testing

Evaluating a Chemical Fume Hood for Containment of Solids, Liquids, and Vapors Using ASHRAE 110, HAM, and ISPE Methods

Allan Goodman, Ph.D., Flow Sciences
Robert Haugen, Ph.D., Flow Sciences

Abstract:

Flow Sciences has more than three decades of experience in designing, manufacturing and testing powder containment devices, predominantly for the pharmaceutical industry. These enclosures have evolved from small balance containment devices connected to remote blowers, to a variety of custom and standard products.

This increased product diversity has been achieved while maintaining the necessary features required for superior containment and airflow conditions conducive for enabling highly sensitive operations such as microbalance weighing and mixing and reacting chemicals.

No product reflects this sophistication more elegantly than the chemical fume hood. Originally designed around 350 years ago to contain accidents and prevent bad odors in the laboratory, the fume hood has become a device that can routinely produce control levels of vapors down to the part-per-billion level. This is particularly important because many researchers may be unaware of the toxicity or even the identity of chemicals routinely produced in experimental chemical reactions.1

In the United States, the primary containment measurement methodology for fume hoods since the late 1970’s has been ASHRAE 110. The latest version of this test, ANSI / ASHRAE 110-2016, uses an SF6(g) diffuser and mannequin with air sampler to determine a tracer gas presence in the breathing zone of a mannequin.2 A limitation of the ASHRAE test is that it is mostly static in nature and, other than the Sash Movement Effect (SME) component, involves no human interaction. In spite of these limitations, most manufacturers of fume hoods sincerely believe that containment of SFgas under the ASHRAE test conditions is a reasonable predictor for particulates as well as vapor containment.

This argument remains unconvincing for many of our customers. Indeed, many industrial hygiene organizations and personnel have not recommended the use of fume hoods for powder manipulation operations of any kind. It is therefore necessary to find new tests which quantify performance and limitations for fume hoods in the context of finely divided powders.

We have therefore chosen here to meld existing techniques centered around ASHRAE 110 with widely-accepted particulate containment measurement techniques4. This combined regimen was then directly applied to a 4’ fume hood so results of all tests could be compared with each other.  If results were found to be consistent, a new combined test using all three phases of matter could be established.

The test results obtained here allow us to make some rather positive preliminary conclusions in this regard.

Introduction:

Flow Sciences offers a wide range of enclosure types, including the ‘Saf – T Flow’ series of fume hoods.  The FAF483055VAA fume hood has a vertical sliding sash enclosure, and airflow through the unit is achieved using a duct system to an exhaust fan with air leaving the building. (Figure 1)

Testing of the unit was broken out into the following components:

  • ASHRAE-110
    • Face Velocity
    • Smoke Visualization
    • Tracer Gas
  • HAM
  • Surrogate Powder / Solvent

The ASHRAE-110, SF6HAM and surrogate material tests were performed at the Flow Sciences facility in Leland, NC.

Other than the SME, the ASHRAE-110 test is static in nature, while the other components are dynamic and require human interaction in and around the face opening of the fume hood. The various tests use different materials, allowing the tests to be used independently, to validate containment performance of the fume hood, or compared to one another to determine each test method as a predictor of the level of containment offered by the equipment.

 

Testing:

Materials used for the testing of the fume hood are either used in standard testing or are acceptable surrogates.  Sulfur hexafluoride is the tracer gas used for the ASHRAE testing and is released at a constant rate determined by the ASHRAE-110 standard.  Lactose is an acceptable surrogate powder as defined by the ISPE good practice guide – Assessing the Particulate Containment Performance of Pharmaceutical Equipment.  Methylene chloride was chosen as the solvent as it is fairly volatile at ambient temperature and does not have appreciable solubility capacity for lactose.  For both of the surrogate materials, sufficient quantities were utilized to provide a robust benchmark challenge to the containment capability of the fume hood.

