Application Articles

API Process Development System

The API Process Development System was designed to provide personnel and product protection when working with powder and liquid substances. The enclosure housed a Mettler Toledo Easy Max 102, vacuum oven, and IKA LR 1000. The unit required a stainless steel base to allow for intensive cleaning protocols with shelves underneath to assist in recirculating the chiller and vacuum pumps needed to operate the process equipment. Operators needed access from the rear of the enclosure for cleaning purposes and there would need to be enough space for movement of equipment inside the enclosure.

The initial task of the process required the weighing of Active Pharmaceutical Ingredient (API) powder utilizing a Mettler Toledo balance. Proper use of the balance required 12-14” of usable linear width within the enclosure. The powder was then to be placed into liquid suspension by way of a magnetic stirrer—this would preserve the structure of the API without any dissolution. A liquid suspension of powder API can also deliver a higher concentration of API than an equivalent volume of liquid solution. Solvents used were ethanol, acetonitrile, and esthers—some of which had flammable potential. Less than one liter of solution would be in a beaker at any given time. The suspension would then be transferred into a Mettler Toledo Easy Max 102 reactor, a unit that is 26” wide, 30” tall, and 30” deep. Additionally, the unit requires 25” of vertical operator access. The Easy Max 102 utilized a chiller unit connection so feed and return lines were integrated into the enclosure.

The process continued as the API solution was then filtered by vacuum filtration onto a filter paper disk that was to be dried in a vacuum oven. Oven dimensions were 15” width, 16” depth, and 21” height—a vacuum pump was needed so a connection for the pump exhaust line to the system exhaust was engineered. An N2 line connected to the oven for gas purge. Upon removal from the oven, the sample was manipulated by the IKA LR 1000—a 20” wide, 30” tall, and 20” deep unit. The LR 1000 uses a sealed glass reaction vessel to mix powders into a dry or wet cake.

A system was engineered since the sample would need to be contained throughout the process. The sample could only enter or exit the system clean. Given the length of physical travel that the sample would endure through the numerous process steps—and the material of construction requirements given the nature of the different substance manipulations—the design had a substantial number of considerations. Polypropylene was chosen for the superstructure.

The API powder entered via a pass-through into a Flow Sciences Hybrid Isolator as mobility inside the enclosure was as important to the operators as safe containment. However, in order for the sample to be removed, a glovebox workstation was designed for a secondary cleaning of the sample before exit via the final pass-through.

The resulting enclosure had a 252” exterior width, a 30” exterior depth, and a 101” exterior height—including the custom stainless steel table with shelves. A deflector shield was integrated into the table where the vacuum pump was positioned to minimize sound pollution in the lab. The system had inlet HEPA filtration, a black phenolic base, and acrylic viewing panels with a hinged door style. The draft shield with glove ports was removable for cleaning. Bag-In/Bag-Out filtration with dual HEPA filters and top mount fans were coupled with vent kits and five thimble connections for connection to house exhaust. A 6” solid waste port with continuous liner was ported into the base. LED lighting and acrylic viewing panels maximized lighting across the workspace, and iris ports and electrical outlets were installed where needed inside for the process equipment.

In general performance tests, the enclosure passed all requirements for ASHRAE and AIHA/ANSI standards and recommended practices and met the CPT of 1000 ng/m3. During surrogate powder testing, no samples from outside of the enclosure exhibited measurable amounts of naproxen sodium above 0.51 ng/m3 TWA. Additionally, task maximum concentrations did not exceed 5.42 ng/m3. These exposures were well below the CPT of 1000 ng/m3.

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Glovebox Workstation with RTP

Transporting HPAPI Product with Containment

Applying the DPTE® transfer system to the Flow Sciences Glovebox Workstation


Glovebox Workstation with RTP

The purpose of this document is to serve as a case study where a containment device was designed to facilitate “interim containment”, or containment during the portion of a process where the product isn’t inside the enclosure. Rather, the product is intermittently contained between Point A (enclosure) and Point B (another enclosure or otherwise contained atmosphere). In this scenario, Flow Sciences designed an enclosure featuring a Getinge La Calhene DPTE® Alpha Rapid Transfer Port (RTP).

 

Background information regarding the client’s process and equipment was provided, which affected the decision-making process leading up to the engineering design of the enclosure. This includes a discussion on engineering decisions and development of design, level of containment, verification testing, and an explanation of how the Getinge La Calhene Alpha RTP combines with a transport capsule to yield leak-free containment during transport.

 

A client was in need of a containment enclosure for an analytical weighing and solution-preparation operation involving Highly Potent Active Pharmaceutical Ingredients (HPAPI) in powder form. Their goal was to transfer product from an enclosure to another enclosure. Internal policy stipulated that the operator’s 8-hour respiratory exposure concentration, expressed as an 8-hour Time Weighted Average (TWA), be less than 500 nanograms per cubic meter (<500 ng/m3) in the breathing zone. Consultative discussions revealed to Flow Sciences that the client was using a Mettler analytical balance for weighing operations. Additionally, it was ascertained that the client was utilizing polyethylene DPTE® Beta Capsules (DPTE® PE Container) in other parts of the facility. The Beta containers were being used for safe transfer of cytotoxic product from one contained work area to a distant other.

