A compound which, when dissolved in water gives a pH of less than 7.0 or donates a hydrogen ion.
A Flow Sciences enclosure which functions to contain processes which involve the transfer of acid from one location (or enclosure) to another (location or enclosure).
Made from polymers of acrylic acid or acrylates. (Synthetic resins and textile fibers)
An integrated or separate device which measures rate which air passes along its sensor; often features an audible alarm which sounds when air velocity is less than the minimum setpoint or greater than the maximum setpoint
Substance for which analysis is being performed.
An instrument for measuring the speed of the wind, or of any current of gas.
Structural feature of an enclosure which allows for the loading/retrieval of material into the enclosure while simultaneously isolating the material from the working area
Type of antimicrobial drug used in the treatment and prevention of bacterial infections. They kill or inhibit the growth of bacteria.
The ingredient in a pharmaceutical drug or pesticide that is biologically active
Term referring to the overall concept of tasks performed inside a containment enclosure device
American Society of Heating, Refrigerating and Air-Conditioning Engineers is an organization devoted to the advancement of indoor-environment-control technology in the heating, ventilation and air conditioning (HVAC) industry.
the methodical regulation of system fluid flows through the use of accpetable procedures to achieve the desired or specified design airflow; this service is provided by the Certification company.
A specific quantity of material produced in a process or series of processes so that it is expected to be homogeneous within specified limits. In the case of continuous production, a batch may correspond to a defined fraction of the production. The batch size can be defined either by a fixed quantity or by the amount produced in a fixed time interval.
a Fume Hood designed to rest on a lab-bench or other work surface at waist height
an enclosure which designed to be placed on a level work surface and contain applications required such a surface; e.g. analytical weighing, chromatography
Alternatively, the enclosure can be perceived as an upgrade in health and safety protection for facilities with a developing laboratory or other applicable workspace
at Flow Sciences; an enclosure or workstation which is designed to rest on a lab-bench (or other worksurface at waist height); isolates respiratory and/or dermal exposure hazards from the surrounding environment
a cleaning kit recommended (and sold by) Flow Sciences; offers decontamination, residue removal and aesthetic cleaning of acrylic and trespa surfaces (i.e. base and viewing panels)
a filter design configuration which allows for the safe changing of filters on applicable FSI enclosures. The filter is contained within a bag during changeout, preventing respiratory exposure to contaminants impacted onto the filter.
The level and type (e.g. objectionable or not) of micro-organisms that can be present in raw materials, API starting materials, intermediates or APIs. Bioburden should not be considered contamination unless the levels have been exceeded or defined objectionable organisms have been detected.
A therapeutic drug or a vaccine, made from living organisms — human, animal, yeast, or microorganisms — licensed under a Biologic License Application by the FDA.
a type of HVAC dampener which can be manually adjusted between the full-open and full-closed state to yield the desired volumetric flow rate from the enclosure to the house exhaust system. Pressure differential decreases as the blast gate is closed.
Mixing two or more [typically powder] substances together to create a homogenous mixture
the raw materials are consistently filled into the mill chamber via an oscillating valve. The fast rotating knives mill the product either by cutting or pounding.
accessories which assist users performing tasks with containerized bulk powder API’s (e.g. Flow Sciences stainless steel lift carts, model FS6551)
|Enclosures designed to contain applications involving [typically HPAPI] powder substances which are containerized in drums or carboys; processes are performed using the powder after they are removed from the container|
an enclosure system designed for the transfer of bulk powder from its original container (e.g. drum, carboy) into another container and/or to be processed further (weighed, dispensed, etc.)
