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Improving Aseptic Compounding in your Pharmacy

Based on recent press related to the fungal contamination of a compounded sterile product (CSP), it is easy to see why improvements to Aseptic Techniques in compounding pharmacies are needed.

PRLog - Dec. 16, 2012 - ST. LOUIS -- This need for improvement should not be restricted to independent compounding pharmacies.  Many hospital pharmacies that compound also have a significant need for improvements.  Though this meningitis situation has brought a lot of media attention to the problem, the actual infection numbers are small when compared to the number of Hospital Acquired Infections (HAIs).  HAIs result in over 90,000 deaths per year.(1)  The cause and source of HAIs is varied and difficult to pinpoint, but this recent press will help raise awareness that, in-fact, some HAIs can be a result of CSP’s contaminated in the pharmacy.  Therefore, it is imperative that all facilities involved in the manipulation of sterile injectable products enforce strict aseptic processing protocols.

NNIS hospital-wide surveillance, 1990–1995
NNIS surveillance 2002, high-risk nursery and ICU component
National Hospital Discharge Survey (NHDS) for the U.S. population in non-federal hospitals(1)

Background:  Looking at the above table from Public health reports(1), bloodstream infection numbers are significant. We assume that, after this outbreak, legal liability concern will broaden dramatically(2).
It is important to first note that there are many processes that should never be attempted by typical aseptic compounding facilities and should only be done by FDA Registered, cGMP compliant sterile production facilities. As a supplier of equipment and products for aseptic compounding, Aseptic Enclosures has visited hundreds of aseptic compounding facilities.  We have decades of experience in the FDA compliant cGMP parenteral pharmaceutical production environment, where aseptic practices are mandated and strictly enforced by the FDA.  Even if there are no problems, facilities found to have poor procedures can be shut down, and people can be criminally indicted.  Unfortunately, the recent fungal meningitis outbreak came as no surprise.  When learning of the outbreak and prior to the source being identified, our initial suspicion was that it was a contaminated product from a single source.

As reported by the News Scientist (3), an early indication of the source of the fungal contamination causing the recent outbreak is that it was a leaf fungus.  How the fungus actually got into the vials has not yet been reported, but one way or another, it is linked to poor aseptic practice

Prevention: Aseptic Enclosures feels that the first step in prevention is a change of attitude toward internal adherence to, and enforcement of, proper aseptic practices as defined by USP 797(4).  Having visited hundreds of hospital pharmacies over the years, we have observed that poor aseptic techniques are at an epidemic level in a vast number of facilities.  Many pharmacy directors agree that this is a serious problem, even in their own facility.  Perhaps because of a lack of infection source identification and accountability, many of the problems have not been corrected.  However, if the FDA and State Boards of Pharmacy step in because of the national attention, or the imminent congressional hearings(5) and the risk of corporate and personal legal liability(13) take hold, attitudes may quickly change.  In fact, we have already had many recent calls concerning pharmacy upgrades.

One pertinent example of this need for adherence to, and enforcement of proper aseptic practices is from a marketing survey we had conducted.  Several years ago, Aseptic Enclosures introduced a new product, “Sterile Alcohol.”  We conducted a study to track the number of hospital compounding facilities using sterile vs. non-sterile Isopropyl Alcohol (IPA) when cleaning their compounding Primary Engineering Controls (PECs), i.e., Hoods/Isolators/Biological Safety Cabinets/Clean Benches.  We found that over 50% of the market was not using sterile IPA.  Perhaps there has been inadequate training concerning the importance of using “Sterile” alcohol.  According to some blogs, there is resistance to the use of sterile alcohol; however, the practice of using non-sterile alcohol for injectable applications is condemned by most Microbiological and Sterilization experts.(4)  The USP called for “Sterile” alcohol no less than 36 times in the chapter.(4)  In fact, it is common practice for spore suppliers to ship their spores to clients packaged in IPA.  In the Parenteral Production environment, a facility found using non-sterile IPA as a final wipe down would likely come under a FDA dissent decree.

Another good example of this need for adherence to, and enforcement of proper aseptic practices is directly related to the lack of usage of Sterile IPA as corresponds with the overall clean-room and PEC cleaning practices.  We have found that an even larger percentage of the hospital compounding market not following the Sterile IPA recommendation of USP 797 is not following the other recommended cleaning practices — as per the USP 797(4).   Because sterile IPA is not fungicidal or sporicidal, it is important to first use a cleaner that is (see AE products page Item AEDC579).  The USP 797(4) also discusses this important first step in cleaning and has additional discussion on the rotation practices of that initial cleaner to avoid microbial resistance.  Rotation of disinfectants is performed in order to prevent selection for resistant organisms.  Rotation of disinfectants is expected by regulatory officials in all cGMP facilities.  Good disinfectant rotation programs need to include chemistries that control a wide variety of microorganisms that mitigate damage to cleanroom and primary engineering control surfaces, but are effective.  Routine disinfectants should be used for daily cleaning of non-product contact surfaces.  This should control vegetative bacteria and remove soil while not damaging cleanroom surfaces — minimizing risks to personnel working in area.  Since routine disinfectants probably don’t affect spores, a sporicidal disinfectant should be applied periodically.  Because sporicidal disinfectants are either highly toxic or very corrosive, and residuals can be toxic, it is important to follow this step up with a wipe off with WFI (Water for injection/irrigation), and finally a wipe down with “Sterile” IPA.  Proper ventilation is also recommended.  In parenteral production, these practices are  mandatory, and most facilities go through a rotation of the cleaners used.

One distinct difference between the hospital compounding and parenteral production facilities is that everything in parenteral production is “sterilized” as it is being brought into the critical clean areas.(7)  Many facilities are moving toward the practice of sterilizing the entire production cleanroom.  Typically, this is done utilizing a Vaporized Hydrogen Peroxide (VHP) process.  The rooms can then be validated as sterile.  However, in some hospitals or compounding pharmacies, the surfaces of many products going into the PEC are not sterile, and this greatly increases the risk of “touch” contamination and further emphasizes the need for superior cleaning practices.  Aseptic Enclosures equipment can be equipped with A VHP Sterilizer.  This equipment can also be retrofitted to existing equipment, but effluent venting is required.  We also offer a UV (see AEUV510) disinfection system that utilizes pharmaceutical grade surface sterilization technology.  The issue with this unit being comprehensive is that the areas in the shadow of the UV light are not treated(9).  As emphasized by the lack of a truly sterile environment, strong emphasis should be placed on frequent disinfection, cleaning and superior aseptic technique.  Using proper cleanroom wipes for cleaning (sterile wipes)(5) and following good aseptic practices for the cleaning procedures is exceptionally important.  The staff microbiologists at Aseptic Enclosures are available for audits and training.


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Source:Aseptic Enclosures
Location:St. Louis - Missouri - United States
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