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Mold and Rust found in Sterile Compounding Pharmacies by FDA
The FDA said Thursday it issued inspection reports to all but one of the pharmacies citing unsanitary conditions and quality control problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation, and employees wearing non-sterile lab coats
Washington DC – Recently, the Food and Drug Administration (FDA) reported it has uncovered potential safety problems at 30 specialty pharmacies that were inspected in the wake of a recent outbreak of meningitis caused by contaminated drugs.
According to AP reports “the agency said its inspectors targeted 31 compounding pharmacies that produce sterile drugs, which must be prepared under highly sanitary conditions. The FDA said Thursday it issued inspection reports to all but one of the pharmacies citing unsanitary conditions and quality control problems, including: rust and mold in supposedly sterile rooms, inadequate ventilation, and employees wearing non-sterile lab coats. The agency generally issues such reports before taking formal action against companies. Inspectors visited pharmacies in 18 states, including Florida, Arizona, Colorado, Tennessee and New Jersey.”
The deadly meningitis outbreak that has been linked to contaminated pain medicine (steroids) was tied to mold and bacteria growing in the supposed “sterile” rooms. These conditions have prompted calls for tighter federal regulation of compounding pharmacies, which have periodically been blamed for crippling and sometimes fatal injuries. In the past, Congress has pushed for more authority over the industry. During the 1990s, compounding pharmacies fought overlapping laws, contradictory court rulings and overall uncertainty about how much power the Food and Drug Administration (FDA) has to regulate compounders.
Upon investigation by the FDA of the New England Compounding Pharmacy Inc., (which was linked to the fungal meningitis infection cases that has now killed 25 people) they found greenish yellow and tarnished discolorations on equipment and in areas where the steroid medicine was mixed. Supposedly, mold and bacteria were found to have exceeded limits the pharmacy set itself. The FDA stated in a preliminary report that cites company documents that “no documented corrective actions were taken to remove the microbial contamination.”
What is a Compounding Pharmacy?
Compounding pharmacies prepare medications in what are called Class 10 to 100K clean rooms, which are supposed to be temperature-controlled, HEPA air-filtered to maintain sterility and monitored for mold and bacteria routinely and an outside AIHA accredited microbiology lab providing the analytical lab results. Compounding pharmacies are used for voluntary reasons, such as adding favorite flavors to a medication or modifications to prescriptions for dose preparation. More recently it has been suggested that some doctors and clinics have turned away from major drug manufacturers and turned to compounding pharmacies because they often charge much lower prices than the major manufacturers.
Microbiology expert Dr Rajiv Sahay, FIAS, Laboratory Director of Environmental Diagnostics laboratory (EDLab) stated “many of the compounding pharmacies that we assess do provide diligent proactive environmental management of the their Class 1 to Class 100K Clean Rooms which provides their clients the surety that the medicines are being made and handled under strict sterile conditions though due to the unregulated conditions there are those compounding pharmacies that lack the effective Clean Rooms environmental strategies necessary to make drugs in sterile conditions.”
What is a Clean Room?
A cleanroom is an environment, typically used in the manufacturing/compounding of drugs or other scientific research that is required to maintain a low level of environmental pollutants/contaminants e.g. dust, airborne and surface mold and bacteria, non viable particles and potential chemical vapors. More specifically, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size and a certain level of colony forming units of mold and bacteria per cubic meter or per contact plate for surfaces. Clean rooms are covered under the US Federal Standard 209E. An example: in a Class 100 Cleanroom (ISO 5/USP 797 Compliance) any cubic foot of air in the Cleanroom should have no more than 100 particles per cubic foot floating around in it larger than 0.05 microns and less than 3 colony forming units (CFU) per cubic meter in the air (or less than 0.1 cubic feet of air).
What can be done to minimize microbial contamination?
A regular quarterly qualitative and quantitative environmental cleanroom monitoring including culturable microbiological levels, adenosine triphosphate (ATP) levels, HVAC system cleanliness and hygiene conditions/levels, HEPA filtration efficacy, temperature and relative humidity conditions and particulate types is recommended in order to assess and control effective cleanliness of cleanrooms.
The Environmental Diagnostics Laboratory (EDLab) at Pure Air Control Services a leader in USP 797/Cleanrooms performs a wide array of microorganisms (bacteria and fungi) including organisms such as Aspergillus sp, Exserohilum sp., Staphylococcus aureus, Legionella pneumophila, ect…
EDLab scientists identify microorganisms by using various modern lab techniques. Some common analysis performed by EDLab to identify microbial conditions include Bio-Scan and Spore Trap analysis, mycological culturable analysis of air/bulk/surface/swab/liquid environmental samples among many others. The type of sampling and analysis performed is determined by project specifications project requirements or individual needs.
For additional information on Clean Room efficacy or Building IAQ surveys you can contact Dr. Rajiv Sahay, Director, EDLab, at Pure Air Control Services, www.pureaircontrols.com 1-800-422-7873 ext 301
About Pure Air Control Services, Inc.
The company’s expanding client roster includes the Florida State University (FSU), University of South Florida (USF), Federal Aviation Administration (FAA), Walt Disney World, General Services Administration (GSA); Allstate Insurance; CBRE, Carrier Air Conditioning; NAVFAC, DOT, USACE, US Army, and many other Fortune 500 companies, school boards, and city, state, and county governments, making Pure Air Control Services the reliable industry leader.
For more information on Pure Air Control Services, Inc. please contact Alan Wozniak at (800) 422-7873 ext 802 or visit www.pureaircontrols.com.
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