Quality-Controlled Efficiency: Considerations in the Modern Pharmaceutical Clean Room

The evolution of mankind creates a constant need for the pharmaceutical industry (PI) to keep up. As technology and medicine develop, so do strains of viruses and bacteria. The PI has to develop effective solutions to evolving problems, and a crucial component of this development is the clean room.

All cleanrooms are not equal. Electronics manufacturing has different requirements than pharmaceutical. There are different methods and limits to consider for the protein-based products created and monitored in pharmaceutical manufacturing.  Just as the public’s needs for pharmaceuticals changes, so do the industry’s needs in clean room design. While quality control is essential to a clean room in any industry, compromising quality in this field can have devastating effects on the public’s health. So what considerations go into today’s pharmaceutical clean rooms?

The PI is not immune to economic crisis. Capital spending on the PI in the United States has fallen, but the need for development continues to rise. Every manufacturing sector seeks efficient, productive operations. According to Pharmaceutical Processing’s article, “The Modern Clean Room,” by Jonnatha Mayberry, today’s PI clean room considerations include: functionality, sustainability, and efficiency – including energy efficiency. All of these factors help companies spend the least amount on the highest possible quality.

Flexibility is a must

With these considerations in mind, the clean rooms that are most appealing are those that are flexible. Facilities that can be reconfigured for multiple projects are still functional if product lines are dropped or not approved. Losing a project is fairly common, so it is important to be able to still use the clean room already purchased on a tight budget.

It is becoming more common for companies to try to remodel or renovate their existing facility rather than purchase a whole new clean room. As a result, architecture and construction of clean room elements have changed significantly. Suppliers are meeting needs that prioritize energy-efficiency and quick construction over form and aesthetics.

Quality Control

Energy efficiency creates some unique challenges when it comes to quality control, especially in ongoing maintenance of the facility. Construction designs in the future may include monitoring systems that detect changes in particulate levels and respond with a change in fan speed to conserve energy when possible. Fan speed and humidity levels are crucial to the integrity of the clean room. If a company alters the power usage of a unit to conserve energy, the results can be disastrous.

One such example occurred about a year ago with the meningitis outbreak linked to the New England Compounding Center (NECC).  The FDA reported finding contaminated spaces and vials at the facility. The result was 14,000 people at risk for fungal meningitis that reportedly killed 25 people and sickened 338 during the outbreak. The cause for contamination was linked to a number of findings that pointed to improper maintenance of clean rooms.

Of the maintenance violations, a significant discovery was the facility’s practice to shut off the air conditioning unit at night. The purpose was to save energy while the room was not in use, but this compromised the very fragile temperature and humidity levels that need to be constant.

Another area of concern was with the autoclaves. These machines are used to sterilize material.  While cleaning the equipment, the FDA found discolorations in two of the NECC’s autoclaves. The pharmacy was not able to provide documentation that their steam autoclaves were capable of product sterilization.

FDA observations of other violations included leaking boilers and standing water near the entrance to the preparation room. The list of neglectful hazards found make this example an extreme one, but any one of the problems found onsite could lead to the growth of bacteria and mold in a clean room.

It is clear that with all the demands for a clean room in the PI, quality control must not be compromised for efficiency or cost. Rather it must be foundation of every element of the clean room. This includes maintenance and upkeep by the companies who use them. Failure to do so can affect the masses.

Clean Room Builders

Finding a company to design and build a clean room means finding a reputable company that you can trust. Gerbig Engineering Company (GEC) has 40 years of clean room experience. They know what manufacturers value in a clean room today and cater to the many needs of quality construction and maintenance.

Some of the advantages of their materials and construction:

  • Design flexibility
  • Material allows walls to be assembled in hours rather than days
  • Clean room can be disassembled and reassembled in another facility
  • Easy modification
  • Recycled and recyclable materials are used
  • Energy-efficient rooms

Additionally, GEC certifies existing cleanrooms, and validates existing facilities and equipment to ensure that maintenance is up to par. Some of their recent projects include:

  • Room Design:
    • Envoy Medical – St. Paul, MN
    • OptionCare Pharmacy – Sauk Rapids, MN
    • Lumen Biomedical – Maple Grove, MN
    • Cleanroom Qualification:
      • Medtronics (several locations including US, Canada, and Singapore)
      • American Medical Systems – Minnetonka, MN
      • Surmodics – Minneapolis, MN

Pharmaceutical companies who need to build new clean rooms or modify existing ones will find a variety of quality hardwall rooms, softwall rooms, equipment, and services with GEC. For information on room design, green initiative, equipment, or any of their other services, call 888-628-0056, email info@gerbig.com, or fill out the information form on this website under the “Contact Us” tab.

 

 

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