 

When the basis of the design was submitted to the Flow Sciences design team, it was decided that the enclosure could be designed to include a Getinge La Calhene Alpha port to coincide with the Beta containers that the client already owned.  As a result, the enclosure incorporated a 24” x 14” Inlet HEPA and 24” x 14” Dual-HEPA Top – Mount fan / filter housing used in conjunction to create lateral, laminar flow across the work surface.  After air is captured by the inlet HEPA filter, the negative pressure top-mounted fan causes the air to slowly move laterally across the workspace. As a result, the statistical interferences of cross-contamination and product loss are attenuated.

 

When implemented into its practical environment, the enclosure seamlessly integrated into the client’s process flow.  After product was weighed, it was containerized for transport.  Even while containerized, an inherent exposure hazard still existed in the event of a catastrophic spill event during transport. Containment during product transport is yielded synergistically by the combination of the Alpha and Beta Rapid Transfer Ports, thereby serving as an engineering control for this hazard.  The client possessed DPTE® PE [Beta] Containers.  Now, as a result of the incorporation of an Alpha port on the side of the enclosure, operators were able to safely insert weighed product into the Beta Container by performing the following steps in chronological order:









In Flow Sciences’ in-house laboratory, the enclosure was tested in accordance with ISO 14644-1 – ISO Class 5 for particles ≥0.3µm/m3. The average result was 2,276 particles with a diameter greater than or equal to 0.3 micrometers per cubic meter air (2,276 particles with diameter ≥0.3 µm per cubic meter air). Additionally, the enclosure provided personnel protection through its negative-pressure containment design and four (4) 10” oval glove ports on the front of the unit. Specifically, “personnel protection” entails employee protection from exposure via the respiratory and dermal routes of exposure. Similar enclosure models in the Flow Sciences Glovebox Workstation (GBWS) series were evaluated internally using surrogate powder testing. During this test, lactose powder was manipulated into the interior of the enclosure while three operators performed operations similar to that of its real-world application. Air samples were taken in the breathing zone of the operator and in several locations throughout the Flow Sciences laboratory. Upon interpretation of the exposure data, Flow Sciences validated that the GBWS series contained down to a respiratory exposure concentration of 30 nanograms per cubic meter (30 ng/m3), expressed as an 8-hour Time Weighted Average (TWA). Compared to the Occupational Exposure Limit (OEL) stipulated by the customer (<500 ng/m3), the validated containment level is sixteen-times (16x) lower; or 6% of the stipulated OEL.

 

The GBWS is capable of containing today’s most toxic powder substances and the operations that involve them. Ray Ryan, Founder and President of FSI states “Flow Sciences is a solution based company. Sometimes we have the solution on our shelves, but most of the time we have to develop a solution to fulfill a particular industry need”.  This case study serves as a prime example of a project where Flow Sciences used a recently developed containment device and augmented it to fit the specific needs of the client. In this case, Flow Sciences fulfilled a need for temporary mobile containment of HPAPI product through the incorporation of the Getinge La Calhene Rapid Transfer Port system.


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Stainless Steel Mettler Balance Enclosure

Application: Powder Weighing and Dispensing with Getinge La Calhene Alpha-Beta Ports

 

This stainless steel enclosure is designed for powder dispensing applications for facilities performing powdered Highly Potent Active Pharmaceutical Ingredient (HPAPI) weighing and dispensing operations. Particularly, it was designed for operations conducted in facilities operating under the stipulations of current Good Manufacturing Practices (cGMPs). The working space allows operators to freely conduct the operation by weighing a large batch (100 grams or more) of powder, dispensing the powder into a container, sealing the container, and cleaning the enclosure after use. Additionally, two ball valve fittings (3/8” NPT) are located on the right side of the enclosure for connection to inert gas sources. This connection is advantageous for sample protection by facilitating dehumidification and deoxidization of the sample environment for powder substances with attributes incurring the need for inert gas (e.g. pyrophoric powders, hygroscopic powders, high reactivity with oxygen, etc.).

After filling the bag with powder, the operator has the capability of moving the bagged powder from the enclosure to another enclosure with protection from exposure during transport. This function is made possible through the usage of an integrated Alpha Getinge La Calhene Rapid Transfer Port (RTP) on the right side of the enclosure. The incorporation of the Alpha RTP facilitates safe transfer by allowing the attachment of a Beta RTP conjugate capsule to the Alpha RTP. Following attachment, the operator is able to transfer the desired amount of powder (or aqueous solution*) from the enclosure interior, through an opening created by the Alpha/Beta connection, and into a Beta RTP capsule. From here, both the Alpha and Beta conjugates are sealed and the Beta capsule is used as a transport vehicle to the other enclosure. Referring back to the previous paragraph, the enclosure also allows for the transfer process occur, in reverse, after the Beta capsule is transported to the next enclosure or RTP-compatible device.

When designing the enclosure, Flow Sciences also considered ease and efficiency of process flow. Thus, its interior layout accommodates space for 1-2 analytical balances as well as sufficient working space around each balance for safe and effective use during your operation. Specifically, the operator is provided with ample room to move their arms to weigh, removed weighed powder, and dispense the powder into the bag.

After Factory Acceptance Testing (FAT), the enclosure was proven to contain down to an 8-hour Time Weighted Average (TWA) concentration of 100 nanograms per cubic meter of air (ng/m3). The actual level of containment was proven to be 0.06 ng/m3.

The “Containment Target”, as depicted in the image above, is the respiratory exposure concentration specified by the customer. The “Surrogate Powder Testing Result” is the actual exposure concentration result from air samples taken during performance validation testing conducted by FSI. The surrogate “contaminant” sampled during the FAT was a powder substance with attributes similar to that of the actual contaminant.

