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.


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

Contract Development and Manufacturing Organizations (CDMOs) provide a comprehensive, single-source drug development and commercial manufacturing solution that requires unyielding safety and processing standards. We believe that understanding the importance of our client’s process first is the key to a successful partnership.

Achieve and maintain low humidity or oxygen levels

The Analytical Process Isolator™ or A.P.I. is a continuous process isolator to vented enclosure system that allows for ISO 5 clean processing and intake or outtake through a negative pressure vented cabinet.

Vaccine API Weighing and Processing Glovebox Workstation designed to provide personnel and product protection during the weighing and manipulation (processing) of Active Pharmaceutical Ingredients; provides attenuation of breathing zone exposure down to concentration ranges corresponding with OEB 4 (Occupational Exposure Band 4)(*).

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.

CONTACT INFORMATION

Flow Sciences Inc.

2025 Mercantile Drive

Leland, NC 28451

UNITED STATES

Phone: (910) 763-1717

Contact: Sales

FEATURED ARTICLES

BROCHURES

  • Designing Engineering Controls For High Potency Containment
    2/5/2020

    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
    1/24/2020

    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
    1/24/2020

    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
    1/23/2020

    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
    8/20/2019

    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
    6/25/2019

    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
    6/25/2019

    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
    6/25/2019

    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
    6/24/2019

    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
    6/24/2019

    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
    6/21/2019

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

  • Flow Sciences Hybrid Isolator Series
    6/20/2019

    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
    3/27/2019

    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.