Consulting Services
Relying on our years of experience and seeing both newly
constructed as well as existing remodeled areas, we can help guide you away from
costly errors and oversights concerning your projects. Our recommendations are based on your needs
and the industry standards you are trying to comply with.
Why take the chance on a new project before consulting with us concerning the HEPA filtration industry? We have seen time after time, facilities rely on various contractors and engineers to build their new state of the art rooms or facilities only to find out, that when it comes time to certify the environment to current industry specifications, the facility fails terribly.
Our consultation fees are very reasonable when you consider the cost of an improperly installed or engineered facility. We rely on our experiences and our industry involvement to help focus our clients on the primary end results. We want a facility that is conducive to accurate testing and that will function as designed well beyond the initial installation.
|
|
Environmental Monitoring
Environmental monitoring is one of the most important tests
we offer. As required, pharmacy or
laboratory surfaces, and air, are sampled via an active air sampler. These
samples are incubated and colony forming units are statistically calculated using Feller's Law and documented and compared to
acceptable standardized levels.
An
excellent tool for ensuring aseptic techniques and effective cleaning
procedures are being utilized to minimize the level of bio-burden in your clean
environment. Not only do we test for
viable particles, we can help you implement procedures to reduce these levels
of potential contamination. We keep historical data so we are able to monitor the trends
in the monitoring and notify you of any abnormalities within the monitoring.
We perform many aspects of environmental monitoring depending on your application. Do you need sampling for viable organism in the air or on surfaces? We also provide sampling for particles within the air and can report the concentration ans sizes of those particle distributions. If VOCs are your concern we can monitor for them as well, both known and unknown compounds.
If you are a compounding pharmacy owner or director, you should be doing viable and non-viable monitoring of your pharmacy areas. This includes areas within your hoods as well as in your buffer and ante rooms. Contact Air Safe to learn more about what you should already be doing. The USP 797 document revision become effective on June 1, 2008.
|
|
|
Indoor Air Quality Services
We not only service sterile pharmaceutical areas, but we also extend our expertise to any facility building owner. Are you having complaints from your occupants of your buildings? Are you concerned about the manufacturing plant's exhaust down the street getting into your controlled spaces? We can monitor and document the various compounds that are in the air your occupants are breathing.
Do you have a particular compound you are wanting to see if it is making its way into your building? We can test for both know volatile organic compounds (VOC) as well as unknown compounds. By using the most advanced test equipment available we can monitor the air and give you instantaneous results. We do not have to send our air samples off to some lab for analysis, or equipment does it for us!
We not only do air sampling but can also sample any surface and document the growth as well as identify the growth for you. Air Safe is you one stop shop for all your environmental indoor air quality related testing. Are you building a new facility or adding on to an existing one? We can provide you with the documentation you require concerning various VOCs, formaldehyde, CO2, CO, to mention a few.
We can performing sampling for schools, manufacturing plants, hospitals, research facilities, even your personal residence.
|
|
|
Decontamination Services
Air Safe, LLC. performs biological decontaminations for equipment such
as biological safety cabinets , isolators , incubators, cold rooms, animal rooms
and caging systems , as well as entire BSL suites.
The most cost effective form of decontamination for most
small and medium systems utilize formaldehyde as the decontaminant. Other forms of decontamination include VHP
(Vapor Hydrogen Peroxide), chlorine dioxide, methyl bromide, systematic fogging
and manual spraying and wiping of exposed surfaces. There are pros and cons to each type of
decontamination, and we can assist you in determining which method would be
most beneficial for your environment.
If you work with potentially harmful pathogens or other materials in your hood, DO NOT let your maintenance staff perform any internal maintenance on the hood. The hood must be decontaminated prior to any internal maintenance or repairs. All biological safety cabinets should have the appropriate signage denoting all possible hazards within the unit.
If your decontamination needs are small or large, we have the materials and equipment to handle it. Our response time to emergency critical situations is often with 24 hours. Typical decontamination periods are performed overnight for effective reduction in viable organisms.