Test Material Appearance Particle Size Density (g/cm3) Quantity Used
Sulfur hexafluoride Colorless Gas ~ 3.12Å diameter 0.0062 4L / min
Methylene Chloride (DCM) Colorless liquid or gas ~ 2.94Å diameter 1.33 (l), 0.0035 (g) 3 x 250 mL
Lactose Monohydrate White, crystalline powder <250 µm (≥99%) 1.54 3 x 100g
For comparison, air has a density of approximately 0.0012 g/cm3

Table 1. Summary of test material attributes.

The initial factory acceptance test followed the standard ASHRAE110 and ANSI/AIHA Z9.5 testing protocols using Sulfur Hexafluoride(SF6)as the tracer gas. The following tests were performed:

1)an average airflow velocity at the face opening

2)small and large volume smoke tests

3) a tracer gas test.

The ANSI/AIHA Z9.5 standard testing for the tracer gas was followed, using the generally accepted 50 ppb threshold for factory acceptance.  The tracer gas used in the experiments was 99.95% pure sulfur hexafluoride, set at a flow rate of 4.0LPM.  The tracer gas ejector system is equivalent to that of the ASHRAE-110 standard ejector system.  Table 2 shows an overview of the test results.

 

Test FAF483655VAA
Average Airflow Velocity (fpm) 80.75 ± 4.95
Low Volume Smoke Rating Good
Large Volume Clearance Time (s) 25
Average TracerGas Reading (ppb) Static 0.00
SME 0.00
HAM 2.80

Table2. Summary of general performance testing

It is possible to convert ppb of sulfur hexafluoride directly to units more commonly used in the industrial hygiene field through the following conversion factor:

1ppb = 5.98 µg/m3

Therefore, it is possible to calculate the release rate (inside) and escape concentrations (outside) of the sulfur hexafluoride during testing.  Table 3 shows the release rate concentration and the Short Term Exposure (STE) and Time Weighted Average (TWA) levels of the tracer gas during HAM testing.

ppb µg/m3
Release rate concentration 364,161 2.18e6
Escape STEL 2.80 16.74
Escape TWA 0.015 0.087
Numbers are generated using the following values – CFM of unit tested @80.75 LFPM = 387.90; STE during 2.5 minutes sampling time; TWA based on STE and 8-hour work day.

Table3.  Summary of ASHRAE testing converted to common OEL values.

Surrogate Testing:

All sampling was performed in accordance with the following: best Industrial Hygiene practices; the guidelines published in Section II, Sampling, Measurement, Methods, and Instruments, of the Federal Occupational Safety and Health Administration (OSHA) Technical Manual; and the ISPE APCPPE Guideline.

All samples were collected using filters and portable pumps. Some pumps were stationary both inside and outside the containment area, others were mounted on the experimental subjects as in figure 4 below.  “Loaded” filters were then analyzed using validated analytical methods by a contract analytical laboratory accredited by the American Industrial Hygiene Association (AIHA).

In this study, lactose, an industry accepted surrogate, and methylene chloride (DCM) were utilized to determine the expected containment that a fume hood of this type would provide during manipulation of similar compounds during normal work practices.  These operations included weighing, dissolution and filtering.

A detailed description of the procedural steps used in this test is available from the manufacturer but is considered beyond the scope of this paper. Suffice it to say, tared weighing, dispensing, vacuum filtration, data recording, and cleanup were the key steps. Table 4 shows a summary of the quantities of surrogate materials manipulated, the concentration of powder generated inside the fume hood and the level of material that ‘escaped’ from the fume hood during operations.  As can be seen, for both of the surrogate materials utilized, no filters showed measurable quantities escaping.

Operator Surrogate Amount Handled by Operator Amount Collected on Outside Filters (escape) (µg)
1 Lactose 100 g <0.002
DCM 250 mL <10
2 Lactose 100 g <0.002
DCM 250 mL <10
3 Lactose 100 g <0.002
DCM 250 mL <10

Table 4. Summary oftotal surrogate collected on filters outside fume hood.

