Modular Cleanrooms For the Pharmaceutical Industry
A Cleanroom is a clean air environment and has the function of preventing air particulates of a certain size from entering. A Cleanroom is a requirement in many industries such as science and technology, food production, E-liquids, and healthcare facilities to reduce contamination from unfiltered air. Such contaminants as Chemical vapours, aerosol particles, fibrous materials and microorganisms are but a small example of which contaminants can be harmful to production and research.
Our Modular Cleanrooms are built to comply with the international organisation for standardisation (ISO) 14644-1: 2015.
The ISO 14644-1:2015 compliant Modular Cleanrooms vary between class 1 and 9. The classification of each Cleanroom changes dependent on size and prevalence of the air particulates in the cleanroom. A Cleanroom with the greatest classification (class 1) will be tested for the smallest particulate sizes and lowest frequency whereas the minimum classification of Cleanroom (Class 9) will have a much higher frequency and larger sized range of air particulates entering the clean air space
The test method in which these Modular Cleanrooms are classified is by use of particle counters, which measures the Particles Per Cubic Metre (PPC) by size and quantity. The PPC of an ISO class 9 Cleanroom is equivalent to atmospheric air (similar to the air of the suburbs) with the removal of much larger particles >5 microns being analysed for. A Class 1 Cleanroom will focus on much smaller air particulates of sizes >0.1 microns and >0.2 microns resulting in a much cleaner air enclosure.
An example of this testing requirement is as follows. A Class 7 Cleanroom will be tested for a particulate size of > 0.5 microns with a maximum particle count of 352,000. If this test exceeds the maximum number the Cleanroom will need to be modified and retested to meet the classification.
Cоntаminаtiоn-frее Production Environment
Modular Cleanrooms achieve the clean air quality by use of air filtration HEPA/ULPA technology. These filters are scientifically proven to reduce the size and quantity of air particulates entering a cleanroom. Non-filtered air passes through Filter Fan Units (FFUs) creating a positive pressure area inside the cleanroom. It is this positive pressure that sustains the clean air conditions preventing the backflow of contaminated air into the Clean air space through exhaust openings.
The type of Cleanroom aforementioned assures that only air that has passed through the filtration unit enters the internal area allowing for contamination-free production.
The Cleanroom solution will reduce the likely hood of product contamination and is the first stage of producing a clean air production area. The second steps to take in reducing contamination are preventative measures for the introduction of air particulates caused by personnel working in the cleanroom. This introduction of contaminants can be prevented by the proper use of Cleanroom PPE such as gowning, hair nets and overshoes. This will reduce fibres and potential contaminants from entering the Cleanroom and interfering with Production/ research. Cleanroom operators must undergo training in the reduction of contamination to prevent the introduction of microbial/foreign materials in to the production area.
Our Cleanroom Process
Pharmaceuticals industry and TCA
TCA is dedicated to providing state of the art Modular Cleanrooms for the pharmaceuticals industry, utilising our over thirty years of expertise and our talented engineers. Our Modular Cleanrooms have an outstanding history of build quality, durability and reliability. At TCA our project managers control the design, build and validation from end to end assuring that a project is delivered to the customer’s specification and satisfaction. We control the design process and installation allowing us to be one of the most competitive Cleanroom solutions around boasting our high quality and approachable service.
From Engineering Grade aluminium and Ultra quiet high-efficiency Fan Filter Units to system monitoring and ultra-bright LED panelling, TCA finds fulfilment in offering the best and latest technology to help see your production grow. We are so confident in our ability to provide a long lasting and quality product that all of our Modular Cleanrooms receive a five-year warranty.
Custom Орtiоnѕ Fоr Mоdulаr Cleanrooms
The use of a Cleanroom is crucial for any industry that requires their processes to have a reduced particulate occurrence to avoid the microbial spoiling and/or contamination of goods.