When designing the enclosure, Flow Sciences also considered ease and efficiency of process flow. Thus, its interior layout accommodates space for the Hydro SV and the Mastersizer 3000. Specifically, the operator is provided with ample room to move their arms to fill the cuvette, insert the cuvette into the Mastersizer 3000, and perform analysis; all while retaining space for wiring connections.

*Note:If the Occupational Exposure Limit (OEL) or Occupational Exposure Band (OEB) for the pertinent HPAPI contaminant(s) are lower than 1 microgram per cubic meter of air (1 ug/m3), dissolution of the sample into an aqueous solution is an alternative method to reduce the risk of overexposure during RTP transport.

 

            Additional Information:

Click here for more information regarding Getinge La Calhene RTP Ports.


GET A QUOTE

  • What is being done inside of the enclosure? What type of material (powder, liquid, gas, nuisance odor) is being worked with? How does the material enter and exit the enclosure system? etc...
  • What type of filtration is required? Single HEPA, Dual HEPA, Carbon, House Exhaust, etc... What is the required OEL (Occupational Exposure Limit) for the process, or any other details about containment goals? What is the quantity of powder or liquid, task duration, composition of powder, etc...?
  • What equipment is being worked with? What is the equipment model, size, scope, function, and any other information that will affect the design of the enclosure, including movement, heat output, etc...? *State the specific equipment make and model if available*
  • Drop files here or
  • Are there any additional notes or information that should be considered? Are there any special design requirements?

Stainless Steel Malvern 3000 Enclosure

Application: Small Volume Liquid Dispersion Analysis with Getinge La Calhene Alpha-Beta Ports

 

This stainless steel enclosure was designed for small volume liquid dispersion/particle size distribution analysis methods involving Highly Potent Active Pharmaceutical Ingredients (HPAPIs). Particularly, it was designed for operations conducted in facilities operating under the stipulations of current Good Manufacturing Practices (cGMPs). The working space allows operators to freely fill the Hydro SV cuvette with the aliquot, insert the aliquot into a Malvern Pananalytical Hydro SV, and insert the Micro SV into a Malvern Pananalytical Mastersizer 3000 for liquid dispersion particle distribution analysis. Additionally, two ball valve fittings (3/8” NPT) are located on the right side of the enclosure for connection to inert gas sources for propulsion of the sample into the Mastersizer 3000 for analysis.

After the analysis is complete, the operator has the capability to transfer and transport analyzed product from the enclosure to another enclosure with protection from exposure during transport. This function is made possible through the usage of an integrated Alpha Getinge La Calhene Rapid Transfer Port (RTP) on the right side of the enclosure. The incorporation of the Alpha RTP facilitates safe transfer by allowing the attachment of a Beta RTP conjugate capsule to the Alpha RTP. Following attachment, the operator is able to transfer the desired amount of powder (or aqueous solution*) from the enclosure interior, through an opening created by the Alpha/Beta connection, and into a Beta RTP capsule. From here, both the Alpha and Beta conjugates are sealed and the Beta capsule is used as a transport vehicle to the other enclosure. Referring back to the previous paragraph, the enclosure also allows for the transfer process occur, in reverse, after the Beta capsule is transported to the next enclosure or RTP-compatible device.

After Factory Acceptance Testing (FAT) and surrogate powder exposure simulations, the enclosure was proven to contain to a Time Weighted Average (TWA) concentration below the customer’s specified parameter of 100 nanograms per cubic meter of air (ng/m3). The actual level of containment was proven to be 0.06 ng/m3.

The “Containment Target”, as depicted in the image above, is the respiratory exposure concentration specified by the customer. The “Surrogate Powder Testing Result” is the actual exposure concentration result from air samples taken during performance validation testing conducted by FSI. The surrogate “contaminant” sampled during the FAT was a powder substance with attributes similar to that of the actual contaminant.

When designing the enclosure, Flow Sciences also considered ease and efficiency of process flow. Thus, its interior layout accommodates space for the Hydro SV and the Mastersizer 3000. Specifically, the operator is provided with ample room to move their arms to fill the cuvette, insert the cuvette into the Mastersizer 3000, and perform analysis; all while retaining space for wiring connections.

 

*Note:If the Occupational Exposure Limit (OEL) or Occupational Exposure Band (OEB) for the pertinent HPAPI contaminant(s) are lower than 1 microgram per cubic meter of air (1 ug/m3), dissolution of the sample into an aqueous solution is an alternative method to reduce the risk of overexposure during RTP transport.

 

Additional Information:


GET A QUOTE

  • What is being done inside of the enclosure? What type of material (powder, liquid, gas, nuisance odor) is being worked with? How does the material enter and exit the enclosure system? etc...
  • What type of filtration is required? Single HEPA, Dual HEPA, Carbon, House Exhaust, etc... What is the required OEL (Occupational Exposure Limit) for the process, or any other details about containment goals? What is the quantity of powder or liquid, task duration, composition of powder, etc...?
  • What equipment is being worked with? What is the equipment model, size, scope, function, and any other information that will affect the design of the enclosure, including movement, heat output, etc...? *State the specific equipment make and model if available*
  • Drop files here or
  • Are there any additional notes or information that should be considered? Are there any special design requirements?

