cGMP is short for “Current Good Manufacturing Practice.” This is an FDA-required quality system that makes certain drug and medical device products are manufactured and controlled to the required quality levels. The “current” part in cGMP is critical, as it underscores the fact that drugmakers must be employing current systems and technology, adapting to new regulatory guidance, etc.

cGMP cleanrooms are designed to comply with these changing requirements, and reduce the risk of contamination and mistakes or mix-ups.

While general cleanliness is essential in a cleanroom, it must also adhere to certain requirements in order to become cGMP compliant.


Some of these requirements include:
Particle Control: This includes the control of both viable and non-viable (solid) particles to predetermined levels.

Sterile Assurance: For aseptic processing, the cleanroom has to be designed and qualified so the sterility of the product is assured. That is the main point of this requirement.

Regulating the Environment: Conditions like temperature, humidity, and air pressure need to be kept within certain ranges and monitored on a regular basis.

Documentation and Validation: This involves a lot of records and training plans. IQ, OQ, and PQ protocols are part of it, along with other documentation, to show the facility is operating as it should.

An effectively designed custom cGMP cleanroom includes a variety of features to ensure compliance and performance. Here are some of the most important design considerations:

Wall Systems: Surfaces shall be smooth, non-shedding, and resistant to chemicals required for sanitation. Materials such as FRP (fiber-reinforced plastic), uPVC, and high-quality stainless steel are popular.

Flooring: Heat-welded, solid vinyl with coved corners is standard, and provides a seamless, smooth surface to prevent the buildup of germs and bacteria. Static-dissipative choices are also offered for use in controlled environments where static charges are a concern.

Ceilings: Cleanroom-rated ceiling systems may have coved junctions and flush-mounted lighting to eliminate corners where dust could collect.

Air Handling Systems: An effective air handling system is the lifeline of a cGMP cleanroom. It needs to be able to generate and maintain positive air pressure so that contaminants are pushed out. The system employs a combination of filters, including high-efficiency particulate air (HEPA) filters, and in the most demanding spaces, ultra-low particulate air (ULPA) filters, that remove particles from ambient air.

The design can also include room side replaceable (RSR) filter fan units, which make maintenance and filter changes easier.

Doors & Pass-Throughs: Interlocking doors and pass-throughs are necessary for preserving the cascading pressure and preventing cross-contamination from one area to another.

Monitoring & Controls: Air pressure, temperature, and humidity must be monitored continuously by automated systems that log data. Such systems commonly incorporate audible or visual alarms to indicate any variations, and keep the environment within parameters.

When you compare modular cGMP cleanrooms with permanent construction, there are numerous advantages that can be discussed. Here are a few of the many reasons to go with modular for a custom cGMP cleanroom:

Compliance-Ready: Modular cleanrooms are pre-designed to meet FDA, ISO 14644, and EU GMP Annex 1 requirements.This reduces validation time and provides an easier route to regulatory clearance.The materials are chosen for a long service life and the ability to withstand harsh disinfectants and the daily sanitizing cycles used in a GMP cleanroom environment.

Scalable: The modular design can be scaled up or reconfigured to suit changes in production capacity, batch sizes, and the addition of new manufacturing suites.

Embedded Monitoring: Sophisticated online or offline environmental monitoring systems can be built into the cleanroom infrastructure.

Validation Support: A reliable manufacturer can provide documentation and support for Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to help with facility certification.

The demand for cGMP compliance usually comes from several types of applications, each of which is tied to human health and safety:

Pharmaceutical Drug Manufacturing & Sterile Compounding: Essential for making injectables, solid dose drugs, and other prescription medicines.

Biotech Production: For cell culture, gene therapy, biologics. All need extremely clean environments to avoid cross contamination.

Medical Device Assembly: Implants, surgical tools, and other devices must be assembled in cleanrooms to comply with FDA QSR.

Nutraceuticals and Cosmetics: Some products here also have to meet cGMP rules for safety and quality.

Constructing a cGMP cleanroom requires careful compliance with both international and domestic regulations. Some of the main standards include:

FDA cGMP Regulations: These are the basic U.S. guidelines for drugs and medical devices, establishing minimum standards for manufacturing methods, facilities, and controls.

ISO 14644 Cleanroom Standards: International standards that classify a cleanroom according to the concentration of airborne particles in the air. For manufacturing processes, GMP cleanrooms are classified from ISO 5 to ISO 8.

EU GMP Annex 1: It provides specific guidance on sterile product manufacturing in Europe, and is invaluable for companies that are producing worldwide.

ASTM, IEST, and OSHA: These cover a range of cleanroom functions, from testing procedures to staff safety.

There is no one-size fits all solution for cleanroom compliance. Whatever the manufacturing process, a cGMP-tailored cleanroom can be designed to meet those requirements. Some of the main features that can be configured include:

Wall Materials: FRP and powder-coated steel, each with different levels of strength and chemical resistance.

Flooring: Heat-welded vinyl, static dissipative vinyl, epoxy, and even raised-access flooring.

Air Management: Systems design can be single-pass, recirculating, or hybrid airflow systems. HEPA and ULPA filters can be changed according to the desired ISO classification.

Exhaustive Controls: These can interface with Building Automation Systems (BAS) and Building Management Systems (BMS), and include alarmed sensors for pressure, temperature, and humidity, all of which report in real time.

Special Builds: If you have unique requirements, for example sterile suites, aseptic fill suites, or cleanrooms for nuclear materials, our team can add the features you need.