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AGAPE Instruments Service - FAQ
Why is it that after your technicians changed the HEPA Filters in my Biological Safety Cabinet, they left the filter(s) in the box(s) here at our facility? Agape Instruments Services, Inc. only provides the service of HEPA filter replacement and then recertification after completed. Agape does not remove used HEPA filters from a site for a number of reasons. 1. Depending on the use of the Biological Safety Cabinet, the HEPA filters must be disposed of differently.
a. When used for Chemotherapy Drug Manipulation, they must be disposed of as “Chemo Waste”
b. When used for biological containment, the BSC is decontaminated using paraformaldehyde. This decontamination will provide destruction of all living organisms except PRIONS (Mad Cow Disease). After this decontamination, the HEPA filters are now considered regular trash. Agape Instruments Services, Inc does not remove old filters from a job site. We do not have the ability to transport them and are not setup to dispose of “Chemo Waste”. Why does my Biological Safety Cabinet need to be decontaminated before having the HEPA filters changed? Agape Instruments Services, Inc. requires that all Biological Safety Cabinet’s used for biological hazardous work be decontaminated prior to panel removal to gain access to contaminated plenums. This ensures both the safety of our technicians and the safety of any employees in the immediate area. *Remember, anything that has been used in the BSC that produced a particle is now trapped in the HEPA filter. Removal of the filter may cause trapped particles to become airborne when the filter is removed from the BSC and exposed to the room. *Agape Instruments Services, Inc. follows NSF/ANSI 49 Annex G for performing paraformaldehyde decontamination. Why can’t I be in the room during Paraformaldehyde Decontamination? Agape Instruments Services, Inc. requires that access be restricted during Biological Safety Cabinet decontamination for safety reasons. The reason that we use paraformaldehyde, is the fact that it is very efficient in deactivating the biological hazard inside the BSC. According to studies, 10 PPM is enough to kill a lab rat, 100 PPM is enough to kill a human, and the inside of a BSC during decontamination is 10,000 PPM. As you can see, it would not take a very big leak to cause some major problems. For more information regarding paraformaldehyde decontamination please see OSHA Regulations Code of Federal Regulations, Title 29, Formaldehyde-1910-1048 which addresses monitoring; posting of regulated areas; respirator selection, protection, and fit testing: medical surveillance; hazard communication and training; and record keeping. What is USP 797? Incidences of patient morbidity and mortality associated with improperly prepared or contaminated sterile preparations have prompted the FDA to consider regulating or even banning pharmacy compounding. The first official, enforceable sterile preparation-compounding requirement in the United States took effect on January 1, 2004, when United States Pharmacopeia published USP Chapter <797>. This Chapter is now the US standard for pre-administration manipulations of compounded sterile preparations (CSPs), which includes compounding, transportation, and storage. <797%gt focuses on protecting patients and therefore applies not only to pharmacies but to all sites where CSPs are compounded and to all personnel who compound sterile preparations, regardless of practice setting or profession. When do my Biological Safety Cabinet, Laminar Flow Clean Bench, Fume Hood, Isolator, and/or Cleanroom need tested? The testing frequency is determined by the application of use, industry practices, and the governing body that oversees the particular device. Device Governing body Testing Frequency
BSC NSF 49 When New, Moved, or Serviced.
At least annually thereafter. (NSF 49)
Semi-annual (USP-797) LFCB IEST-RP-CC-002.2 Annual (IEST), Semi-annual (USP-797) Isolator USP797 & CETA CAG-002 Semi-annual (USP-797) Fume Hood ANSI/SEFA & ASHRAE 110 Annual Clean Room FDA & USP797 & International At least annual (FDA)
Semi-annual (USP-797) |
National Sanitation Foundation
| Controlled Environment Testing Association (CETA)
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This intel was contributed by Ankh
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May, 2012
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