Stainless Steel FTIR Enclosure

Application: Fourier Transform Infrared (FTIR) analysis with Getinge La Calhene Alpha-Beta Ports

 

This stainless steel enclosure was designed for Fourier Transform Infrared (FTIR) Spectroscopy analysis methods involving Highly Potent Active Pharmaceutical Ingredients (HPAPIs). Particularly, it was designed for operations conducted in facilities operating under the stipulations of current Good Manufacturing Practices (cGMPs). The working space allows operators to freely load samples and accessories (such as those associated with the Thermo Fisher Nicolet spectrometer series) into the spectrometer. A ball valve fitting (3/8” NPT) is located on the left side of the enclosure for connection to an inert gas source for purposes such as sample column purging, deoxidization of sample column, etc. Additionally, there are two NEMA 4X-rated electrical receptacles located inside of the enclosure for connection to a power source and two iris ports (or “glands”) which facilitate data connections from the spectrometer to your computer.

After the analysis is complete, the operator has the capability to transfer and transport analyzed product from the enclosure to another enclosure with protection from exposure during transport. This function is made possible through the use of an integrated Alpha Getinge La Calhene Rapid Transfer Port (RTP) on the right side of the enclosure. The Alpha RTP facilitates safe transfer by allowing the attachment of a Beta RTP conjugate capsule to the Alpha RTP. Following attachment, the operator is able to transfer the desired amount of powder (or aqueous solution*) from the enclosure interior, through an opening created by the Alpha/Beta connection, and into a Beta RTP capsule. From here, both the Alpha and Beta conjugates are sealed and the Beta capsule is used as a transport vehicle to the other enclosure. Referring back to the previous paragraph, the enclosure also allows for the transfer process occur, in reverse, after the Beta capsule is transported to the next enclosure or RTP-compatible device.

After Factory Acceptance Testing (FAT) and surrogate powder exposure simulations, the enclosure was proven to contain to a Time Weighted Average (TWA) concentration below the customer’s specified parameter of 100 nanograms per cubic meter of air (ng/m3). The actual level of containment was proven to be 1.15 ng/m3.

The “Containment Target”, as depicted in the image above, is the respiratory exposure concentration specified by the customer. The “Surrogate Powder Testing Result” is the actual exposure concentration result from air samples taken during performance validation testing conducted by FSI. The surrogate “contaminant” sampled during the FAT was a powder substance with attributes similar to that of the actual contaminant.

 

*Note:If the Occupational Exposure Limit (OEL) or Occupational Exposure Band (OEB) for the pertinent HPAPI contaminant(s) are lower than 1 microgram per cubic meter of air (1 ug/m3), dissolution of the sample into an aqueous solution is an alternative method to reduce the risk of overexposure during RTP transport.

Additional Information:


GET A QUOTE

  • What is being done inside of the enclosure? What type of material (powder, liquid, gas, nuisance odor) is being worked with? How does the material enter and exit the enclosure system? etc...
  • What type of filtration is required? Single HEPA, Dual HEPA, Carbon, House Exhaust, etc... What is the required OEL (Occupational Exposure Limit) for the process, or any other details about containment goals? What is the quantity of powder or liquid, task duration, composition of powder, etc...?
  • What equipment is being worked with? What is the equipment model, size, scope, function, and any other information that will affect the design of the enclosure, including movement, heat output, etc...? *State the specific equipment make and model if available*
  • Drop files here or
  • Are there any additional notes or information that should be considered? Are there any special design requirements?

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: https://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://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:

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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: https://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://flowsciences.com


Containing ADC Development

80 Years Later: The Fight Against Cancer Continues

 

This year marks the 80th Anniversary of the National Cancer Institute, established by President Franklin D. Roosevelt to support research on the causes, diagnosis, and treatment of cancer. Since the 1940s, cancer researchers have produced nothing short of astonishing science.

 

The development of antibody drug conjugates (ADCs) ranks among one of the most important advancements in cancer treatments in recent history. The ability to precisely target abnormal cells throughout the body and deliver highly toxic drugs to the center of tumors significantly improves upon the negative side effects of traditional chemotherapies that employ a total war approach to defeating cancer.

 

Anti-cancer drug development has not come without challenges for pharmaceutical companies that manufacture ADCs. The potency and effectiveness of ADCs are dependent upon engineered nanoparticles (ENPs) — the cytotoxic payload that destroys cancer cells — but little is known about the environmental and human health hazards posed by ENPs. The promise ENPs hold for patients is why we continue to wield them in the quest for a cure despite a full understanding of their key physical characteristics, chemical properties, and associated hazards.

 

Yet, we can still minimize occupational exposure by applying the precautionary principle. When working with nanoparticles, employers must evaluate workplace-engineering controls and include effective source ventilation and capture protocol to minimize exposure risk. According to the National Institute for Occupational Safety and Health (NIOSH), “A well-designed exhaust ventilation system with a high-efficiency particulate (HEPA) filter should effectively remove nanomaterials.”

 

Flow Sciences, Inc. has partnered with pharmaceutical companies and laboratories that work with hazardous chemicals like those used in manufacturing ADCs. We specialize in designing task-specific containment enclosures that minimize product loss and exposure to nanoparticles during the complex and sensitive manufacturing processes that characterize ADC production.

 

The Glovebox Workstation series of enclosures provide containment for toxic applications using highly potent APIs requiring isolation that meets or exceeds ISO 5 clean processing. The Glovebox Workstation comes standard with a HEPA inlet that creates a clean environment ensuring product protection; it also uses horizontal laminar flow to reduce turbulent airflow and reproduce consistent, performance-based results. We have submitted the Glovebox Workstation to third-party testing and confirmed containment levels at or below 50 ng/m3 with balance stability to the 7th decimal place. This makes the Glovebox Workstation ideal for the initial phases of conjugation process development that require accurate methods and precise data with minimal scattering.

