After investing in a new or upgraded IV cleanroom to achieve USP Chapter <797> compliance, the primary challenge shifts from acquisition and implementation issues to perpetual issues surrounding a facility’s ability to consistently maintain a sterile compounding environment therein. In fact, frequent and effective cleaning of the cleanroom is the key factor in insuring contamination control over your sterile products environment in the long run. The generally accepted principle of proper cleaning of controlled environments comprises manual cleaning methods to reduce dirt and other foreign particulate matter followed by chemical disinfection treatments to mitigate contamination risk. Ultimately, cleaning frequency should be directly proportional to IV medication preparation activity, and maintaining an active environmental monitoring program will provide feedback to both the diligence of cleaning activities and the optimization of cleaning frequency.
Equipment and Policies
As with any cleanroom operation, cleaning requires specialized equipment. Examples of proper equipment, including liquid disinfecting cleaning solutions, pre-saturated and dry wipes, surface cleaning systems, cleanroom storage bins, floor mats, disposable mop heads, etc, are highlighted in the following special Buyer’s Guide. These items are specifically made for cleanrooms and have proven track records in reducing the risk of microbial contamination. Please note that using routine equipment that is not cleanroom compatible can actually contribute to higher contamination in the sterile IV compounding area.
Again, as stated in USP <797>, cleaning and sanitization policies and procedures must specify cleaning agents, equipment used, as well as how often and what areas are to be cleaned. Cleaning and sanitization is best done during off-peak shifts, such as nights and weekends, and should be done frequently. Documentation should include date and time, the area cleaned and disinfected, and the initials of the cleaning personnel. This type of record keeping can then demonstrate long term <797> compliance.
Rotation of Proper Products
Rotation of sanitizers in the cleaning process is particularly important given the prevalence of antibiotic-resistant microorganisms in a hospital setting. Thus, cleaning programs are most effective when sanitizers and cleaning products are rotated on a periodic basis. The rotation of sanitizers will combat the potential of developing microorganism resistance in your cleanroom. The addition of a sporicidal disinfectant, such as bleach or Spor-Klenz, to your overall sanitization is highly recommended as well.
Of note, concerns have surfaced recently over the discontinuation of sodium thiosulfate wipes. The reality of the situation is that these wipes simply neutralize bleach, so this neutralizing effect of sodium thiosulfate serves to help guard against corrosion of stainless steel furniture and engineering controls over the long term. Corrosion can cause equipment failure by creating stainless steel pitting, which reduces the overall effectiveness of the surface as a barrier to microbial contaminants. In order to fill the void of these pre-saturated wipes, some facilities are making their own sterile sodium thiosulfate and saturating sterile wipes themselves, while other pharmacies are sourcing the solution from alternative vendors. A third option includes other sporicidal solutions that are available as an alternative to bleach and can be used without sodium thiosulfate neutralization.
Ultimately, proper cleaning and disinfection of your sterile products area is key to <797> compliance as well as confident sterile products generation. It should be treated as the specialized service it is, one that has great impact on contamination levels, and therefore on the safety of both employees and patients. Simply using a sterile products cleanroom does little to protect your employees, patients, and the medications themselves if compliant cleaning practices are not strictly adhered to. Implementing, and most importantly, maintaining a proper cleanroom cleaning program is vital to your overall pharmacy operation.
Fran McAteer, MS, MBA, is vice president of quality at Microbiology Research Associates, Inc, an FDA-registered contract microbiology testing laboratory specializing in USP testing for pharmaceuticals, biologics, and medical devices.
Enter our Sweepstakes now for your chance to win the following prizes:
Just answer the following quick question for your chance to win:
Entries are limited to one entry per person in any active sweepstakes.
Thank you for your entry.