 

During testing, a single filter was located inside the enclosure to measure the airborne concentration of lactose.  Since only a single filter was used, the concentration for each operator was assigned to be the same.  For DCM, volumes were measured at the start and end of the process for each operator. The difference in volume was used as a means to determine a worst case concentration of vapor (assuming total evaporation).5

 

Table 5 shows a summary of ‘Short Term Exposure’ (STE) and ‘Time Weighted Average’ (TWA) levels for each operator with both surrogates, both inside and outside of the fume hood.  These values are useful in determining the suitability of control devices as various ‘Operator Exposure Bands’ (OEBs) exist and are often determined by the end user. (N.B. The TWA is based on the concentration determined for the STEL and an 8-hour work day).

Operator Powder Concentration Inside (STE) Max Outside (STE) (µg/m3) Concentration Inside (TWA) Max Outside (TWA) (µg/m3)
1 Lactose 5.64 (µg/m3) ND 0.38 (µg/m3) ND
DCM 61.90 ppm ND 4.12 ppm ND
2 Lactose 5.64(µg/m3) ND 0.31 (µg/m3) ND
DCM 55.29 ppm ND 3.00 ppm ND
3 Lactose 5.64 (µg/m3) ND 0.33 (µg/m3) ND
DCM 50.20 ppm ND 2.93 ppm ND
ND – Levels were below reporting limit for analysis (2 ng for lactose; 10 µg for DCM)

                       Table 5.Summary ofsurrogate concentrations inside and outside fume hood.

 

Table 6 shows a summary of the total number of samples collected and exposures to surrogate materials for all operators.  Of the twenty-seven samples taken for each surrogate material for all operations, no samples showed detectable levels outside of the fume hood.

Powder Tested Total Number of Samples Breathing Zone Samples Area Samples
Total Number Number With Detectable Quantities Total Number Number With Detectable Quantities
Lactose 23 6 0 12 0
DCM 4 3 0 1 0

Table 6. Summary of operator.

Discussion:

From all of the data presented, it can be seen that the Flow Sciences Saf-T fume hood series, when used with good laboratory practices offers exceptional containment of potentially harmful substances. In static testing, the fume hood contained tracer gas to an average level of 0.00 ppb, well below the ANSI/AIHA Z9.5 standard threshhold for factory acceptance testing.

In the dynamic version of the tracer gas testing, or HAM testing, again the unit performed very well, with escape of the tracer gas at an average of 2.80 ppb.  This suggests two things:

  1. That the fume hood provides exceptional containment even under situations more accurate of the desired use;
  2. That the static and dynamic tracer gas tests of Flow Sciences’ fume hoods are indicative of the level of containment provided.

During the surrogate testing, a more aggressive challenge was performed using two materials designed to mimic ‘real world’ operations.  With both the ‘powder’ and ‘vapor’ surrogate materials, the fume hood offered superb containment.  No filters from subjects or the test room showed measurable amounts of surrogates outside the fume hood.

Conclusions:

An extensive evaluation of the containment capability of an FAF483655VAA from the Saf-T Flow series of fume hoods offered by Flow Sciences, Inc. was performed using both static and dynamic testing conditions.  In each of the tests performed, the level of material ‘escaping’ from the fume hood was significantly lower than concentrations generated inside.  This is particularly important when the vastly different physical characteristics of the test materials is considered.  Additionally, the static versus dynamic testing using the tracer gas showed excellent correlation, suggesting that either test is predictive of the containment capability of the fume hood.  Furthermore, the containment shown during the very aggressive surrogate powder testing show that this style of fume hood is capable of offering excellent protection to personnel during tasks of the nature described.

