Points to consider for developing a USP-797 compliant cleaning and sanitization program


Proactive tactical planning will ensure adherence to standards

By Fran McAteer, Microbiology Research Associates

The obvious objective in effective cleaning is the removal of contamination acquired from daily activities in the cleanroom. In order to better perform a robust cleaning, it is necessary to evaluate and understand the sources of contamination. Implementing an effective cleanroom cleaning and sanitization program is based on some tactical considerations for pharmacists. Even though cleanrooms are designed and built to rigorous standards, each cleanroom is unique and is a function of the products, process, and people involved. Sterile product areas have their own unique characteristics. For example:

  1. Some compounding cleanrooms have more staffing associated with them. They have more pharmacists and technicians. Therefore, potential sources of contamination may come from viable sources such as sweat, skin, hair, etc. From a microbiological viewpoint, this represents potential contamination from such bacteria as Staphylococcus, Streptococcus, or Micrococcus species.
  2. Another type of cleanroom may have more refrigerators and freezers for medication storage. This equipment provides a large surface area for water condensation, which is based on temperature and humidity differences between the cleanroom and the equipment. The source of contamination from this compounding area may be water based. From a microbiological viewpoint, this represents potential contamination from molds and Gram-negative bacteria such as Pseudomonas species.
  3. The third type of cleanroom may be more specialized, using automated filling equipment for transparenteral nutrition (TPN). The potential sources of contamination may be non-viable particles from repetitive movements and larger amounts of ingredients. From a microbiological viewpoint, this contamination may represent Gram-positive spore formers.

By evaluating the different sources of contamination in a cleanroom, the pharmacist can better choose a more effective cleaner and/or sanitizer. The basic requirement for implementing a cleanroom cleaning and sanitization program is the microbiocidal properties of the cleaners and/or sanitizers. The cleanroom contamination may require broad spectrum activity against vegetative bacteria; maybe fungicidal activities against yeast and mold contamination; or possibly sporicidal activity against spore-forming bacteria. These different types of “cidal” properties for different sanitizers may provide the cleaning efficacy that a particular cleanroom may need.

A second consideration centers on the creation or augmentation of an environmental monitoring program. Simply put, environmental monitoring tests for viable and non-viable levels in a cleanroom. Viable particle monitoring looks for microbial contamination on surfaces or in the air, while non-viable testing checks particle counts at specific sizes. Environmental monitoring goes hand in hand with an effective sanitization program. It provides the continuous feedback loop on the performance of the cleaning program. An environmental monitoring program should include samples sites, location maps, testing frequency, action/alert levels, and test procedures. An effective program must also be governed by standard operating procedures that document the purpose, responsibility, and procedures necessary for an effective program. Environmental monitoring results should be trended over time and by location to demonstrate overall effectiveness and control of the cleaning/sanitization program.

In formulating an effective cleaning program, a tactical risk assessment analysis should be undertaken. This strategy assessment will evaluate the overall impact of potential contamination on such factors as drug cost, prescription quality, and medication complexity. For example, a contaminated CSP will have devastating consequences to hospitals and compounding pharmacies, including patient harm, medication recalls, and malpractice lawsuits. The risk assessment tactic will provide hospital management with consequences, costs, and a clear indication of the levels and frequency of cleaning and sanitization needed.

In today’s regulatory environment with USP <797>, a key tactic is to review compliance and documentation. This is a critical concept. The cleaning and sanitization needs to be qualified, which incorporates methodologies such as cleaning validation and disinfection efficacy studies. These validation tests demonstrate the effectiveness of the program by utilizing proven compendial guidelines.

Proactive tactical planning will ensure implementing an effective cleanroom cleaning and sanitization plan that meets acceptable compliance and quality standards. Contamination potentials, monitoring programs, and risk assessments will provide overall objectives, critical measurements, and managerial justification for successful implementation.

Fran McAteer 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. The author has expertise and experience in implementation of USP <797> programs for hospital pharmacies and acts as a consultant for many hospitals.