In The News
Managing Equipment Needs while Designing and Building a Biopharma Facility
By Greg Lundell, Director of Asset Management, Genesis AEC
Pharmaceuticals have always been complex products commercialized after years of research and clinical trials. Launching a new drug requires identifying the root cause of a health problem, determine a strategy to counteract that problem, and execute a research and development strategy. And if a pharma company is lucky, the clinical trials show the drug is safe and effective, and they can successfully scale it up to manufacturing scale and supply it reliably to the public.
That simplistic overview takes levels of development that all starts with infrastructure. The modern pharmaceutical research and development space, production facility, or quality testing laboratory is built by incorporating planning, architectural and engineering design, construction management, and execution, and equipment installation and startup.
To successfully startup the equipment needed to facilitate cutting edge research into the production of biopharmaceutical products at the end of construction, the equipment needs to be defined by the scientists who will use it before anyone ever breaks ground. The architectural, mechanical, electrical, and plumbing requirements all must be defined so the facility can be properly designed and engineered. Understanding the overall needs early in the planning phase is critical to successful construction execution, and therefore critical to the eventual installation and startup of that equipment.
The process starts at concept. A new facility is being built, or a current lab needs remodeling. The researchers are excited about their new home but need direction to navigate budgetary constraints, help to pick the proper equipment and accessories for their needs, and someone to make sure this is translated to the proper quotes, purchases, and installation activities. This is where a focused group can help complex projects stay on course. The equipment management team helps translate the scientific needs of the final laboratory customer, the scientist, into the architectural and engineering requirements of the laboratory design team.
For example, a researcher may need a microscope. Seemingly simple enough, it takes up some level of physical space, needs to plug into a wall for a light source, aka have electrical requirements, and that’s pretty much it, right? Some microscopes, however, are highly sophisticated and require more physical space, heating and cooling, and a computer control and data capture capabilities. If the unit is used to generate data that may support a company’s FDA submission, there are data integrity and IT requirements that must be met; quickly, the simple gains complexity that all needs to be thoroughly planned for.
Once the equipment has been selected, and laboratory planning has been completed, i.e., there is a defined physical space and utilities on the plan for each piece, the team can help manage the installation aspects of the project. During construction activities, there are sometimes questions of utility placement; how high should this gas line be, should it be on the right or left of the instrument, how long is the cord? Ensuring there is an available resource who is knowledgeable about the equipment on hand is critical to this execution stage.
Procurement is up next, and the planning and management of lead times vs. early delivery needs or lack of on-site storage are all considered. Some projects require early delivery of instrumentation that utilizes a computer in order for groups to validate the software and IT connectivity. Other projects need to rely on just in time (JIT) delivery due to the lack of storage space on site and concerns over moving sensitive equipment around a construction area.
As installation activities progress, there is the need to manage the vendor access to the construction site and the paperwork they generate. For a facility performing GMP (Good Manufacturing Practice) work, this includes specific Commissioning, Qualification, and Validation (CQV) activities aimed at ensuring there is proof positive that the equipment has been installed properly and operates correctly. Only once this has been performed and approved by all parties can the equipment, and laboratory in general, be used to perform work.
By connecting all of the various stages of the development of a new laboratory, manufacturing, or quality testing facility, a firm can ensure they are handing off a fully operational project upon turnover. Committed to delivering facilities for life-saving therapies, Genesis AEC has identified the need to manage the laboratory equipment needs of our clients proactively. We have the technical staff on board to provide support throughout the project lifecycle, thereby guaranteeing project success.
Originally published by Network Magazine.
Glossary:
- Biopharmaceutical products: Medical drugs produced using biotechnology, including proteins, nucleic acids, and living cells used in therapy.
- Good Manufacturing Practice (GMP): A system ensuring consistent production and control of products according to quality standards.
- Just in time (JIT): Inventory management method where materials arrive just when needed, reducing waste and increasing efficiency.