Overall, the Flow Sciences fume hood, when used in conjunction with good lab practices, is capable of providing workers with the protection they need for applications using solids, liquids and gases.6


References:

  1. https://www.cdc.gov/niosh/docs/2012-147/pdfs/2012-147.pdf
  2. https://webstore.ansi.org/standards/ashrae/ansiashraestandard1102016
  3. http://ateam.lbl.gov/hightech/fumehood/doc/LBID-2561-HAM_SidebySide.pdf
  4. https://ispe.org/publications/guidance-documents/assessing-particulate-containment-performance
  5. The concentration of DCM was calculated based on the total volume loss of the liquid during each operator’s process and is assumed to be constant throughout the whole process.The total loss was converted to an average loss per minute based on duration of task.  Using Ideal gas volumes (22.4L/mol) a vapor volume per minute was calculated.  This was then converted to a ppm concentration based on the volume of air flowing through the fume hood.
  1. A full report containing all of the information presented here including the surrogate test protocol can be obtained by contacting Flow Sciences, Inc. at 1-800-849-3429.


DR. ROBERT HAUGEN
Director of Product and Technology Development

Robert K Haugen  currently designs chemical laboratory containment equipment and develops new relevant technologies for Flow Sciences Inc.in Leland, North Carolina. He has also held positions at Kewaunee Scientific, Jamestown Metal Products, and St. Charles Manufacturing in similar capacities for 31 years. Previously, he did analytical chemical work at the University of Illinois (DNA, wastewater, and crop research) and Lawrence Livermore Labs in California (nuclear weapons research).

Dr. Haugen began his career as a curriculum writer for the Illinois Office of Education, developing texts on energy, urban management, and industrial pollution topics.

He received all his degrees from the University of Illinois in Urbana-Champaign, and is currently a member of the American Society of Heating, Refrigeration, and Air Conditioning Engineers, the American Chemical Society, and the National Fire Protection Association. He has participated in the development of both ASHRAE 110-1995 and the current 2016 update.



Summary, Containment Testing of Saf T Flow Chemical Fume Hoods

DR. ROBERT HAUGEN
Director of Product and Technology Development

Robert K Haugen  currently designs chemical laboratory containment equipment and develops new relevant technologies for Flow Sciences Inc.in Leland, North Carolina. He has also held positions at Kewaunee Scientific, Jamestown Metal Products, and St. Charles Manufacturing in similar capacities for 31 years. Previously, he did analytical chemical work at the University of Illinois (DNA, wastewater, and crop research) and Lawrence Livermore Labs in California (nuclear weapons research).

Dr. Haugen began his career as a curriculum writer for the Illinois Office of Education, developing texts on energy, urban management, and industrial pollution topics.

He received all his degrees from the University of Illinois in Urbana-Champaign, and is currently a member of the American Society of Heating, Refrigeration, and Air Conditioning Engineers, the American Chemical Society, and the National Fire Protection Association. He has participated in the development of both ASHRAE 110-1995 and the current 2016 update.

Over a period of time ranging from 11/6/2013 onward, the range of standard Saf T Flow Fume Hoods shown below were tested by Flow Sciences using the ASHRAE 110-1995 methodology.  Details of the individual tests are available separately from Flow Sciences; total results are summarized below:

ASHRAE 110-2016 Saf T Flow Test Data Summarized by Volumetrics, Hood Description, and Catalog #:

Procedures and Equipment:

In each test position, face velocities were established using a TSI thermal anemometer and a velocity grid specified in section 6.2 of the ASHRAE 110 standard.

The ASHRAE 110-2016 test procedure used employs a sulfur hexafluoride diffuser set at 30 PSI with a diffusion rate of 4 lpm. Tests were run with the mannequin in place for 5 minutes and SF6concentrations in the mannequin-breathing zone recorded.

An SME (sash movement effect) test was run for a total of two minutes and included opening and closing the vertical sash twice in 30-second intervals over the two minute run. Tests were run with the mannequin in place and SF6 concentrations in the mannequin-breathing zone recorded.

