A Clear Light for a Fast World

Clean Modules Ltd. have completed a new facility at CTP Wipac’s Buckingham plant, for the manufacture of exterior lighting for prestige cars.
 
The plant is used to apply scratch resistant coatings to the intricately moulded front lenses, to improve durability and performance. The coatings have to be applied in a clean atmosphere, with close control of humidity and temperature. Once coated, the lenses are assembled under clean conditions, together with other components to form high quality, sealed, lamp units.
 
Clean Modules Ltd. provided the special coating equipment and air systems, as well as the Clean Rooms, using their capability to deliver more than just Clean Rooms.

"The new lens coating and assembly facility has enabled us to set world class standards for the manufacture of complex exterior lighting assemblies for some of the most demanding customers in the world. We are delighted with our new facility, which meets all of the requirements we set Clean Modules”
Neil Sibley, Business Unit Director, CTP Wipac Ltd.

Containerised Clean Room from Clean Modules Goes to the Antarctic
 
Clean Modules, the established supplier of modular Clean Rooms, have successfully developed a mobile Clean Room in a container for use in harshest of environments, the Southern Oceans around Antarctica.
 
The container Clean Room was specially designed and built for the Chemical Oceanography Department at the Leibniz Institut für Meereswissenschaften (ifM-Geomar) in Kiel, Germany, who are researching the role of trace metals on primary productivity in the ocean. The container Clean Room was used for the first time during EiFeX (European Iron Fertilisation Experiment), a mesoscale experiment in which algae growth in the iron-limited Southern Ocean was promoted by adding iron oxide (ferrous sulphate) to a 50 km2 study site. This approach has been suggested as a possible method to remove anthropogenic CO2 from the atmosphere and thus mitigate the effects of global warming.
 
The bespoke container accommodates two technicians and consists of an ISO Class 7 Clean Room with an ISO Class 5 Laminar AirFlow (LAF) bench, complete with anchor points to secure the contents, a Change Area and Plant Room with an Un-interrupted Power Supply (UPS).
 
Careful consideration was given to every aspect of design and construction: the room has a built in seawater sampling system and meets low trace element standards to enable sensitive scientific monitoring. To cope with the extreme environment in the Southern Oceans, serious thought was given to risk of seawater penetration and corrosion, not to mention the rough conditions on board the research vessel Polarstern. The module is certified as meeting the requirements of the American Bureau of Shipping offshore accommodation modules.
 
The container Clean Room went on its first mission in early 2004 and according to Dr Peter Croot, it “proved to be excellent at maintaining Clean Room conditions despite the environment encountered outside. During storms waves broke over the Clean Room and a neighbouring container was even stoved in 40-50 cm after a direct hit. The door of the Clean Room didn’t leak and this is a remarkable achievement in itself for the Southern Ocean. During the cruise we were able to collect and analyze open ocean samples with apparently little or no contamination, as demonstrated by low background iron concentrations of 10-100.

Pre-despatch shot of external container with door/air handling etc

Clean Room container (bottom rear) during its maiden voyage to the Southern Oceans on board Polarstern

ISO Class 5 LAF complete with anchor points to cope with severe weather

Clean Modules Provide Prestigious Turnkey GMP Clean Room Solution for UK Stem Cell Bank
 
Clean Modules, the experts in modular prefabricated Clean Rooms, have completed a major new facility that complies with EU GMP and has been accredited by the MHRA under the DOH Code of Practice for Tissue Banks for the UK Stem Cell Bank (UKSCB) at the National Institute for Biological Standards and Control (NIBSC) in Hertfordshire. This article highlights some of the key features of this impressive new facility, which is of international importance to the United Kingdom as a leader in the field of bioscientific research.
 
Effective Use of Modular Construction
Clean Modules won this major new contract because of their specialisation in the use of cutting edge modular construction techniques. This meant the project could be completed quickly, with the minimum of disruption to other NIBSC activities and to a cost-effective budget. An additional benefit, especially for this rapidly developing new research field, is the adaptability of the modules to cope with changing demands and the potential for expansion by extending the facility.
 
