Cleanroom Feasibility, Resilience & Sustainability

• Cleanroom Classifying and Validation Servicing
• Test as service
• Monitoring as Service
• Thermal Image
• CFD
• Cleanroom relocation and decommissioning
• Energy Efficiency & Optimization
• Cleanroom Regulatory & compliance consulting

Cleanroom Classifying and Validation Servicing

In order to show that the cleanroom environment is in control, it is necessary to demonstrate that the air supplied to the cleanroom (internal link) is of sufficient quantity to dilute or remove the contamination generated within the cleanroom and that the air supplied to the cleanroom is of a quality that will not add significantly to the contamination levels within the cleanroom. As part of the cleanroom performance validation, the level of microbial contamination should also be measured at the “in operation” state in order to demonstrate compliance and, in some cases, gain historical data to establish alert and action limits.

Our comprehensive clean room validation report describes in detail the raw data acquired from our test results and measurements taken on site. Our reports clearly identify whether or not a room or device meets the relevant standard. The cleanroom validation reports also include plan drawings of all the areas surveyed, showing HEPA Filter (internal link) locations, airborne particle count positions, differential pressures, recovery rate locations and other information appropriate to the validation. Copies of calibration certificates are also included in all reports. Our reports are complying with cleanroom standards.

Classifying Your Cleanroom

Cleanrooms are classified by the cleanliness of their air. Classification is the process of qualifying the cleanroom environment by the number of particles using a standard method. This is done according to ISO 14644-1; (internal link) international standard, having been adopted by the European Union in 1999, and the USA in 2001. We understand the various cleanroom classifications and can advise on yours. Facilities designed for pharmaceutical development or manufacturing, need to conform to either GMP and/or ISO 14664:2015.

All cleanrooms have a classification which is determined by the concentration of airborne particles, ranging from 0.1μm to 5μm. Nanoparticles which are smaller than 0.1μm and macroparticles which are larger than 5μm are not covered within this range, however more information on these particle sizes is available upon request.

In order to show that the cleanroom environment (internal link) is in control, it is necessary to demonstrate that the air supplied to the cleanroom is of sufficient quantity to dilute or remove the contamination generated within the cleanroom and that the air supplied to the cleanroom is of a quality that will not add significantly to the contamination levels within the cleanroom. As part of the cleanroom performance validation, the level of microbial contamination should also be measured at the “in operation” state in order to demonstrate compliance and, in some cases, gain historical data to establish alert and action limits.

Our comprehensive clean room validation (internal link) report describes in detail the raw data acquired from our test results and measurements taken on site. Our reports clearly identify whether or not a room or device meets the relevant standard. The cleanroom validation reports also include plan drawings of all the areas surveyed, showing HEPA Filter locations, airborne particle count positions, differential pressures, recovery rate locations and other information appropriate to the validation. Copies of calibration certificates are also included in all reports. Our reports are complying with cleanroom standards.

HVAC and Clean Room Validation

There are many reasons why cleanroom and HVAC (internal link) validation is done. The facility's design must be suitable for its intended use, the environment, equipment, and facility must meet User Requirement Specifications (URS), the environment, equipment, and facility must comply with specified regulatory requirements, and the environment, equipment, and facility must work together as a system to meet established standards.

We offer a wide range of services related to clean room validation (internal link) through our network of highly qualified experts.

For all room classifications, GCRC carries out HVAC validations in accordance with ISO 14644-1,2,3, EU GMP/EC GMP, WHO-TRS-937, WHO-TRS-961, and Schedule M (National Regulatory Body) criteria.

Cleanroom Healthy Environment Test as Service

Clean Room Testing – GCRC Environmental Services (Keyword)

Cleanroom testing and routine monitoring are necessary to make sure that contamination levels stay within allowable bounds.

Clean Room Testing: (internal link) GCRC are specialists in clean room testing to meet the requirements of all current standards and guidelines.

The Procedure for Clean Room Testing

Many aspects of the air supply from your ventilation system need to be examined to make sure your clean room environment is operating efficiently. These tests are applicable to all types of clean rooms, regardless of whether they use a unidirectional or non-unidirectional air flow system and are used for the production of pharmaceuticals, sterile and aseptic work, heart valve banks, nuclear medicine, blood labeling, gene and cell therapy, assisted reproduction, TPN, cytotoxic work, or any other industry.

In order to ensure that there is sufficient air to dilute or remove any contamination created within your clean room, we must measure the amount of air and its quality to make sure that contamination is not being added to rather than removed.

In order to reduce the amount of contaminated air that enters your clean area and to make sure there are no spots in the room with high concentrations of pollutants, we also need to monitor the air flow to make sure it is going from clean to less clean areas.

