ABOUT FLOW SCIENCES, INC.

Flow Sciences IS containment, serving global markets that handle HPAPI processes which require nanogram levels of protection. FSI’s evolution reflects the needs of the customers it serves by incorporating new technologies that enable safe work with highly potent compounds in non-sterile and sterile environments, including those where controlled humidity and low oxygen are concerns. FSI produces glove boxes that meet cGMP requirements and are used for breakthrough medical research in anti-body drug conjugates to develop and manufacture anti-cancer drugs, oncology compounds, and Nano pharmaceuticals. FSI has strategic business alliances that support its efforts and tactical acquisitions which have expanded FSI’s materials of construction, industry regulations/compliances, and increased sophistication of its containment products.

MAJOR MARKETS:

Pharma and Biopharma projects continue to grow in scope every year, making safety and performance crucial. FSI’s expertise in serving HPAPI manufacturing is utilized by major pharmaceutical companies looking to expand operations into new, more potent cytotoxic drug production. Increased potency requires better containment performance—FSI leads the industry through its own testing and third-party validation. FSI enclosures are trusted and used by every major organization in the pharmaceutical industry, from analytical laboratories to pilot/plant and cGMP.


Sterile & Non-Sterile Glove Boxes And Containment Systems For HPAPI Processing


SERVICES OFFERED:

  • Expert Containment Consultation
  • Designing, Engineering, and Manufacturing Made-in-USA Custom Enclosures
  • Expansive Standard Product Line with the Industry’s Shortest Lead Times
  • Aseptic Solutions through partnership with IsoTech Design
  • Installation Qualification, Operational Qualification
  • Factory Acceptance Testing to ANSI/ASHRAE 110-2016 Standards at FSI
  • Surrogate Powder Testing with Comprehensive Reporting at FSI
  • ISPE Good Practice Guide
  • Certifier Training
  • Operational Documentation
  • On-site Installation & Service
  • 1:1 Mock-up design consultation and manufacturing

FEATURED PRODUCTS/SERVICES

There are many factors and criteria that must be met to comply with the standards of USP 795 and USP 800. The containment enclosures (C-PEC) play an active role not only in the containment of particulate, but also in the overall air changes in the room (C-SEC).

Safety
The Glovebox Workstation series provides containment for highly toxic applications using APIs that need more safety than an opened face enclosure. FSI engineering controls are built in to prevent loss of containment. Third Party testing has proven containment on these units to below 30 ng/m³ based on process and quantity.

Bulk Powder Enclosure for Media and Buffer Preparation designed to provide personnel protection while working with powder substances. The enclosure features include acrylic superstructure, black phenolic base, 20” base cutout with flange/trespa cover/SS ring, hinged door style, top mount fans, and HEPA filtration.

HPAPI Capsule Inspection System is designed to provide personnel protection during the inspection of filled capsules containing Highly Potent Active Pharmaceutical Ingredient (HPAPI) powder. Accommodates space for an analytical weighing balance and capsule inspection bats (paddles). Acrylic viewing panels above enclosure face provide continuous, uninterrupted line of sight during inspection processes. Inspected product may be safely removed from the enclosure by inserting material through a continuous liner cut-out located in the center of the enclosure base. Waste is removed from the right-side continuous liner.

Tangential Flow Filtration Enclosure designed for effective personnel and product protection while working with HPAPI powder when performing TFF (tangential flow filtration) of conjugated liquids. The enclosure features polypropylene superstructure with light-filtering acrylic panels designed to protect light-sensitive product. Additionally, the enclosure features (2x) large hinged barn doors from each side, supporting table with bottom shelf made from black phenolic, and (2x) iris ports on each side. LED lighting feature includes white and yellow color settings. Powder-coated steel table with leveling pads also included.

The Quadro Comil / High Shear Diosna Milling and Granulation Enclosure designed to provide personnel protection down to a respiratory exposure concentration of 100 nanograms per cubic meter (ng/m3) during milling and granulation operations.

HPAPI Drying and Multi-Fill Suite designed as a complete sampling system with a nitrogen glovebox enclosure for processing and drying of HPAPI (High Potency Active Pharmaceutical Ingredients) connected to a laminar flow hood. Designed for product and personnel protection during filling of small sampling containers.