Relevant illustrations from the standard are shown below:

Approved ASHRAE Standard 110-2016 used as an overarching methodology

Ejector Assembly Used in ASHRAE110 and Human as Mannequin Tests

 

In each test position, face velocities were established using a TSI thermal anemometer and a velocity grid specified in section 6.2 of the standard.

The ASHRAE 110-2016 test procedure used employs a sulfur hexafluoride diffuser set at 30 PSI with a diffusion rate of 4 lpm. Tests were run with the mannequin in place for 5 minutes and SF6concentrations in the mannequin breathing zone recorded.

An SME (sash movement effect) test was run for a total of two minutes and included opening and closing the vertical sash twice in 30 second intervals over the two minute run.  Tests were run with the mannequin in place for and SF6 concentrations in the mannequin breathing zone recorded.

Relevant illustrations from the standard are shown below:


The HAM Containment Test

 

While comprehensive dynamic tests are not a part of ANSI/ASHRAE 110-1995, it is evident that the low face velocity fume hood vulnerabilities might go unmeasured unless kinetic challenges are systematically introduced into our Safe-T Flow evaluation program.

The researchers decided to “borrow” a kinetic challenge test rather than design a hood to pass the lone and rather perfunctory dynamic sash movement test (SME Test) already in the ASHRAE 110 standard.

The Human as Mannequin Test

Funded jointly by Lawrence Berkeley National Laboratory and the California Energy Commission in 2005, the ECT group investigated kinetic challenges to low velocity fume hoods by developing a special test that used a human with an air sampler in front of a fume hood manipulating equipment in a specifically defined manner.

For this adapted version of the HAM test, the researchers placed a breathing zone monitor on a tripod stand so it and the analysis equipment would not be jarred by the moving operator.  Final array is shown below in Photo #1.  The HAM tests involve conducting a series of choreographed activities using objects located within the hood. The objects consist of two 100 ml measuring cups, a 100 ml scoop, and a spatula.

The modified timed sequence of activities follows the layout shown in Photo # 1

  1. Stand at hood opening with arms to side.
  2. Insert and remove hands and arms
  3. Move objects #1 through #4 from six inch line to twelve inch line
  4. Exchange position of objects. (1 to 2, 2 to 3, 3 to 4, and 4 to 1)
  5. Transfer liquid from scoop #1 to scoop #2.
  6. Place spatula in empty cup.

Each sequence of activities is conducted over a period of approximately 70 seconds


Conclusion:

All Flow Sciences Saf T Flow fume hoods pass ASHRAE 110-1995, using criteria set forth in ANSI/AIHA Z 9.5, Section 6.3.7.  A containment level of 0.050 PPM must be achieved in each test to pass, using the pass-fail level of 0.050 PPM established in AIHA Z 9.5; all data from all tests are much lower than this!

ASHRAE 110-2016 Saf T Flow Test Data Summarized by Volumetrics, Hood Description, and Catalog #:

Photos of Hoods under Test



FSI Testing Performance - Laboratory Testing Services

LELAND, NC, December 18, 2018 —Flow Sciences, Inc. (FSI) evaluates and ensures that every enclosure shipped to their customer meets all relevant standards. FSI performs procedures from the American Society of Heating, Refrigeration, and Air Conditioning Engineers (ASHRAE) 110-2016 – Methods of Testing Performance of Laboratory Fume Hoods. Examples of testing procedures include flow visualization (local and large-volume challenges), tracer gas exposure modeling via human as mannequin (HAM) testing. These procedures are conducted in-house as Flow Sciences’ Factory Acceptance Testing (FAT). FAT testing is analogous to the “as manufactured” (AM) test as mentioned in ASHRAE 110-2016. Additionally, testing is conducted at the customer’s location upon request. This test is analogous to the “as installed” (AI) test. Flow Sciences, Inc. refers to this this test as the “SAT”, or Site Acceptance Test.

