Glossary

The material floating on the surface of a liquid mixture (often the liquid component that has the lowest density).

The off-label uses of a drug may become additional on-label uses if the company submits a Supplemental New Drug Application and the FDA approves the application. SNDAs may take years to process and can be expensive. When a drug is off-patent or if the off-label use is for only a small population, there is little incentive (except that it is easier to advertise on-label uses) for a firm to obtain an SNDA.

Organization engaged to satisfy the specified requirements of a cleanroom or clean zone.

(ISO) Organization or person that provides a product.

An organization or individual internal or external to the user associated with the supply and/or support of products or services at any phase throughout a systems life cycle.

(ISO) Any organization or individual contracted directly by the customer to supply a produc or service.

Building or area owned by the end manufacturer or supplier of the equipment to be tested.

The ongoing process of evaluating a supplier against established quality standards, managing noted deficiencies, and working with supplier to improve the quality of its products or services and documentation.

Conditioned air supplied mechanically to the space (room), measured here in cubic feet per minute (CFM) (Divide by 0.6 to get cubic meters per hour (CMH).

Air volume supplied into an installation from final filters or air ducts in unit time (m³/h). ISO 14644-3.

The sequence of processes involved in the production and distribution of a commodity. A supply chain normally encompasses the following three functions:-Supply of materials to a manufacturer;-The manufacturing process; and,-The distribution of finished goods through a network of distributors and retailers to a final customer.Companies involved in various stages of this process are linked to each other through a supply chain.

(IEEE) Software that aids in the development and maintenance of other software; e.g., compilers, loaders, and other utilities.

(IEEE) All testing required to verify system operation in accordance with design requirements after the major component is energized or operated.

(ICH Q1A (R2)) Data, other than those from formal stability studies, that support the analytical procedures, the proposed re-test period or shelf life, and the label storage statements. Such data include (1) stability data on early synthetic route batches of drug substance, small scale batches of materials, investigational formulations not proposed for marketing, related formulations, and product presented in containers and closures other than those proposed for marketing; (2) information regarding test results on containers; and (3) other scientific rationales.

A gene that can reverse the effect of a mutation in other genes.

Mutations in suppressor genes are able to overcome (suppress) the effects of mutations in other, unlinked, genes. A common, and very useful, kind of suppressor mutation occurs within the gene encoding a tRNA molecule and results in a change in the tRNA's anticodon. Such a mutant tRNA can reverse the effect of chain-terminating mutations, such as amber or ochre, in protein-encoding genes.

All surfaces as defined by Part SF of the current ASME BPE Standard and/or the owner/user or manufacturer and referred in Ra microinches (µin.), or microns (µm).

This term shall apply to all interior surface finishes accessible and inaccessible, that directly or indirectly come in contact with the designated product in bioprocessing equipment and distribution system components. Final criteria shall be determined by Ra values rather than polishing methods.NOTE: For commonly utilized Ra readings on stainless steel product contact surfaces for the biopharmaceutical industry refer to Table SF-3 of the ASME Bioprocessing Equipment (BPE - 2007) an International Standard.

This term shall apply to all interior surface finishes accessible and inaccessible, that directly or indirectly come in contact with the designated product in bioprocessing equipment and distribution system components (ASME BPEa-2000). Final criteria shall be determined by Ra values rather than polishing methods.NOTE: For commonly utilized Ra readings on stainless steel product contact surfaces for the biopharmaceutical industry refer to Table SF-3 of the ASME Bioprocessing Equipment (BPE - 2007) an International Standard.For Piping, Tubing, and Fittings:1.As fabricated2.Pickled and/or passivated3.Bright hydrogen annealed4.Mechanically polished5.Mechanically buffed6.Chemically polished7.ElectropolishedFor Sheet, Strip, and Plate:1.As fabricated. Without any specific surface treatments.2.Rolled Finish. Manufactured by either hot or cold rolled process.3.No. 1. A dull, hot rolled finish, annealed and pickled.4.No. 2D. A dull, cold rolled finish, annealed and pickled.5.No. 2B. A bright, cold rolled finish, annealed and pickled.6.No. 4. A general purpose polished finish widely used for architectural panels, trim, and sanitary equipment. Following initial grinding with coarse abrasives, the surface is finally finished with lubricated 150 grit abrasive belts.7.No. 4S. Processed as No. 4 except the final surface is polished to a smother finish. The purchaser must specify this alternative finish; the specification must state a No. 4 finish, using a 240 or 320 grit mechanical polish, whose particular surface roughness must meet the specified Ra value.8.No. 6. A dull finish having a lower reflectivity than No. 4. It is produced by a tampico brushing in a medium of abrasive and oil and is used primarily for architectural applications.9.No. 7. A finish with a high degree of reflectivity, produced by buffing to a finely ground surface without removing the grit lines.10.No. 8. The most reflective finish, obtained by polishing with successively finer abrasives and buffing extensively with very fine buffing rouges. This finish is most widely used for press plates, mirrors, etc.For Wrought and Cast Forgings:1.As fabricated or machined2.Mechanically ground, polished, or buffed3.Abrasive blast cleaned, using one of the following methods:a.Sand blastb.Shot blastc.Glass blastd.Wet blast4.Slurry polished5.Roll deburred6.Chemically cleaneda.Acid washed (pickled and passivated)b.Solvent washed7.Electropolished

Class 1. Welds are to be ground smooth and flush. Visual pits and weld defects are removed.Class 2. Welds are ground smooth but not flush. The upper surface of the bead is removed, but visual pits and weld defects are not removed.Class 3. Welds as welded, no grinding.

Particles of foreign material in a metallic matrix. The particles are usually compounds such as oxides, sulfides, or silicates, but may be a substance foreign to and essentially insoluble in the matrix.

Surface iron oxide layer present when the 316L stainless steel's iron composition signal is higher than its chromium signal at the surface.

Surface proteins that are unique to certain cell types, which are visualized using antibodies or other detection methods.

Presence of molecular (chemical, non-particulate) substances in the sorbed state that may have a deleterious effect on the product, or surface of interest, in the cleanroom or controlled environment.

A foreign substance that adheres to a surface by chemical reaction, adhesion, adsorption, or ionic bonding (for example, corrosion, rouging, and staining).