Rayner Intraocular Lenses, the world-leading life sciences company, is the only manufacturer of intraocular lenses (IOLs) in the UK. It designs and manufactures IOLs and proprietary injection devices for use in cataract surgery and its products have been used to surgically restore the sight of millions of people worldwide.
The company is a member of the Rayner group, which has had interests in optics since it was established in 1910. The company has grown continually, now selling to more than 70 countries and it remains at the forefront of innovation. To support future growth, the company is moving to a new state-of-the-art manufacturing plant that will dramatically increase its production capacity.
The creation of this world-class facility, which is due to open in October 2015, has been a collaboration between Morgan Sindall Professional Services (MSPS), the multidisciplinary design consultancy, and Rayner’s internal resource. MSPS is providing architectural, civil and structural, process, mechanical and electrical, BREEAM and CDM services. With experience that has seen it design in excess of two million square feet of cleanroom space over the past 20 years, it is well placed to partner with Rayner to ensure the new facility delivers real value.
The team includes Mike Collins, a consultant project director at Rayner, Mark Dickson, sector director of life sciences at MSPS and David Downing, MSPS’s principal architect.
Facility requirements: Having predicted reaching maximum production capacity in its existing facility, Rayner put out to tender a brief that would future-proof its production capabilities.
In partnership with MSPS, Rayner will deliver a state-of-the-art manufacturing facility producing intraocular lenses for sale to markets worldwide
Implantable medical devices are subject to rigorous technical and quality standards, imposed by the regulatory authorities around the world. With this in mind, Mike Collins comments: ‘In partnership with MSPS, Rayner will deliver a state-of-the-art manufacturing facility producing intraocular lenses for sale to markets worldwide. The decision to base the facility in the UK is a tribute to the quality and productivity leap that will be achieved in this country.’
MSPS’s front-end engineering and process skills were employed to develop User Requirement Specifications (URS) and the multidisciplinary design solution was developed in a Buildings Information Management (BIM) environment, co-ordinated through the building design software Revit, such that MSPS could clearly and visually communicate the design’s attributes and benefits.
Part of the MSPS process engineering consultation included production of the Process Equipment Requirement Specifications, which included many complex bespoke items. This translation of critical user requirements, of both performance and validation, into detailed documents for the supplying vendors was successfully achieved with a collaborative approach, led by MSPS, with input from Rayner’s operations team. The equipment chosen will deliver the greatest efficiency and benefits to the business’s production.
The consultancy will support a phased occupation to take place, ensuring no interruption to production
The new development is close enough to Rayner’s existing facility to retain its highly skilled, specialised workforce and the consultancy will support a phased occupation to take place, ensuring no interruption to production.
CO2 and energy consumption: A key driver for Rayner was minimising the overall energy consumption that is often associated with ISO Class 7 and 8 cleanrooms. To achieve this, studies were undertaken to determine the most efficient and practical way of reducing CO2 and energy use.
The studies concluded that optimising the efficiency of the central plant and distribution systems, rather than significantly improving the fabric performance of the building, was the most efficient solution, due to the large amount of air that has to be conditioned and circulated through the cleanrooms. For this reason the following features were incorporated into the design:
- Reduction in specific fan powers by limiting the velocity of air within HVAC system components and by specifying ‘low pressure loss’ fittings
- All pump and fan motors over 1.1kW will incorporate variable speed drives
- All fan and pump motors will be minimum IE2 Class High Efficiency
- Variable capacity HVAC systems (capacity modulation depending on demand and night set-back air-change rates in cleanrooms)
- The low temperature hot water (LTHW) and chilled water system serving the HVAC equipment is a two-port system incorporating variable speed pumps to deliver LTHW and chilled water volume as required by the HVAC coils at any given time
- Selection of high efficiency chiller plant (i.e. plant will have a better Energy Efficiency Ratio (EER) than the minimum of 2.5 set out in the Non-domestic building services compliance guide)
- Selection of high efficiency boiler plant (i.e. plant will have a better gross seasonal efficiency than the minimum of 86% set out in the Non-domestic building services compliance guide)
- A low air leakage (permeability) for the building envelope has been specified – 5m3/(hr/m2) at 50Pa; this is half the minimum requirements of a new build
- Implementation of combined heat and power (CHP) to input into the building’s heating, process and power systems. This will only have an impact of reducing CO2.
