Sterile Re-Packing Cleanrooms

Sterile Re-Packings Cleanrooms are clean air environments where a specific size of air particulates is prevented from entering. The cleanroom is used to filter polluted air as per the requirements of certain industries such as pharmaceuticals, E-liquids, healthcare facilities, as well as science and technology.

The types of impurities that are kept out of the cleanroom through filtering include airborne microbes, dust, chemical vapours, and aerosol particles among others. We have Sterile Re-Packings Modular Cleanrooms that satisfy the requirements of the international organisation for standardisation (ISO) 14644-1: 2015.

The ISO 14644-1:2015 standard of Sterile Re-Packings Modular Cleanrooms are classified into different categories, from class 1 to 9. Classifications are set depending on the level of pollutants the cleanroom maintains as well as their sizes. The class 1 range of Cleanrooms, which stands as the greatest, will be evaluated for the lowest frequency and smallest particulate size while the least classification (Class 9), will have a larger air particulate size and higher frequency than all other Cleanroom classifications.

To test Sterile Re-Packings Modular Cleanrooms and classify them, particle counters are used to measure the Particles Per Cubic Metre (PPCMM) of the environment by size and quantity. The Particles Per Cubic Metre of an (ISO) 14644-1: 2015 Class 9 Modular Cleanroom corresponds to normal atmospheric air with contaminants >5 microns not allowed into the environment.

Smaller air particulates of sizes >0.2 and >0.1 microns are focused on with Class 1 Cleanrooms, which results in a much cleaner environment. An example of this testing requirement is as follows.

The evaluation of Class 7 Cleanrooms focuses on an air particulate size of >0.5 with a particulate count of 352,000 at most. The Sterile Re-Packings Cleanroom will have to be modified and re-evaluated if it goes over the required particle count and size to qualify for the classification.

Production in a contamination-free environment

HEPA and ULPA filters are typically used to maintain the clean air environment in Sterile Re-Packings Modular Cleanrooms. The use of these filters have passed scientific evaluation and are proven to keep out certain amounts and sizes of air particulates from a cleanroom. The cleanroom gains a positive pressure area when Filter Fan Units (FFUs) process unfiltered air that passes through it. The positive pressure is responsible for sustaining the state of clean air that prevents the backflow of polluted air into the Cleanroom via exhaust openings.

With the above-mentioned cleanroom, contamination-free manufacturing is allowed to take place as air that hasn’t gone through the filtration unit will be prevented from entering the clean air space.

Modular Cleanroom Benefits

  • Modular Construction
  • Quick Assembly Time
  • Versatility
  • Reconfiguration
  • Airflow Control
  • Inexpensive Modifications

Deploying a Sterile Re-Packings cleanroom solution is the first stage of producing a clean environment for production and it substantially lessens the risk of product contamination. The next steps involves making sure personnel don’t contaminate the cleanroom. With the proper use of Cleanroom PPE like overshoes, gowning, and hair net, the introduction of pollutants into the clean air space can be avoided. This will reduce fibres and potential contaminants from entering the Sterile Re-Packings Cleanroom and interfering with Production/ research. Operators of Sterile Re-Packings Cleanrooms must be adequately trained on contamination reduction processes to keep the Cleanroom safe from contamination.

Cleanroom Design, Build & Validation

  • Budgeting and planning
  • Engineering, design & layout
  • Airflow and filtration design
  • Construction and Installation
  • Full Certification of our product
  • Industry-specific equipment installation
  • Validation

Pharmaceuticals industry and TCA

TCA is dedicated to providing state of the art Sterile Re-Packings Modular Cleanrooms for the pharmaceuticals industry, utilising our over thirty years of expertise and our talented engineers. The Sterile Re-Packings Modular Cleanrooms we provide have a remarkable history of reliability and durability. Every project delivered by us at TCA goes through strict supervision from planning to validation in order to ensure our customers are satisfied. Our cleanroom solutions are one of the most competitive due to the fact that we oversee our design and installation processes.

From Ultra-bright LED panelling to Engineering Grade aluminium, TCA derives a sense of accomplishment in providing the most sophisticated technology to help you increase productivity. We are so confident in our ability to provide a long lasting and quality product that all of our Sterile Re-Packings Modular Cleanrooms receive a five-year warranty.

Industry demands

Cleanrooms are critical in the production and research processes of industries that require a minimised level of particulate occurrence in order to avoid product contamination.

A Cleanroom is essential for a controlled air space reducing the incidence of particulate contamination via air filtration. Cleanrooms are used in the production of medical devices, semiconductors, food products, electronics and a lot more.

We’re always dedicated to make sure you invest in the Cleanroom that is most effective for your production or research purposes. You can be guided by our experts if you’re entirely sure of the standard of Sterile Re-Packings Cleanroom your industry requires.

We design and build all our Sterile Re-Packings Modular Cleanrooms to comply to the ISO 14644-1: 2015 standard. These ISO 14644-1:2015 compliant Cleanrooms vary in classification between ISO 1 and 9. The size and quantity of air particulates in a Cleanroom will determine the class it belongs to. Cleanrooms that fall into ISO 1, which is the highest classification, will be tested for the lowest quantity and sizes of air particulates whereas those that fall into ISO 9, being the least, will be evaluated for the highest quantity and sizes of pollutants entering the clean air area.

To evaluate Sterile Re-Packings Modular Cleanrooms and place them in a class, the use of particles counters is employed to measure the Particles Per Cubic Metre (PPCM) of the cleanroom. Each Particle counter measures airborne particulates by size and also quantity. An ISO class 9 Cleanroom has a PPCM akin to regular atmospheric air with the elimination of bigger particles (>5 microns) being verified while testing for an ISO class 1 cleanroom will concentrate on accounting for much smaller contaminants of >0.1 and >0.2 microns making the enclosed space much cleaner.

Containment solutions

Containment solutions are important in situations where dangerous air particulates that emanate from the production process need to be prevented from contaminating the outside air. Sterile Re-Packings Modular Cleanrooms can be made to keep production safe by introducing contamination-free air into the work space and contain hazardous materials that come about during production through the use of ULPA, HEPA, or Carbon filters. With our help at TCA, you can have containment solutions installed in your modular cleanroom that will see to the prevention of hazardous substances entering the outside air, keeping you out of the crosshairs of regulators.

Due to the differences in hazardous materials that stem from diverse quantities which depend on use, every containment solution we provide has to be unique. This means that the level of containment can change from customer to customer. We’ll consult with you to make sure we deliver the required system for your use.

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 and control the air flow within the 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.

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, much more. We pride ourselves in being able to meet design requests however unique in shape and size they may be.

phillip.godden
Phillip Godden

Phillip Godden is the Founder & Chief/Executive Officer at Total Clean Air.

Working Hours

  • Monday 08:00 - 19:30
  • Tuesday 08:00 - 19:30
  • Wednesday 08:00 - 19:30
  • Thursday 08:00 - 19:30
  • Friday 08:00 - 19:30
  • Saturday 08:00 - 19:30
  • Sunday 08:00 - 19:30