Aside from ASHRAE testing methodologies, Flow Sciences tests other functionalities of containment devices; one example is vibration isolation. During this test, vibration is purposefully initiated and its effect on the measurement of the balance is analyzed in accordance with Flow Sciences’ data reproducibility standards. In essence, the enclosure’s capability of isolating a balance from vibrational interferences stemming from the external environment is put to the test. Additional information regarding vibrational interferences can be found here.

For High Potency Active Pharmaceutical Ingredient (HPAPI) powder enclosures, FSI conducts surrogate powder testing to quantitatively assess containment performance. During the test, samples are collected using standard industrial hygiene field sampling methods. Following the test, samples are sent to a third-party analytical laboratory accredited by the American Industrial Hygiene Association Laboratory Accreditation Program (AIHA-LAP). Third-party IH companies can also be employed to perform the evaluation in FSI’s test facility.

For more information, please email your inquiry to info@flowsciences.com

CAMERON FAULCONER, IH-MESH
Industrial Hygienist / Product Manager

Cameron Faulconer is an Industrial Hygienist with a wide breadth of experience, spanning between commercial manufacturing, to home residences. His inspiration for his choice of career is communicating the value of preserving the health and safety of employees using the most effective and efficient means possible. Therefore, Mr. Faulconer found his place in the “Engineering Controls” rung of the hierarchy of hazard controls.

As a problem solver, Mr. Faulconer believes that the best safety solutions are created through consultative conversations with those who seek solutions. He believes communicating information derived from these conversations to be critical to the continued understanding of the toxicological impacts of the work environment.

His personal motto is “protecting the safety and health of employees from what can and cannot be seen with the naked eye”.


Performance Validation by Third Party Industrial Hygienists


Flow Sciences, a leading provider of containment solutions for laboratory, pilot plant, and manufacturing facilities consults with third party industrial hygienists to conduct in-house Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) to ensure customers’ products perform at the level they need.

Flow Sciences partners with experienced third-party Industrial Hygiene (IH) consulting professionals from partnering companies to verify the containment performance of an enclosure using the following standardized testing methodologies:

 

  1. Surrogate Powder Testing at Flow Science’s Laboratory

 

Following IH consultation, Flow Sciences conducts personal and area air sampling inside our in-house laboratory following thorough decontamination. Air samples are run while demonstrators perform a mock task with little instruction and then submitted for AIHA Lab Accreditation Program (LAP) approved analysis. Finally, Flow Sciences’ team of scientists and engineers analyzes the resulting data and determines if the enclosure performs better than its Containment Performance Target (CPT).  Many customers choose to use their own operators and are invited to observe and participate in the testing at Flow Sciences.

 

  1. Surrogate Powder Testing at Client Site

 

If the customer requests an SAT, Flow Sciences utilizes staff from an IH company to perform the same testing methods as the FAT. However, the test is performed at the customer site. This testing option affords the customer the opportunity to verify the performance of their enclosure by having the test conducted using their own Standard Operating Procedures (SOPs) and employees.

 

  1. ASHRAE-110and ANSI/AIHA Z9.5 – Laboratory Ventilation

 

In accordance with the previously mentioned methodologies, Flow Sciences conducts Average Airflow Velocity Measurements, Flow Visualization, Large Volume Smoke, Tracer Gas, and Surrogate Gas testing. Flow Sciences utilizes consultation from IH consulting professionals to design a sampling protocol to model employee exposure in the field.

 

For more information, visit www.flowsciences.com/testing/

To view more testing results, visit www.flowsciences.com/performance/


CAMERON FAULCONER, IH-MESH
Industrial Hygienist / Product Manager

Cameron Faulconer is an Industrial Hygienist with a wide breadth of experience, spanning between commercial manufacturing, to home residences. His inspiration for his choice of career is communicating the value of preserving the health and safety of employees using the most effective and efficient means possible. Therefore, Mr. Faulconer found his place in the “Engineering Controls” rung of the hierarchy of hazard controls.

As a problem solver, Mr. Faulconer believes that the best safety solutions are created through consultative conversations with those who seek solutions. He believes communicating information derived from these conversations to be critical to the continued understanding of the toxicological impacts of the work environment.