The demonstration that a particular instrument or device produces results within specified limits by comparison with those produced by a reference or traceable standard over an appropriate range of measurements.
consists of improvements to an organization’s processes taken to eliminate causes of non-conformities or other undesirable situations.
a type of equipment which removes excess or unwanted dust from the surface of shaved or cut tablets; this term usually applied to pharmaceutical applications
a task typically performed in a pharmaceutical manufacturing setting; involves the filling of pre-fabricated capsule “shells” with active pharmaceutical ingredients (API)
Carbon filtering is a method of filtering that uses a bed of activated carbon to remove contaminants and impurities, using chemical adsorption. … Active charcoal carbon filters are most effective at removing chlorine, particles such as sediment, volatile organic compounds (VOCs), taste and odor from water.
a function provided by applicable Flow Sciences enclosures which isolates personnel from exposure to hazards incurred by carbon-nanotube product
a human-created material or substance which contains carbon atoms or carbon-based molecules; typically applied in biological applications or tasks involving organic material OR a substance or material using an organic chemical reaction to perform a certain action or task
an accessory which allows movement of enclosures by way of wheeled casters
is a company that serves other companies in the pharmaceutical industry on a contract basis to provide comprehensive services from drug development through drug manufacturing. This allows major pharmaceutical companies to outsource those aspects of the business, which can help with scalability or can allow the major company to focus on drug discovery and drug marketing instead.
the leading national public health institute of the United States; its main goal is to protect public health and safety through the control and prevention of disease, injury, and disability in the US and internationally.
|a professional ventilation service provided by an organization which ensures compliance with regulatory stipulations, compatibility between enclosure and house exhaust system, and calibration of face velocity alarm and other applicable enclosure components|
is the use of applied mathematics, physics and computational software to visualize how a gas or liquid flows — as well as how the gas or liquid affects objects as it flows past.
in the imperial measurement system, used to describe the rate at which a three-dimensional channel of travels beyond a designated Point of Measurement; see Volumetric Flow Rate
the volumetric flow rate required to facilitate the operational flow rate range (60-100 lfpm)
Change control is a procedure that ensures changes are implemented in a controlled and coordinated manner. A change control system provides checks and balances in the quality system by tracking, reviewing and approving the changes.
|is a company that partners with a manufacturer or producer to market and sell the manufacturer’s products, services, or technologies. This is usually done through a co-branding relationship.|
a category of Flow Sciences enclosures which functions to contain chemical laboratory processes (which typically generate toxic fumes)
the separation of a mixture by passing it in solution or suspension or as a vapor (as in gas chromatography) through a medium in which the components move at different rates.
A method of cleansing all contaminants from the interior surfaces of process equipment without dissembling it.
|A cleanroom or clean room is an environment, typically used in manufacturing, including of pharmaceutical products or scientific research, as well as aerospace semiconductor engineering applications with a low level of environmental pollutants such as dust, airborne microbes, aerosol particles, and chemical vapors. More accurately, a cleanroom has a controlled level of contamination that is specified by the number of particles per cubic meter at a specified particle size.|
is screen milling/conical milling technology for achieving uniform particle size distributions and deagglomeration dispersions in the pharmaceutical, food and fine chemical industries.
A process in which a bulk drug substance is combined with one or more excipients and/or another bulk substance to produce a bulk product.
|a computerized program which visualizes the flow of a fluid, (air, in terms of Flow Sciences) through a space (e.g. Flow Sciences enclosure)|
a type of enclosure which completely isolates the enclosure interior form the surrounding environment. E.g. Flow Sciences Nitrogenema TM (END) Series
the attenuation of respiratory exposure to harmful substances through isolation of such substances from the breathing zone of the operator; i.e. reducing the 8-hour TWA concentration value to selected contaminants in the solid particulate and/or gaseous stages
devices which Flow Sciences designs, manufactures, and sells that protect and isolate personnel from respiratory, dermal, ingestion, and other routes of exposure to contaminants incurred and used to complete a particular scientific process. Where applicable, a device manufactured by Flow Sciences which protects product [inside the device] from cross-contamination and loss by way of excessive and/or turbulent airflow
The C-SEC is the room in which the C-PEC is placed. It incorporates specific design and operational parameters required to contain the potential hazard within the compounding room (e.g., restricted access, barriers, special construction technique, ventilation, and room pressurization are components of the secondary control strategy).
A type of C-SEC with nominal airflow (12 ACPH) and room pressurization requirements (negative pressure between 0.01 – 0.03 inches of water column) as they pertain to HD compounding. The C-SCA is limited for use with a BSC or CACI when preparing low or medium-risk level CSPs with 12-hour or less BUDs or preparing nonsterile HDs in a C-PEC.
