High Tech Manufacturing

High Tech Manufacturing

Functional performance. Optimised solutions.

Connect 2 Cleanrooms provide world-leading organisations with critical environments for advanced manufacturing. Our modular cleanrooms create controlled manufacturing conditions to ISO 14644, facilitating the production of a reliable and consistent product that is predictable in performance.

With an end-to-end service, our multidisciplinary team design, deliver and commission complete cleanroom systems, undertaking full project management and ongoing maintenance. Decades of experience in functional and mechanical system design, means the technical specification and reliability of our cleanrooms is second to none.

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    Design & Project Preparation

    Through collaborative consultancy in the design and engineering phase, our team of in-house engineers will deep-dive into your process to develop the right structural and mechanical system design to deliver results for you.

    When transforming your URS into a functional and detailed design specification, our team will balance operational requirements, workflow optimisation, running costs and building regulations, resulting in a fully optimised solution.

    We will create a seamless interface between your facility and cleanroom, using Building Information Modelling (BIM), point cloud surveys and CFD airflow modelling to plan performance with exacting accuracy. With technical 2D designs and virtual 3D renders, we’ll offer you a preview of the entire facility before it is built, allowing you to visualise and integrate workflow and layout.

    Working to the latest BIM standards, we operate with increased levels of coordination, through clash detection and prefabrication. Our off-site construction offers a more accurate and timely installation ensuring cleanroom projects are completed on-time.

    Conceptual design

    Conceptual design is the very first stage of the cleanroom design process, where layouts and other models, such as renders, are used. It is a draft consisting of ideas and concepts about what space the room should offer, including:

    • The required classification(s)
    • The type of control of specific parameters such as differential pressures, temperature and humidity
    • Whether to apply dedicated or segregated zones
    • How to best facilitate internal logistics of people and products

    This phase allows you to evaluate the proposed specification. We will work collaboratively with you to achieve the right combination of operational parameters that will deliver results.

    Detailed design

    In the detailed design phase, the ideas and concepts evolve to concrete plans, required specifications and exact definitions of dimensions, materials and components, defined in a User Requirement Specification (URS).

    The initial URS defines the processes, equipment, operations, capacities and the environmental criteria for the cleanroom design. In the URS, designers need to review the flow of people and products through the facility to assess the optimum layout for regulatory compliance, efficient operation and the minimisation of cross contamination opportunities.

    It is vital that relevant personnel from production, quality, logistics, maintenance and engineering are involved in the early stages of the design. This avoids reworking of design layouts and minimises costly errors by overlooking or misinterpreting practical issues.

    Once the URS has been approved, the functional design specification (FDS) will be developed.

    BIM

    Our team of Autodesk certified design engineers carry out designs following the latest BIM standards and workflows. By working in this way, we are able to collaborate with clients and coordinate with any other contractors involved in a facility build, resulting in greater accuracy and higher quality results.

    Using modern surveying equipment, we 3D scan the current environment of our client’s facilities and carry out clash detection to verify that the proposed cleanroom design operates in line with the planned process and its surrounding environment.  2D and 3D models allow our clients to visualise their project, including virtual reality walk-through tours to test the layout and workflow.

    Due to the structural and mechanical requirements, cleanrooms are complex systems. By applying Design for Manufacture and Assembly (DfMA) principles, we are able to manufacture and assemble more efficiently. This improves the installation experience for our clients, resulting in smoother project management and a shorter project lifecycle.

    Digital Modelling

    The time to embed performance and sustainability to a cleanroom design is at the front end of the process. 

    C2C use digital modelling to assess the interrelationship between process, plant and equipment, verifying the accuracy of a technical solution, before we manufacture and install the room. Every cleanroom, whether it is being retrofit or as part of a complete new build, needs a seamless interface with its surrounding facility.

    A 3D building information model helps optimise a cleanroom design solution. 3D laser surveys enable our design engineers to ensure that the design solution provided is fully optimised to accommodate any existing mechanical and electrical interfaces or existing building layout requirements.

    Airflow Modelling

    CFD Airflow Modelling is used to demonstrate that air-flow patterns do not present a contamination risk. Cleanroom materials, leakage rates, oxygen requirements, exhaust volume and speed as well as air inflow are calculated and balanced to ensure exact requirements are delivered

    The example on the right shows the calculations and modelling to determine the quantity of fan filter units (FFU) required in a GMP facility: 45 FFUs against 60 FFUs.

    The off-site construction method can be used for a variety of cleanroom purposes including large open spaces with no internal supports. Using pre-fabricated panels, apertures and fixtures are prepared off-site to minimise time, reduce safety risks and reduce the need for specialist trades on site, e.g., electricians. Door systems are delivered as hybrid systems with frame handles, glazing and interlocking systems in place.

