GMP Clean Room

Sunnyda GMP Clean room

Cleanrooms come in different types. Some might be the normal cleanrooms with a few cleanliness levels while others might need more equipment to make them meet stringent cleanliness levels. That is something we look at in this guide to help you learn more about GMP cleanrooms. Let us see what such a cleanroom is all about.

What is a GMP Clean room?

Figure 1 A Fully Set Up GMP Cleanroom

GMP stands for Good Manufacturing Practices. As such, the GMP cleanrooms are supposed to be tailored to meet the quality production standards of some products or sometimes research. The products made in a GMP cleanroom need to have consistently high quality, designed to be appropriate for the intended use, and meet the marketing authority. That is why there are several grades of GMP cleanroom to help you understand which would be ideal for specific applications.

What are the GMP Clean room Grades?

When it comes to the cleanroom grades, there are a few things to always consider. These cleanrooms would be classified based on if the product should be terminally sterilized or there is the need to conduct aseptic processes.

There are four main grades of GMP cleanrooms. They include;

• Grade A – this is mostly used in cases of filling products. The products might be exposed to the environment for longer, thus the need for more protection to keep the product in good condition. A good example is when filling ointments, emulsions, creams, and suspensions.

• Grade B – this grade, is great for the grade A zone operations. It is mostly used when there is the need for transferring the less critical tasks that do not necessarily need grade A GMP cleanroom.

• Grade C – For this grade type, it is mostly used for filing products that are still unusually at risk of being contaminated. The same can be used for the preparation of solutions that have to be sterile filtered.

• Grade D – Such cleanrooms are mostly for handling products and components before filling. They can still be used for handling the components immediately after washing.

Grade A is equivalent to ISO 5, grade B is equivalent to ISO 5 still, grade C will be equivalent to ISO 7, and Grade D would be equivalent to ISO 8 cleanrooms.

Below is a table with more information about the various GMP cleanroom types in the market.

Figure 2 Table Showing Several GMP Cleanroom Grades

What is the Size of a GMP Clean room?

The size of a GMP cleanroom can be compared to the other types of cleanrooms available in the market. This is in the sense that cleanroom sizes depend on the user’s needs. Even if the manufacturer might have a standard size, most of the time the size will be tailored to suit the user better. So, contact Sunnyda today if you need more information about the best size for a GMP cleanroom.

What are the Cleaning Requirements of GMP Clean rooms?

It is vital that you always clean your GMP cleanroom to keep it working as expected. When it comes to cleaning the GMP cleanroom, there are two main types of cleaning you would do. They include decontamination cleaning and routine cleaning.

GMP Clean Room for industrial use

Decontamination cleaning

This type of cleaning can be done during or after the cleanroom has been constructed or has gone through some renovations. Another scenario is when you have a spill in the GMP cleanroom. Make sure that such a spill is cleaned as soon as possible. Each time you clean the spill or any small dirt deposits in the cleanroom, it helps to avoid particulate build-up.

There are times you may close the GMP cleanroom specifically for decontamination. This is mostly planned so that there can be thorough decontamination of the various surfaces to leave you with a contaminant-free cleanroom.

Routine cleaning

There is still the option of routine cleaning. This is the type of cleaning that would be done at regular intervals. It can be weekly, monthly, or bi-monthly. It depends on the operations in the cleanroom. It is vital that you always keep in mind the routine cleaning methods. If you fail to maintain the routine, you can end up with the accumulation of dirt in the cleanroom.

Routine cleaning is mostly outsourced to professionals. They would know how best to clean the cleanroom leaving it spotless until the next time you need cleaning again.

powder coated air shower

What are the Differences Between FDA and EU GMP Cleanroom Classifications?

When looking for a GMP cleanroom, the chances are you will come across the US (FDA) or EU GMP cleanrooms. So, what are the differences? Understanding these differences can help you choose the right cleanroom for your application.

These two mostly vary based on particle sizes, the types of sterile processes, the occupancy state, and Zone D application. Below is a chart comparing the two so that you can quickly identify the possible differences between the two.

Figure 3 Differences Between FDA and EU Cleanrooms

Keep in mind that even the GMP cleanroom would have different grades. It is worth noting that the grades would be the same in both situations with some subtle differences. Always talk to your cleanroom manufacturer to help you understand which one would be great for your project.

How Do You Pick the Right Door for a GMP Pharmaceutical Clean room?

You may have thought that GMP cleanrooms use the same type of doors like the ones you see in your house or office. However, that is not the case at all. The GMP cleanrooms require specialized doors to help in ensuring that the cleanroom works correctly all the time.