The undesired introduction of impurities of a chemical or microbiological nature, or of foreign matter, into or onto a raw material, intermediate, or API during production, sampling, packaging or repackaging, storage or transport.
an atmosphere controlled by scientific equipment to maintain and adjust certain atmospheric parameters according project specifications
a fume hood base cabinet which is designed to store corrosive chemicals and keep corrosive vapors isolated from the enclosure interior
the total, cumulative cost of an enclosure from the time of purchase and acquisition until the end of use
A ventilated device designed and operated to minimize worker and environmental exposures to HDs by controlling emissions of airborne contaminants. Examples of C-PECs include Class I, II, or III BSCs, CACIs, and CVE (e.g., powder hood). C-PECs used for nonsterile compounding do not need to have ISO Class 5 air quality. C-PECs used for sterile compounding shall have ISO Class 5 air quality.
is an organization that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provide such services as biopharmaceutical development, biologic assay development, commercialization, preclinical research, clinical research, clinical trials management, and pharmacovigilance. CROs also support foundations, research institutions, and universities, in addition to governmental organizations (such as the NIH, EMA, etc.).
Contamination of a material or product with another material or product.
|A recess (resembling a kitchen sink) which functions to cpature and drain excess liquid from the interior of a Fume Hood|
a quote generated by Flow Sciences which affords the customer with an enclosure designed specifically for their containment needs
a room designated for the removal of personal protective clothing and other PPE; typically exist in facilities with applications involving powdered contaminants at a high potency
|An impurity resulting from a chemical change in the drug substance brought about over time and/or by the action of e.g., light, temperature, pH, water, or by reaction with an excipient and/or the immediate container/closure system. Also called decomposition product.|
the process by which a work space is created and implemented into use; at Flow Sciences, the conceptual process by which an a conceptual enclosure schematic is created prior to being physically produced
typically circular and composed of heavy glass, a small container intended to preserving moisture-sensitive items, substances, and chemicals
|A means of producing a tablet without granulation. The active ingredient is blended with excipients, typically at least a filler-binder, a disintegrant and a lubricant and then the blend is compressed on a tablet machine. The filler-binders are usually special grades of excipients (for example spray dried lactose) exhibiting good flow and compaction properties to enable the DC process.|
|is a requirement for all solid oral dosage forms and is used in all phases of development for product release and stability testing. It is a key analytical test used for detecting physical changes in an active pharmaceutical ingredient (API) and in the formulated product.|
Representatives of the Flow Sciences brand that carry the product offering and assist with other functions including sales, installation, support, and more.
|a bag system that allows for the safe disposal of waste. Eliminates the waste exposure to the outside environment and prevents cross contamination with waste and residues.|
a laboratory method of removing excess moisture from powdered product and compressing the dried product for capsulization or compaction into a state appropriate for dosing
a feature of FSI’s Hybrid Isolator Series, a housing which contains a fan capable of automatically adjusting its rate of rotation in response to the installation/removal of the draftshield
indicates the enclosure filtration system is comprised of two HEPA filters
aka. Hybrid Isolator Series; an enclosure series which doubles as a Vented Balance Safety Enclosure (VBSE) and a glovebox enclosure; features a dual-speed fan which automatically adjusts rotational speed (and volumetric flow rate) upon installation/removal of the gloveport draftshield
a device which decreases the respiratory exposure concentration of a process involving harmful chemicals and/or substances to a concentration value/range recognized as safe by the employer
aka. Nitrogenema Series; a series of FSI enclosure models which facilitates a reduced Oxygen and Relative Humidity environment in the interior of the enclosure. A positive-pressure enclosure series which features an automated purge-cycle to maintain reduced oxygen/relative humidity conditions.
a method of hazard control, manifested as engineered machinery, which eliminates or reduces exposure to a chemical or physical hazard
|aka. Vented Balance Safety Enclosure (VBSE); Biological Safety Cabinet – Class I, Containment Primary Engineering Control (C-PEC) – a series of FSI enclosure which typically is purposed to contain applications involving the weighing and processing of powdered substances|
aka. Vented Balance Enclosure (VBE); an enclosure series which features an all-acrylic superstructure and a dished phenolic base. Lightweight and features highest portability of all FSI standard enclosure series.