The building comprises three modules, which were constructed off-site and transported to NIBSC for installation and final fitting out. Meanwhile the site was prepared to receive the modules and the necessary services were installed. Managing the project this way ensured contractors could be supervised and required access to the site for only a limited period of time. This was an important factor for such a key research facility, with a reputation and image to maintain.
 
The finished Clean Room suite comprises of three Grade B (ISO Class 5) Laboratories, each connected by a special folding stainless steel transfer hatch and Change Areas to a Grade C (ISO Class 7) Common Service Area. A HEPA filtered Grade C stainless steel transfer hatch links this to the liquid Nitrogen storage area and autoclave. An outer corridor links the Clean Rooms to associated Office, Storage and Plant Areas and the NIBSC main building.
 
Specialist Air Handling Requirements
To meet the stringent demands of the UKSCB, Clean Modules had to design and install five separate air systems, complete with an uninterruptible power supply, that could all be controlled independently. The three laboratories each have their own dedicated air handling, as does the liquid nitrogen storage area and there is an extra system to provide additional peak airflow requirements, to meet safety requirements.
 
Within the Grade B Laboratory Clean Rooms, the Grade A air environment necessary to produce GMP compliant cell lines is maintained within Class II microbiological cabinets.
 
The independent air handling for each of the Clean Laboratories has three modes, including normal operation for the production of cell banks for therapeutic use and cell lines for research. A fumigation mode is employed to sterilise the facility, followed by a carefully controlled ventilation mode to complete a twenty-four hour cycle and ensure all the formaldehyde is removed safely.
 
Latest Computer Controlled Monitoring
In view of the significance of the work of the UKSCB, it was necessary for Clean Modules to incorporate a complete Facility Monitoring System (FMS) into the project. The clean room laboratories and storage area have sophisticated computer controlled data acquisition and monitoring which continuously checks room pressures, temperature and humidity.
 
To meet the latest Annex 1 and EU GMP requirements, each Laboratory has been equipped with separate continuous particle counting in the Grade A cabinets and Grade B environments. The FMS system also provides a comprehensive continuous monitor and record of room pressures and temperature, as well as the liquid nitrogen storage system, refrigerators and other process equipment.
 
The supporting FMS software has been validated to GAMP® 4 and CFR21 part 11. The system is operated from the facility office, with a direct link to the main site computer network for monitoring and alarm functions, with a capability of off site upgrades when required. This is something that Clean Modules are now seeing incorporated into many of the new project specifications they are currently building.
 
As a result of the extensive computer control systems, the UKSCB can electronically match the pedigree of cell lines to the conditions in which they were produced and stored and print hard copy for inclusion in the complete Quality Record.
 
Importance of Safety
Safety is also a key feature for the UKSCB and this is built into the unit with oxygen levels being checked continuously for depletion at all operational stages of the process. The staff are protected by CCTV and “lone worker” monitoring and each Laboratory has an individual panic alarm. The inclusion of an autoclave within the unit means all waste can be sterilised prior to safe disposal.
 
International Significance of the UKSCB
The Head of the UK Stem Cell Bank, Dr Glyn Stacey commented “The UKSCB is the world’s first public cell line banking facility of its type and has received many visitors from the UK, Europe and around the world. The Laboratories are capable of producing well-characterised quality controlled cell banks of the highest quality to enhance clinical research and support the development of new therapeutic treatments for a number of serious medical conditions.
 
The Head of Operations, Mr Steve Murray stated “Clean Modules were selected after competitive tendering. We have been impressed with their response and adaptability. The project has been completed to time and cost. The high standard achieved has made a major contribution to a successful accreditation by the MHRA, thereby enabling us to offer a first class service to stem cell research and therapy world-wide”.
 
Following the success of this key project, Clean Modules are already working on other related Clean Room applications such as Tissue Banks in healthcare and research institutions and they have recently completed a gene therapy laboratory for a UK NHS Hospital Trust.

1. Fast and efficient installation of the prefabricated modules ensured a cost-effective project for the UKSCB.

2. Facility plant room containing five independent air-handling systems and an uninterrupted power supply.

3. A Grade B Clean Room Laboratory with Grade A microbiological safety cabinet installed which has continuous particle counting and environmental monitoring.

