AS CLEANROOM OR thumbnail  

Cleanroom Certification

We provide certification services for all types and sizes of cleanrooms and other controlled environments, from small cleanrooms with just one HEPA filter to facilities with hundreds of HEPA filters.  We have the knowledge, equipment and manpower to meet your facilities’ needs.

A standard cleanroom certification will assess air quality and the ability of the engineering controls to remove particulate contamination.  Typical testing includes Air Velocity Testing/Air Change Rates, HEPA Filter Integrity Testing, Particle Count Testing, and Room Pressurization.

Additional cleanroom testing may include:

Viable Environmental Sampling

Visual Airflow Smoke Test with optional Video Documentation

Sound Level Testing

Lighting Output Testing

Temperature / Humidity Testing

Room Decontamination Services

Filter Repairs & Replacements

Airflow Uniformity Testing (parallelism)

Industry Standards:

In our industry, standards are very important.  They define the methods which we use to validate the performance of your cleanroom.  The following are the standards we utilize in the certification of your cleanroom:

  1. IEST-RP-CC-006.3; Testing Clean Rooms
  2. IEST-RP-CC-002.2; Unidirectional Clean Air Devices
  3. IEST-RP-CC-007.1; Testing ULPA Filters
  4. IEST-RP-CC-034.2; HEPA and ULPA Filter Leak Test
  5. ISO 14644; Cleanrooms & Associated Environments (supersedes FED 209E)
  6. USP 797; Pharmaceutical Compounding – Sterile Preparations
  7. USP 800; Pharmaceutical Compounding - Hazardous Drugs

All of our test reports and compliance certificates will reference a unique tracking number to facilitate accurate record keeping.  We keep records in accordance with ISO 9001 documentation practices.

Cleanroom Certification Procedures

Air Safe utilizes the Institute of Environmental Sciences and Technology Recommended Practice 006.3 and the ISO 14644 Standard as benchmarks for the certification of most standard configuration cleanrooms.  Testing may vary if an alternative method would provide a more accurate assessment of the cleanroom’s true performance.

Each individual cleanroom facility manager determines which test(s) he/she is contracting Air Safe to perform.  Air Safe cannot ensure total compliance with any standard unless all testing is performed by Air Safe.  Air Safe will however guarantee compliance concerning each individual test performed by Air Safe.  If deviations from the standard testing procedure(s) are required from the facility manager, a written statement must be signed by the facility manager denoting such deviations.

Air Safe will make recommendations concerning the performance of each facility cleanroom as well as recommendations as to which tests should be performed in order to meet the specific criteria set forth.  All data concerning the certification of the cleanroom is presented in a Final Report which contains all raw and calculated data used in assessing the cleanroom’s performance. 

     
Clean Benches Thumbnail  

Clean Bench Testing

The standard Laminar flow 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 acceptance, no leak in excess of .01% of the upstream challenge concentration.

Additional testing may include: Particle Count Classification, Viable Environmental Sampling, Sound Level Testing, Florescent Light Testing, Ultra-Violet Light Testing, Electrical Testing, Vibration Testing, and Temperature/Humidity Testing.

All testing conforms to applicable current test standards, which are denoted on every electronically generated test report.  No handwritten illegible reports from Air Safe!  Our reports are generated in the field, and then reviewed at our office to ensure accuracy.  A compliance certificate is issued and applied to the unit denoting test date, status, and re-certification due date.

Air Safe provides certification, preventative maintenance, and repairs for all types of hoods as well as other related air cleaning equipment.

Which Standards are these types of devices tested to?

The national standard used by Air Safe to certify the hood's performance is the IES-RP-CC-002.2, Laminar Air Flow Devices.  Often these hoods are tested to the manufacturer's guidelines, which generally follow the IEST guidelines.

Other standards apply to some of the additional tests available.  These may include:

  1. ISO 14644; Cleanrooms & Associated Environments (supersedes FED 209E)
  2. IEST-RP-CC-034.2; HEPA and ULPA Filter Leak Test (referenced in 002.2)
  3. NSF 49-Annex “E” (guidelines for light, vibration and electrical testing) 

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.

Air Safe works directly with the manufacturers to provide you with all of your warranty related services for your equipment.  Don’t see your equipment manufacturer listed here? No problem!  We have a database full of testing specifications accumulated over time and update it with each new piece of equipment we come across to ensure consistent testing every certification.

     
bsc05 thumbnail  

Biological Safety Cabinet Testing

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.  The final test is a visualization of airflow.