The LEV III™ Series for process equipment provides safety from chemical vapors generated during processes such as flash chromatography, evaporation from rotary evaporators, and other process equipment applications.
measure of the air volume added to or removed from a space; often expressed as air changes per minute (ACM) and/or air changes per hour (ACPH)
|A component of a drug product other than the API, that is intentionally added to the dosage form to enable processing into patient friendly medicines, to control the rate at which the API dissolves from the dosage form, to aid drug stability and other reasons. For solid oral dosage forms, main classes of excipients include diluents or filler-binders, disintegrants, glidants, lubricants, coating materials, and stabilising agents.|
the opening on a containment enclosure device through which air passes from the surrounding environment into the enclosure
used to describe the rate at which air flows through the Face Opening from the environment surrounding the enclosure
in-house performance validation testing performed by FSI; includes, but is not limited to, ASHRAE 110 and flow visualization testing as a component of FSI’s Quality Control procedures
|a test conducted by FSI to verify if products satisfy engineering specifications and meet minimum containment requirements|
the food and drug administration is a government agency established in 1906, that governs the production and development of drugs and food. The FDA regulates a wide range of products, including foods (except for aspects of some meat, poultry and egg products, which are regulated by the U.S. Department of Agriculture); human and veterinary drugs; vaccines and other biological products; medical devices intended for human use; radiation-emitting electronic products; cosmetics; dietary supplements, and tobacco products.
a term utilized on FSI’s website and marketing literature to describe a category of functional capabilities which augment the basic function of an enclosure or fume hood
a term used by FSI to describe a part which is comprised of a fan, filter, and exhaust port. This part facilitates a negative-pressure environment after proper certification and/or balance of volumetric flow with house exhaust fan
a medicinal product which has undergone all stages of production, including packaging in its final container.
A fume hood conforming to SEFA standard which is mounted onto the floor or designated walking surface; is in contrast with SEFA-conforming fume hoods which are designed to mount onto another surface, such as a workbench, table, or base cabinet
a branch of business located in Shanghai, China
|a piece of equipment designed to remove moisture bound to powdered substances by surface tension and chemical bonding|
|A device that dries powder using mechanical force and/or airflow to evaluate and aerate it, increasing interstitial particle spacing and driving off moisture.|
|a fume hood or enclosure (equipped with appropriate organic filtration media) designed to remove gaseous and aerosolized formaldehyde (a known carcinogen)|
An ingredient or mixture of specific ingredients; that is, drug substances and excipients in specific amounts, defining a given product.
|A chemical fume hood protects the user while a biosafety cabinet protects the user, the environment, and the material. chemical fume hoods do not have HEPA filtration.|
A cabinet designed to be located directly below the base on of a Fume Hood. Flow Sciences offers an array of base cabinets which have distinct protective qualities
|term for “electrical wire and connections which are structually integrated into a fume hood”|
term for “pipes and connections which facilitate the supply and discharge of liquid in a fume hood”
often confused with other containment devices not included within this definition, an enclosure device which isolates the operator from exposure hazards of an application that is required to (or is preferred to be) removed from the enclosure interior by way of vacuum pressure from a central, house exhaust system; an enclosure device which features connections to source liquids and gases required to complete the operation
an international quality standard that is provided by ICH, an international body that defines a set of standards, which governments can then transpose into regulations for clinical trials involving human subjects.
deals with the guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs intended for human consumption.
cut out in the enclosure for the attachement of gloves to protect product and user.
|is a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.|
an organism that has been modified by gene technology
|is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.|
|a slab of granite typically placed under an analytical balance which dampens vibrational energy adversely affecting the accuracy of weight and mass measurements|
the process of forming grains or granules from a powdery or solid substance; depending on chemical composition of product, poses the risk of hazardous particulate disturbance and respiratory exposure
A hazardous drug is any drug identified as hazardous or potentially hazardous by the National Institute for Occupational Safety and Health (NIOSH) on the basis of at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low doses in humans or animals, genotoxicity, and new drugs that mimic existing hazardous drugs in structure or toxicity. NIOSH maintains a list of antineoplastic and other hazardous drugs used in healthcare settings.
