Bio/Pharmaceutical Facility Design and Operation: A Primer - Pharmaceutical Technology

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PharmTech

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PharmTech Europe

Bio/Pharmaceutical Facility Design and Operation: A Primer
A Q&A with Michael Lacey of the National Institute for Bioprocessing Research and Training

Pharmaceutical Technology
Volume 37, Issue 4

Water systems

PharmTech: What considerations does a company need to make with setting up and maintaining bio/pharmaceutical-plant water systems?

Lacey: Pharmaceutical water technology is well-established with a large number of 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 pretreatment 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 L and WFI is more expensive, and so consider the cost of the loss of a 10,000-L 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). There are automated water controls that can be well utilized to save on water and cost.

GMP Certification

PharmTech: 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.

Communication

PharmTech: Communication is crucial. Could you comment on this based on your experience?

Lacey: 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.

Reference

1. BioPharm Intl. 26 (2) 46-51 (2013).


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