Additional testing may include: Particle Count Classification, Viable Environmental Sampling, Sound Level Testing, Florescent Light Testing, Ultra-Violet Light Testing, Electrical Testing, Vibration Testing, and Temperature/Humidity Testing.

All testing conforms to applicable current test standards, which are denoted on every electronically generated test report.  No handwritten illegible reports from Air Safe!  Our reports are generated in the field, and then reviewed at our office to ensure accuracy.  A compliance certificate is issued and applied to the unit denoting test date, status, and re-certification due date.

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!

A Note to BSC Users with Exhaust Systems!
Current NSF 49 standards require Type A2 Biological safety cabinet which are ducted to an exhaust system are required to have a “canopy” style exhaust transition equipped with an airflow alarm.  Cabinets which are directly connected to the exhaust system are no longer permitted even with an alarm!  Contact us for more information on converting your old hard connection to a canopy, or adding an alarm to your existing canopy connected hood.

Which Standards are these types of devices tested to?

The national standard used by Air Safe to certify the hood's performance is the NSF 49-Annex “E”.  Often these hoods are tested to the manufacturer's guidelines, which generally follow the IEST guidelines.  The NSF 49 document references several IEST Recommend Practices which outline the fundamentals of testing

Other standards apply to some of the additional tests available.  These may include:

  1. ISO 14644; Cleanrooms & Associated Environments (supersedes FED 209E)
  2. IES-RP-CC-002.2, Laminar Air Flow Devices
  3. IEST-RP-CC-034.2; HEPA and ULPA Filter Leak Test (referenced in 002.2)

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.

     
Animal Unit Testing Thumbnail  

Animal Units

Air Safe provides airflow and HEPA filtration certification for all manner of research animal cage air units, dump stations and cage change stations.

We service all manufactures such as:  Allentown Caging, Techiplast, NuAire, Baker Company, Lab Products, Alternative Design and Labconco as well as custom fabricated enclosures.

Do you need to replace your prefilters but do not want to hassle with procuring them, stocking them and having your personnel change them. Contact us and we will be happy to implement a filter change out program for you!

     
Isolator thumbnail  

Isolator Certification

Air Safe can certify and service all types of isolators and gloveboxes.  This includes Compounding Aseptic Containment Isolators (CACI), Compounding Aseptic Isolators (CAI) used in pharmacy settings as well as Class III atmospheric gloveboxes utilized in high containment facilities.  Not only can we certify the airflow and integrity of the HEPA filters installed, we can also perform leak test on the chambers.

Other important tests which can be performed are:

  1. Recovery Testing
  2. Particle Count Testing
  3. Viable Microbial Sampling
  4. Visual Airflow Testing
  5. Alarm Calibration
  6. Ingress and Egress Test
  7. Particle Containment Integrity and Enclosure Leak Test
  8. Gauntlet Breach Air Velocity Test
  9. Volatile Hazardous Drug Containment Test -Total Exhaust
  10. Volatile Hazardous Drug Containment Test-Partial-Recirculating
  11. Hazardous Particle Containment Test

Isolators can be a much cheaper alternative to renovating an entire pharmacy to comply with USP <797>.  These devices are best suited for low volumes of sterile compounding.  While very effective when used with proper procedures in place, they can be cumbersome for some technicians to use effectively due to the additional movement limitations cause by the glove port access.

Air Safe, LLC recommends the use of unidirectional airflow isolators versus non-unidirectional (turbulent) airflow isolators for clients wishing to comply with the USP <797> document on pharmaceutical compounding.

It has been our experience when performing recovery testing on non-unidirectional airflow isolators, the recovery time can exceed 30 minutes.  The recovery test provides the user of the isolator information about how long it takes the isolator to “recover” to an acceptable ISO Class 5 environment after an introduction of simulated contamination.  Field testing of unidirectional airflow isolators has shown recovery periods of less than one minute.

     
   

Video Documented Smoke Studies

Air Safe has several years of experience performing Video Smoke Documentation services for our pharmacy compounding clients.  USP 797 & FDA regulated 503A/B Compounding Pharmacies are recommended to document airflow patterns both in static and dynamic (every certification) operational conditions. 

Despite all the metrics used to verify the performance of your ISO Class 5 devices, visually verifying the airflow patterns in your environment is the only true objective way to prove that your Primary Engineering Controls are truly performing as they were designed.  Our videos are edited with title screens and muted to only include the necessary aspects of your smoke study, and to help save you time explaining what each video means.  Air Safe can identify problem areas and help develop solutions to ensure your operation is as efficient and effective as possible.