in industry standards, an air filter which removes, at a minimum, 99.97% of particles which have a diameter size greater than or equal to 0.3 micrometers (um)
typically features pleated paper filtration media, High Efficiency Particulate Air (HEPA) emprically proven to prevent the transport of particulate matter at least 99.97% of the time down to a particle diameter of 0.3 micrometers; the term “HEPA” signifies filtration efficiency of particulates, does not imply a specific composition of filter media
|a systematic order of prioritization to represent the magnitude of effective between each control method category. Often expressed as a visual model and recommended by the US Occupational Safety and Health Administration (OSHA), National Institute of Occupational Health and Safety (NIOSH), and the Center for Disease Control and Prevention (CDC).|
when pertaining to respiratory exposure, an Active Pharmaceutical Ingredient (API) or intermediate with an occupational exposure limit (OEL) at or below 10 micrograms per cubic meter of air (10 ug/m3) as an 8-hour Time Weighted Average (TWA).
an insturment that works on the principle of the seperation of the material according to the molecular weight and polarity. Used for testing compounds in chemisty laboratories.
|Heating, Ventilation, and Air Conditioning|
aka. EHA Series; an enclosure series which doubles as a Vented Balance Safety Enclosure (VBSE, C-PEC) and a glovebox enclosure; features a dual-speed fan which automatically adjusts rotational speed (and volumetric flow rate) upon installation/removal of the gloveport draftshield
|an accessory available for order from FSI; allows the loading and removal of bulk powder drums or carboys into FSI enclosures with a bulk powder container cutout on its base|
|A material’s ability to absorb moisture from its surroundings.|
the conduct of clinical research to support marketing applications for drugs. Provides a unified standard for designing, conducting, recording, and reporting research involving human subjects.
science and art devoted to the anticipation, recognition, evaluation, prevention, and control of those environmental factors or stresses arising in or from the workplace which may cause sickness, impaired health and well-being, or significant discomfort among workers or among citizens of the community.
in terms of Health and Safety Engineering: the process of mechanically introducing fresh air to an enclosed space in order to refresh/remove/replace the existing atmosphere
|in animal research business sector, an equipment system which simulates reproducible animal exposure to airborne, aerosolized contaminants (respiratory exposure hazards)|
the opening through which air from the surrounding environment passes, thereby entering the enclosure
a service which verifies the functional performance of an FSI enclosure or fume hood through a series of verification steps and execution of corrective actions (if and where applicable to correct non-conforming parts or systems); conducted a component of Factory Acceptance Testing through a simulated installation of the subject enclosure
|a feature available on applicable FSI products which allows electrical connectivity via a female electrical outlet panel (or plug) in the interior of the enclosure|
a term used to describe Flow Sciences’ breadth of business internationally; please follow the link to explore FSI’s international distribution partners
The documented verification that the facilities, systems and equipment, as installed or modified, comply with the approved design and the manufacturer’s recommendations.
orifices typically located on the left or right side of the enclosure which allows for the insertion and removal of cables and cords necessary to begin, conduct, and finish a run of an application and/or process
is an International Standard that gives. requirements for an organization’s quality manage- ment system (QMS). It is part of a family of standards. published by the International Organization for Stand-
an application category defined by FSI to encompass facilities which utilize automated tools and equipment to complete tasks with limited or no human interaction or manipulation
a design tactic engineered by FSI which protects biological product by facilitating parallel, non-turbulent channels of moving air slightly above the surface of the product; significantly reduces potential for particulate contamination and cross-contamination from other substances inside the enclosure
containment enclosures which facilitate LFBC (see Lateral Flow Bio Containment [LFBC])
a lighting panel which features a light-emitting diode light source; augments visibility of the work surface
when ventilation is used as an engineering control method, a device designed to prevent dispersion into the air of dusts, fumes, vapors, and gases in concentrations causing harmful exposure
an enclosure or fume hood designed to contain respiratory, dermal, ingestion, hazards which are manifested in the liquid state of matter during the process performed inside of the enclosure
|an enclosure designed to facilitate the containment and execution of tasks producing liquid waste products in need of discardment|
an enclosure (equipped with proper acid filtration) or fume hood which
A process by which material is rapidly frozen and dehydrated under high vacuum.
