Contamination can be caused by a number of environmental factors such as people, activities (such as movement), outside contaminants, HVAC systems and more. Contamination or particles can be found in the form of fibers, hair, skin flakes, bacteria, cosmetics and more

A person in a sitting position produces about 100 thousand particles. A person walking 5 miles per hour produces 10 million!

Ambient air outside in a typical urban environment contains 35,000,000 particles per cubic meter.

As per ISO 14644-5: 2005 – Part 5, Operations section which specifies basic requirements for cleanroom operations in a checklist under six headings, and cleaning one of them:

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Patented Binary Ionization Technology (BIT) activates and ionizes a 7.8% Hydrogen Peroxide (H2O2) sole active ingredient-based solution into a fine mist/fog known as ionized Hydrogen Peroxide (iHP).

iHP contains a high concentration of Reactive Oxygen Species (ROS), consisting mostly of hydroxyl radicals (OH) is the killing agent. OH, are one of the most powerful oxidizing agents in nature, and during TOMI’s iHP process, kills bacteria and fungal spores and inactivates viral cells by destroying their proteins, carbohydrates, and lipids. This leads to the cellular disruption and/or dysfunction allowing for the quick decontamination of targeted areas, objects and large spaces.

• Leaves no residue
• Quick application
• Small micron size
• Evenly dispersed
• No bleach chlorine, acetic acids, dyes.
• Require no mixing
• No-touch disinfection
• Compatible with Electronics
• High log efficacy

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According to BS EN 12469:2000 and the Advisory Committee on Dangerous Pathogens (ACDP), Microbiological Safety Cabinets (MSC) should be fumigated.

We offer Equipment Bio-Decontamination Service (EBDS) specifically designed to fumigate microbiological safety cabinets, incubators, robotic enclosures and similar laboratory equipment.

By combining your decontamination with routine servicing or annual inspections we can minimize disruption and drastically reduce the downtime of your facility.

Whether you require decontamination using hydrogen peroxide or formaldehyde, our fumigation services provide reliable kill levels against a broad spectrum of airborne and surface microbiological contamination. Fumigation Validation It is important to validate the fumigation using Biological Indicators (BIs) to verify effectiveness. There are various types of BIs available depending on the type of fumigant used.

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In order to show that the cleanroom environment 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 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.

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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; 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.

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According to the IS EN ISO 14644-2 standard, every time a cleanroom is put into operation initially or changes its intended use, a validation must be performed. The initial setup of a cleanroom requires a validation to be performed over a specified period of time to ensure that the cleanroom is functioning as required over the given period of time Measuring the performance of your cleanroom or controlled environment is crucial when you need to regulate the level of airborne particulate contamination. Depending on your specific requirements, some or all of the following performance tests would form part of the annual or routine validation testing.

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It’s essential that all cleanrooms are routinely tested, monitored and certified to ensure that they continually perform efficiently and stay within their designed classification parameters. Additional performance tests such as airflow visualization, particle deposition rates, recovery rate and containment leak should be undertaken during commissioning and every 4 years thereafter, unless significant changes have been made to the airflow system or facility. Temperature and humidity are measured as required, subject to the requirements of the cleanroom user.

For more information, please contact us: info@gtsco-uae.com