His personal motto is “protecting the safety and health of employees from what can and cannot be seen with the naked eye”.


Non-Sterile Hybrid Isolator

Abstract 

In 2011, Flow Sciences, Inc. was commissioned with providing an isolator for a large pharmaceutical company that was capable of protecting its employees by reducing their exposure below the occupational exposure level (OEL) of highly potent active pharmaceutical ingredients (APIs) in an isolator. Here we describe the unit designed and constructed and the in-house testing results. 

Background 

In the ongoing search for new therapeutic treatments, pharmaceutical companies are developing a new class of active ingredients known as High Performance Active Pharmaceutical Ingredients (HPAPI). As the name suggests, these compounds are highly potent and therefore it is critical that exposure to the pure material is minimal. More commonly associated with oncology drugs, an ‘explosion’ of HPAPIs is predicted over the next 5 years due to the high levels of research currently being conducted in this area. 

Clearly, with the advent of this phenomenon, containment of these compounds from the scientists tasked with working with them is of major concern. One reason for this is the high expense often associated with new equipment designed to handle the task. In order to combat these potentially high capital outlays, many companies are looking at alternative methods of containment, including modification of existing equipment. The Non-Sterile Hybrid Isolator, offered by Flow Sciences, Inc., is one such method of reducing the cost of containment (Figure 1). 

Figure 1. Non-Sterile Hybrid Isolator with bag in/bag out and main chamber. 

The isolator is designed to protect personnel from exposure to chemicals including HPAPIs by fully encompassing equipment used by scientists during processes such as weighing, crushing and bag in/bag out procedures. The isolator has been developed using Flow Sciences’ expertise in fluid dynamics and can be designed and manufactured to fit the customer’s needs. 

Case Study 

In 2011, Flow Sciences, Inc. was tasked by a major pharmaceutical company with the design, construction and installation of a non-sterile hybrid isolator for use by its employees during powder handling operations. The design of the isolator included a bag in/bag out (BIBO) annex and a main enclosure. 

After installation of the isolator, a third party industrial hygiene consulting company, IES engineers, was contracted to perform Site Acceptance Testing (SAT) and determine the effectiveness of the isolator. Using industry accepted testing methods; IES performed sampling of the air, surface and the testing area environment to evaluate the containment performance of the isolator using a surrogate powder (naproxen sodium) during typical operator procedures. The design containment performance target (CPT) for the VBE air samples was set at 75 nanograms of surrogate powder per cubic meter (ng/m3) of air. This value was chosen to provide an additional margin of safety compared to the OEL for an API of 150 ng/m3. Surface samples were collected and used for reference purposes. All of the containment verification testing activities were performed using industry accepted practices.1-3 

Procedure 

Prior to the containment verification assessment, the sampling strategy developed by IES was approved by the client and included typical and maximum use scenarios. The procedures, using naproxen sodium as an API surrogate, were: (1) reference standard development, comprising of: (a) dispensing approximately 500 mg of naproxen sodium into volumetric flasks; (b) development of a buffer capacity, which included dispensing of approximately 1 g of naproxen sodium into 50 mL water, followed by 5 minutes of mixing; (2) minor cleaning procedures of the VBE interior, including a wipe down of the floor surfaces and gloves with methanol and removal of equipment and materials used during the procedures. Each procedure was performed three times establish a greater level of confidence in the containment verification data. 

Airborne samples were collected from personal, source, and area locations. Personal samples were collected within the breathing zones of the operators. Source samples were collected at 200 mm from the potential emission source and area samples were collected at distances no closer than 1.5 m from the process or equipment and at a height of 1.5 m. These samples were then analyzed and exposures quantified. 

Baseline samples were collected for all locations prior to performing the operations. 