     
Trace Gas Thumbnail  

Trace Gas Testing

Could there be traces of nitrous oxide in your surgical suites or post anesthesia care unit?  Air Safe can test for exposures in your surgical suite for waste anesthetic gases.  This test/certification can give you and your personnel a piece of mind when it comes to exposure, safety, and being in compliance with the standards.

Air Safe, LLC completes a thorough test of the anesthesia machine(s) using the latest testing procedures.  Special attention is given to areas that are at high risk for leaks including vaporizers, cylinder yokes, absorber canisters, scavenging systems, breathing systems, and drop lines coming into the operating room.  Testing also consists of checking the flows within the vacuum or waste anesthesia gas disposal (WAGD) and testing the room’s pressure.  

Air Safe can test/certify all makes and models of anesthesia machines.  We are a third party testing/certification company, providing professional service to make sure there is no exposure.  If exposure is detected we will identify and document the levels and notify the proper personnel.  All testing information is compiled into a custom report for your facility.

Additional Testing/Certifications

Post Anesthesia Care Unit (PACUs):  This is an important as PACUs can have high concentrations of waste anesthetic gases.

Standards referenced above are included in the following:

1. NIOSH Pub. 77-140; Occupational Exposure to Waste Anesthetic Gases and Vapors
2. NIOSH Pub. 94-118; Request for Assistance in Controlling Exposures to Nitrous Oxide during Anesthetic Administration
3.  ACGIH-Industrial Ventilation-“A Manual of Recommended Practices”
4.  NFPA Pub. 99C 2005 edition; International Codes and Standards Organization – Gas and Vacuum Systems.

We are accustomed to performing these services around daily hospital schedules and work closely with the facilities engineering office personnel.  We realize some hospital rooms and departments are not always accessible, but we will work with each department to ensure and verify every aspect of the medical gas system available.

Give us a call if you have any questions or would like a quote on performing this detailed testing for your facility. 

     
Medical Gas Thumbnail  

Medical Gas Certification

Medical Gas Certification consists of a comprehensive inspection process using the NFPA 99C Gas and Vacuum Systems Verifications for new construction and renovations.

Air Safe, LLC provides medical gas certifications for healthcare facilities that are being built, renovated, or changing out any equipment to their medical gas systems.  Technicians work intensely with the contractor, engineer, and facilities personnel to make certain the medical gas system is in compliance with current standards and to provide documentation of compliance.  

Any time the medical gas system has been breached it shall be certified by an ASSE 6030 verifier, per NFPA 99.


Testing and Inspection of:

•    Medical Gas Source Systems –Bulk, Manifolds, Pumps, and Compressor Systems
•    Outlets, Valves, and Alarms
•    Particulate Analysis
•    Cross-connection and Labeling Verification
•    Flow and Pressure Testing
•    Proper Piping Configuration

Medical gas annual verification consists of a comprehensive annual inspection process in accordance with the NFPA 99 Medical Gas Verifications.

The annual inspection for an existing healthcare facility can be performed to verify that the medical gas and vacuum systems throughout the facility are working properly and to identify any safety concerns within the facilities medical gas and vacuum systems.  All inspections are completed using NFPA 99 and ASSE 6000 in order to validate compliance with today’s standards and provide documentation of compliance.

The medical gas piped systems, alarms, and sources should be retested on an annual basis per NFPA 99.

We can calculate your air change rate using traditional methods as well as more accurately measuring air changes with the use of tracer gas.  This method allows for us to pinpoint problem areas within a room concerning airflows.

     
Decontamination Services Thumbnail  

Decontamination Services

Air Safe, LLC performs biological decontamination for equipment such as Biological Safety CabinetsIsolators, incubators, cold rooms, Animal Rooms And Caging Systems, as well as entire BSL suites.

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.

It is paramount that the individual(s) performing the decontaminations are educated and very experienced in the entire process to assure safety. 

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 designed to 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.

Decontamination Methods

There are several methods that can be employed to decontaminate equipment, rooms and in-line HEPA filter banks.  Each method has unique pros and cons, and we can assist you in determining which method would be most beneficial for your environment. Keep in mind that in general, any substance that will effectively kill microbes can be potentially harmful to humans! Great care is taken by Air Safe to ensure the safety of our technicians and your staff during any decontamination procedure.

Gaseous Formaldehyde: The most cost effective form of decontamination for most small and medium systems utilize formaldehyde as the decontaminant. A granular form of formaldehyde is heated until it vaporizes within the sealed environment, then ammonia is used to neutralize the formaldehyde. The main Pro to this method is the relatively low cost. Cons include residue left over from neutralization and the potential risks of formaldehyde escaping an unsealed environment.