 

ADC development depends upon thorough control and tracking of molecular-level characteristics, including: drug-to-antibody ratio (DAR), monomer content, drug distribution, and cell killing activity or antigen recognition. It also depends upon designing a process that controls for successful experimental parameters within selected ranges so that the manufacturing of ADCs can be scaled up to grams. Certain purification techniques that are crucial in the manufacture of ADCs can only be performed on process solution volumes at the gram scale. As ADC production continues to be scaled up for early clinical phases, the success of the manufacturing process will ultimately depend upon careful analysis and control during the earlier experimental phases.

 

ADC production requires a laboratory that can handle the initial familiarization phase as well as further investigation, observation, verification, purification, and scale-up. Flow Sciences has designed several containment options that cover the entire scope of ADC development. We offer a Hybrid Isolator for working with highly toxic APIs and the LEV III (local exhaust ventilation) enclosure that is built for scale-up operations. All of our enclosures designed for ADC development have undergone rigorous engineering and performance testing so that you can work confidently as you explore new cancer treatments.

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Contained Environmental Systems – from Flow Sciences

When it comes to keeping employees and equipment safe and laboratories or production lines hygienic, traditional vented enclosures and hoods are being challenged to provide increased protection for personnel working with the products produced within the workstation. Flow Sciences’ Contained Environmental Systems provide ideal environments for handling a variety of potent powders and mixtures from Active Pharmaceutical Ingredients (APIs) to carbon nanotubes and other nanomaterials, across the scope of laboratory, production line and research settings.

 

The Contained Environmental Systems line consists of four enclosure types that are ready for bench top applications in standard sizes; and can be customized to fit industry- or task-specific needs and standards. Each of these systems features ergonomically designed glove ports with Bag-In Bag-Out HEPA filtration (as appropriate) and come in a range of sizes to make maximum use of available bench top space.

 

Enclosures in the series include:

Temperature and Humidity Contained Environment (THCE)

Vented Atmosphere Contained Environment (VACE)

Controlled Atmosphere Contained Environment (CACE)

Hybrid Isolators – available in two configurations; one which uses make-up air from the room and the other which uses HEPA filtered make-up air.

 

THCE – Temperature and Humidity Contained Environment

The THCE features patented LFBC (Lateral Airflow Bio Containment) technology. A unique Bag-in/Bag-out HEPA filtration system protects employee breathing zones and prevents environmental contaminants from entering the chamber and keeps potent APIs, nanomaterials and other matter from exiting the chamber and causing health and safety concerns within the laboratory environment.

 

Flow’s design team not only considered safety when designing the THCE, but also employee comfort. Glove ports allow users to reach any part of the THCE while staying protected from potent powders, and LED lighting provides adequate in-chamber illumination with little heat and little energy use.

 

Included are a touch screen interface and data-logging software, both designed for ease of use and to accommodate a variety of data recording. A temperature and humidity sensor allows users to monitor in-chamber conditions and adjust them to the ideal conditions for work.

 

Flow Science’s THCE conforms to ASHRAE 110-95. Factory Acceptance Testing (FAT) is available to validate the performance and guarantee that each unit meets client containment standards.

 

VACE – Vented Atmosphere Contained Environment

The Vented Atmosphere Contained Environment from Flow Sciences features lateral airflow and in one configuration utilizes positive air pressure to reduce the risk of product contamination. Ideal for analysis and dosing of bottling liquid or solid APIs, handling nanomaterials, the VACE draws ambient room air through HEPA filters, providing a non-contaminated, gentle airflow across the work air.  Out-flowing HEPA filters prevent materials from contaminating the work surface environment.

 

VACE units are customizable to meet industry-specific needs and safety specifications. Options include stainless steel or phenolic work surfaces and various configurations of HEPA filters, and are available in a range of sizes and configurations designed to accommodate laboratory and production-line equipment. Glove ports are also available in a range of sizes.

 

Each VACE unit is equipped with glove ports and large acrylic windows to allow users to easily see and access the chamber while safely and comfortably completing work tasks, cleanup and routine maintenance. Alternate materials of construction along with Factory Acceptance Testing are available.

 

CACE – Controlled Atmosphere Contained Environment

CACE units allow operators to control the atmosphere within the chamber, creating the ideal low-oxygen or inert gas environments as their applications require. Inlet and purge valves make it easy to adjust the makeup of the atmosphere within the chamber, while pressure gauges and probe connections allow for effective monitoring of the chamber.

 

Each CACE unit features wide glove ports and can be made from a variety of materials including all-acrylic body construction and work surfaces made from stainless steel or chemically resistant phenolic with or without stainless steel insets.

 

 

Hybrid Isolator

As new, highly potent APIs and nanomaterials continue to enter the workplace, Flow Sciences Hybrid Isolators are available to ensure the safety and hygiene of workers and work environments. The hybrid isolator was designed to protect workers from exposure by fully-encompassing equipment and products used during research and development; weighing, loading and distributing powders; and other manufacturing processes. Ideal for powder handling, housing sensitive equipment and a host of other applications units are available for customer customization.