To conduct these tests, we will measure and verify the following in each cleanroom we work in:

• Air Flow Velocity: We will measure and record the air velocity in unidirectional systems, and the air supply in non-unidirectional systems.
• Pressure Differential: We'll test to make sure your clean room's air constantly flows from clean to less clean places, with your clean room's pressure being higher than that of nearby less clean locations.
• Testing for Leaks in the Filter Installation Process: Ventilation system's high efficiency particulate air (HEPA) filter and its integrity will be checked using dispersed oil particulate (DOP).
• Testing for Containment Leaks: We will examine the design of your clean room to make sure that no leaks from nearby higher-pressure work areas could contaminate the air.
• Air Movement Control: By observing how the air moves in your clean room, we can make sure that there is enough air movement to remove or dilute pollutants and stop any contamination from building up.
• Room Recovery: After a particle pollutant is released, we will assess how well the airflow is working and gauge how soon a clean room returns to its typical level of cleanliness.
• Airborne Particulates and Microbial Concentrations: Lastly, we will measure the particulate and microorganism concentrations to make sure they meet your clean room's specifications.

We might also need to test the room's heating and cooling capacity, relative humidity, temperature, lighting, and vibration levels, depending on how your clean room is operating.

GCRC Clean Room Testing Services

We offer the full range of performance tests, with a focus on MHRA-licensed clean room testing and validation. These tests include:

• Recovery testing
• HEPA filter integrity testing
• Room differential pressure measurement
• Airflow visualization
• Non-viable airborne particle monitoring
• Temperature and humidity monitoring and uniformity mapping
• Containment and induction leak testing
• Airflow volume flow measurement and air change rate calculations for non-unidirectional systems.

After any clean room testing or validation service, we will provide you with clear, well-structured reports that may be assembled, quality-checked, and provided to you while you're still on-site, minimizing the amount of time your operations are offline. This way, we can make sure you understand our approach and your results.

Your report will include a brief overview of our findings, along with specifics about the acceptance criteria we tested against and the site-specific procedures related to them. It will be fully customizable to your requirements as well as those of the standards we are testing against. We will provide you with test certificates and calibration certificates for every piece of equipment we utilized, in addition to layout drawings that show where our testing was conducted. We will also record any suggestions for potential enhancements.

GCRC is a team of highly skilled clean room testing engineers that provides thorough validation services in compliance with all current standards and recommendations.

Cleanroom Monitoring as a Service

Clean Room Monitoring

A cleanroom monitoring system measures air quality, pressure, temperature, humidity, and other variables continually. Cleanrooms are necessary for a variety of manufacturing, healthcare, and research purposes. The air in the clean rooms is incredibly clean, as the name suggests.

Controlled variables include dust, airborne particles, air composition, airborne mold particles, microorganisms, and so forth. Furthermore, the humidity and temperature will be regulated. For instance, in the pharmaceutical manufacturing sector, clean rooms are necessary for the production of medications. The medications shouldn't be contaminated during production by any particles. In order to prevent outside air particles from entering the interior, we additionally control the air pressure.

Why should a cleanroom be constantly observed?

There are two reasons why cleanroom monitoring is done:

• Any time contamination can occur, which adversely affects the output and quality of goods produced there. These incidents can go unnoticed for days or even weeks in the absence of a continuous environmental monitoring system, potentially leading to millions of dollars worth of goods being passed through a polluted cleanroom and possibly resulting in an expensive product recall or disposal.
• Keeping track of previous information for internal standard operating procedures (SOPs) and audits. Historical information has many applications, such as helping to set up cleaning and maintenance routines, and also meeting the records needed to comply with corporate data retention policies, regulatory bodies, and customers.

Cleanroom monitoring is essential for ensuring compliance with ISO 14644 and GMP standards, maintaining the integrity of controlled environments, and preventing contamination.

Cleanroom Monitoring Parameters and Tools

1. Temperature Monitoring: Maintain optimal conditions for sensitive operations and equipment.
2. Relative Humidity (RH) Monitoring: Control humidity to prevent microbial growth and ensure equipment safety.
3. Airborne Particle Monitoring: Ensure particle counts comply with ISO class requirements.
4. Surface Cleanliness Monitoring: Assess contamination on cleanroom surfaces.
5. Microbial Monitoring: Detect and control microbial contamination.
6. VOC and Gas Monitoring: Measure volatile organic compounds (VOCs) and gases to ensure air quality, VOC levels, and specific gases like CO₂, CO, O₂, NOx, H₂S.
7. Airflow and Air Velocity Monitoring: Ensure adequate air circulation and laminar flow.
8. Differential Pressure Monitoring: Maintain airflow direction and prevent contamination.
9. Air Exchange Rate Monitoring: Validate the number of air changes per hour (ACH).
10. Electrostatic Discharge (ESD) Monitoring: Prevent static discharge from damaging sensitive components.
11. Noise Level Monitoring: Ensure noise levels are within acceptable limits for worker comfort.
12. Lighting Levels: Maintain sufficient illumination for cleanroom activities.