Managing Engineering Controls Outside of the Cleanroom


December 2010 - Vol. 7 No. 12 - Page #32

Q & A with Eric Kastango,
MBA, RPh, FASHP

Pharmacy Purchasing & Products: How should environmental monitoring processes differ for primary engineering controls used in a segregated area versus those located within the cleanroom?
Eric Kastango: USP Chapter <797> states that environmental monitoring has to be conducted in all environments where sterile compounding occurs, and this holds true for segregated compounding areas. So, even when a compounding aseptic isolator (CAI) is located in a non-ISO classified space, we are still concerned about microbial bioburden produced in and around this engineering control. The challenge for many pharmacists is that while the chapter requires that monitoring occur twice a year, at minimum, it does not delineate action levels for the environment. The chapter simply requires the sampling be done to provide an understanding of what is happening both in and around the device leaving pharmacists wondering as to what standard of cleanliness they should be working toward. I would suggest sampling more often in this scenario so that you can trend your levels and determine if the segregated area is becoming dirtier or cleaner over time. A good place to begin is with the action levels for ISO class 8, which provide a benchmark for air quality to 100 CFUs per cubic meter of air, or 1000 liters.

PP&P: Is fingertip testing required with isolators used outside of a cleanroom?
Kastango: Yes, <797> requires that sterile gloves be worn inside the fixed isolator sleeves, just as they are required within a hood or biological safety cabinet. This is based on the committee’s expectation that any glove that could potentially touch a critical site must be sterile. Therefore, glove fingertip testing must be conducted. Typically, this testing can be included as part of the individual employee’s media fill testing.

Many isolators come with heavy-duty rubber gloves, but I recommend replacing those with regular non-sterile gloves with a long cuff that can be attached to the gauntlets to serve as the fixed sleeves. In this setup, the user would don a pair of sterile gloves as part of their daily setup, thus meeting the guidelines. Determining how often to change gloves is a common challenge in the pharmacy. At a minimum, sterile gloves used inside the chamber should be changed at least once a day if not more frequently. Keep in mind that if components brought into the isolator are not properly disinfected first, external contamination is transferred to the inside of the isolator and then after touching the component with your gloves, any subsequent poor technique, such as touching a needle, hub, or vial septum, could result in direct contamination of the compounded product.

PP&P: When should the fixed gauntlet sleeves be changed?
Kastango: Too often pharmacists assume the sleeves should be changed only during certification, or even annually. This is not the case; they should be inspected for tears or holes on a weekly basis. This is particularly important with negative pressure compounding aseptic containment isolators (CACIs), as any hole will draw dirty air into the isolator, which could lead to contamination problems.

PP&P: What PPE should be worn when compounding in an isolator located outside of the cleanroom?
Kastango: <797> states that the manufacturer has to provide supporting evidence that garbing is not required. However, the main concern herein is the potential exposure from the handling of hazardous drugs. We do not want our staff exposed to contamination on the outside of vials, so at a minimum, gloves should be worn along with shoe covers to limit the spread of contamination. So, while the chapter defaults to the manufacturers’ recommendation, consider the products that are being compounded and assign garb requirements accordingly. As well, include these requirements in your policies and procedures manual so employees have clear guidance on safe practices. Clear, consistent policies that are not subject to interpretation are key to a successful pharmacy operation. Furthermore, the pharmacy director should enforce these policies with vigorous management to ensure they are followed consistently. Keep in mind the adage: People respect what others inspect.

PP&P: What are the regular cleaning requirements for an isolator located outside of the cleanroom?
Kastango: Isopropyl alcohol should be used routinely throughout the day to disinfect surfaces and a germicidal detergent should be used at least once daily to clean the device. For comprehensive guidance on this subject, see Best Practices for Cleanroom Infection Control by Keith St. John in the May 2010 issue of PP&P. Note that if environmental services—not pharmacy—is responsible for cleaning the segregated compounding area around the engineering control, pharmacy should meet with them to ensure proper procedures are in place.

PP&P: What practices should differ for engineering controls located in the cleanroom versus those located outside of it?
Kastango: With any isolator, there is the risk that contamination can enter from the surrounding environment. Clearly, this risk increases with isolators placed outside of the cleanroom, requiring increased vigilance in maintaining the internal surfaces and environment, as well as the surrounding environment. Additionally preventative maintenance schedules like changing pre-filters must be performed and documented according to the manufacturer’s instructions.

PP&P: What practices would you recommend for sampling for hazardous drugs within and around the engineering control?
Kastango: To my knowledge, there is no good guidance establishing acceptable levels of surface contamination of hazardous drugs. Testing for these drugs is expensive and time consuming. Based on the literature, if you are handling hazardous drugs, you can expect to find contamination on multiple surfaces and in multiple areas of the pharmacy. The key for preventing contamination is to follow good work practices as offered in the NIOSH Alert: Preventing Occupational Exposures to Antineoplastic and Other Hazardous Drugs in Health Care Settings.

PP&P: What are the signs that it is time to replace an isolator?
Kastango:Isolators are pretty durable pieces of equipment, so typical replacement needs are usually limited to a new fan motor or HEPA filter. Nonetheless, your isolator must be certified every six months and if the certifier is following CETA guidelines you can rely on him or her to give you a good sense of your isolator’s remaining lifespan.


Eric S. Kastango, MBA, RPh, FASHP, is the president, CEO, and owner of Clinical IQ LLC, a provider of customized process and educational strategies for the pharmaceutical, medical device, and health care industries.  A member of USP’s Sterile Compounding Committee, he has practiced in the field of both hospital and home care pharmacy since 1980.

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WHERE TO FIND: CAIs/CACIs (Compounding Aseptic Isolators & Compounding Aseptic Containment Isolators)

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