 

Hybrid Isolators are equipped with directional LED lighting, acrylic construction (for increased in-chamber visibility) and air plenums designed to ensure the proper air speed and flow within the chamber. Glove ports from 8”-10” provide workers with ample room for a comfortable work environment, and a removable face allows for easy instrumentation setup and teardown. Standard units come equipped with dual HEPA filters and Bag-In Bag-Out filtration and ante-chamber. Customizable to fit industry- and task-specific laboratory apparatus FAT and Surrogate Powder testing are available to ensure containment for the process.

 

Jason Frye produced this story with the assistance of Steve Janz, VP Marketing and Business Development for Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators or product from exposure to hazardous particulates and vapors while performing delicate operations.


Sampling and Dosing Starts with Containment

When sampling and dosing active pharmaceutical ingredients (APIs) or high-potency APIs (HPAPIs), containment can be critical. Good laboratory practices (GLP) and the proper equipment designed and calibrated to facilitate GLP when transferring, mixing or blending APIs can reduce product waste, product contamination and minimize lost profit as well as create a healthier, contaminant free environment for lab operators.

 

Part of every lab’s GLP should be the utilization of contained environmental systems, fume hoods or specialty containment solutions designed to help control the mixing or blending environment, making it more suitable to the delicate task at hand. For powdered APIs, a controlled environment means one free of excess humidity, moisture and other contaminants. With liquid APIs, the best environment will be one free of the risk of contamination as well as the proper airflow within the enclosure that will not cause the APIs to evaporate to quickly.

 

The key to containment and control is airflow. With properly designed hoods and equipment enclosures, airflow within the unit will contain loose particles, allow liquids to evaporate at normal rates, pull hazardous fumes and particles away from the operator and into a safe disposal area. High quality hoods use face-opening airspeed that will safely contain particles within the unit and keep contaminants out while facilitating a good work environment for the operator, making for easier product handling by the operator while still offering maximum containment.

 

Traditional fume hoods require face-opening airspeeds at or exceeding 100 linear feet per minute (lfpm). That volume of air moving at such a high rate of speed will encourage liquids to evaporate quickly; disturb balances; cause powder loss from transport containers, mixing vessels and sampling tools; additionally, for equipment operators, the noise and speed of the air within the fume hoods can become exhausting and frustrating to work in.

 

Specialty hoods and enclosures can reduce the face velocity to 70-75 lfpm or lower, depending on the application, while lessening or even eliminating issues that come with mixing and blending API powders and liquids. By using hoods, enclosures and protected systems that incorporate lower wind speeds and engineered solutions that eradicate the hidden vortices, eddies and cross currents that disturb powders and hasten the evaporation of liquids, labs can better control their loss in material and operator time.

 

Protected systems are alternatives to clean rooms that incorporate a series of benchtop and freestanding units designed to enclose equipment for measuring, transporting, mixing and dispensing APIs and joined by sealed pass-through chambers can help lab operators exercise greater control over employee safety and final product quality. These joined, protected workstations allow laboratories to be configured in the most efficient way and minimize the necessity of bulky and uncomfortable pieces of personal protective equipment, allowing lab operators to be more comfortable and move more freely about the lab while remaining safe and unexposed to harmful APIs.

 

Jason Frye produced this story with the assistance of Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.

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Industry Trends: Risk MAAP Overview

Below is the second part of a conversation with George Petroka, Director of BioPharma/EHS Services at IES Engineers, about trends and changes he sees within the industry, specifically related to Risk MAAP assessments.

 

George Petroka: With so much pharma work going to contract manufacturers, [contract manufacturers] have to demonstrate they’re not getting cross contamination from your product to my product and they have to be able to show that. The Food and Drug Administration (FDA) or European Medicines Agency (EMA) wants to see [proof labs aren’t cross contaminating and causing safety risks for producers and end users] because of the potency or the fact that you’re dealing with certain therapeutic classes such as cytotoxics or if you have two hormones, one is male one is female, you want to keep them from mixing.

 

For a while there – 10-12 years ago – the industry was saying, “You need to build dedicated facilities [for one-run productions].” Even the regulatory agencies got in on it. That’s really expensive and restrictive. So, the International Society of Pharmaceutical Engineering’s containment committee said to the FDA, “This isn’t science based. We have to be able to show scientifically that you need these proved segregations [of pharmaceutical components].”

 

So they put together this document, Risk MAAP. It came up with a couple of things, the most important of which was defining standard methodology for cleaning verification because all across pharma, we used different methodologies; we used 1/1000 of the Acceptable Daily Intake (ADI), LOD (Limit of detection), we used 10 parts per million, which was just arbitrary. Or you’d use visual, which meant, if you can see it, you’ve got a lot there.

 

So that was the first thing, come up with a standard methodology. It’s an ADI, but they called it an ADE – Acceptable Daily Exposure. It’s like setting an OEL. You use a “No observed effect level” then you apply safety factors. The safety factors are different than in an occupational setting because you’re looking a broad population – elderly and children versus worker population – and you’re not usually compromised (?)[4:45] so you’re safety factors are higher and your numbers (Average Daily Exposure (ADE)/ADI) are lower. The ADE is usually micrograms per day.

 

That pretty much stays with the compound the way an Observed Effect Level does. Except you do base it on the dosage form. An ADE would be different for solid dosage than for parenteral (injectable). With the solid dose you have a built in safety factor of taking something orally versus injecting it directly

 

Question: So, once you’ve determined your ADI, what then?