Clean Modules Construct Major New Clean Room Building for Glan Clwyd Hospital Pharmacy
 
Clean Modules, the experts in modular prefabricated Clean Rooms, have constructed a major new free-standing two-storey Clean Room building for the Pharmacy Department at Glan Clwyd Hospital in North Wales.
 
The MHRA approved facility has three Grade B (ISO Class 5) aseptic suites, complete with isolators and laminar flow cabinets for cytotoxic and TPN preparation. To meet the latest clinical demands, the building also houses one of the first Gene Therapy Clean Rooms designed specifically for this purpose and incorporating a single pass air system to avoid any risk of cross contamination. These Clean Rooms are supported by Grade C (ISO Class 7) Preparation Areas, featuring specially constructed spray booths adjacent to the transfer hatches designed to minimise alcohol inhalation in this busy environment.
 
The building is constructed from fourteen pre-fabricated modules, making it one of the largest modular Clean Room facilities in the country. It also contains a non sterile suite for dry powder and wet ointment preparations. The two-storey design provides the space for Clean Room cleaning equipment, dry product storage and most importantly, a walk in Cold Store, to replace the previous need for multiple ‘fridges and provide more effective operation and stock handling. Other features include special access points for equipment removal and to provide emergency access for the Clean Room technicians.
 
The facility highlights the flexibility of modular construction to cope with demands in the general areas outside the Clean Rooms. Consideration has been given to access from the main hospital for both staff and patients using the Gene Therapy Suite. For this reason a lift has been installed together with a disabled toilet.
 
Clive Sparkes (Clinical Director IM&T) said; “The modular construction provided us with the best solution to our needs. The flexibility of this design meant we were able to find a suitable space in which to create the exact facility we required. Clean Modules took us through the process step by step, and minimised the disruption to staff, patients and visitors because the major construction went to plan and took only weeks to complete. We are delighted with the results; we have a superb new state-of-the-art unit, which is a comfortable working environment and which came in on budget.”

1. Completed building

2. Aseptic Preparation Room

3. View into Grade B laminar flow aseptic room from Grade C Preparation Room

Clean Modules Ltd. Provide New Purpose Built Aseptic Unit for Leeds Teaching Hospitals Deploying the Latest Gassing Sterilisation
 
Clean Modules Ltd., the experts in modular prefabricated Clean Rooms, have provided Leeds Teaching Hospitals NHS Trust with a brand new MHRA licensed aseptic unit. Leading the trend towards off-site new builds, the facility was constructed with dose banding and the integration of the latest gassing system in mind to deliver safe and efficient sterile processing.
 
Constructed within easy reach of both St James and Leeds General Infirmary, the 275m2 unit has dedicated Grade C Cleanrooms for CIvAS (Central Intravenous Additive Service), Cytotoxic and Sterility Testing each containing Grade A isolator cabinets.
 
These utilise new hydrogen peroxide gassing technology in the form of a Bioquell rapid gassing Clarus Port. This connects to two La Calhene 4-glove isolators fitted with bagging out systems to create a streamlined CIvAS unit. To maximise this investment, specialist ducting has been installed enabling the Cytotoxic and sterility test isolators to also be gassed.
 
Clean Modules Ltd. designed the unit to incorporate designated space for preparation, storage and quality checks. Due to its scale, careful consideration had to be given materials flow, through passthrough areas and transfer hatches. This resulted in the creation of a central quality inspection and sterility testing resource immediately adjacent to the production areas.
 
Emphasis on Healthcare Clean Modules Ltd. used their experience in the construction of over 30 hospital and healthcare cleanroom suites to manage this project. This experience, of aseptic processing in particular, helped ensure Leeds Hospitals were guided through the complete development, from concept to validation and MHRA approval.
 
Commenting on the Clean Modules role; Ian Goss, Chief Pharmacist said: "Clean Modules demonstrated their knowledge of the NHS and the inspector to bring about our new unit on time and to the agreed budget."
 