VHP (Vapor-Phase Hydrogen Peroxide): Possible the safest method of all, but also the most expensive.  VHP machines are generally self-contained, but tend to be cost prohibitive. Even renting a unit can cost thousands of dollars. Yikes! The future of this method is very promising once the cost comes down.

Chlorine Dioxide: There are several methods used to generate ClO2 gas.  Some systems use tablets that react in water, other methods are self-contained systems. The chlorine gas is then removed from the space using chemical filters. This method is slightly more costly than traditional methods, but the contact time to ensure decontamination is reduced by about half.

Methyl Bromide: Once used as a pesticide, this ozone depleting gas is no longer used in our industry.

Manual spraying and wiping of exposed surfaces: Often included in more robust room decontaminations, manually cleaning exposed surfaces is a recommend adjunct to other decontamination methods. This is the only effective method for removing non-biological contamination such as chemical or cytotoxic drug residue.

     
Consulting Thumbnail  

Consulting Services

One of our most under-utilized 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.

     
 AS Laboratory thumbnail  

Environmental Monitoring

A robust viable sampling plan is validation that your processes produce sterile products. Critical areas to your process need to be sterile under working conditions.  Air Safe performs viable sampling under dynamic conditions 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. 

Air Safe embraced viable air sampling early on, before the current USP <797> document became effective.  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.  With our experience, 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.

Environmental monitoring is one of the most important tests we offer to our pharmacy clients.  As required for compliance with USP <797> and FDA 503A/B standards, pharmacy air in controlled environments is sampled via an active air sampler which impacts a metered volume of air onto agar media plates. These samples, along with surface contact samples, are sent to an accredited laboratory for identification of any colony growth.  These laboratory reports are included in your final certification report.

     
ASHRAE  

Fume Hood Certification

The standard fume hood certification includes face velocity testing to document and obtain an acceptable airflow and calculated total CFM volume, through the front opening of the hood with the sliding sash at a height that allows functional use.  Visual airflow testing is also performed on every hood.  The national standard used by Air Safe to certify the hood's performance is the Laboratory Ventilation ANSI/AIHA Z9.5-2003

ASHRAE 110 Testing 
Air Safe
 strongly recommends the ASHRAE-110 tracer gas performance test be performed on all fume hoods.  Once the testing has been performed and the hood is operating at an acceptable level, the hood should not need to be tracer gas tested again unless environmental conditions change.  Changes such as room modifications, HVAC system adjustments, equipment locations or procedural changes would warrant a retesting to confirm the changes do not impact the safety performance of the fume hood.

Trace gas testing is the one true way to asses if you fume hood has full containment.  Many times it is not the hood that is causing the problem.  Many times the room conditions affect the performance ability of the hood negatively.  Do not assume that just because you have airflow going into the front of your hood that it must be containing everything generated with the hoods work area.  ASHRAE-110 tracer gas test will let you know how well, or not so well your hood is doing concerning its ability to contain the potentially harmful compounds and gases.

Air Safe utilizes the MIRAN SapphIRe XL portable infrared air analyzers and Sulphur Hexafluoride (SF6) tracer gas to perform ASHRAE-110 testing.  Owning multiple units allows us to perform this testing in a much more efficiently manner than many other companies.  Our technicians have been trained on the usage of the equipment so you can be assured your final test data is accurate and fully documented.

We generate custom reports with detailed graphs denoting all environmental conditions during the testing.  The final rating of your fume hood is accurately backed up with raw data.

     
van01 thumbnail  

Repair Services

Air Safe prides itself in being able to repair almost any device, provided that we are able to source the required parts.  Some equipment out there is up to 25+ years old!  These older hoods can still have HEPA filters and blower motors replaced as long as the rest of the hood is still in good shape.  Air Safe will assess the condition of your devices and make recommendations accordingly in your report.  You can be assured that we will do everything possible to get your device back up and running as soon as possible.  This includes ordering parts, making the repairs and certifying the equipment after the necessary repairs are made. 

We have long been the one of the only Authorized Warranty Service Representatives for all of the major manufacturers in our industry including, but not limited to:

  • Baker
  • Germfree
  • Labconco
  • NuAire
  • Thermo Fischer
  • Tecniplast

As the new era of technology is built into the most current devices, Air Safe maintains continued education to keep up to date on new innovations in the industry.

HEPA Filter Replacements
Air Safe
 works with several filter distributers in order to get our clients the best quality and value replacement HEPA filters.  We can have filters made for practically any device, new or old.  Due to the nature of the HEPA filter distribution process, the majority of HEPA filters are made to order.  Lead time on HEPA filters can be up to 4-6 weeks depending on order size.

     

24 hour emergency services available