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.
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.
- 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
Containment Liability: Choosing Assurance Or Insurance
Engineering controls designed to mitigate exposure and create separation between the operator and the toxic material are available in many different forms, all with their own unique advantages and risks. This article will look into various forms of containment while asking the question, is your liability assured or insured?
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.
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.