Ultra-Low Humidity Dispensing Enclosure for Solvents and Solids designed to provide product protection during solvent and solid dispensing operations which require an ultra-low humidity contained environment. Enclosure features acrylic superstructure coated with static-dissipative coating.

Agilent 218 Solvent Delivery Module Enclosure designed to provide personnel protection while working with liquid substances. Designed to work with an Agilent 218 Solvent Delivery Module with dimensions of 19” x 12” x 8”. Enclosure features include polypropylene superstructure, black phenolic base, acrylic viewing panels, sliding doors, LED lighting, vent kit, and iris ports on both sides. LED lighting and Acrylic viewing panels maximize lighting across the workspace.

Malvern Morphologi G3 Particle Analyzer Enclosure designed to provide personnel protection while working with powder substances. The enclosure features include polypropylene superstructure, flat screen swing arm mount, sliding sash door style, 3” iris ports on both sides, travel cart for Malvern Morphologi G3 with 2” iris port, digital alarm, glass panels, hinged door style, top mount fan, vent kit, thimble connection, HEPA filtration, and enclosure table. Glass panels maximize lighting across the workspace.

The Lyophilizer Cryodesiccation Suite designed to provide personnel protection while working with powder substances. Designed to work with a lyophilizer with dimensions 450mm (L) x 450mm (W) x 450 mm (H) (17.72” L x 17.72” W x 17.72” H).

The CleanFlow is a unidirectional, positive pressure, laminar air flow workstation.

The Hardwall IsoSphere™-ST is a positive pressure non-unidirectional airflow isolator or unidirectional CRABS for small, medium, and large volume sterility testing with vaporized hydrogen peroxide decontamination integration.

The IsoSphere-AF is a positive pressure unidirectional airflow isolator or RABS for small, medium and large volume aseptic filling.

The ChemoSphere is a safe, clean, cost-effective C.A.C.I. for chemo compounding that is USP <797 / 800>, OSHA, AND NIOSH compliant.

The MicroSphere is a clean, cost-effective C.A.I for sterile compounding, that is USP <797> compliant.

Hybrid Isolator series (EHP and EHG) provides containment for highly toxic applications using APIs and HPAPIs that require personnel and/or product protection.

Advantech Sonic Sifter Powder Weighing and Transfer Enclosure designed to provide personnel protection during compacting and coating operations involving Highly Potent Active Pharmaceutical Ingredients (HPAPI).

Highly Potent API Weighing Suite designed to provide personnel protection down to a respiratory concentration of at least 50 nanograms per cubic meter of air (ng/m3). Design accommodates sufficient space for storage and usage of 1-2 analytical balances and/or microbalances.

Lateral Flow API Weighing and Dispensing Enclosure designed to provide personnel and product protection when weighing 0.5 kilograms (kg) of API powder.

Automatic Tablet Press Enclosure designed to provide personnel protection tablet pressing operations involving a Carver Press 800 ANE with dimensions 35.43” x 23.62” x 39.37 [900mm X 600mm X 1000mm]. Enclosure features a polypropylene superstructure, black phenolic base dished to contain spills, and (3x) removable sliding doors for easy loading/unloading of equipment and processed product.

Downflow Booth for Freeze Dryer/Lyophilizer designed for product protection when conducting vial-filling and loading vialed product into a freeze-dryer. Features a 304 stainless steel alloy superstructure and perforated stainless steel base.

For use in pharmaceutical, chemical, biological, and toxicological laboratory settings. Specifically designed to provide maximum containment for balance applications. The opening of the enclosure has uniquely designed acrylic airfoils that allow a smooth turbulence-free airflow that prevents balance fluctuation. Weigh down to 5 places without fluctuations or loss of product. The work surface is black for easy powder detection, constructed of tough, chemically resistant phenolic resin, and has a dished bottom for containing spills. Enclosures feature an ergonomic, energy efficient design with angled front for worker comfort.

API Process Development System designed to provide personnel and product protection while working with powder and liquid substances. Designed to house a Mettler Toledo Easy Max 102, Vacuum Oven, and IKA LR 1000.