|aka. freeze drying; a process in which water is removed from a product via freezing and subsequently placed under sufficient negative pressure thereby allowing the frozen product to change directly from solid to vapor without passing through an intermediate liquid phase (i.e. sublimation induced by cryodessication)|
a work area designed to accommodate and facilitate the processing of mail where the processing procedure involves (or is subject to) contamination with harmful and/or illicit substances
in terms of Flow Sciences, the types of materials of which containment enclosure devices are composed (includes structural, plumbing, electrical, and accessory components, and more)
a balance for weighing masses of a fraction of a gram.
|one millionth of a gram.|
FSI enclosures designed to contain processes involving the use of a microscope to analzye a sample posing health hazard(s)
|a type of pharmaceutical manufacturing equipment which pulverizes [typically powdered] product to a size small enough for capsulization or to progress to the next operation in the manufacturing process|
in terms of FSI products, a gage which measures the pressure differential between the input and output sides of a HEPA filter in the Fan/Filter Housing; displays measurements as inches of water column (i.e. iwg, i.w.g.)
an attachement available for enclosures that require rinsing with water after testing of application is preformed.
a Flow Sciences enclosure suite which contains applications involving mixing and blending operations; isolates the mixing operation from the blending operation
a representation of an FSI product composed of non-functional structure material, such as hardwood, to serve as a visual preview for a customer wishing to tangilbly estimate the spacial requirements of the final, manufactured product
an enclosure designed to contain processes involving containerized bulk powder product; contains to an exposure concentration between 1-999 ng/m3 (nanograms contaminant per cubic meter air)
one billionth of a gram.
a third-party industrial hygiene consulting company which, in the past, has certified specific Flow Sciences enclosure models as safe when working with contaminants on the nanogram level
the branch of technology that deals with dimensions and tolerances of less than 100 nanometers, especially the manipulation of individual atoms and molecules
the United States federal agency responsible for conducting the research and making recommendation for the prevention of work-related injury and illness.
|an FSI enclosure designed to contain necropsy applications and the chemical contaminants known to be typically present during such applications, such as formaldehyde and contaminants left undetected until necropsy analysis is performed (e.g. postmortem testing of skin from a cyanide poisoning fatality)|
See END Series for example; any FSI positive-pressure enclosure which uses a connected Nitrogen source to purge the enclosure interior of unwanted Oxygen
|the regulatory or non-regulatory upper limit of respiratory exposure concentration for a particular contaminant in workplace air; typically established and enforced by competent authorities|
|Occupational exposure banding, also known as hazard banding, is a process intended to quickly and accurately assign chemicals into specific categories (bands), each corresponding to a range of exposure concentrations designed to protect worker health. … The output of this process is an occupational exposure band (OEB).|
a mechanism to quickly and accurately assign chemicals into “categories” or “bands” based on their health outcomes and potency considerations
Test result that does not comply with the pre-determined acceptance criteria (i.e. for example, filed applications, drug master files, approved marketing submissions, or official compendia or internal acceptance criteria).
Is generally a stability result that does not follow the expected trend, either in comparison with other stability batches or with respect to previous results collected during a stability study. However the trends of starting materials and in-process samples may also yield out of trend data.
a portion, step, or “substep” of a Process or Application
the opening through which filtered air leaves the enclosure; e.g. recirculation into room, passage into house exhaust system
|a fume hume bypass system which allows for automatic adjustment of volumetric flow rate upon opening/closing of the fume hood sash opening. Automatic adjustments are facilitated by passive diffusion of makeup air into the bypass opening, located above the sash|
typically, a visual representation of the attributes of an analyzed sample. E.g. the distribution of particle diameter sizes, distribution of chemical components of a sample and their respective concentrations; aka. particle categorization
a structural feature of an enclosure which allows and facilitates the transfer of material(s) from one enclosure to another
|enclosures designed to contain applications involving the manipulation of organic tissue (human and animal tissue)|
protection of employees using an enclosure from the health hazards of airborne contaminants inside the enclosure (may also apply to employees working in the vicinity of the enclosure)
in British. noun. any one of a class of resins derived from phenol, used in paints, adhesives, and as thermosetting plastics. See also Bakelite.