    As a more cost-effective solution for clients, the off-site method allows you to stay within your allocated budget and control lead times, as decisions are made well before the installation date. More time is allocated to the complex and critical design stage. This ensures accuracy and reduces the installation time on site, which minimises business disruption, as well as offering a cleaner, safer and less congested site.

    Off-site construction offers a more accurate and timely installation with less chance of failure, with all elements being tested prior to delivery to site ensuring these cleanroom projects are completed on-time and within budget.

     

    Materials, Air Handling & Controls

    Over the years, we have developed proven envelope solutions and reliable HVAC concepts for many applications. Our complete systems meet the required ISO classification, as well as qualification to international engineering and building standards and regulations.

    Structural and mechanical system design is essential to achieve functional and regulatory compliance. Our cleanrooms deliver the highest quality with controlled running costs. Each one features an air handling system that is optimised for the intended application and operates with redundancy to improve reliability.

    Our ECO2 environmental monitoring and control system helps simplify all aspects of cleanroom management. It allows control of the full range of cleanroom auxiliary items to achieve optimum conditions for lighting, temperature, humidity and particle counts. Users can remotely control and monitor multiple rooms, and it can be integrated with existing facilities management systems and business management systems.

    The UltraTech Versatile panel system creates a versatile technical solution to suit a range of industries; from aerospace to nanotechnology. The insulated panels come in variable widths and heights to suit layouts, making it a flexible solution for an ultra-tight system.

    The UltraTech Versatile range includes doors, windows, lighting, profiles and service conduits and  electrical raceways to create a flush interface between wall panels where a service cavity is required, providing you with a fully integrated envelope solution.

    The panels are 100% inspected for quality and utilise CLEANsafe coating to give a fully smooth finish. Panels are tested to withstand rigorous cleanroom cleaning procedures and products.

    When combined with C2C’s advanced cleanroom design and efficient decentralised air handling, the panel envelope system creates a market-leading and regulatory-compliant cleanroom environment.

    Why Choose UltraTech Versatile?
    • Semi-flush and fully flush integrations
    • Choice of cores – QuadCore, ECOsafe PIR, MF core or Aluminium Honeycomb
    • Wide range of CLEANsafe coating systems
    • HYGIENEsafe anti-bacterial coating option
    • FM rated, dependant on thickness and core
    • Integrated envelope solutions - doors, windows, technical panels, profiles and other components

    The HVAC system is a vital component to deliver the level of compliance required in a controlled environment.

    An effective cleanroom must deliver a high-volume of air through filter media to remove particulate and, where applicable, microbial contamination. The supply air may also need to be temperature and humidity-controlled to support the process needs and the ventilation requirements of all cleanroom staff.

    What is decentralised air handling?

    Decentralised air handling requires no central air handling unit (AHU). Instead, it features the constituent parts of an AHU, broken down into separate pieces of plant. Fan filter units (FFUs), temperature control units and dehumidification modules are distributed locally.

    Once seen as the prerequisite plant for compliance, the AHU is ever more frequently being replaced with this decentralised approach. Benefits range from reduced construction costs and complexity, to an increase in usable footprint and flexibility.

    Benefits include:

    • Energy Efficiency
    • Modularity
    • Individual Controls
    • Plant space
    • Lead time
    • Flexibility to change specification

    The ECO2 cleanroom control system was developed by Connect 2 Cleanrooms to provide optimised automatic cleanroom control and monitoring.

    The flexible system can be incorporated during the cleanroom design phase, but can also be quickly and easily retro-fitted or scaled up if the size of a cleanroom needs to be increased.

    The system is designed to minimise energy use, extend filter life and allow the simple control of modular cleanrooms, creating a culture of continuous improvement.

    Real-time visibility

    Our ECO2 control system gives real-time visibility on a cleanroom’s performance by monitoring pressure differentials, temperature, relative humidity, particle counts and other requirements.

    Complete cleanroom control

    The digital, touch-screen panel – which can be operated while wearing lab gloves – allows control of the full range of cleanroom auxiliary items, including fans, lighting, temperature, humidity and more.

    Control access is set using predetermined access levels to prevent unauthorised access to critical controls. The system can be operated on a timed setup allowing power saving outside operational hours.

    Continuous monitoring with alarm function

    Continuous monitoring is provided through remote sensors that are located in the critical points of operation. The system is set up to alarm if any monitored parameters vary outside of a user-specified threshold. This enables set limits to be continuously monitored and flagged if there is an excursion.

    SMS or email alerts can be sent when an issue is detected, for example if an element of the cleanroom is in need of service or falls outside defined operating parameters. This is accompanied by a visual on-screen warning for added peace of mind.

