Biotechnology Cleanroom

A Cleanroom is a controlled atmosphere, where particulate and microbial contamination is controlled to prevent the introduction and proliferation of substances that might contaminate the environment. For all Cleanroom and associated controlled environment activities, the international benchmark standard is ISO 14644. This is supplemented by the standard ISO 14698, which deals with bio-contamination control.

Biotechnology is growing as an industry and is vitally important to our ever-changing world. It is also an industry where control of processes is crucial. Biotechnology Cleanrooms are highly controlled, usually adhering to the regulations of ISO Class 5 or better.

The biotechnology industry requires Cleanrooms and controlled environments that can precisely regulate the concentration of airborne particles, as well as temperature, humidity and atmospheric pressure. Within this sector, there are a variety of biological Cleanroom applications, including, but not limited to: laboratories, production facilities, bio-exclusion zones and animal breeding facilities.

Total Clean Air is the UK’s foremost builders of high-quality Cleanrooms that meet the highest international standards for various industries. We are the leaders in innovative Cleanroom delivery, including planning, biotech design, biotech construction and biotech certification. We cover the entire cleanroom implementation process, from concept to certification.

When it comes to biotech Cleanrooms that meet rigid requirements, we design, create, and install the best modular Cleanrooms in the industry. With extensive cross-market industry knowledge, we deliver high-performing cleanroom environments that enhance your business results.

Modular Cleanroom Benefits

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

Why Biotechnology Facilities Need Cleanrooms

Biological cleanroom technology is in high demand, as businesses strive to achieve Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP). Biotechnology Cleanrooms play an important role in biotechnology research, as they help to ensure scientific data is reliable and not distorted due to contamination. In biotech facilities, these controlled environments help to ensure product quality.

Clinical research laboratories often conduct the first-in-human clinical studies of investigational medications on behalf of biotechnology companies. They need to comply with all international standards and these exacting requirements are a distraction task for most researchers with more important priorities.

Likewise, Cleanrooms for animal supply facilities are established according to the classification of risk zones from Class 1 (not likely to cause illness in humans) to Class 4 (likely to cause serious illness in humans and with a risk of environmental contamination).

Materials which are developed or processed for animal or human therapy in a biotechnology facility often require extensive laboratory designs, which must comply with exacting standards set up by the regulators. This is where biotechnology Cleanrooms come in. They provide secure environments with controlled air filtration, lowering the possibility of product contamination or large particulate interference with critical process manufacturing. They create classified environments to protect processes from harmful airborne contamination, maximising performance by protecting sensitive equipment from harsh surrounding environments.

Because of the highly secure and specialised environments that Cleanrooms require, a team of professional engineers and designers with extensive experience in cleanroom technology handle the design and construction. This ensures the finished product will continue to meet the regulatory specifications, as well as make life easier for scientists working in the lab.

At Total Clean Air, designing and constructing a biotechnology cleanroom layout is where we excel. Our Cleanrooms support a logical workflow, which means less contamination risk, less mistakes and less stress for the people working in it.

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

Planning and Designing a Biotechnology Cleanroom

At Total Clean Air, our engineers design and build biotech facilities and laboratories used for drug or research purposes, where appropriate cleanroom designs are essential. We manufacture ideal seamless wall, floor and ceiling solutions for any clean environment, including biotechnological facilities. Our proprietary system is heat-welded together to form a sealed internal shell that helps to eliminate the risk of contamination.

Our Cleanrooms provide a controlled atmosphere, where particulate and microbial contamination is easily controlled, thereby preventing the growth of microbes in the otherwise sterile environment. Additionally, our cleanroom surfaces can withstand the force of impact and are impervious to liquids and chemicals, making them easy to maintain and clean.

Whilst designing a biotechnology cleanroom, we ensure it is protected by a shell, which is a physical barrier made up of partitions, ceilings, doors and floors, separating various classified and unclassified areas. These areas must meet a certain number of design criteria or very specific performance requirements, such as mechanical performance, geometry, ergonomics, fire hazard properties, sound proofing, and much more.