Based on a CHP electrical output of 534,360kWh p.a., the CHP will provide 12% of the building’s total energy consumption. This exceeds the planning requirement of 10% energy provision through renewable energy. These also significantly contributed to achieving the BREEAM ‘very good’ status, a requirement of the UK Planning authorities.
Future capacity: The facility has been designed utilising lean manufacturing principles, which make processes more efficient with the systematic elimination of waste, adding overall value to a manufacturing facility for the duration of its lifecycle.
One of the disadvantages of building a lean facility, however, is that increasing capacity through further waste reduction is no longer an option, since nearly all waste should have already been eliminated. To resolve this, an innovative solution was devised where, by increasing the footprint of the initial processing area, it will be possible to increase initial capacity by more than 300% during the lifecycle of the facility, at minimal initial investment.
Further increases in both efficiency and capacity are already being worked on through process development
Further increases in both efficiency and capacity are already being worked on through process development. However, in this tightly regulated industry these changes can take considerable time and resource to implement. This solution allows Rayner the time to look at process development as part of a future growth strategy.
Maintaining a cleanroom environment – contamination: Unsurprisingly, when manufacturing products that are surgically implanted into the human body, contamination control and therefore retaining a cleanroom environment with not only particulate filtration, but also tight humidity control of the utmost integrity, is crucial. Design forethought into maintenance is therefore critical to ensure electrical fittings, for example, can be changed and machinery and equipment maintained without losing the integrity of the space.
Decisions were made early in the design process to enable the cleanroom areas to be easily maintained with minimum impact on the process equipment, and therefore the process flows.
Both process and build environment equipment and systems were categorised into one of the following:
- Direct impact – where failure directly affects product quality and/or safety (usually process equipment)
- Indirect impact – where failure may indirectly affect product quality and/or safety (HVAC and process utilities)
- No impact – where failure will not affect final product quality/safety.
All direct impact equipment and systems will be the subject of rigorous audit by the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). The audits will consider all aspects of the equipment, including maintenance. Standard operating procedures (SOPs) will be established for the operation and maintenance of such equipment, and to make the audit procedure as straightforward as possible, it is essential that processes are robustly carried out and reported.
The new building, due to open in October 2015, has been designed to achieve the BREEAM ‘Very Good’ status
In addition to the above, intelligent design has been used to reduce the risk of maintenance affecting systems indirectly in the following ways:
System redundancy – Critical systems have a level of in-built redundancy to ensure a backup of components and methodologies during failure and/or maintenance operations.
Locating maintainable devices outside the clean area – A full walk-on ceiling has been incorporated over the cleanrooms so that maintenance can be done from outside the clean area. Back access luminaires will be used so that they can be maintained from the walk-on ceiling.
Using remote control centres to monitor environment – Electronic monitoring will be installed to enable the environment within the cleanroom to be monitored and adjusted from outside.
Separating critical environmental management system (EMS) from building management system (BMS) – By separating the two management systems, the EMS, which is audited by the FDA and MHRA, can be regulated without an overhaul of the entire system.
Good Manufacturing Practice: This is key to the design of the new facility, and will be integral to all aspects of the building including its operation, the materials used and their cleaning and maintenance. Auditors will regard maintenance as a GMP risk, and so robust documentation will be used to mitigate that risk and assure auditors that the necessary steps are taken.
The required auditing of such facilities reaches far beyond the documentation for specific equipment review; for example, GMP regulations require ongoing proof that all employees are trained appropriately before they enter GMP areas to carry out maintenance. Training includes a thorough understanding of the need for policies, procedures and work instructions for all direct and indirect impact equipment and systems.
Mark Dickson says MSPS was chosen for its leading experience in complex manufacturing: ‘We have delivered a design that makes intelligent use of internal space to ensure increased output and a reduction in operating costs. Our design goes beyond building regulations to reduce energy consumption, which is detailed on a per lens basis.’
The design has been used to create an environment that promotes best practice. The end result will be a facility that supports the business in delivering intraocular lenses for sale in growing markets worldwide.