|facilities which produce products which are not (yet) mass-produced or undergoing preliminary testing before release to the public; typically experiences a high rate of change in layout of production lines and changes in product composition and method(s) of manufacturing. Enclosures designed for this type of facility are typically custom manufactured to contain products which are not well-known to the public and/or do not have an established OEL.|
is a device used to direct air flow through the containment system.
a synthetic resin that is a polymer of propylene, used especially for ropes, fabrics, and molded objects.
similar to Metal Inert Gas (MIG) and Tungsten Inert Gas (TIG) welding; fuses two pieces of polypropylene together to form a joint
the act of physically touching and [potentially] rendering powdered substances airborne; i.e. performing a task where movement of a powdered product is required for completion of task
an accessory offered by FSI for added ease of access to printed outputs from contained equipment/processes
a term referring to the tasks executed between the beginning and end of one “run” of an application
see LEV III Series, EVP Series
a purpose of FSI enclosures which entails the protection of product integrity
A sequence of three letters at the beginning of an FSI enclosure model number. E.g. ETA 483024ABD
The sum total of the organised arrangements made with the object of ensuring that all APIs are of the quality required for their intended use and that quality systems are maintained.
|is a general term for activities in connection with corporate or governmental innovation. Research and development is situated at the front end of the innovation life cycle, which may end with commercialization.|
|A general term used to denote starting materials, reagents, and solvents intended for use in the production of intermediates or APIs.|
the process of restoring something dried to its original state by adding water to it.
The ratio of the actual water vapour pressure of the air to the saturated water vapour pressure of the air at the same temperature expressed as a percentage. More simply put, it is the ratio of the mass of moisture in the air, relative to the mass at 100% moisture saturation, at a given temperature.
|Repeatability expresses the precision under the same operating conditions over a short interval of time. Repeatability is also termed intra-assay precision.|
|A systematic process of organizing information to support a risk decision to be made within a risk management process. It consists of the identification of hazards and the analysis and evaluation of risks associated with exposure to those hazards.|
The robustness of an analytical procedure is a measure of its capacity to remain unaffected by small, but deliberate variations in method parameters and provides an indication of its reliability during normal usage.
a device typically used in laboratories to efficiently and gently remove solvent components from liquid samples
a membrane which facilitates a seal of the enclosure interior from the surrounding environment. FSI’s bulk powder membrane set is designed with the capability to adapt the size of the membrane according to the diameter of the bulk powder drum or carboy
|indicates the enclosure filtration system is comprised of one HEPA filter|
|a performance validation service or procedure which measures the performance of an enclosure through the analysis of personal air samples taken during the execution of a customer’s SOPs; often performed to confirm and verify whether containment performance complies with customer’s expectations and the metrics produced as a result of the FAT.|
|a cabinet which is designed for the safe storage of flammable and oxidizing solvents|
is a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations. SOPs aim to achieve efficiency, quality output and uniformity of performance, while reducing miscommunication and failure to comply with industry regulations.
|a set of step-by-step instructions compiled by an organization to help workers carry out complex routine operations|
A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a drug substance or drug product should conform to be considered acceptable for its intended use. “Conformance to specifications” means that the drug substance and / or drug product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are critical quality standards that are proposed and justified by the manufacturer and approved by regulatory authorities.
|isolation of an application involving the use of a “spray dryer” model of equipment (e.g. a Flow Sciences enclosure designed to contain an operaiton involving a Buchi B290 )|
a form of steel containing chromium, resistant to tarnishing and rust.
A substance that decreases the surface tension of a liquid.
an FSI accessory which is manufactured specifically for the support of a particular enclosure or enclosure model
typically a process conducted in pharmaceutical manufacturing settings; a process during which pressed tablets are coated with material to [typically] render the tablet bioavailable via its intended route of administration (orally, sublingually); see Tablet Pressing
a process typically conducted in a pharmacetical manufacturing setting; a process involving the compression of Active Pharmaceutical Ingredients (API) into state prior to coating and polishing. Thus, creating a medicinal tablet.
an FSI enclosure which was designed specifically for particular task; the enclosure may be designed for a particular type of process or even a particular equipment model
a tough synthetic resin made by polymerizing tetrafluoroethylene, chiefly used to make seals and bearings.