A Cleanroom is essential for a controlled air space reducing the incidence of particulate contamination via air filtration. Cleanrooms are used in industries such as food production, research, medical devices, electronics, production, Science and Technology, semiconductors and more.
At TCA we are here to make sure you invest in the most suitable design for your application purposes. If you are unsure of the standard of Cleanroom required for your industry we can guide you in the right direction.
Our modular Cleanrooms are built to comply to the international organisation for standardisation (ISO) 14644-1: 2015. These ISO 14644-1:2015 compliant Cleanrooms vary in classification between ISO 1 and 9. The classification of a Cleanroom changes dependent on the size and prevalence of the air particulate in the cleanroom. A Cleanroom with the highest classification (class 1) will be tested for the smallest particulate sizes whereas the lowest classified Cleanroom (Class 9) will have a much larger size and a greater quantity of air particulates entering the clean air space.
The Cleanroom validation test method in which these Cleanrooms are classified is by use of particle counters, measuring the Particles Per Cubic Metre (PPC). Each Particle counter measures the particulates by size and also quantity. The PPC of an ISO class 9 Cleanroom is equivalent to atmospheric air with the removal of much larger particles (>5 microns) being tested for whereas an ISO Class 1 will focus on much smaller air particulates ( >0.1 microns and >0.2 microns) resulting in a much cleaner air zone.
A containment solution is suitable for you if you have a hazardous substance that needs to be removed via a filter before reaching the outside air. This can be set up in a Cleanroom that both protects product by introducing filtered air and contains hazardous materials by extracting through a HEPA (High-Efficiency Particulate Air), ULPA (Ultra-Low Particulate Air) or carbon filter. At TCA we can provide the solution to your containment needs preventing the exposure of hazardous chemicals to the outside atmosphere with the aim to help you become ever more compliant with your regulators.
Each containment solution we provide is unique as not two hazardous materials are the same and vary on quantities dependent on the use. This means that the level of containment can change from customer to customer. We will work with you to find the solution most practical to your use.
Frequently Asked Questions
Airflow and Filtration
Our Cleanrooms are designed to be compliant to the specified ISO 14644-1:2015 grading. With this in mind, we take into consideration the level of air filtration required and the end function of the cleanroom. The level of air filtration required is determined by the air changes per hour (ACH, this determines how many Filter Fan Units are to be used in the cleanroom. What we also determine by the strategic positioning of the FFUs and Exhausts is the flow of air around the cleanroom. This can mean the difference between a uni-directional (laminar flow) and a non-unidirectional (turbulent flow) airflow around a cleanroom potentially leading to a contaminated product. With this in mind, we can greatly increase the number of ACH in a Cleanroom and control the air flow of a cleanroom.
Filtration of air is controlled by our ultra-quiet, high-efficiency filtration modules. These filtration modules automatically compensate for a build-up of dust and other materials that occur over time within a HEPA/ULPA filter increasing the fan speed to reach the set flow rate. This increases the life of the filter, reducing cost overtime for the end user.
Range of intеrсhаngеаblе mоdulаr сlеаnrооm components thаt саn be utilisеd tо imрrоvе the оvеrаll intеgritу оf the еnvirоnmеnt, inсluding.
Cleanrooms Customised to Your Needs
At TCA there is no such thing as a standard modular cleanroom. Each Cleanroom we design is made to fit your unique work conditions and is designed with your needs in mind. We make each modular Cleanroom to order and make you part of the design process.
With TCA you have the option of doing almost anything with a cleanroom design. This means that your Cleanroom can be many shapes and sizes fitting the most obscure of rooms and can have a range of finishes. We have yet to find a design that we could not accommodate.
Our customisable options mean that all components of the Cleanroom such as doors, windows, lighting ceilings and filtrations can be altered to better suit your needs. You also have the option of installing furniture, air showers, pass through chambers, fire suppression, Air-conditioning and much more. We pride ourselves in being able to meet design requests however unique in shape and size they may be.