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| Aseptic Transfer (in Isolators) | 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 oven
8. 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. |
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| ASME Bioprocessing Equipment (BPE- 1997) | An American National Standard that covers, either directly or by reference, requirements for materials, design, fabrication, examination, inspection, testing, certification (for pressure systems), and pressure relief (for pressure systems) of vessels and piping for bioprocessing systems, including sterility and cleanability (Part SD), dimensions and tolerances (Part DT), surface finish requirements (Part SF), material joining (Part MJ), and equipment seals (Part SG) for the bioprocessing systems in which the pressure vessels and associated piping are involved. This Bioprocessing Equipment (BPE) Standard does not address all aspects of these activities, and those aspects that are not specifically addressed should not be considered prohibited.
Requirements of this Standard apply to:
1. All parts that contact the product, raw materials, and/or product intermediates during manufacturing, process development, or scale-up.
2. All equipment or systems that are critical part of product manufacture, such as Water For Injection (WFI), clean steam, ultrafiltration, intermediate product storage, and centrifuges. ASME/ANSI B31 Code for Pressure Piping
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.
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. |
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| Assay | A technique (test) for measuring a biological response or for determining characteristics such as composition, purity, activity, and weight. |
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| Assimilation | The formation of cellular material utilizing small food molecules and energy |
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| At Rest | HVAC room condition when unmanned, and without machinery operating. Previously called "static condition". |
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| Atmospheric Tank (Fire Code) | A storage tank designed to operate at pressures from atmospheric through 0.5 pounds per square inch (psig) (3.4 kPa). |
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| Atomic Absorption Spectrophotometry | A highly sensitive instrumental technique for identifying and measuring metals in water. |
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| Audit Comment | A feature of the audit trail that aids both originator and reviewer in understanding why the originator performed a specific action. CFR 21 Part 11 does not require entering the reason for a record change, but some predicate rules (such as GLPs) do expect an explanation. It is important that the user interface for entering audit comments prevents users from changing the audit trail itself |
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| Audit Trail | A computer-generated and time-stamped record of who did what, when. CFR 21 Part 11 requires audit trails to be generated independently of operators. An audit trail must capture all activities related to creating, modifying, and destroying records on a system. |
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| Auger Electron Spectroscopy (AES) | An alternative surface analysis that can detect all elements with an atomic number greater than that of helium with the additional ability to analyze sub micron-diameter features. It is not as quantitative as ESCA and cannot determine the chemical state of an element. The primary advantage of Auger is that when combined with etching, a chemical depth profile can be measured rapidly and can image the distribution on the surface of spatial limitation resolution of 100 to 1,000 angstroms (depending on the equipment capability). |
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| Austenite | A face-centered cubic crystal with high solubility for carbon (about 2%); an allotropic form of iron resulting from steel being heated above the transformation temperature. |
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| Autegoneous Weld | A weld made by fusion of the base material without the addition of filler. |
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| Authentication | The process of identifying a person, system, or company sufficiently to allow access to a system or part of a system. |
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| Authentication Mechanisms | Also known as authority checks, or authorized signers are mechanisms distinct from authorization that grants or denies access to a network resource, authentication programs are used by system administrators to establish and verify as conclusively as possible that a person logging in to the network is who he or she claims to be. FDA says that "authority checks" are to "ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system, input or output device, alter a record, or perform operations". |
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| Auto Immune Disease | A disease in which the body produces an immunogenic response against self-antigens. In some cases, predominantly one organ is affected (e.g. hemolytic anemia and chronic thyroiditis); in others, the disease process is diffused through many tissues (e.g. SLE (Systemic Lupus Erythematosis)). |
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| Autoclave | An apparatus into which moist heat (steam) under pressure is introduced to sterilize or decontaminate materials placed within (e.g. filter assemblies, glassware, etc.). Steam pressure is maintained for pre-specified times and then allowed to exhaust. There are two types of autoclaves:
1. Gravity displacement autoclave: this type of autoclave operates at 121ºC. Steam enters at the top of the loaded inner chamber, displacing the air below through a discharge outlet.
2. Vacuum autoclave: this type of autoclave can operate with a reduced sterilization cycle time. The air is pumped out of the loaded chamber before it is filled with steam. |
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| Automated System | Any facility system or piece of equipment that is controlled with limited or no manual intervention. |
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| Automatic Welding | Welding with equipment that performs the welding operation without adjustment of the controls by a welding operator. The equipment may or may not perform the loading and unloading of the work. |
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| Autoradiography | A technique that uses X-ray film to visualize radioactively labeled molecules or fragments of molecules; used in analyzing length and number of DNA fragments after they are separated by gel electrophoresis. |
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| Autosome | A chromosome not involved in sex determination. The diploid human genome consists of 46 chromosomes, 22 pairs of autosomes, and 1 pair of sex chromosomes. |
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Glossary V2.0 |