Before, you would get GMP cleanroom doors being made of wood. However, that has changed a lot. GMP regulations prohibit the use of such types of doors. This is because they are likely to harbor more contaminants than what most people would want to see in their cleanrooms.

The new GMP cleanroom doors are mostly made of stainless steel material. The material would be polished to keep it smooth and free from bacteria. Also, the doors would not easily warp or have crevices such as wood to a point they provide breeding grounds for bacteria and other contaminants.

Do not worry about the weight since the doors are made using stainless steel. This is because the weight is not much to a point some would be worried about it. Also, the material is generally easy to clean. You could use the same cleaning solutions you use for cleaning the cleanroom walls and they should work fine.

new alloy FFU unit

Where Can You Buy a GMP Clean room?

Buying a GMP cleanroom should not be hard generally. You can be sure to get one from top brands such as Sunnyda. The aim is to seek more advice on choosing the correct GMP cleanroom grade. If you can get the best grade, you can be sure that it will deliver on the best performance you need.

The team at Sunnyda will help you know the progress of your order too. This is aimed at making sure that your cleanroom is delivered on time. Installation can still be done on demand.

clean room sliding doors with protective bar

How are GMP Clean rooms Designed Based on Classifications and Industry?

When it comes to cleanroom classifications, they are mostly classified based on various factors. Below are some of the factors to keep in mind for GMP cleanroom classification.

Filtration

You always have to consider the filtration performance of the GMP cleanroom. Look at the cleanliness level a cleanroom can achieve. It is from this information that it can be classified to fall under a certain grade of GMP cleanroom.

As part of filtration, some models would use HEPA filters while others can use ULPA filters. The ULPA filter is vital for filtering up to 99.9999% compared to the HEPA filter which has an efficiency of 99.997%. As much as you might think the difference is not much, it can matter a lot in some applications.

The airflow patterns

The airflow patterns are vital to ensure there is consistent clean air flowing into the cleanroom. The most common pattern is laminar airflow. For this type of pattern, the clean air is pushed only in one direction thus there is no contaminating of the clean air.

You could have mixed airflow too. However, it is not the most preferred option in high-grade GMP cleanrooms.

Pressure type

The chances are you will get two main options under pressure type. They include positive pressure and negative pressure. The positive pressure will keep the contaminants out while the negative pressure design would keep them in. As such, consider the application first. If you are dealing with hazardous materials, use negative pressure as a way of keeping such materials from getting out of the cleanroom.

HVAC control

You would still want proper HVAC control based on the various projects you are handling. This system allows you to control the temperature, air circulation, and humidity in a cleanroom. If the system is controllable, you can have an easier time changing the various conditions to suit your needs. Well, no one wants too much humidity in the cleanroom.

What is the Correct Steel Grade for GMP Cleanrooms?

Figure 5 Conducting Several Tests in a GMP Cleanroom

For a while now, stainless steel has been a top choice for those who need to set up cleanrooms. It could be used for the wall panels or the furniture too. Since there are many grades available in the market, which would be great for a GMP cleanroom?

The three main options include 430 stainless steel, 304 stainless steel, and 316 stainless steel. Here is an in-depth look at these grades to help you learn more about them.

430 stainless steel

For this type, it is made to be ferritic and non-hardened. However, it is good in terms of good corrosion resistance and can easily be formed into different shapes. As such, it is a top choice for its mechanical properties. Also, it is able to resist nitric acid thus it would be used in cases where the cleanroom might have exposure to harsh chemicals.

304 stainless steel

This is probably the most common and widely used cleanroom stainless steel. Because of its versatility, it can be a top choice for making many cleanroom furniture and benches too sometimes. What you need to know is that it does not have the best corrosion resistance as the 316 stainless steel grade.

This steel grade is also great for making sinks, cutlery, and flatware we use in our homes. It should definitely be a great choice for most cleanroom applications.

316 stainless steel

The biggest difference between 304 and 316 grades is that the latter has the addition of molybdenum. This addition is vital to make it resist corrosion even better. As such, this type of steel would mostly be used in cleanroom environments with a lot of chlorides and sodium. It is why you would get the most used GMP cleanroom surfaces being made of this material.

The 316 stainless steel would also be slightly more expensive than the 304-grade because of its added performance against corrosion.

dynamic pass through box middle of the cleanroom window

What is the Difference Between the Negative and Positive Air Pressure GMP Cleanrooms?

If you are considering buying a GMP cleanroom, you can expect to come across options such as positive pressure and negative pressure GMP cleanrooms. What is the difference between these two? Which is better?

