powder

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”.


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


Isolator Containment Levels for a Fraction of the Cost

PRESS RELEASE

Contact: Flow Sciences, Inc.

Tel: (800) 849-3429

Fax: (910) 763-1220

 

 

 

 FOR IMMEDIATE RELEASE

Flow Sciences’ Hybrid Isolator Contains to Less Than 50 ng/mwith Bulk Powders 

LELAND, NC, June 26, 2018 — Flow Sciences, a leading provider of containment systems for laboratory, pilot plant, and manufacturing facilities, now offers a Bulk Powder Hybrid Isolator glovebox that is proven by third-party acceptance testing to facilitate an interior concentration of less than 50 nanograms per cubic meter (50 ng/m3).

 

The system maintains all of the engineering controls of the standard Hybrid Isolator, but is now designed to include a 20” cutout and a membrane set which can accommodate 3 bulk powder drum diameter sizes. The membrane set also prevents powder from spilling over the lip of the drum during pouring operations. In addition, it can be shipped with a hydraulic lifting jack which allows the customer to lift a drum through the base of the enclosure into its interior to work with the bulk powders in a contained environment.

Flow Sciences’ consultation process breeds innovative solutions, which drives the evolution of our standard products. This adaption of our Hybrid Isolator Series is a perfect example of who we are as a company. Every interaction with end users and engineers adds to our growing enclosure repertoire, which continues our corporate vision of providing the best containment solution for numerous applications. Using our TaskMatch application search tool, we combine today’s consumer-oriented market with our own expert consultation to create a product of optimal performance.

In the constantly connected landscape of today, the ever increasing toxicity of active pharmaceutical ingredients (APIs) presents the ever increasing need for personnel and/or product protection. At Flow Sciences, we consistently strive to ensure the safety of the whole process by engineering and manufacturing optimal enclosure. Flow Sciences creates engineering controls for hazards that cannot be eliminated or substituted.

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

[dt_fancy_separator]

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: https://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: https://www.flowsciences.com