 

George Petroka: So you come up with that number, then you look at the manufacturing process. Am I making a solid dose, am I making a tablet? Then you look at the batch size, number of batches and surfaces you want to clean. You put those numbers into a calculation along with your ADE and you come up with a clean limit. Cleaning limit for something with 10kg would be different from 100g. You have much greater potential for exposure. You then have a good, scientifically based cleaning limit that you then can use to evaluate your potential cross contamination.

 

Cross contamination comes from airborne – not so much airborne actually, but it’s one method – mechanical, where you get it on surfaces, that’s the one they’re really concerned with; product mix up, again that can be managed through bar coding.

 

You do all that then do a failure mode and effect analysis to evaluate your risk level by getting a number.

 

Where Flow Sciences come in, by doing certain levels of containment and establishing certain containment controls, particularly containing at the source, you control and reduce your risk potential for cross contamination. So, you don’t have to build a full facility [for one product run]. It’s better, obviously, like occupational, for cross contamination, it gives you a control at the source, lower cost, less impact.

 

Jason Frye produced this story with the assistance of Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.

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Challenges in Nanomaterial Processing

We sat down to discuss nanotechnology, nanomaterials and safety issues within this upstart industry with Donna Heidel, CIH, Prevention Through Design Coordinator for the CDC/NIOSH (Centers for Disease Control/National Institute for Occupational Safety and Health) Education and Information Division; and Charles Geraci, Jr., PhD., CIH, the Coordinator of the CDC’s Nanotechnology Research Center. What Heidel and Geraci had to say revealed a set of issues that go deeper than simple safe handling best practices.

 

Question: What are some of the big concerns with lab safety when it comes to organizations that are producing or handling Nano technological components?

 

Charles Geraci, Jr: First thing I’m going to do is help you out—it’s not nanotechnology that’s the issue. Nanotechnology is a collection of sciences that do a lot of things. One of the things that’s real important for us in occupational safety and health is it creates new materials or new forms of old materials. So, it’s the nanomaterial that’s the real hook.

 

Through the magic of nanotechnology you are now proposing to make or handle new materials that are called nanomaterials. They come in a variety of forms and the form you choose to use is what drives your need for containment and control. If you chose to use a nanomaterial which might be called a nanoparticle or nanofiber or nanoplatelet, but it is the nanometer scale form of a material. It’s likely to be one of the few brand-new-to-the-world materials like carbon nanotubes or, more than likely, it’s the new nano-scale formulation of a familiar material like nanosilica or nanoaluminum, so we’re kind of working in both arenas – new material versus a new size and form of a known material.

 

Either way, this puts a whole new spin on material science, whether you’re in ceramics or plastics or paints or of you used physical materials, sooner or later, someone in your company or someone in your organization is going to come up with the idea of using the nanometer form of that material. So, the real challenge is because of their size and shape, but let’s just stay with size. At the nanometer scale, they’re so much smaller than all the things we’ve learned so much about at the micrometer scale – we all know about hazards, control and containment in the micron and micrometer range, now we’re working three orders of magnitude smaller, so a lot of the things we thought we knew about the physics, chemistry and behavior of materials are being relearned in many cases.

 

So we’re in a new grey area that’s cool and exciting, but it carries with it some concern, some health and safety concerns.

 

The biggest concern is inhalation. Right now, not a lot of evidence that nanoparticles can penetrate the skin easily or readily, but there is a lot of evidence…it does represent an airborne…an aerosol of nanoparticles does represent a real or a demonstrable inhalation hazard, so that’s what we want to control.

 

Donna Heidel: The question becomes, are nanoparticles so different that current controls don’t work, or is everything ok?

 

Charles Geraci, Jr: What we’re seeing here, in two cases, primarily in labs, [is that] they are OK if you assume everything works well for nanoparticle formulation and use of materials. That’ s a nice way of saying that your average, everyday conventional or bypass laboratory fume hood is not the best containment device for dry powder form of nano-scale material.

 

That’s where a device like the one produced by Flow Sciences fills a need. It’s good containment; it’s not turbulent containment; it’s flexible containment in that it can go where the project needs are. And so, I think as far as a company like Flow Sciences is concerned, that’s a need they can meet. And it’s been met well for years in the pharmaceutical world, but now you have a whole new population of people and a growing population of people moving into that ultra-fine powder applications and use space where the pharma, cosmetics and pigment worlds used to be. Now there’s a whole bunch of new people, including research labs, who need to learn how to deal with it.

 

So, you might be synthesizing these materials and trying to purify and characterize them or you might be bringing some of these materials into your lab and developing an application – a plastics lab is a great example. Nothing more fun to see than a couple of materials scientists who call themselves plastics engineers dealing with synthetic-organic chemistry they find in biology and the mechanical engineer come up with a really cool new application of nanomaterials in a composite. None of them have a clue what each other’s safety rules are all about.

 

The CDC and NIOSH have released papers outlining safe practices and prevention through design principles; these papers are available free of charge at www.cdc.gov/niosh. Navigate to topic pages on nanotechnology and prevention through design to download or read these reports today.

 

The National Nanotech Initiative, a collection of 25 government agencies working to establish safe practices, have published many articles on safe materials handling and other issues surrounding nanotechnology and nanomaterials. Learn more at www.nano.gov.

 

Jason Frye produced this story with the assistance of Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.

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Mixing and Blending Starts With Containment

When mixing or blending active pharmaceutical ingredients (APIs) or high-potency APIs (HPAPIs), containment is king. Good laboratory practices (GLP) and the proper equipment designed and calibrated to facilitate GLP when transferring, mixing or blending APIs can reduce product waste, product contamination and minimize lost profit as well as create a healthier, contaminant free environment for lab operators.