    Data

    Fully auditable data, with trends as well as real time data that can be extracted in as little as two minutes.

    Batch control

    Clients can record batch ID against datasets, making it suitable for full audit trail requirements for traceability of data.

    Digital, touch-screen control

    The Human Machine Interface (HMI) is a full colour Touchscreen, displaying cleanroom status. The HMI allows clients to monitor and control all environmental parameters within the cleanroom environment.

    • Touch-screen has IP54 rating
    • Icon-based, intuitive interface
    • Password protected
    • Program reminders for service
    • Provides remote diagnostics
    • Integrate with existing facilities management systems and business management systems (BMS)

    Commissioning & Qualification

    The final qualification of your room is more than just a procedural finish of the build. Applying Good Design Practices, Good Engineering Practices and Good Documentation Practices, this final step closes the loop, verifying the Performance Qualification against the agreed URS.

    In the commissioning phase we will verify the mechanical completion, verify and execute Factory- and Site Acceptance Testing and continue with a formal Installation- and Operational Qualification. While commissioning can be viewed as primarily an engineering test, qualification testing is directed with oversight from the quality assurance team.

    After the Performance Qualification we will provide you with a technical Validation Report and deliver your qualified project within time and on budget.

    Commissioning verifies that what was specified in the URS and FDS was installed and that it functions properly. The primary objective is to verify the engineering requirements and specifications as stipulated in the URS and FDS.

    This phase is typically split in activities referred to as Factory Acceptance Test (FAT), Site Acceptance Test (SAT), and Installation Qualification (IQ).

    Factory Acceptance Test

    A Factory Acceptance Test (FAT) is a process that evaluates any bespoke or customised equipment during and after the assembly process, by verifying that it is built and operating in accordance with design specifications.

    Site Acceptance Test

    A Site Acceptance Test (SAT) is a tool to determine the functionality of the equipment at site before installation.

    Installation Qualification

    Installation Qualification (IQ) is a documented process that ensures your facility and equipment provide what is required.

    Examples of what may be included are:

    • Checking room sizes and room finishes
    • Checking floor colours in different graded areas
    • Checking presence of vision panels into rooms

    IQ also includes the examination of equipment, to check it corresponds with documentation. We will perform a check, which is then verified by you to ensure both parties are confident that the key architectural and functional components of the system are present and satisfactory.

    Next, the validation or qualification process is executed in order to demonstrate that the facility, air handling components and equipment perform as specified in the project design documents.

    The primary objective is to verify and document that the facility, systems and equipment that have a direct impact on product quality are rigorously tested and performance is consistent within the defined parameters, and that all of this is well documented.

    Operational Qualification

    Operational Qualification (OQ) is a documented program to demonstrate that the Cleanroom, when operating within the defined parameters, can consistently perform and maintain the specified conditions.

    In action, this means identifying and inspecting facility and equipment features that can impact final product quality.

    The OQ should cover worst case scenarios. For example, if the cleanroom still operates correctly at the minimum and maximum temperature and humidity limits specified in the URS.

    During OQ, each test must be carried out individually. For example, if the same sensor is used for temperature and humidity, our test engineers will test these functions separately.

    The output of this phase of qualification is an OQ report detailing how the functional requirements of the cleanroom meet what is specified in the URS.

    Performance Qualification

    Performance Qualification (PQ) is usually the final step in initial qualification.

    For the initial Performance Qualification our test engineers will repeat what has been done at OQ but now under load, rather than as built.

    For a cleanroom particle count, this would be Operational, as opposed to At Rest. For a piece of equipment, e.g. a freezer or incubator, it would be working with its typical load, rather than being empty.

    Ongoing Performance Qualification requires a repeat of the initial testing on the cleanroom to ensure that its operation continues to meet initial requirements as the facility ages. This is also described as requalification or re-validation. It provides an ongoing assurance that facilities and equipment continue to meet their original specifications.

    ISO 14644-2 recommends to complete risk assessments and monitoring plans to determine the frequency of testing and validation to their individual processes. The suggested maximum time interval between airborne particle concentration testing of a cleanroom of ISO class 5 and below is 6 months and ISO class 6 and above is 12 months.

    Tests may include but not be limited to:

    • As built/At rest Particle Counts
    • Air Volumes and Air Change Rates
    • Filter Integrity Testing
    • Pressure Differentials
    • Temperature and Humidity Levels
    • Recovery Rate Testing
    • Smoke Visualisation Airflows
    • Containment Leak Testing
    • Light (Lux) Level Testing
    • Sound Level Testing
    • Door interlocks Testing

    Are you about to start a High Tech Cleanroom project?

    Get us involved and we will guide you through your project step by step.