Glossary

The key issue in all contained aseptic environments. Aseptic transfer is essential for change parts, components, and even product to enter and exit an isolator system without sterility challenges. There are an increasing number of ways to make an aseptic transfer. The following is a brief list of some of the key techniques:1.Alpha Beta Systems Double Door Systems: also called RTPs (Rapid Transfer Ports) and HCT (High Containment Transfer). When mated, the two ports act as one door, protecting the internal and external environments.2.Alpha Beta Dry Heat Sterilized: similar to Alpha Beta port with the additional safeguard of a heat sterilized seal.3.UV and Pulsed Light: light sterilization/sanitization. Sterilizing the system by making use of a wide spectrum of light within the transfer chamber.4.One Shot Systems: basically, two halves coming together. Similar to an Alpha Beta port but simpler, cheaper, and capable of only a single connection.5.Heat Welded Bag Systems: passed in or passed out using a continuous polyethylene liner which is heat sealed and cut to maintain the integrity of the internal and external environments.6.Steam Sterilized: the liquid component or powder path is clean steam sterilized after connection and prior to transfer.7.Autoclave/Depyrogenation/Dryheat: pass through for batch. Use of conventional autoclave to sterilize a canister provided with an Alpha Beta port and filters to allow the passage of steam and safe aspiration on cooling. Depyrogenation/Dryheat uses dry heat to sterilize and at sufficient temperature depyrogenate components, typically glassware, in a batch oven8.Depyrogenation Tunnel: standard volume glassware entry. Depyrogenation/Dry heat uses dry heat to sterilize and at sufficient temperature to depyrogenate components, typically glassware, in a tunnel allowing continuous input.

Any type of reproduction not involving meiosis or the union of gametes.

American Society for Gastrointestinal Endoscopy

American Society of Hematology

Atherosclerotic Heart Disease

American Society of Heating, Refrigerating & Air Conditioning Engineers

Application Specific Integrated Circuit(s)

American Society for Microbiology

American Society of Mechanical Engineers

American Society of Mechanical Engineers - Bioprocessing Equipment Standard

The ASME Bioprocessing Equipment Standard was developed to aid in the design and construction of new fluid processing equipment used in industries that require a defined level of purity and bioburden control.The Standard typically applies to:1.Components that are in contact the product, raw materials, or product intermediates during manufacturing, development, or scale-up.2.Systems that are a critical part of product manufacture, (e.g., water-for-injection (WFI), pure steam, filtration, and intermediate product storage).

A number of individually published Sections, each an American National Standard. Rules for each Section reflect the kinds of piping installations considered during its development, as follows:1.B31.1 Power Piping: piping typically found in electric power generating stations, in industrial and institutional plants, geothermal heating systems, and central and district heating and cooling systems.2.B31.3 Process Piping: piping typically found in petroleum refineries, chemical, pharmaceutical, textile, paper, semiconductor, and cryogenic plants, and related processing plants and terminals. Certain piping within a facility may be subject to other codes and standards, including but not limited to: (a) ANSI Z223.1 National Fuel Gas Code: piping for fuel gas from the point of delivery to the connection of each fuel utilization device. (b) NFPA Fire Protection Standards: fire protection systems using water, carbon dioxide, halon, foam, dry chemical, and wet chemicals. (c) NFPA 99 Health Care Facilities: medical and laboratory gas systems. (d) Building and plumbing codes, as applicable, for potable hot and cold water, and for sewer and drain systems. (also see: Fluid Service (piping))3.B31.4 Pipeline Transportation Systems for Liquid Hydrocarbons and Other Liquids: piping transporting products that are predominately liquids between plants and terminals and within terminals, pumping, regulating, and metering stations.4.B31.5 Refrigeration Piping: piping for refrigerants and secondary coolants.5.B31.8 Gas Transportation and Distribution Piping Systems: piping transporting products that are predominately gas between sources and terminals, including compressor, regulating, and metering stations; gas gathering pipelines.6.B31.9 Building Services Piping: piping typically found in industrial, institutional, commercial, and public buildings, and in multi-unit residences, which does not require the range of sizes, pressures, and temperatures covered in B31.1.7.B31.11 Slurry Transportation Piping Systems: piping transporting aqueous slurries between plants and terminals and within terminals, pumping, and regulating stations.

American Society of Nephrology

American Society of Non-destructive Testing

American Society of Non-Destructive Testing

American Society of Plumbing Engineers

A vapor or gas that can cause loss of consciousness and death due to lack of oxygen.

Automatic Sloper Placement Unit

American Society for Quality (formerly ASQC)

Analyte Specific Reagent

American Society for Reproductive Medicine

A technique (test) for measuring a biological response or for determining characteristics such as composition, purity, activity, and weight.

(USP) Analysis (as of a drug) to determine the quantity of one or more components or the presence or absence of one or more components.

(USP) The set of data used to determine a single potency for all samples included in the bioassay.

American Society of Safety Engineers