In 2012, a fungal meningitis outbreak in the United States was traced to a compounding pharmacy in the Northeast. The pharmacy distributed contaminated vials to medical facilities in 23 states. These were administered to more than 14,000 patients before anyone linked symptoms to the tainted medication.
By the time the source was isolated and the drug recalled, 48 people had died and 720 required treatment for persistent fungal infections. Investigators later discovered both procedural shortcuts and significant failures in cleaning and maintenance at the pharmacy.
This is not an isolated instance of inadequate cleanroom sanitation. The FDA maintains a well-populated list of inspections and citations conducted between 2006 and 2012 on its website. During this period, approximately one out of six infractions arose from failure to meet cleaning and sanitation standards.
Responding to regulatory audits and inquiries can cause significant disruption of a company’s operations. However, improper sanitation in cleanrooms and other critical GMP areas can have tragic results.
Every cleanroom requires a carefully controlled environment maintained in keeping with Good Manufacturing Practices to prevent contamination. While proper air filtration, careful lab design and well-designed operating procedures establish cleanliness levels, thorough routine sanitation and environmental monitoring assures that quality production continues without interruption.
Strict adherence to cleaning standards is especially vital in GMP spaces since most contaminants are microscopic. A single microbe in a batch of drugs could cause the entire output to be quarantined or discarded, leading to product recalls or FDA action with steep financial implications.
Although procedures vary based on each cleanroom’s purpose and the standards required, there are some universal myths and facts that can inform strategies for optimal cleanroom maintenance.
Myth #1: Anyone can clean and maintain a cleanroom environment
Every successful company should be cautious with operating costs. Tasking current employees with cleanroom upkeep might seem like the most cost-effective maintenance plan. While such simplification is tempting, it poses a number of problems:
• Employees already working in the cleanroom may be familiar with equipment and work done there, but lack training in effective and efficient cleaning methods.
• Adding custodial responsibilities for cleanroom staff takes time away from their primary job function and can lead to complacency.
• Do you really want your six-figure PhD cleaning up after each production batch?
The maintenance of cleanroom and GMP areas must meet stringent sanitation requirements. These include equipment-appropriate cleaning agents, methods and products, as well as suitable frequencies of cleaning for various surfaces. The work can be difficult and time-consuming because it must be performed by cleaners wearing protective garments, gloves, boots, eyewear, masks and head coverings.
Most janitorial companies are not trained to clean under these conditions or to meet the rigid requirements for proper cleaning and documentation in such controlled environments. This can lead to failed inspections or potentially disastrous contamination.
When it comes to cleanrooms, if it wasn’t documented, it didn’t happen.
Fact #1: Cleaning staff must be rigorously trained in Good Manufacturing Practice
Using an outside contractor specially trained in GMP solves both of the above problems. Regimented cleaning protocols carried out with contractual accountability and third-party validation can produce consistent high-quality service. In addition, this can avoid costly citations and production interruptions.
When choosing a cleanroom service provider, evaluate their human resource and training processes to ensure adequate training occurs before a cleaner ever steps foot on site.
A good cleanroom service provider has:
• Clear guidelines in place to train new staff in GMP methods to meet and adhere to Standard Operating Procedures (SOP) and integrate documentation into the cleaning routine.
• Periodic refresher training to keep staff up-to-date on new methods and makes sure everyone is working to meet the highest standards of Quality Assurance and Environmental Health and Safety
• Clear supervision and low worker turnover maximize cleaning consistency and regulatory compliance.
Myth #2: A checklist of tasks is adequate information for cleaning staff
Cleaning staff need much more than a checklist. They must know the unique purposes of cleanroom operations to understand the need for the strict cleaning protocols and the potential consequences of any contamination
A specialized cleaning contractor can help clients determine the best procedures and frequencies to keep the right levels of cleanliness. With an informed understanding of the reasons for sanitation processes and documentation requirements, they can also be partners in maintaining high standards. A contractor will also work to ensure that the cleanroom remains operational, safe, productive and meets quality standards.
Fact #2: Cleanrooms require a well-developed and implemented Standard Operating Procedure
Designing an effective SOP can keep the cleanroom running efficiently. While manufacturers typically design these procedures to facilitate lab functions, including a maintenance specialist early in the process can keep the cleanroom operational and reduce interruptions.
Cleanroom maintenance offers distinct challenges because of the sensitivity of the tasks performed in the room. The environment, process, tools and people in a cleanroom generate contaminants on an ongoing basis. These become nearly invisible airborne particles with the potential to settle in critical areas.