning as all the surfaces are visible.

The instrument display can also be read properly if there is good lighting only. The lighting should be uniform and consistent so that there is no chance of error in the process of manufacturing medicines.

Insurance and Flexibility

A Pharmaceutical Clean Room shall be designed in such a way that it can accommodate any new equipment and processes that might be introduced in the future.

The insurance allows you to be satisfied with any small damages to the cleanroom.

Constructing Materials

The construction material used for the inner surfaces must be a type that does not shred any particles. It shall not just be sturdy but also it should not contaminate the air.

The material must be well-matched with all your cleaning products and must be resistant to corrosion or breakdown.

Laundry and Showers

Good water treatment and an elaborate plumbing system are a must if you are planning to purchase a Pharmaceutical Clean Room.

It also needs a constant hazardous waste treatment facility that stops the entry of contaminants into the environment.

Hazardous Substance

A Pharmaceutical Clean Room deals with a lot of hazardous substances which must not be released in the environment without treatment. Negative air pressure might be helpful in this regard.

The warmest air shall also be given special treatment. Separate entrances and exits shall be there to ensure no spreading of hazardous substances. Personal protection is also necessary.

How to Operate your Pharmaceutical Clean Room?

Once your Pharmaceutical Clean Room has been set up, you must know how to operate it properly so that its integrity can be maintained.

Take care of the following things while operating it:

• Be careful about any contamination risk around it.

• Maintain a stable electricity connection either with a help of a battery or regular electricity supply.

• Only a small number of trained employees shall be allowed to operate it at one time.

• The cleaning and maintenance routine shall be strictly followed.

• It needs constant monitoring.

• Frequent recertification of your Pharmaceutical Clean Room is a must.

What are the Cleaning Tips for your Pharmaceutical Clean Room?

For the cleaning of your Pharmaceutical Clean Room, you must be careful about the following points:

• Only use a recommended disinfectant that has been recommended by the manufacturer or the supplier.

• Follow a strict cleanliness routine.

• There should be a cleanliness audit every two weeks.

• The filters must be replaced after a certain time so that there is no accumulation of debris and air can easily flow through them.

Conclusion.

A Pharmaceutical Clean Room is well equipped with all the basic and innovative equipment and comes in great quality. It has plenty of features which enhance the productivity of the company.

Only regular maintenance and proper care can lead to the high reliability and durability of a Pharmaceutical Clean Room.

FAQs of Pharmaceutical Clean Room.

What is Meant by Particle Count in a Pharmaceutical Clean Room?

In a Pharmaceutical Clean Room, there is a test carried out to count the number of airborne particles by their size in a fixed volume of air. It is done while the cleanroom is being operated and at rest.

What is a Room Recovery Rate in a Pharmaceutical Clean Room?

Room recovery rate refers to the time taken after one process for a Pharmaceutical Clean Room to be ready for the next process. This time interval has a significant value.

What is an Integrity Test in a Pharmaceutical Clean Room?

An integrity test in a Pharmaceutical Clean Room is also called dispersed oil particulate testing. It is done to see the efficiency of the HEPA filter.

What is the Assembly of HEPA Filters in a Pharmaceutical Clean Room?

The HEPA filters of a Pharmaceutical Clean Room are made up of randomly arranged mat assembled fibers. It is usually composed of fiberglass and has a diameter between 0.5 to 2.0 microns.

What is the Air Change Rate of a Pharmaceutical Clean Room?

The air change rate of a Pharmaceutical Clean Room refers to the number of air that has been changed. It is measured as air changes per hour. Normally its value is 20 to 40.

What are the Necessary Utilities for a Pharmaceutical Clean Room?

The necessary utilities for a Pharmaceutical Clean Room include electricity, water, compressed air,

and vacuum etc.

What shall be the Location of the HEPA filter in a Pharmaceutical Clean Room?

The HEPA filter shall be installed either within an air handler or in the ceiling of the Pharmaceutical Clean Room at the inlet of the plenum.

What are the Two Types of Air Filters Used in a Pharmaceutical Clean Room?

The two types of air filters used in a Pharmaceutical Clean Room are HEPA and ULPA respectively.

Which Stainless Steel is used in the Assembly of a Pharmaceutical Clean Room?

A 316L stainless steel is used in a Pharmaceutical Clean Room. It is a corrosion and rust-resistant material and has increased tensile strength.

Aluminum is also used in Construction but stainless steel has greater advantages.

How to Check the Filter Effectiveness of a Pharmaceutical Clean Room?

To check the filter effectiveness of a Pharmaceutical Clean Room, you must check the arrestance and efficiency of the filter.

Both these factors determine the productivity of the filter and cleanroom collectively.