Facility Design and Operation: A Primer - NIBRT's Michael Lacey provides an overview of biopharmaceutical facility design and operation. - BioPharm International

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Facility Design and Operation: A Primer
NIBRT's Michael Lacey provides an overview of biopharmaceutical facility design and operation.

BioPharm International
Volume 26, Issue 2, pp. 46-51

WATER SYSTEMS

BioPharm: What considerations does a company need to consider with setting up and maintaining biopharmaceutical plant water systems?

Lacey: Pharmaceutical water technology is well established with a large number or reputable and capable designers and providers available. For purified water (PUW), a good system will invariably include reverse osmosis (RO) and electrodeionization (EDI), with ozone as a sanitizer. It is critical that the raw water is carefully considered and factored into design; not enough attention is given to the quality of mains water and the pre-treatment of it. I can highly recommend ultra-filtration (UF) as a pre-treatment technology, we have installed this in NIBRT with excellent results. For water for injection (WFI), distillation is mandatory in Europe and almost the norm everywhere. It's important to get the system sizing correct, especially if considering multiple-effect stills. For maintenance, it is important to get specialist help from the vendors; however, I can't over-emphasize the importance of comprehensive in-house monitoring by doing daily and weekly checks, this is a basic form of condition-based monitoring and is very effective.

Environmental aspects of water systems can be somewhat overlooked. We have talked about energy wastage; however, we also use and waste quite a bit of water in this industry. Pharmaceutical plants are generally metered by local authorities and they are charged by the cubic meter for water. This can be wasted in fairly innocuous ways. For example, PUW or WFI distribution loop pumps usually have "flushed" mechanical seals and the flushed water goes down to drain. It will look like a small flow, but this can drain a large tank over an extended period over 24 hours. The same applies to ozone sensors that are also flushed. So we waste a lot of PUW and WFI, which costs money, and depending on the location and the type of water plant, the cost can be very high—PUW is estimated to cost more than 60 cents per litre, WFI is more expensive, and so consider the cost of the loss of a 10,000 litre tank.

In terms of process, clean-in-place (CIP) is a common technology used in biopharmaceutical plants. It has the significant side benefit that it uses water efficiently. This technology is repeatable and reliable.

Of course we use water for more mundane reasons also e.g., drinking, washing, toilets etc. There are automated water controls that can be well utilized to save on water and cost.

GMP CERTIFICATION

BioPharm: GMP certification is important for the industry. What key GMP and cleanroom considerations need to be kept in mind if a company is trying to obtain GMP certification for its facility?

Lacey: The key points in terms of GMP are that the facility must suit the operations being carried out and must minimize any possibility of errors and contamination. Achieving this is all about adopting best-practice conceptual and detailed design, and so the design process is crucial. Assuming the right teams are in place with the appropriate skills and experience, the current building and process technology is such that, while it is an onerous task, it is relatively straightforward technically to build and validate a facility. Given the nature of our business, a somewhat conservative approach is best.

The increase in single-use and containment technologies offers opportunities. Where before critical operations may have taken place in a Grade A environment with Grade B background, newer technologies means that we can use rooms with a lower classification which are more cost-effective to build, maintain, and operate due to reduced energy usage, filtration requirements, and so on.

BUSINESS CONTROL

BioPharm: Control of facilities and their operations is crucial as is communication throughout the plant. Could you comment on these aspects based on your experience?

Lacey: I take this to mean "business control". In general, a company must have business systems that work well together, including planning, production, quality, and asset care. Systems should be integrated as far as possible with the same objectives.

In more specific areas, staff training is crucial in the biopharmaceutical environment. Companies must teach people upfront how to behave in a critical environment. Operators need to learn "off-the-job" so that less mistakes are made "on-the-job". The problem with training on the job is that mistakes can spoil or contaminate costly batches of product. So not only must companies train people upfront, but they must continuously carry out refresher training.

We also need to consider automation when talking about business control. The industry tends to think of automation in terms of direct control of specific equipment and processes, but a wider view should be taken. The larger multinational firms are well aware of this and practice such an approach. Automating business processes through the use of financial planning and control systems can help management at the higher business level, for example enterprise-resource planning (ERP) systems such as SAP.

At the process and equipment level, automation has been a feature for many years, with distributed control system (DCS) and supervisory, control, and data acquisition (SCADA) systems such as Delta V being commonplace. However, manufacturing execution systems (MES) are being increasingly used to bridge the gap between the high-end and low-end systems, providing shop-floor control of processes, and delivering strong benefits such as electronic batch records (EBR). Companies should avoid "islands of automation" and instead develop an automation strategy and integrate systems.

Asset care is also important—and I do not just mean maintenance, but rather, the lifecycle management of equipment and facilities. Computerized maintenance management systems (CMMS) or enterprise asset management system (EAMS) are tools that can greatly assist and automate asset care. I am a big believer in the use of the TPM (total productive manufacturing/maintenance) approach as well as use of Lean/Six Sigma programs to improve productivity.

Finally, good and effective communication is probably one of the single greatest needs in a company and not every company does it too well. Companies have to maximize teamwork within their operations, and good communications are vital. Communication needs to be two-directional, (i.e., top-down from management with an opportunity for staff to respond and put forward ideas). I strongly encourage meetings and briefings at the operations level, daily, and weekly. Verbal communication is so important, person-to-person and face-to-face. Email is a very useful tool; however, all too often it is a poor substitute for verbal interpersonal communication; that is a skill we should maintain and develop. People are our principal assets and companies need to put a strong effort into developing people and developing communications and teamwork.

Michael Lacey is plant manager at NIBRT, Fosters Avenue, Mount Merrion, Blackrock, Co. Dublin, Ireland.


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