As can be seen from the table above, all samples collected for the various zones were well below the CPT of 75 ng/m3 air 3

Summary 

In summary, FlowSciences designed, constructed, and installed a non-sterile hybrid isolator for a large pharmaceutical company to limit exposure of employees to APIs during powder handling operations. Containment Verification Testing of the isolator, using a surrogate powder, was performed at the pharmaceutical company by IES, a third party industrial hygiene consulting company. The test results demonstrated that the isolator provided effective containment of powders to the CPT of 75 ng/m3 for the tasks performed. 

References 

1) American Society of Heating, Refrigerating and Air-Conditioning Engineers, “Method of Testing Performance of 

Laboratory Fume Hoods, ANSI/ASHRAE 110-1995” Atlanta, GA, 1995. 

2) International Society for Pharmaceutical Engineering, “ISPE Good Practice Guide: Assessing the Particulate 

Containment Performance of Pharmaceutical Equipment,” Second Edition, 2012. 

3) Section II: Sampling Measurements and Instruments of the OSHA Technical Manual 

 

Contributing Authors: 

• Steve Janz, Flow Sciences, Inc. 

• Allan Goodman, Ph.D., University of North Carolina, Wilmington; 

• George Petroka, Director BioPharma/EHS Services CIH, CSP, RBP, IES Engineers 

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For a PDF of this Press Release or for questions or comments, please contact us below:

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About Flow Sciences, Inc.

Flow Sciences is the world’s leading developer of containment solutions for research and development laboratories, pilot plants, automation equipment and robotics, manufacturing and production facilities where toxic or noxious potent powders, fluids, or gases require safe handling while weighing, mixing, processing, or manufacturing. Since its start in the 1980s and with the introduction of the Vented Balance Safety Enclosure (VBSE™) in the 1990s, Flow Sciences has gone on to develop a comprehensive line of over 500 enclosures, including industry standards like the Vented Balance Safety Enclosure (VBSE™), the Contained Vented Bulk Powder Enclosure, and innovative laboratory technologies like the FS1501 Nitrogen Controller and the Bag-In/Bag-Out HEPA Filtration System. For its accomplishments, Flow Sciences received an Expert Achievement Award from the U.S. Department of Commerce for accomplishments in the global marketplace, the Deloitte and Touche North Carolina Technology Fast 50 Award, the UIBS R&D and Technology Collaboration Award, along with many others. During the 1990s, Flow Sciences pioneered the Vented Balance Safety Enclosure Series (VBSE™) which introduced the first independent fan exhaust system to isolate vibrations for balance accuracy, swiftly becoming the world leader in laboratory safety equipment. Flow Sciences technologies are now used to improve safety and containment in virtually every industrial sector around the globe, from pharmaceutical, food processing, robotics, chemical, forensics, agriculture, academia, infectious diseases, asbestos, tires, biotechnology, batteries, and nanotechnology. Flow Sciences has over 30 years of expertise in the development of containment solutions that deliver superior engineering quality and service at each level of controlled airflow containment systems. Flow Sciences offers the incorporation of Computational Fluid Dynamics (CFD), further refining the process of presenting personnel and product protection through framed enclosure solutions. The company’s Flow Sciences China division serves as a market leader in mainland China, spearheading the development of solutions throughout Asia. Under its Flow Sciences brand, Flow Sciences offers the best in laboratory containment, and is committed to finding containment solutions that meet your needs.

 

All other product names and trademarks are the property of their respective owners, which are in no way associated or affiliated with Flow Sciences.

 

Headquarters: Leland, NC USA:

Flow Sciences, Inc., 2025 Mercantile Drive, Leland, NC 28451;

Tel: 1-800-849-3429, Fax: 1-910-763-1220, Email: information@flowsciences.com,

Web: http://www.flowsciences.com/

 

Flow Sciences, Inc. Public Relations:

Jonathan Mann 2025 Mercantile Drive, Leland, NC 28451;

Tel: 1-910-332-4846 direct, Email: jmann@flowsciences.com,

Web: http://www.flowsciences.com