Frequently Asked Questions
Here you will find answers to common questions that we are frequently asked. We will continue to update this information as needed. If you have any further questions please feel free to give us a call at either of the numbers listed below:
Toll Free: (800) 829-0293
Local: (513) 870-0293
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 Service 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”
2.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 Service 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 Service 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 Service follows NSF/ANSI 49 Annex G for performing paraformaldehyde decontamination.
Why can’t I be in the room during Paraformaldehyde Decontamination?
Agape Instruments Service 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> 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.
You can find more information on USP 797 at the following link:
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)
|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)
Why doesn’t my Fume Hood or Laminar Flow Clean Bench need decontaminated?
Decontamination is performed to inactivate biological hazards prior to service work, relocation, or disposal. Since your fume hoods and clean bench’s are not designed for use with biohazardous work, they do not need decontamination.
What has to be done if we use Radioisotopes in our hood?
If you use Radioisotopes in your hood then the unit must be cleaned prior to service work. After completion of the cleaning, the unit should be swabbed and the samples processed to assure that the unit is free of radioactive material. Contact your Radiation Safety Department for assistance.
My Biological Safety Cabinet (BSC) is alarming. What can be the cause?
There are different types of alarms that are used to make sure that safe operating conditions exist. Here are some examples of BSC alarms and why they are important:
One alarm is the sash (glass) height alarm. Its purpose is to alert the user if the sash is opened passed the safe sash height that is set by the manufacturer. When a sash is opened past the recommended height it can cause an unsafe work condition. Each BSC is designed to have a sufficient inflow of air through the face of the hood to assure that nothing escapes the unit. When a sash is opened up beyond that safe sash operating height, this causes the inflow velocity to drop and can potentially cause loss of containment. If your hood is alarming, check to see if the sash is lined up with the manufacturers marks that indicate safe operating height.
Another type of alarm that is used on BSC’s is an airflow alarm. These alarms generally measure either the airflow or pressure in the exhaust system. A low alarm in the exhaust system can be an indication that the unit is experiencing low inflow velocity which can cause loss of containment. If your hood is ducted to the outside and is alarming due to low airflow, check the blower on the roof. A slipping or broken belt is the most likely cause.
If you have a BSC that is alarming and the sash is lined up with the safe operating height mark, please contact Agape Instruments to have a qualified technician dispatched to investigate the alarm and get you back up running ASAP.
What kind of decontaminations do you provide?
Agape offers Paraformaldehyde, Chlorine Dioxide and Vaporized Hydrogen Peroxide (VHP®) decontaminations. Each one offers certain benefits. The following table describes the different methods:
Comparison of Decontamination Methods
|Ability to Penetrate HEPA Filters||YES||YES||YES|
|Toxicity (TWA PEL)||0.75 ppm||0.1 ppm||1.0 ppm|
|Starting Humidity Requirement (RH)||60-90 %||60-85%||10-80%|
|Non-Corrosive||YES||YES (Without Chlorine)||YES|
|Methods of Removal||Neutralizer||Scrubbing||Catalytic Conversion|
|NSF Validated for BSCs||NO||YES||NO|
|EPA Approved for Large Spaces||YES||YES||YES|
|Typical Cycle Time||12hrs+||3-4 hrs||2-4 hrs|
VHP is a registered trademark of STERIS Corporation