Stainlees Steel Glovebox for Cytotoxic Drug Development designed to provide personnel protection while working with powder substances.

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, 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.

The HPAPI Package Inspection Suite is designed to provide personnel and product protection down to a respiratory exposure of at least 100 micrograms per cubic meter air (100 ug/m3). Package inspection operations involve manipulation of highly potent pharmaceutical ingredients (HPAPI), such as fentanyl. 

Mettler XS204 Powder Weighing Enclosure designed to provide personnel protection when working with powdered substances down to a respiratory exposure concentration of less than 1 microgram powder per cubic meter of air (<1 ug/m3). Design accommodates sufficient space for efficient, ergonomic execution of powder weighing operations utilizing the Mettler XS204 Analytical Balance with dimensions (DxHxW) of 17.84” x 12.67” x 10.35” [453mm x 322mm x 263mm].

Integrated Glovebox and Hybrid Isolator for HPAPI Processing designed to provide personnel protection while working with powder substances.

CONTACT INFORMATION

Flow Sciences Inc.

2025 Mercantile Drive

Leland, NC 28451

UNITED STATES

Phone: (910) 763-1717

Contact: Sales

FEATURED ARTICLES

  • Evolving Containment In Pharma Manufacturing Facilities

    Pharmaceutical manufacturing is now undergoing significant transformation. COVID-19 and its pressure on nearly every aspect of human life has put a gigantic emphasis on rapid development of prescriptives, vaccines, and accelerated means for pharmaceutical mass-production. This paper characterizes the new production directions in pharmacy and describes flexible equipment to improve pharma efficiency, purity, and production safety in the coming decade.

  • The Challenges Batch And Continuous Manufacturing Bring To Containment Product Design

    Methods and techniques used in pharmaceutical manufacturing are broadly reviewed. There are two basic models of pharma manufacturing: batch and continuous. Both approaches are defined. It is concluded that both approaches have elements of the other. Generally speaking, many pharma manufacturing procedures are transitioning from the batch to the continuous approach.

  • Five Tests For Pharmaceutical Containment

    As active pharmaceutical ingredients increase in potency and become more hazardous to work with, pharmacological and chemical containment devices are required to meet containment performance targets through independent testing before use in laboratories can begin. Typically, we test containment equipment against some minimum performance standard. This is necessary to protect procedural integrity and the sensitive products undergoing processing.

  • Vibration Isolation For Enclosures

    It is crucial in analytical environments that precise weighing takes place inside containment where potent powders being weighed do not escape into the lab. Flow Sciences incorporates a low vibration fan subassembly in its design by using a balanced fan, thicker low static pressure filters which put less strain on the motor, and a soft gasket junction between the fan subassembly and the containment unit. The purpose of this paper is to measure the effectiveness of these three vibration isolation strategies.

  • Particle Analysis Suite Facilitate Flexibility In Dynamic Laboratory Work Environment

    Flow Sciences is known for their flexibility and their unique reception of customer needs. When approached by a client with a specific design request, Flow Sciences was able to work with the client, including supplying a fiberboard mockup so they could make additional considerations before finalizing the design, to come up with a solution.

  • HPAPI Processing And Drying Suite For Operator And Product Protection

    A two-part enclosure consisting of a single pass air flow glove box enclosure and a nitrogen purge enclosure was designed to provide protection to the operator and product.

  • HPAPI Containment Solution For A Benchtop Vacuum Oven Process

    Finding a solution to provide personnel protection when working with Highly Potent Active Pharmaceutical Ingredients (HPAPI) is very tricky. This case study describes a situation where a containment solution was designed for a benchtop vacuum oven process. Learn more about Flow Sciences’ Discovery process and how it resulted in a containment solution.

  • The Oncology Workstation With EziDock CSV6 HPAPI Transfer For Superior Personnel And Product Protection

    The Oncology Workstation with EziDock CSV6 HPAPI Transfer was designed to provide personnel and product protection while working with powder substances. It was determined due to the high OEL that a glovebox workstation would best suit the application, and an Ezi-Dock high containment transfer system was used due to its capacity to handle hazardous chemical and pharmaceutical products.