typically a controlled laboratory testing environment where temperature and humidity or controlled and/or altered depending on project specifications; typically involves products which are sensitive to certain levels of temperature or humidity
The occurrence of structural malformations in a developing foetus when a substance is administered during pregnancy.
at Flow Sciences, a term used to describe tasks performed to achieve an unachieved goal or to ascertain an unknown result
an FSI accessory which is deisgned for the secure connection between flex tubing and enclosure (or remote Fan/Filter housing) exhaust port. Ultimately assists in the connection of the enclosure to a house-exhaust system
an average exposure concentration value which a sum of exposure per unit time, weighted by the total time of sampled exposure
aka. histological tissue sample preparation; a biological or biotechnical operation performed to create samples for future processing
a deductive chemical laboratory method which is used to determine the concentration of an indentified analyte. A known concentration of titrant (placed into the sample to “tease” it) reacts with the analyte. The volume of titrant placed into the sample immediately at the point of reaction is known as the “titration volume”
Total organic carbon (TOC) is the amount of carbon bound in an organic compound and is often used as a non-specific indicator of water quality or cleanliness of pharmaceutical manufacturing equipment.
an enclosure which features a Fan/Filter Housing on the top; specifically, this type of FSI enclosure contains at least one filter capable of filtering an organic [typically non-particulate] substance
a component of a top-mount enclosure (e.g. ETA Series, EHA Series, etc.), located on the top of the enclosure working area; isolates the fan and filter(s) from the surrounding environment
if the the enclosure in need of filter replacement is a bag-in-bag-out enclosure (ETA, EHA, and custom enclosures based the these series), a replacement filter kit is required to safely replace the filter. If the enclosure in need of replacement is not a BIBO model, then the replacement filter is typically shipped without additional supplies
|see ETA Series or EHA Series|
|See ETA or EHA Series|
|a style of filtration featured on FSI enclosures which entails an FFH mounted above the top plenum; works in conjunction with airfoils and plenums to facilitatte laminar flow across the workspace|
dead air box for the transfer of materials in and out of an enclosure.
Tray drying is a batch process used to dry materials that are liquid or wet cake. The input materials are batched, placed into trays and loaded into AVEKA’s overhead ovens for drying. Tray drying works well for material that requires more gentle processing or cannot be atomized in an air stream due to viscosity.
Flow Science enclosures which feature a draft shield capable of being configured in two distinct locations while retaining containment
A federal governmental administration in the United States whose mission is to assure safe and healthful working conditions for working mena nd women by setting and enforcing standards and by providing training, outreach, and assistance.
The United States Pharmacopeial Convention (USP) is a nonprofit scientific organization founded in 1820 in Washington, D.C., that develops and disseminates public compendial quality standards for medicines and other articles (Bylaws, Articles II, and VII).
|General Chapter <800> provides standards for safe handling of hazardous drugs to minimize the risk of exposure to healthcare personnel, patients and the environment.|
Ultraviolet and visible (UV-Vis) absorption spectroscopy is the measurement of the attenuation (weakening of strength) of a beam of light after it passes through a sample or after reflection from a sample surface.
A documented program that provides a high degree of assurance that a specific process, method, or system will consistently produce a result meeting pre-determined acceptance criteria.
|A containment system designed to offer personnel protection while manipulating potent powders.|
a kit offered by FSI to facilitate connection of an applicable enclosure to a house-exhaust system
see END Series
see ETA Series
a method of product protection employed by FSI’s deisgn of an enclosure; minimizes impact of vibrational interference on measurements (typically analytical balace measurements of weight and/or mass)
The measurement of a materials resistance to flow.
FSI enclosures are offered in 110-120V or 220-240V
the volume of air which passes per unit time
an accessory offered by FSI to facilitate the safe removal of waste product from the interior of the enclosure to a disposal container
|pertaining to laboratory applications of the term, typically the measurement of weight of mass of a sample of powdered product; typically measurements range in the microgram to nanogram range of quantification|
a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948, headquartered in Geneva, Switzerland. The WHO is a member of the United Nations Development Group. Its predecessor, the Health Organization, was an agency of the League of Nations.
the surface inside of the enclosure where the operator performs his/her work