Please note: If an entire room or many rooms are to be decontaminated the facilities must be leak free. It is important to understand when performing large scale decontamination this fact. Many owners of building and labs may think their room or lab is air tight, but once a decontamination is commenced it is easily determined that the room is not completely sealed. There are various methods to determine a facilities "tightness". Air Safe can utilize tracer gas in order to determine problem areas concerning facility leakage.
It is paramount that the individual(s) performing the decontaminations are educated and very experienced in the entire process to assure safety.
|
|
Tracer Gas Testing
Do have areas which are susceptible to cross contamination between critical departments and labs? Are you having problems with the receiving dock vehicles' exhaust emissions getting into your facility?
Air Safe has the expertise to diagnose and locate the problem areas. We utilize invisible, odorless, harmless tracer gas to locate airflow patterns and problems throughout your facility. This can be as simple as an office space air intake being situated too close to an unacceptable exhaust system, or diagnosing cross contamination due to improperly installed HVAC systems.
This testing can verify that air from one area either is or is not present in another area. This takes the guessing out of the equation. By using state of the art infrared analyzers we can"see" exactly what is going on concerning the air flow within a building.
We are trained experts in the use of this highly technical equipment. If personnel safety or product containment is an issue, this test could save you an enormous amount of time and money it would typically need to determine what the problem is.
Tracer gas testing can also be used to determine true air change rates for a facility, room, or even a particular location within a room, or at a critical process location. Typical air balancing testing can only calculate what the overall air changes for an area would be based on the entire area. This assumes that all air is evenly distributed throughout the area, which is often no the case.
Give us a call if you have any questions or would like a quote on performing this detailed testing for your facility.
|
|
|
Bio Safety Cabinet Certification |
|
|
|
|
Biological Safety Cabinet Certification
We service and certify all types of Biological Safety
Cabinets. Do you have a Class I, Class
II, Type A1, A2, B1, B2, or a Class III device?
If you are not sure what type of cabinet you have, give us a call and we
will let you know!
The standard BSC hood certification includes air velocity
testing to document and obtain an acceptable airflow and calculated total CFM
volume, meeting the manufacturer’s specifications. The HEPA filter integrity test is also
performed to document acceptable performance of no leakage in excess of .01% of
the upstream challenge concentration.
Additional testing includes:
airflow smoke test, sound level testing, florescent light testing,
ultra-violet light testing, electrical testing, vibration testing, cabinet leak
testing, particle count classification and temperature testing. Decontamination's are also performed as
requested or required for internal maintenance.
All reporting is printed out electronically on-site via
computer, and a compliance certificate is issued and applied to the unit
denoting test date, status, and re-certification due date.
STANDARDS
The national standard used by Air Safe, LLC. to certify the
hood's performance is the NSF 49 document on Class II (Laminar Flow) Bio-hazard
Cabinetry, as well as the manufacturer's guidelines. Certifications are required in order to
maintain compliance by a number of governing agencies such as the FDA, USP,
Joint Commission Agency as well as many others.
Air Safe supports equipment manufactured by:
Abatement Technologies, Agnew Higgins, Abbott Laboratories,
Air Control, American Scientific, Atmos Tech, Baker Company, Bellco, Bio Quest,
BBL, Bio Safe, Bio Clean, Capt Air, Canadian Cabinets, CCI, CCL Classic Modular,
Clean Air Products, Clear Air Systems, Dexon, Duralab, EACI, Envirco, Esco, Fisher
Scientific, Flow Sciences, Forma Scientific, Gelaire, Germfree Labs, Gruenburg,
Hamilton Industries, Hemco, Hoffman, Holten, Howorth Air, HR Inc, I.S.O. Tech
Design, Integrated Air Systems, Iroquois, Isle Industries, Johnston Labs,
Kendro, Kewaunee Scientific, La Calhene, Lab Products, Labconco, Laminaire,
Laminar Flow Inc, Lerner Labs, Lipshaw, MIC, Microviod, Microzone, Modular,
Mopec, NuAire, Pureaire Corp, Sci-Med, Sterilaire, St. Charles, Thermo Fisher
(Forma) Scientific, Torit, Veco, Weber, Westinghouse, and all forms of
manufactured cleanrooms.
|
|
|