 

Part of every lab’s GLP should be the utilization of contained environmental systems, fume hoods or specialty containment solutions designed to help control the mixing or blending environment, making it more suitable to the delicate task at hand. For powdered APIs, a controlled environment means one free of excess humidity, moisture and other contaminants. With liquid APIs, the best environment will be one free of the risk of contamination as well as the proper airflow within the enclosure that will not cause the APIs to evaporate to quickly.

 

The key to containment and control is airflow. With properly designed hoods and equipment enclosures, airflow within the unit will contain loose particles, allow liquids to evaporate at normal rates, pull hazardous fumes and particles away from the operator and into a safe disposal area. High quality hoods use face-opening airspeed that will safely contain particles within the unit and keep contaminants out while facilitating a good work environment for the operator, making for easier product handling by the operator while still offering maximum containment.

 

Traditional fume hoods require face-opening airspeeds at or exceeding 100 linear feet per minute (lfpm). That volume of air moving at such a high rate of speed will encourage liquids to evaporate quickly; disturb balances; cause powder loss from transport containers, mixing vessels and sampling tools; additionally, for equipment operators, the noise and speed of the air within the fume hoods can become exhausting and frustrating to work in.

 

Specialty hoods and enclosures can reduce the face velocity to 70-75 lfpm or lower, depending on the application, while lessening or even eliminating issues that come with mixing and blending API powders and liquids. By using hoods, enclosures and protected systems that incorporate lower wind speeds and engineered solutions that eradicate the hidden vortices, eddies and cross currents that disturb powders and hasten the evaporation of liquids, labs can better control their loss in material and operator time.

 

Protected systems are alternatives to clean rooms that incorporate a series of benchtop and freestanding units designed to enclose equipment for measuring, transporting, mixing and dispensing APIs and joined by sealed pass-through chambers can help lab operators exercise greater control over employee safety and final product quality. These joined, protected workstations allow laboratories to be configured in the most efficient way and minimize the necessity of bulky and uncomfortable pieces of personal protective equipment, allowing lab operators to be more comfortable and move more freely about the lab while remaining safe and unexposed to harmful APIs.

 

Jason Frye produced this story with the assistance of Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.

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Chromatography Cabinets: Task-Specific Containment Enclosures

When one of Flow Sciences’ clients came looking for a way to safely vent the exhaust from a flash chromatographer (a bench-top device that separates elements in a solution for distinct use in a more pure state), they got to work. The solution they came up with was large enough for a Teledyne Isco CombiFlash chromatographer and provided the safety the customer needed along with freeing up scarce fume hood space for other work.

 

Flow Sciences’ Teledyne Isco CombiFlash hood enclosure provided a safe, effective fume hood that protects the lab worker while giving them the room and visibility within the enclosure needed to complete their tasks.

 

“Since chromatography units use smaller amounts of volatile solvents, our hood enclosures are ideal for Teledyne Isco’s CombiFlash and other HPLC devices,” said Steve Janz, Vice President of Marketing and Business Development for Flow Sciences.

 

Because the hood enclosures have a small footprint and can be connected directly to the lab’s existing exhaust system, Flow’s hoods allow lab workers to allocate precious fume hood space to units and operations that require more vigorous ventilation. An optional ventilation fan and carbon filter kit is available for laboratories where safety regulations may be more stringent.

 

Installing a Teledyne Isco CombiFlash hood enclosure takes less than a half-day of downtime, with most installations taking around three hours; this means less downtime and more production runs through a chromatographer.

 

CombiFlash hoods are available in 2-foot and 3-foot widths, allowing for maximized use of available bench space within laboratories. The hoods are made with a dished phenolic resin base for easy cleanup, transparent acrylic walls for visibility, a dual-position sash for ease of operator interaction with the enclosed equipment, gash shock hinges for easy raising and lowering of the sash, an exhaust port and optional ventilation fan and carbon filter kit for easy exhaust ventilation.

 

“Our Teledyne Isco CombiFlash hood enclosure is finding a lot of traction within agra-chemical and other chemical-discovery labs where they already have a chromatographer but they need a safe, well vented place to put it,” Janz says. “We’re proud of this product, but we’re even more proud that it’s one of many task-specific enclosures we’ve engineered for laboratory environments.”

 

CLICK HERE FOR MORE INFORMATION

 

Jason Frye produced this story with the assistance of Flow Sciences Inc., which produces containment systems for laboratories, pilot plants and manufacturers. These products are designed to protect operators from exposure to hazardous particulates and vapors while performing delicate operations.

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Why Containment and Proper Hood Use is Important in Animal Science Laboratories

Douglas B. Walters, Ray Ryan, and Sai Kotha

 

Several articles appeared recently in Lab Animal News about the importance of bio-containment in the planning and design of animal laboratories1, 2,3.  As these papers state the planning, design, construction and commissioning of these facilities is difficult and complex for many reasons.  These reasons include complying with regulations and guidelines, accomplishing the work mission, identifying potentially hazardous agents, performing a risk assessment on the proposed agents and operations, providing an environment free from worker and environmental exposure, and doing all this within budget restraints.

 

This article describes recent advances in ventilation and hood design that significantly increase worker safety because containment is dramatically improved.  At the same time tasks can be preformed better and more efficiently.  In addition, initial purchasing costs are lower and because airflow is less and more efficient energy consumption is less resulting in substantial savings in utility costs.

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