  • Modular Containment Unit Solution For A Genevac EZ2 Elite Evaporator

    Flow Sciences, Inc. was tasked with designing a modular containment unit that would house a Genevac EZ2 Elite Evaporator and allow for transfer of materials post-manipulation into a separate, connected balance enclosure for weighing. Read how they were able to deliver the product within the client's very specific size and performance specification.

  • The API Process Development System For Personnel And Product Protection

    The API Process Development System was designed to provide personnel and product protection when working with powder and liquid substances. Read more about this solution that offers easy operator access for cleaning purposes, inlet HEPA filtration, bag-in/bag-out filtration with dual HEPA filters, and LED lighting and acrylic viewing panels maximized lighting across the workspace.

  • Glovebox Design Encloses Milling Processes

    A manufacturer required a glovebox that would enclose milling processes done by either a Fitzmill L1A or a Quadro Comil. Read how the design features allowed the operator the access and flexibility that they needed while achieving the containment requirements that were required.

  • Mini-Spray Dryer Encloser Solution For Pharmaceutical Application

    A client required the design and build an enclosure that could house the Buchi B-290 Mini-Spray Dryer during process. See how this designer/manufacturer was able to provide a solution that could offer containment down to less than one microgram per cubic meter.

  • Toxic Treatments: Controlling Exposure Risks In ADC Manufacturing

    The potency and effectiveness of the ADCs are dependent upon engineered nanoparticles (ENPs), but little is known about the environmental and human health hazards posed by ENPs.

  • Evaluating A Chemical Fume Hood For Containment Of Solids, Liquids, And Vapors Using ASHRAE 110, HAM, And ISPE Methods

    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. In this study, Flow Sciences chose to meld existing techniques centered around ASHRAE 110 with widely-accepted particulate containment measurement techniques. 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.

  • Validation Of A Glovebox Workstation

    Many existing research labs, pharmaceutical and biopharmaceutical manufacturers, and contract manufacturing organizations (CMO’s) are not designed nor are they equipped with the engineering controls to safely handle the manufacture of ADC’s. The safe manufacture of ADC’s requires more modern facilities, equipment, and engineering controls as well as programs, practices, and procedures to adequately protect the operators and the work environment. Read the steps that must be taken to consider a glovebox workstation fully validated to manufacture ADCs safely.

  • Critical Considerations When Selecting A Vented Balance Enclosure

    This paper discusses the primary benefits of the vented balance enclosure, which is critical to the safe and effective weighing of potent powder compounds, APIs, and nanomaterials. 

  • Manufacturer Finds Solution For Transporting HPAPI Product with Containment

    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. read how Flow Sciences used a recently developed containment device and augmented to fit the specific needs of the client.

  • Shipping, Assembling, And Installing Bulky Exhaust Equipment In A Lab

    Though delivering, unloading, staging, and assembling are required steps in all lab construction, there are design aspects of lab equipment that can contribute to its successful field installation.

  • Getting What You Need In A Laboratory Hood

    Understand what information you should be communicating to the manufacturer to ensure you get the best lab containment equipment, built correctly the first time.

  • Venting Fume Hood Base Cabinets — A Better Way

    Frequently, companies have used fume hood exhaust to ventilate hood base cabinets. There is both the need for this practice and the designs for them are frequently not well thought-out. 

  • 10 Worst Containment Engineering Mistakes

    Engineering is a process to develop a design to solve a problem. In the world of containment engineering, careful premeditation is important to the completion of a successful engineering project.

  • The Keys To Superior Containment In Compounding Applications

    This paper reviews why very bad things happen when either quantity or purity of Highly Potent Active Pharmaceuticals is not properly maintained during the compounding process. 

  • 10 Considerations For Balance Stability

    Stability of your weighing balance is paramount when it comes to collecting reliable data. Depending on the problem, taking obvious action for a seemingly obvious solution may not result in success.

  • Flow Sciences, Inc. Partners With Three Companies To Contain Lyophilization Process Of New HPAPI

    On December 19, 2018; Allan W. Ader, Ph.D. (Safebridge Consultants, Inc.), and Richard Hirsh, CIH (Nektar Therapeutics) conducted a presentation along with Allan Goodman, Ph.D. of Flow Sciences, Inc. (FSI).

