Choosing a Cleanroom Certifier


May 2013 - Vol. 10 No. 5 - Page #32

Ensuring your cleanroom is truly clean is fundamental to producing safe and effective compounded sterile preparations (CSPs) for patients. Recent systemic failures at several compounding pharmacies illustrate the severe repercussions of not maintaining robust aseptic technique. One element of a safe medication use process is choosing a cleanroom certifier knowledgeable in <797> requirements and capable of improving your hospital’s cleanroom practice through verifying cleanroom cleanliness and recommending improved practices. 

Charter Care Health Partners health system in Rhode Island is comprised of two hospitals, the 220-bed Roger Williams Medical Center (RWMC), which includes two outpatient chemotherapy infusion clinics as well as an extended care facility, and St. Joseph Health Services’ (SJHS) 359-bed Our Lady of Fatima Hospital. Our inpatient pharmacy cleanroom was built approximately seven years ago, and construction of our cancer center IV cleanroom was completed four years ago. Ensuring that our cleanrooms are <797> compliant and that our CSPs are safe are vital concerns; thus, partnering with a knowledgeable, experienced cleanroom certifier able to identify any sterility issues and help ensure <797> compliance is a high priority.

Choosing a Cleanroom Certifier
The principal benefit of partnering with a well-qualified cleanroom certifier is the assurance that our CSPs are produced in a safe environment. When evaluating which certifier would be the best match for our hospital, our major considerations were services offered, the quality of those services, and cost. We sought to identify a vendor that was cognizant of both USP <797> and state-specific requirements. As such, we needed a vendor that could certify our hoods and cleanrooms every six months, per <797>, and perform environmental sampling every month, per Rhode Island Board of Pharmacy policy for low- and medium-risk preparations. For sterile compounding areas producing high-risk preparations, the state board requires a weekly evaluation, although this requirement does not affect our hospital as we rarely use high-risk preparations. In the event we do receive an order for a high-risk medication, it is outsourced.

In addition, it is critically important that a certifier be knowledgeable in all aspects of cleanroom and engineering controls certification; they must understand what they are testing for and why. For example: 

  • ISO Class 5 primary engineering controls (PECs) must operate within a buffer area that meets ISO Class 7 requirements, unless barrier isolators are used
  • The buffer area must be supplied with HEPA-filtered air
  • Anterooms separate from buffer areas must meet a minimum ISO Class 8 environment, just as is required in the cleanrooms
  • PECs must be certified every six months

When queried as to why a test is performed, the method of testing, or the pass/fail criteria, the vendor must be able to explain the reasons for and methods of testing in easily understood language. Thus, excellent communication skills also are of critical importance. 

A quality certifier should be able to provide guidance on preparing for an accreditation or state board of pharmacy inspection. In addition, testing failures should be addressed immediately. For example, if the cleanroom pressure differential is not to standard, your vendor should be able to present a solution to correct the problem. The vendor we ultimately chose to certify our engineering controls and cleanroom was able to answer all of our questions immediately and thoroughly. They shared their SOPs and also made suggestions to improve our hospital-specific SOPs, demonstrated consistent and thorough knowledge of <797> requirements, provided a competitive pricing plan, and clearly presented their capabilities. For example, the vendor suggested how frequently cleaning solutions should be rotated and where to place demarcation lines. 

Be sure your vendor is able to supply references from past customers; contact these references to gauge the certifier’s skills and professionalism. In our experience, however, we have found that references can be of limited usefulness, as not all hospitals are committed to a high level of compliance and may not adhere to stringent requirements. Ask your vendor for references from facilities that are similar to your hospital in both size and level of compliance.

To ensure best pricing, re-evaluate the extent and quality of the services you receive against the annual cost for these services, and do not hesitate to negotiate rates and evaluate what other vendors offer. Recently our vendor instituted a rate increase, and consequently we sought price quotes from a variety of other vendors. We ultimately decided to remain with our current vendor after they matched their rates to those of their competitors; their decision to lower their pricing was due in part to our expanding pharmacy services. A pharmacy renovation, our recent affiliation to SJHS, and the opening of a new cancer center necessitated additional certifier oversight, and we were able to leverage this growth during our negotiations. 

Determining Required Services 
Prior to selecting a vendor, it is important to evaluate both state and federal regulations to determine the cleanroom certification services necessary for your hospital. At RWMC, we require our vendor to provide testing and monitoring of all elements related to <797> compliance, including verifying the cleanliness of all engineering controls and the cleanroom, as well as conducting environmental monitoring, air sampling, pressure differentials, HEPA filter testing, fingertip and media fill testing of personnel, and temperature and humidity testing. Our sister hospital performs their media fill testing, fingertip testing, and environmental monitoring in-house, as they have the capacity in-house to do so. 

Our vendor performs environmental monitoring testing monthly and certifies the cleanroom every six months. They provide a full report of the environmental monitoring results each month, which includes at least two signatures from the certifier and details the methods used to conduct each type of testing, the guidelines followed, pass/fail criteria, and results. These reports are reviewed to ensure we are in compliance and to identify any trends, such as temperature and humidity increases or decreases, and bacterial and fungal growth occurrences. 

In addition, the vendor provides regulatory updates as necessary—for example, informing us when a new test needs to be added due to changing regulations. A proactive cleanroom certifier should provide regular updates regarding new or revised regulations that affect your pharmacy practice, and should maintain a dynamic relationship with your hospital, being available to answer questions whenever they are identified. 

Ensure Effective Staff Training
A complete staff training program should include clear, uncomplicated education on <797> compliance that is based on your hospital’s policies and procedures. USP <797> contains extensive cleanroom cleaning requirements, so a staff training program must delineate exactly what your pharmacy needs to do to maintain compliance, including processes for aseptic technique, management of hazardous drugs, and cleaning and disinfecting. 

Previously, we relied on a staff pharmacist with extensive <797> knowledge to design a robust training program to ensure staff competency. However, when this pharmacist moved from the area, it became evident that we needed a more comprehensive approach. As a result, we purchased an online <797> training program to improve our annual staff training. In addition, we are considering additional training solutions, including hiring our cleanroom certifier to provide staff training that complies with USP <797>. 

Future Projects
Maintaining <797> compliance and providing safe medications to patients are the most important considerations in our decision to partner with a cleanroom certifier, and the peace of mind that results from knowing our compounding environment is compliant has been the most significant benefit of working with our vendor.

Our certifier is assisting us in other ways as well. For example, they provided useful guidance regarding the design and construction of a satellite pharmacy that our hospital opened recently. More specifically, they provided a cost and compounding efficiency comparison utilizing a self-contained aseptic isolator (ie, glove box) that adheres to ISO 5/Class 100 cleanliness standards versus a cleanroom design with HEPA filtration rooms that adhere to the same cleanliness standard. We anticipate utilizing our certifier as a valuable reference for ensuring safety and compliance in future projects.


James J. Melfi, RPh, PhD, is the director of pharmacy services with Charter Care Health Partners, Roger Williams Medical Center, Providence, Rhode Island. His professional interests include pharmacoeconomics, managed care pharmacy benefit design, and inventory and utilization management.

Melissa Barroso, CPhT, is the pharmacy operations manager at Charter Care Health Partners Roger Williams Medical Center in Providence.

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