Medical Injection Moulding Cleanrooms

A Medical Injection Moulding cleanroom is an enclosed zone where airborne particulates and pollutants are maintained at specific levels. 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.

Aerosol particles, bacteria, pathogens, chemical vapours, fibrous materials and more are types of pollutants that can hurt the manufacturing process in these industries. Our Medical Injection Moulding Modular Cleanrooms are built to comply with the international organisation for standardisation (ISO) 14644-1: 2015.

The ISO 14644-1:2015 compliant Medical Injection Moulding Modular Cleanrooms vary between class 1 and 9. The class of each Cleanrooms can change depending on prevalence and size of air contaminants in the cleanroom. The Class 1 classification is the greatest in the range and it is tested for the lowest frequency and smallest particulate size while the Class 9 classification represents the least in the range and is valued based on a higher frequency and larger air pollutants present in the cleanroom at any given time.

To test Medical Injection Moulding 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 ISO Class 9 Modular Cleanroom’s PPCM has a semblance with regular atmospheric air but filtration of much larger air contaminants >5 microns is accounted 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. Here is an example of this kind of testing requirement.

A Modular Cleanroom that falls in Class 7 will be tested for the presence of an air particulate size of >0.5 microns where the highest particle count should be capped at 352,000. Modifications will have to be put in place if the Medical Injection Moulding Cleanroom does not meet the requirements for this classification.

Contamination-frеe production

Medical Injection Moulding Modular Cleanrooms maintain strictly low levels of air particulates through the use of ULPA/HEPA filters. 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. When non-filtered air goes through Filter Fan Units (FFUs), a positive pressure area is introduced and maintained in the clean air environment. This positive pressure helps maintain the controlled level of clean air by preventing contaminated air from entering back into the cleanroom through perforated openings.

Pollution-free manufacturing is fostered through the mechanism of the aforementioned type of Medical Injection Moulding cleanroom as it only allows the air that passes through the filtration unit to enter the internal space.

Modular Cleanroom Benefits

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

Deploying a Medical Injection Moulding cleanroom solution is the first stage of producing a clean environment for production and it substantially lessens the risk of product contamination. The second steps that should be taken in mitigating contamination are measures that will avoid cleanroom personnel from bringing in pollutants. This can be achieved through the proper use of PPE for cleanrooms such as hair nets, overshoes, and gowning. This move will see to it that certain numbers of contaminants like dust and fibres do not enter the cleanroom and disrupt research/production. Medical Injection Moulding Cleanroom operators must undergo training in the reduction of contamination to prevent the introduction of microbial/foreign materials in to the production area.

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

TCA and Pharmaceuticals industry

At TCA, we leverage our experience that has spanned over three decades, as well as our talented engineers to deliver the best Medical Injection Moulding Modular Cleanrooms available. Our Medical Injection Moulding Modular Cleanrooms have long been known to be durable, reliable, and of the highest build quality. Every project delivered by us at TCA goes through strict supervision from planning to validation in order to ensure our customers are satisfied. We oversee the design and installation process which makes us provide one of the best Cleanroom solutions in the world.

We gain professional satisfaction in deploying the latest state of the art technology, from system monitoring to Ultra-quiet high-efficiency Fan Filter, in order to see you maximise production. All our Modular Cleanroom solutions come with a five-year warranty, which is a testament of our confidence in the products we deliver.

Industry Prerequisites

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.

The Cleanroom is crucial for reducing particulates in the production environment via air filtration. Cleanrooms are used in the production of medical devices, semiconductors, food products, electronics and a lot more.

At TCA, we are here to make sure you invest in the most suitable design for your application purposes. We can also point you in the right direction if you’re unsure about your Medical Injection Moulding Cleanroom requirements.

We design and build all our Medical Injection Moulding Modular Cleanrooms to comply to the ISO 14644-1: 2015 standard. Cleanrooms of this standard fall in different classes – from ISO 1-9. The size and quantity of air particulates in a Cleanroom will determine the class it belongs to. ISO 1 Cleanrooms, which are the highest classification, are valued based on having the least number and sizes of particulates while the lowest class (ISO 9), will be evaluated based on the larger quantities and a higher presence of air particulates in the enclosed space.

To the determine the class of a Modular Cleanroom, particle counters are used to measure the size and quantity of particulates in Particles Per Cubic Metres (PPCM). Every particle counter determines the size and quantity of air particulates. Evaluations for ISO class 9 Cleanrooms are aimed at the removal of larger air contaminants (>5 microns) as they have the PPCM of suburban air whereas the elimination of smaller air pollutants (>0.1 and >0.2 microns) are accounted for in ISO 1 cleanrooms.

Containment solutions

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. Medical Injection Moulding 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.

The containment solutions which we deliver are uniquely built due to the fact that dangerous substances vary according to output and size. This goes to mean that each customer’s containment needs can differ from that of others. 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

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  • Tuesday 08:00 - 19:30
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  • Friday 08:00 - 19:30
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  • Sunday 08:00 - 19:30