Three main contamination risk types in a biotechnology cleanroom include particulate contaminants, biological agents and cross-contamination. Particulate contaminants are of the largest concern; therefore, the ability to keep the room clean using stick-built components to maintain a cleanable surface condition is crucial.

Biotech Cleanrooms tend to be sanitised in different ways, and so different products are applicable, depending on the sanitisation methods employed. The technology we make use of ensures the seal of the cleanroom isn’t broken should sanitation or filter changes occur.

When designing and constructing a biotechnology cleanroom, concealed areas for bacterial growth are unacceptable. Biotechnology Cleanrooms typically focus heavily on pressurisation control, elimination of cross contamination and filtration of outdoor air, as well as indoor air. The goal is to reduce the potential for contamination; although there are many factors such as preparation and lack of quality assurance, an unclean environment is the first and easiest to correct.

During the design phase, we pay maximum attention to filter efficiency and integrity. All air entering a cleanroom is treated by one or more filters. These filters can include single pass or re-circulating systems with various airflow options. Technologies such as CFD airflow modelling and point cloud surveys are just some of what we use to plan and maintain performance with definite accuracy.

For the high level of control necessary in biotechnology, we offer Hard Wall Cleanrooms that can be built to comply with the most stringent classification; these can be free-standing or incorporate your existing structure. Our Rigid Wall Cleanrooms can also provide a suitable environment for biotech applications with a great degree of versatility should your facility need change.

Standards Required Of a Biotechnology Cleanroom

At Total Clean Air, our solid wall, floor and ceiling surfaces meet or exceed all industry standards and regulations. Whether you’re replacing an existing controlled environment or installing a brand-new biological cleanroom, we can help your biotechnology facility achieve superior cleanroom standards.

Built to the highest level of bio-contamination control, our biotech Cleanrooms can be used as pilot plants and then converted directly into production suites, with no change in the facility itself. All materials used in construction are industry finest in bio-contamination control and comply to the highest standards. All our Cleanrooms are designed and built with ISO 14644-1 standards.

Our GMP compliant validated biotech Cleanrooms are delivered by our in-house engineering, design and construction management staff, ensuring your biotech cleanroom is delivered to meet cost, schedule and operational requirements. To ensure a cleanroom is capable of reaching the desired cleanliness levels, it’s extremely important that the air supplied into the cleanroom is filtered using filters that conform and are certified to a standard that governs high efficiency air filters.

This not only sets out the efficiency standards demanded from these air filters, but also the testing methods required to classify these filters into categories. The air is filtered into the units using HEPA filters with a 99.99% efficiency on 0.3 micron particles. Our cleanroom specialists will create and design an air filtration system with premium HEPA filters and effective air filtration systems to ensure your cleanroom operates with the most advanced equipment available in the industry.

Our Laminar Flow Hoods are HEPA or ULPA-filtered positive-pressure environments, designed for applications that require a clean work space. Our biotechnology Cleanrooms utilise a powerful fan to draw in ambient air and purify it with high-quality filtration media to provide exceptionally clean, purified airflow inside the hood.

Our biotechnology Cleanrooms are designed and built to eliminate cross-contamination and bio-growth by using the highest quality materials. We have extensive experience in designing and constructing pharmaceutical and biotechnology Cleanrooms. Many biotechnology Cleanrooms are specified at Class 1000 to 100,000.

We offer an integrated approach from planning to implementation, providing all the services and approved products necessary to deliver controlled environment solutions. We guarantee that our Cleanrooms meet your project requirements and exceed your expectations for quality and service.

Total Clean Air for a Guaranteed Secure Environment for your Critical Processes.

At Total Clean Air, we are committed to delivering top of the line Cleanrooms for the biotechnology industry, using our years of experience and skilled engineers. Our Cleanrooms have a proven record of reliability, quality, and industry experience. We offer first class cleanroom services, which include:

  • Budgeting and planning
  • Airflow and filtration design
  • Engineering, design and layout
  • Construction and installation
  • Industry specific equipment installation
  • World class service

At Total Clean Air, your contamination control requirements are our priority.

phillip.godden
Phillip Godden

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

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