Under positive pressure GMP cleanroom, it means that the air pressure in the cleanroom is higher than what is outside. This is done by pumping the clean air into the cleanroom continuously to ensure there is proper maintenance of the positive pressure.

The priority of such a design is to help in keeping the contaminants out of the cleanroom as much as possible. Even in case, there is a leak, the air pressure will keep the working area free from contaminants too.

The positive pressure GMP cleanrooms would mostly be used in areas where the product is made has to be protected from particulates. Such could be the microelectronic industry where it is vital that even the tiny particles are kept at bay.

As for the negative air pressure, it would have lower air pressure in the GMP cleanroom interior than the exterior. This is done by filtering the air out of the cleanroom rather than the one coming in. The goal of such a GMP cleanroom is to generally keep any possible contaminants from escaping past the cleanroom walls to the outside. There is the need to make sure the windows and doors are completely shut to maintain the low pressure.

The negative air pressure cleanrooms would be best used in the pharmaceutical sector. A good example is biochemical testing or in hospitals for quarantine in case of contagious patients.

What Should You Keep in Mind When Installing a GMP Clean room?

Figure 5 Servicing a Filter in a GMP Cleanroom

It does not matter whether it is a high-grade cleanroom or a lower grade GMP cleanroom as they all need proper planning before you can install them. Here are some of the things to always keep in mind whenever you think of installing GMP cleanrooms.

• Does the process you need to handle require a cleanroom? This should be the first question to consider so that if you end up getting a GMP cleanroom, you know it is worth the price. There are times you might find that not all processes need a cleanroom, some would simply require a clean environment, but not a cleanroom. It might help if you talk to experts in the sector such as Sunnyda to help you learn more.

• You will also have the option of choosing either modular or traditional cleanrooms. For this reason, it would be best if you can understand the differences between the two GMP cleanrooms before making up your mind. The modular GMP cleanroom is now the most recommended because of the many benefits it can offer. Most people find the modular cleanroom great in terms of cost, ease of setting up, and expandability in the future.

• The type of cleanliness is also vital. You would want to learn more about the different GMP cleanroom grades before making up your mind. Sometimes, you do not always have to pay high amounts for a cleanroom you would utilize fully. First look at the application then it will guide you to pick the best GMP cleanroom that you need for the job.

• The delivery time from the manufacturer is important. As we all know, time is money. As such, look at how long it would take for the manufacturer to complete making the GMP cleanroom. In most cases, it will take a few weeks for manufacturers to produce the GMP cleanroom. It would be nice to get updates on how the cleanroom manufacturing is coming along.

Once the cleanroom is correctly set up, what follows is that you need to ensure the GMP cleanroom protocols are followed. Sometimes you may have to include experts in the sector to help train your employees on how to maintain the cleanroom protocols. This ensures the cleanroom remains working properly over the years.

How is a GMP Cleanroom Tested and Validated?

Cleanroom Testing and validation are crucial procedures for anyone owning GMP cleanrooms. These processes help to see if your cleanroom can meet all the vital specifications and standards. It often comes down to the class of the GMP cleanroom. Some would have more requirements to keep them at a certain level while others not so much.

Testing and validation processes will be mostly contracted to firms that have the expertise to handle such processes. What is important is that you always get reliable contractors with experience in testing and validating GMP cleanrooms.

So, some of the tests that would be conducted on a GMP cleanroom include;

• Particle count

• Air volume and velocities

• HEPA filter testing

• Temperature and humidity tests

• Pressure differentials

• Particle recovery

• Fume hoods etc.

The list is expected to be longer if your GMP cleanroom handles sensitive materials. There is the need to ensure the cleanroom can remain within the best working conditions all the time.

Some might ask, how often should a cleanroom be tested and validated? It will depend on the certification schedule in most cases. There are some checks that can be done monthly, others annually, while others every six months.

No matter the type of test, make sure it is done at the right time. This will help prevent possible costly problems and repairs in the future. Some of the tests do not even take long, you might be surprised at how you can get them done fast.

What is the Lifespan of a GMP Clean room?

The lifespan of a GMP cleanroom largely varies with the use. Most people find such cleanrooms having some impressive lifespan. Most would last for over a decade without doing much. They can even go on for long if you follow the recommended manufacturer maintenance schedules. Such schedules are important to help the cleanroom to run normally.

Conclusion

GMP cleanrooms are vital for many operations you might think of. Do not let the GMP name confuse you as these are the same cleanrooms you may have used before. The difference is how they are classified. If you ever have any more questions on GMP cleanroom, Sunnyda can provide you with all the answers. Simply get in touch today.