Mark Jackson, Quality Manager added; "Clean Modules have guided us through the complexities of a new build, their advice on layout, and the integration of the gassing system made the project much easier to achieve."
 
Clean Modules Ltd. specialise in the design, construction and project management of Clean Room installations, controlled environments, clean air and conditioning systems. Clean Modules Ltd. has grown dramatically in the last ten years and now has six project engineers and three full construction teams on site.

Work sheet prep. area	Inspect and label
View from warehouse to Cleanroom	Civas cleanroom with gassing

Clean Modules Create Market Leading Stem Cell and Fertility Facility in Sheffield
 
Clean Modules, the experts in modular prefabricated Clean Rooms, have completed a groundbreaking facility that combines stem cell research with clinical Invitro Fertilisation (IVF) treatment. Believed to be the first in the world, the unit includes EU GMP Grade B cleanroom laboratories together with Grade C operating theatres in a layout designed to optimise the complex workflow.
 
Built in a restricted 270m² site within the Jessop Wing of the Royal Hallamshire Hospital for the NHS and University of Sheffield, Clean Modules had a difficult brief and very tight sixteen week timescale to meet the demands of IVF patients waiting for treatment. The commission was for the complete package from planning, project management, build and full IQ OQ PQ validation.
 
Professor Harry Moore stated; “Clean Modules have created a pioneering new facility that will become the benchmark for other stem cell research centres in the UK and worldwide. We are delighted with the results for both the University and the Hospital." Senior Embryologist, Rachel Cutting added, “The facility provides our patients with the considerate and straightforward approach, yet behind the scenes there is a complex cleanroom facility delivering a much needed service.”
 
Expertise in Stem Cell Facilities
Clean Modules utilised the experience gained constructing the flagship UK Stem Cell Bank (UKSCB) at the National Institute for Biological Standards and Control (NIBSC) to design and build the facility. This included interpreting the standards governing fertilisation and embryology and MHRA approval.
 
Patient confidentiality was another critical consideration built into the design.
 
Effective Use of Modular Construction
Clean Modules won this major new contract because of their specialisation in the use of cutting edge modular construction, which meant the project could be completed quickly, with minimal disruption to other hospital activities and to a cost effective budget.
 
The finished facility comprises of two segregated areas controlled by proximity card access. The clinical side includes two Grade C (ISO Class 7) Operating Theatres for egg retrieval and embryo transfer with bespoke one way transfer hatches connected to the culture preparation and IVF laboratories.
 
The research side has six Grade B (ISO Class 5) cleanroom laboratories each dedicated to a specialist task. In the Stem Cell Laboratory, Embryology, Andrology and Micromanipulation rooms, Type 2 Grade A safety cabinets are used to provide safe clean working environments. The Cryo Preservation Laboratory is equipped with controlled rate freezing and Dewar liquid nitrogen storage to hold stem cells prior to use.
 
Latest Computer Controlled Monitoring
To meet the stringent requirement covering stem cell research, including a stand alone air handling system, Clean Modules installed a complete Facility Monitoring System (FMS) validated to GAMP®4 and CFR21 part 11. This sophisticated computer controlled data acquisition and monitoring system continuously checks particle levels, room pressures, temperature and humidity in the cleanrooms. A consequence of the development in monitoring systems is the absence of traditional Magnehelic pressure gauges.
 
The FMS system also monitors the liquid nitrogen storage vessels, freezers, refrigerators, incubators and gas levels to ensure conditions are optimised for cell preservation. Variation outside set parameters is covered by an alarm system monitored twenty four hours a day within the main hospital.

Official opening by Professor Colin Blakemore (Head of Medical Research Council) with Professor Bill Ledyar & Professor Harry Moore (Sheffild University) and Dr. Glyn Stacey (Director, Stem Cell Tissue Bank, NIBSC)

Professor Colin Blakemore viewing the stem cell lab at the official opening with Professor Harry Moore, Professor Bill Ledyar and Dr. Glyn Stacey

Stem cell laboratory	Andrology laboratory	Egg receiving facility
Embryo Implantation Theatre with HEPA filtered zone	Micromanipulation lab