SUGAR LAND-Industrial Info-September 10, 2012–Researched by Industrial Info Resources (Sugar Land, Texas)–Astute Pharmaceutical & Biotech Industry companies are putting more dollars in their annual maintenance budgets to ensure their products are manufactured to the highest standards. According to Industrial Info’s Pharmaceutical Tracker, there are 531 active pharmaceutical and biotech maintenance projects worth an estimated $670 million in North America.
Because of this, an increased number of subcontractors, such as mechanical/high-voltage alternating current companies, original equipment manufacturers and general contractors, are beginning to focus their resources in these types of environments. This is good news to not only for the vendors, but for the end consumer as well.
The Pharmaceutical & Biotech Industry is among the most highly regulated and scrutinized sectors by government entities. The U.S. Food and Drug Administration, the Environmental Protection Agency, and state regulators all have a claim to regulate these industries. Biotechnology and pharmaceutical production facilities must meet strict standards and protocols to be compliant with these agencies and to be able to sell their products to the general public. Much has been invested in these products through the research and development and the clinical trial processes, and the end product may take several years to gain approval. With this vested interest, pharmaceutical manufactures strive to meet the meticulous standard of Good Manufacturing Practices (GMP) in the commercial production of their drugs.
To obtain GMP status, the individual manufacturing suites, production and packaging lines must constantly be serviced and equipment often must be replaced. This places a particular onus upon the maintenance departments of these companies, as well as contractors, to meet these strict guidelines.
The top challenges of life-science maintenance departments to meet GMP standards are complex and varied. Maintenance concerns include a lack of proper training of maintenance staff and contractors; modern maintenance management techniques that are not applied; new equipment purchased without consideration of the maintenance requirements; performed maintenance that is not properly documented; a lack of consideration for the impact on product quality by lubricants; maintenance plans that are not updated after new equipment is introduced; and, most notably, prioritization of each piece of equipment on the resulting product quality.
Considering prioritization of equipment, it is common to treat every piece of equipment equally when it comes to maintenance. However, equipment falls into four distinct classes of impact pertaining to product quality: direct impact, indirect impact, no impact, and safety/environmental impact.
“Direct impact” equipment is any equipment whose stoppage would directly affect product quality, such as a centrifuge. The failure of “indirect impact” equipment may obliquely affect a process or system, thus affecting the manufactured products, including temperature monitors and calibrated validation systems. “No impact” equipment will not have an effect on final product quality; these include peripheral items, such as security gates. Finally, “safety/environmental impact” affects systems like boilers, whose failure may affect the safety of the manufacturing environment.
Industrial Info Resources (IIR), with global headquarters in Sugar Land, Texas, and eight offices outside of North America, is the leading provider of global market intelligence specializing in the industrial process, heavy manufacturing and energy markets. Industrial Info’s quality-assurance philosophy, the Living Forward Reporting Principle™, provides up-to-the-minute intelligence on what’s happening now, while constantly keeping track of future opportunities.