  • Common Fume Hood Containment Problems

    While there are “bad” fume hoods, anything wrong with the entire system (exhaust fan, ductwork, building configuration, regulative dampers) may cause a lack of containment in a hood.

  • Save Energy And Lab Space : Flow Sciences’ Local Exhaust Ventilation Hoods

    Flow Sciences, a leading provider of containment systems for laboratory, pilot plant, and manufacturing is now shipping the LEV III™, an addition to its expanding line of standard enclosures.

BROCHURES

  • Designing Engineering Controls For High Potency Containment

    Engineering controls are necessary to extract and remove toxins to prevent inhalation, dermal, and other exposures as well as cross contamination of samples.

  • Flow Sciences Pilot Plant/Manufacturing Process Solutions

    The ability to be effective is both a challenge and an opportunity as contracts are processed and delivered. Safety, performance and reproducibility are of the utmost importance, as the CMO or CRO rely on their equipment to manufacture consistent products and results, while keeping their personnel or product safe. At Flow Sciences, we pride ourselves in the ability to engineer solutions that contain applications properly while creating consistent results.

  • Flow Sciences Containment Solutions

    Flow Sciences, Inc. provides engineered containment solutions from research to production. From Occupational Exposure Bands (OEB) 3 to 5, we build to suit your application. Whether in powder manipulation where balance stability is paramount, or using specific manufacturer equipment needing containment, or operating in a temperature and humidity controlled environment, Flow Sciences keeps your personnel and product safe.

  • Aspetic And Non-Sterile Glove Boxes And Containment Systems For HPAPI Processing

    As more information becomes available about the toxicity and potency increases across the marketplace, the need for personnel and/or product protection grows. Flow Sciences is the world leader in sophisticated containment to meet these challenges with proprietary engineering and design that allows for the creation of validated engineered solutions.

  • Lateral Flow Bio Containment Isolator For HPAPI Processing: LFBC™ Brochure

    The Glovebox Workstation series provides containment for highly toxic applications using APIs that need more safety than an opened face enclosure. FSI engineering controls are built in to prevent loss of containment. Third Party testing has proven containment on these units to below 30 ng/m³ based on process and quantity.

  • Flow Sciences Local Exhaust Ventilation Series

    Save energy and lab space by moving process applications out of fume hoods. Local exhaust ventilation is the most effective and efficient containment for flash chromatography, rotovaps, and more.

  • Flow Sciences Bulk Powder Containment Series

    The Bulk Powder series provides containment for large transfers of powder and pilot plant / manufacturing applications. FSI engineering controls are built in to prevent loss of containment. Third Party testing has proven containment on these units to below 1 μg/m³ based on process and quantity.

  • Flow Sciences Lab Design

    Whether you are designing a new laboratory or renovating an existing facility, it’s important to consider the fitness and applicability of fume hoods. Flow Sciences’ Saf-T-Flow™ Fume Hood Series are ducted for maximum safety and efficiency with minimum energy input.

  • Flow Sciences Compounding Pharmacy Enclosures

    The Flow Sciences vented enclosure is essential to protect your health and ensures safety by containing powder and virtually eliminating exposure to potent powders.

  • Flow Sciences Nitrogenema Series

    Containment at its driest. This enclosure is capable of protecting your process by nearly eliminating moisture or oxygen with the flow of inert gas.

  • Flow Sciences Contained Vented Enclosure Series

    The CVE series provides containment for various benchtop/scale up and nanotechnology applications.

  • Flow Sciences Hybrid Isolator Series

    With the explosion in usage of High Potency Active Pharmaceutical Ingredients (HPAPI’s), containment of these compounds and personnel protection have become of major concern to scientists. In order to combat potentially high capital outlays for equipment, many companies are looking at alternative methods of containment, including modification of existing equipment. The Hybrid Isolator, offered by Flow Sciences, Inc., is one such method of reducing the cost of containment.

  • API/HPAPI Containment Solutions For Pharmaceutical Manufacturing

    Solve your containment challenge by working with a company that understands your process, CPT, expectations, facility allowances and restrictions as well as specific equipment specifications.