How to Design an Ideal Cleanroom to Meet all The Requirements?

An ideal cleanroom combines accurate engineering design, high-quality fabrication, impressive finish and control strategy. Otherwise, it can’t be considered a clean room. A regulated company clean room that doesn’t produce potent chemicals or hazardous biologicals has specific characteristics.

A room falls under the clean room category only if it meets the GMP requirements defined in the GMP code and other standards of the local health authorities.

What’s the necessity of a clean room?

The manufacturing of non-sterile medicinal products requires no GMP guidance to be followed. But, using clean areas with adequate filtered air ventilation is always best, as the products or open containers are exposed.

On the other side, you have to use a clean room for manufacturing sterile medicinal products, as directed in the EU and PIC/S GMPs. Apart from the limits of airborne particulate concentration, there are several other requirements for a standard room to become a clean room.

In short, when manufacturing a non-sterile medicinal product, you must be extra cautious with classifying the clean areas. Besides, many regulators, including the Australian TGA, expect you to comply with all the conditions for a Grade D room if you grade a room as Grade D, as defined in the annexes of EU and PIC/S GMPs.

So, once you have classified a room as a Grade D room, you have to maintain, in any way, the level of cleanliness and face the costs and consequences of it.

What Type of Clean Room Is Needed?

As a manufacturer of non-sterile medicinal products, you must define your cleanroom standards by following national and international guidelines. Manufacturers typically define a standard class for airborne particulate concentration, like ISO 14644-1 ISO 8, a pressure cascade regime, and outline gowning as clean corridor design.

But, if you manufacture sterile medicinal products, following the EU or PIC/S GMPs Annex 1 is a must for you.

How to determine if it’s a clean or dirty corridor?

Low-moisture medicinal products like capsules and tablets are dusty and dry, with a higher risk of cross-contamination. There is a chance that the powder escapes out of the room and enters the corridor to which the pressure differential of the “clean area” were positive. It may then transfer to the cleanroom next door.

It’s relieving that most dry formulations don’t usually support microbial growth. Therefore, it’s a standard rule to manufacture powders and tablets in “clean corridors” to prevent the floating microorganisms from finding an environment to thrive. But the rooms are, thus, pressurized negatively to the corridor.

For liquid, aseptic, low bioburden and sterile products, the microorganisms find supportive media to flourish. When an aseptically processed product is being manufactured, a single microorganism can prove to be catastrophic. These facilities, therefore, have “dirty corridor” designs to protect the cleanroom from potential organisms.

How should the cleanroom doors swing?

Cleanroom doors should generally swing inward into the cleanroom to help maintain positive air pressure and prevent contaminants from entering the controlled environment. This means that the door handle will be on the side of the door facing the outside of the cleanroom, and the door will swing inward when opened.

What are the sources of contamination?

It ought to be noticed that cleanrooms don't dispense with pollution; they control it to a satisfactory level.

Our veritable concern is microbial defilement by and large. There was no such thing as customarily the innovation to quantify microbial pollution continuously straightforwardly, so the "every single airborne particulate" limits were utilized and extrapo

lated/accepted to address conceivable airborne microbial defilement risk.

So the GMP's set out characterizing and controlling wellsprings of particulates to forestall conceivable "microbial pollution".

Work force present in a cleanroom typically are the most elevated wellspring of airborne particulates, and microbial pollution risk, so legitimate gowning and restricting the quantity of staff into a room should be painstakingly controlled to be inside the cleanroom plan.

What makes a room a “clean room”?

There are three parameters for defining a clean room and a clean area.

1. Internal surface

A cleanroom will have all its surfaces "smooth and impervious." Moreover, the surfaces will not generate contamination, like flakes or dust, or allow microorganisms to proliferate. The surfaces are so solid and rigid that they won't crack or shatter. There are various suitable materials, like Dagard panelling with sliding doors, to build these surfaces.

1. Clean room airflow

A clean room has a controlled airflow with fixed temperature and humidity. A clean room mostly has Air Handling Units to consume 60% of the site power. The more air a room uses, the cleaner the room is. Temperature and humidity modifications are costly, and therefore, the systems and AHU recirculate 80% of the air and, at the same time, remove contamination while stabling humidity and temperature.

Supply and return air

The layout of a clean room essentially prioritizes the location of the supply and return air grilles.

How to operate a clean room?

Operating a clean room requires a few steps. Those are: -

Contamination prevents operations, and combating its potential is a mandatory step in operating a clean room.

Controlling access to the room is necessary. It should be strictly for trained people only, that too in a limited number.

Cleaning the room regularly in a standard procedure is a must.

Proper maintenance of the room and equipment is another crucial step.

Regular recertification of the clean room.

Regular monitoring of the airflow filters.

Cleanroom jargon

Here are some clean room jargon, technical aspects and acronyms.

• Air change rate: - How often the air changes is essential.
• Micron: - A micron is one-millionth of a metre. Human hair is 100 microns, and bacteria is 1-2 microns.
• HEPA filters: - High-Efficiency Particulate Air, a vital cleanroom equipment, has a large filter to remove airborne particles. Monitoring and testing of HEPA should be frequent.
• Dispersed oil particle testing: - This testing is for checking whether HEPA is working efficiently.
• Airlock: - It can be a large room or a small cupboard for storing equipment in or out of the clean room.

Room recovery rate

Particle count

Cleanroom certification: - ISO Class

ISO 8 is the standard starting level for cleanroom particulate cleanliness.

Annexe 1 or ISO?

There are Grades A to D to determine the cleanliness of clean rooms for sterile products.

Cleanroom certification involves a series of testing. The tests are required to ensure the cleanroom operation is up to the class or grade.

Final words:

Reputed registered pharmaceutical architects and engineers offer the most effective solution for those who want to build one room cleanroom or a mega-comple.