Setting up a modern analytical laboratory to meet current pharmaceutical challenges

When designing a new analytical laboratory, whether the project is a complete new build or the repurposing of existing space for a new use, it’s essential to carefully consider and plan numerous aspects of the facility

Although many of these points may seem obvious, overlooking them can lead to a delay in the build or, worse, an inefficient end result. At the outset, it is important to define exactly what analytical services will be required from the laboratory to plan properly for the instrumentation, space and computer systems needed to support those services. Additionally, one must ask what additional items will be required to support the instruments, such as software and hardware qualification, as well as considering the transfer, revision or implementation of standard operating procedure (SOPs). Importantly, once these are defined, it’s important to assess whether the projected budget matches the vision for the laboratory’s capabilities.

Additional considerations must be made in some circumstances, including whether the laboratory will be servicing internal clients or those from elsewhere. This will determine the outputs from the laboratory regarding how to meet the requirements and expectations of those clients.

When repurposing an existing space, it is particularly important for upfront planning to be done carefully, including a thorough evaluation of existing physical aspects such as heating, ventilation and air conditioning (HVAC), electricity supply, plumbing and the building infrastructure. This will allow the build and/or the move to go smoothly and efficiently … and without large amounts of disruption or unforeseen costs being incurred. From a budgetary standpoint, the more detailed a vision is laid down at the outset and the more thorough the initial groundwork is, the better. It is important to envisage when delays and issues may arise and make plans for contingency actions. Factoring all these items into timescales and budgets will give a project manager greater control of the project, while simultaneously providing the opportunity for most of these situations to be prevented. This will minimise the number of changes to the plan once the project is under way.

Phase one: funding and planning

The planning process should get under way at least 6 months before the laboratory is scheduled to go live. At the outset, the funding levels required to achieve the desired scope of the project should be established and, as mentioned, key to success here is a detailed understanding of the laboratory’s purpose and its expected services and deliverables. These will direct the instrumentation that will be required within it, and the amount of space that will be necessary to ensure the full complement of staff can work efficiently and comfortably. Compatibility with current or future planned computer data systems is also important. The more complete the vision of the finished lab, the easier it will be to get it constructed and running on time and within budget.

With the basic plan in hand, conceptual drawings indicating the eventual locations of everything from water and utility lines and power supply to computers and instruments can be created. This is always a more extensive (and intensive!) exercise than might be imagined at the outset. As well as large infrastructure items such as transformers and HVAC, there are decisions to be made such as whether to reuse previous cabinetry or invest in new, or whether to stay with existing, familiar instruments and software or opt for new equipment. Retaining the same instrument supplier will avoid having to retrain analysts, and existing spare parts should be directly usable. As with other capital expenditure processes, it is always advisable to get at least three quotes for everything to assess the cost and “value” of investments.

If new analytical instruments are chosen, then there may be knock-on additional requirements such as revising SOPs or possibly even writing new ones, as well as considerations regarding equipment qualification efforts and documents. If these are not in place in good time, there is a risk that there will be a fully functional laboratory that cannot be used — as it is impossible to qualify the instruments for good laboratory practice (GLP) and good manufacturing practice (GMP) purposes without suitable SOPs. The process of installation and qualification should be addressed well ahead of the scheduled opening, as well as considering compatibility with current or planned computer data systems and software.

Less tangible issues must also be considered, such as software and data integrity, and also validation requirements. In some cases, additional investment may prove to be cost-saving down the line. For example, although a state-of-the-art glassware washing system may cost in the region of $50k, it takes just an hour to take glassware from dirty to dry — compared with several days with some less expensive or more basic systems. The upfront investment, although costly on paper, not only saves a lot of time but also reduces the outlay on glassware while simultaneously accommodating for potential future expansion.

Phase two: revising and executing plans

As the project gets under way, perhaps 2–4 months ahead of the laboratory’s go-live date, fine-tuning these initial plans is essential to keep progress moving on and avoid the need for rework. It is at this stage that keen observation and insightful thinking will pay dividends when meeting planned timelines. There are many moving parts and doing everything at the right time, and in the right order, is essential.

Keeping rework to a minimum will reduce the likelihood of budget overruns. It is therefore important for the facility manager to keep on top of all the contractors’ activities and carefully co-ordinate the building/installation of walls, floors and ceilings with the piping, drainage, electrical works, HVAC and so on. Items such as an uninterruptable power supply, computers and cabling, and the location of lab benches and fume hoods must be considered. Even auxiliary items such as a refrigerator, a microwave, sink and filtered water in the break room require advance planning.

Cambrex’s facility in Charles City (Iowa, USA) is located on a 45-acre site and manufactures a wide range of APIs and pharmaceutical intermediates, including highly potent molecules and controlled substances

The timing of inspections must also be co-ordinated if the building’s Certificate of Occupancy — or equivalent outside the US — is to be granted in time for laboratory operations to start. Staffing should also be considered at this stage, as it takes time to interview and hire the right people if the work represents an expansion from existing capabilities.

Phase three: the plan comes together

In the month or two before opening, the hard work and planning done during the earlier stages start to come to fruition. Readily available commonplace laboratory items such as glassware, consumables, balance supplies and chemicals are ordered during this time, but there may be some last-minute items, which may be important but not necessarily critical, that will come to light. These will often be items that one takes for granted and may have been missed off initial budgets, such as lab stools or printers, or specialty chemicals or other materials.

This is why it is important to have a contingency fund so such omissions can be remedied without exceeding the budget. However carefully everything is planned, something is always missed. But the greater the detail and thought involved in that planning, the less impact on the budget this is likely to have.

At this stage, the preplanned co-ordination of relocating people should be under way. When will they start in the new lab and what capabilities need to be in place to provide them with a viable work environment as quickly as possible? How can work output be maintained during the move? And if this is an additional laboratory, rather than a replacement, how will staff in the two locations communicate with each other, particularly if they are some distance apart?

Phase four: going live

At this stage, all of the major equipment and instruments should have been installed and qualified for GMP use, complete with fully approved SOPs. The laboratory spaces will be appropriately stocked to allow for proper workflow, with staff in place doing analytical tests.

However, this is not the end of the process. Once the lab is occupied and in operation, it is important to take stock of what happened to inform future planning processes.

The different stages of the project should be revisited to determine whether any improvements in planning might have made a difference to the time or cost of the project. That way, the next time a similar project is undertaken, it should be easier, quicker and more cost-efficient, with fewer items required for a fully functional laboratory being missed. Detailed planning and careful execution of those plans are key to a smooth operation.

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Cambrex (more information, website)