Understanding the requirements
It is important to understand the overall scope of the project and the size and type of clean room suite needed. You will need to determine:
- the expected product range and capacity of the new suite
- whether a MS licence will be required, or whether the clean room suite will operate as an unlicensed unit under Section 10 exemption
Early engagement with clinical users is essential to ensure that current and future service needs are fully understood. This will determine whether the new clean room suite will provide a continuation of existing services only, or whether an expansion to the range or capacity is required.
The potential impact of future changes must be considered at this stage, for example:
- future developments of services by the NHS Trust, ICB or Health Board
- merging or transfer of services from other sites
- collaboration between other organisations within local networks
- new product types, for example ATMPs (consider link to ATMPs resources), biologicals that may be needed as part of future services
The user requirement brief
The overarching requirements are documented in a user requirement brief (URB). This provides a high-level summary of the user’s needs and forms the basis for initial contractor engagement. It provides the basis for the User Requirement Specification (URS), which will be developed later in the project and outlines:
- regulatory requirements
- project scope (including product range, staffing, facility classifications, and timelines)
- process flows
- equipment needs, such as clean air devices
- any Quality Control equipment
- the qualification requirements
The sections below explore the considerations that will inform your URB.
Meeting Annex 1
The 2022 version of Annex 1 EU GMP describes the current expectations of the Medicines and Healthcare products Regulatory Agency (MHRA) for the environment required for the preparation and manufacture of sterile medicines.
Although this is primarily for Specials manufacturers, services operating under Section 10 exemption should also conform to the requirements of Annex 1.
The article about responding to Annex 1 EU GMP changes (SPS page) (registration required) highlights changes from the previous version (2007) and includes MHRA responses to some common questions. Several of these relate to the incorporation of various technologies including gassing isolators, continuous air pressure monitoring and ventilated transfer hatches.
Understanding current technology
Visiting some recently completed pharmacy clean room builds is strongly recommended, to gain an understanding of how newer facilities operate and what might be possible or desirable in your new suite. During the visit you may observe technology, for example automation, transfer sanitisation, process flows and control systems, that will allow informed design decisions to be taken.
Options for new builds
Options for delivery of the new build will then be considered. These could include:
- strip out and replace in current location
- build in another location on the same hospital site
- build on another site owned by the Trust
- build on a new site not on current Trust property, for example a modular build in warehouse style commercial property
All options carry differing risks, benefits and costs and will affect the logistics of running the future service. Project constraints will include the physical space available at each location, as well as limitations on time and budget.
Projects undertaken on Private Funding Initiative (PFI) sites may have additional operational and contractual considerations. Seeking advice from recently completed PFI builds is recommended.
Service continuity during the project
Where a refurbishment of an existing suite is planned, the impact of an extended period of downtime for the existing service must be considered. The costs of purchasing out-sourced products will be considerable and should be factored into the overall business case.
It is also essential to plan for dependencies, such as the sequencing of construction phases. Whether the existing unit can remain operational during the build and commissioning of the new suite will depend on the option chosen.
If building in a new location, the existing service can often continue as normal, but the time and effort required by the senior aseptic team to oversee the new build is considerable. The impact on the capacity plan for the existing service should be assessed and additional staffing resource considered.
Space requirements
Consider the size and nature of the service and how many clean air devices (CADs) you will need. A good starting point is to look at your current capacity plan. Consider facility down time and the future demands on the service.
Location, location, location
When identifying your site, consider where the service users are located and how this will affect delivery times for urgent or short shelf-life products. Consider transport times, delivery costs and the efficiency of the service overall.
Support services and utilities
For all sites, including refurbishment of existing facilities, consider critical risks to the suite arising from drains, sluices, toilets and washrooms either above or below the suite. In ageing NHS hospital buildings, existing services may not appear on any current drawings held by the Estates department and only come to light once the strip out of existing fixtures has commenced. These can cause project delays and additional costs. If not adequately removed as part of the build, they can cause service disruption and risks to products and patients throughout the life of the new suite.
When planning to use a new site, particularly an industrial site not previously used for this purpose, consider the ability of the site to support the service. This includes assessing the adequacy of the electrical supply, mains water and drainage to the site.
Workforce considerations
Consider workforce requirements both during the build project and once working in the new facility.
During the project
Workforce requirements will vary throughout the project. A considerable amount of senior staff time will be required from the beginning of the project throughout planning, building and throughout each validation stage.
During the early stages the impact of implementing the new build can be particularly intense for the senior aseptics staff, where planning and reviewing design proposals are critical.
Once the new suite has been handed over to the local team, the Performance Qualification (PQ) stage involves much of the wider aseptics team. This is the stage where standard operational procedures (SOPs) are developed, staff are trained in the new unit and operations are validated. The involvement of all operational staff is significant and many units report difficulties in maintaining the service from the old facility during this time. Planning for staffing during the PQ phase is therefore vital.
Working in the new suite
The way in which staff will work in the new suite is likely to change. Arrangements for entering and leaving the suite, including gowning procedures, will be compliant with the latest GMP standards and may take more time than in your previous unit. The numbers of support staff and supervisors required to operate in the new unit may differ depending on the layout.
During the planning stage, it is advisable to assess the staffing requirements needed to optimise both capacity and workload delivery in the new suite. This assessment will be required as part of the business case. Additionally, the proposed service opening hours and staffing complement should be carefully considered to ensure sufficient time is available for maintenance, cleaning, and validation activities.
If your new clean room suite is to be in an off-site location, not adjacent to the hospital facilities, consider how your proposed workforce will reach the site, and how recruitment or retention may be affected. For these reasons it is important to socialise plans and communicate potential changes to staff members early in the planning process.